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Terminex
Mifepristone + Misoprostol
Terminex
Mifepristone + Misoprostol
Indications
Termination of pregnancy
Indication detailsView
This kit is indicated for early Menstrual Regulation (MR)/termination of pregnancy up to 9 weeks (63 days) of gestation.
Therapeutic classView
Drugs acting on the Uterus, Prostaglandin analogues
PharmacologyView
Mifepristone: Mifepristone is a synthetic steroid with anti-progestational activity results from competitive interaction with progesterone at progesterone-receptor sites. Based on studies with various oral doses in several animal species, the compound inhibits the activity of endogenous or exogenous progesterone and the Menstrual Regulation (MR) results. During pregnancy, the compound sensitizes the myometrium to the contraction-inducing activity of prostaglandins.
Misoprostol: Misoprostol is a synthetic analogue of prostaglandin E1. It causes myometrial contraction by interacting with specific receptors on myometrial cells. This interaction results in a change in calcium concentration, thereby initiating muscle contraction. By interacting with prostaglandin receptors, Misoprostol causes the cervix to soften and the uterus to contract, resulting in the expulsion of the uterine contents.
Misoprostol: Misoprostol is a synthetic analogue of prostaglandin E1. It causes myometrial contraction by interacting with specific receptors on myometrial cells. This interaction results in a change in calcium concentration, thereby initiating muscle contraction. By interacting with prostaglandin receptors, Misoprostol causes the cervix to soften and the uterus to contract, resulting in the expulsion of the uterine contents.
DosageView
This can only be prescribed by qualified medical professionals who are able to assess the gestational age of an embryo and to diagnose ectopic pregnancies. The qualified medical professionals must also be able to provide surgical Intervention/MVA (Manual Vaccum Aspiration) in cases of incomplete abortion or severe bleeding or have made plans to provide such care through others and be able to assure patient access to medical facilities equipped to provide blood transfusions and resuscitation, if necessary.
Day 1 (First visit): Mifepristone administration: One tablet of Mifepristone (200 mg) is taken in a single oral dose under the supervision of a qualified medical professional in a clinic, medical office or hospital.
Day 2 (Second visit): Misoprostol administration: 24-48 hours after ingesting the Mifepristone tablet, the patient takes four 200 microgram tablets (800 micrograms) of Misoprostol buccally or sublingually. Misoprostol tablets can be administered by the patient herself (place two tablets on each side of cheeck & gum or under the tongue). She should wait for 30 minutes. During the period immediately following the administration of Misoprostol, the patient may need medication for cramps or gastrointestinal symptoms. The patient should be given instructions on what to do if significant discomfort, excessive bleeding or other adverse reactions occur and should be given a phone number to call if she has questions following the administration of Misoprostol.
Day 10 to 14 (Third visit): Post-treatment examination: Patients must return to the clinic, medical office or hospital within 10 to 14 days after the administration of mifepristone. This visit is very important to confirm by clinical examination or ultrasonographic scan that a complete termination of pregnancy has occurred.
Patients who have an ongoing pregnancy at this visit have a risk of fetal malformation resulting from the treatment. Surgical termination/MVA is recommended to manage Menstrual Regulation (MR)/termination of pregnancy failures.
Day 1 (First visit): Mifepristone administration: One tablet of Mifepristone (200 mg) is taken in a single oral dose under the supervision of a qualified medical professional in a clinic, medical office or hospital.
Day 2 (Second visit): Misoprostol administration: 24-48 hours after ingesting the Mifepristone tablet, the patient takes four 200 microgram tablets (800 micrograms) of Misoprostol buccally or sublingually. Misoprostol tablets can be administered by the patient herself (place two tablets on each side of cheeck & gum or under the tongue). She should wait for 30 minutes. During the period immediately following the administration of Misoprostol, the patient may need medication for cramps or gastrointestinal symptoms. The patient should be given instructions on what to do if significant discomfort, excessive bleeding or other adverse reactions occur and should be given a phone number to call if she has questions following the administration of Misoprostol.
Day 10 to 14 (Third visit): Post-treatment examination: Patients must return to the clinic, medical office or hospital within 10 to 14 days after the administration of mifepristone. This visit is very important to confirm by clinical examination or ultrasonographic scan that a complete termination of pregnancy has occurred.
Patients who have an ongoing pregnancy at this visit have a risk of fetal malformation resulting from the treatment. Surgical termination/MVA is recommended to manage Menstrual Regulation (MR)/termination of pregnancy failures.
Side effectsView
Mifepristone: The treatment procedure is designed to induce vaginal bleeding and uterine cramping necessary for Menstrual Regulation (MR). Commonly reported side effects were nausea, vomiting and diarrhoea. Pelvic pain, fainting, headache, dizziness, and asthenia occurred rarely.
Misoprostol: Gastro-intestinal side-effects like diarrhoea, abdominal pain, nausea, flatulence, dyspepsia, headache, vomiting and constipation, shivering, hyperthermia, dizziness, pain due to uterine contractions, severe vaginal bleeding, shock, pelvic pain, uterine rupture (requiring surgical repair, hysterectomy and/or salpingo-oophorectomy).
Misoprostol: Gastro-intestinal side-effects like diarrhoea, abdominal pain, nausea, flatulence, dyspepsia, headache, vomiting and constipation, shivering, hyperthermia, dizziness, pain due to uterine contractions, severe vaginal bleeding, shock, pelvic pain, uterine rupture (requiring surgical repair, hysterectomy and/or salpingo-oophorectomy).
ContraindicationsView
Administration of Mifepristone is contraindicated in patients with any one of the following conditions: History of allergy or known hypersensitivity to Mifepristone, Misoprostol or other prostaglandin, confirmed or suspected ectopic pregnancy or undiagnosed adnexal mass (the treatment procedure will not be effective to terminate an ectopic pregnancy), IUD in place, chronic adrenal failure, haemorrhagic disorders or concurrent anticoagulant therapy, inherited porphyria, If a patient does not have adequate access to medical facilities equipped to provide emergency treatment of incomplete process, blood transfusions and emergency resuscitation during the period from the first visit until discharged by the administering physician.
PrecautionsView
The patient should not give combination of Mifepristone & Misoprostol to anyone else. The combination of Mifepristone & Misoprostol has been prescribed for the patient's specific condition, it may not be the correct treatment for another person, and may be dangerous to the other person if she is or were to become pregnant. Any Intra Uterine Device [IUD] should be removed before treatment with Mifepristone begins. Menstrual Regulation (MR) by surgery is recommended in cases when combination of Mifepristone & Misoprostol fails to cause Menstrual Regulation (MR). Patients who have an ongoing pregnancy at last visit have a risk of foetal malformation resulting from the treatment. Surgical termination/MVA is recommended to manage Menstrual Regulation (MR)/ termination of pregnancy failures.
InteractionsView
Mifepristone: Although specific drug or food interactions with Mifepristone have not been studied, on the basis of this drug's metabolism by CYP 3A4, it is possible that Ketoconazole, Itraconazole, Erythromycin and grapefruit juice may inhibit its metabolism (increasing serum levels of mifepristone).
Misoprostol: Misoprostol has not been shown to interfere with the beneficial effects of aspirin on signs and symptoms of rheumatoid arthritis. Misoprostol does not exert clinically significant effects on the absorption,blood levels and antiplatelet effects of therapeutic doses of aspirin.
Misoprostol: Misoprostol has not been shown to interfere with the beneficial effects of aspirin on signs and symptoms of rheumatoid arthritis. Misoprostol does not exert clinically significant effects on the absorption,blood levels and antiplatelet effects of therapeutic doses of aspirin.
Pregnancy & lactationView
Pregnancy- Mifepristone: is indicated for Menstrual Regulation (MR) (through 63 days pregnancy) and has no other approved indication for use during pregnancy. Patients who have an ongoing pregnancy at the last visit have a risk of foetal malformation resulting from the treatment. Surgical termination is recommended to manage Menstrual Regulation (MR) treatment failures.
Lactation-
Lactation-
- Mifepristone: It is not known whether Mifepristone is excreted through human milk. Many hormones with a similar chemical structure, however, are excreted in breast milk. Since the effects of Mifepristone on infants are unknown, breast-feeding women should consult with their doctor to decide if they should discard their breast milk for a few days following administration of the medications.
- Misoprostol: Although it is not known whether Misoprostol or Misoprostol is excreted through human milk, Misoprostol should not be administered to nursing mothers because the potential excretion of misoprostol acid could cause diarrhoea in nursing infants.
Pediatric usageView
Use in Patients with Hepatic Impairment: Patients with hepatic disease should receive a decreased dose of Misoprostol.
Use in Patients with Renal Impairment: No routine dosage adjustment is recommended of Misoprostol in older patients or patients with renal impairment but the dosage may need to be reduced if the usual dose is not tolerated.
Use in Patients with Renal Impairment: No routine dosage adjustment is recommended of Misoprostol in older patients or patients with renal impairment but the dosage may need to be reduced if the usual dose is not tolerated.
Overdose effectsView
Mifepristone: No serious adverse reactions were reported in tolerance studies in healthy nonpregnant female and healthy male subjects where Mifepristone was administered in single doses greater than threefold of 600mg for Menstrual Regulation (MR). If a patient ingests a massive overdose, she should be observed closely for signs of adrenal failure.
Misoprostol: Clinical signs that may indicate an overdose are a sedation, tremor, convulsions, dyspnea, abdominal pain, diarrhoea, fever, palpitations, hypotension or bradycardia. Symptoms should be treated with supportive therapy. However, because Misoprostol is metabolized like a fatty acid, it is unlikely that dialysis would be the appropriate treatment for overdosage.
Misoprostol: Clinical signs that may indicate an overdose are a sedation, tremor, convulsions, dyspnea, abdominal pain, diarrhoea, fever, palpitations, hypotension or bradycardia. Symptoms should be treated with supportive therapy. However, because Misoprostol is metabolized like a fatty acid, it is unlikely that dialysis would be the appropriate treatment for overdosage.
StorageView
Store in a cool and dry place, protected from light.
Ternilla
Aceclofenac
Ternilla
Aceclofenac
Indications
Spondylitis
Indication detailsView
Aceclofenac is indicated for the relief of pain and inflammation in osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, toothache, trauma and lumbago.
Therapeutic classView
Drugs for Osteoarthritis, Drugs used for Rheumatoid Arthritis, Non-steroidal Anti-inflammatory Drugs (NSAIDs)
PharmacologyView
Aceclofenac is a non-steroidal drug with anti-inflammatory and analgesic properties. It is a potent inhibitor of the enzyme cyclooxygenase, which is involved in the production of prostaglandin. After oral administration, it is rapidly and completely absorbed an unchanged drug.
DosageView
Extended release tablet: The recommended dose in adults is one 200 mg Aceclofenac tablet daily or as prescribed by the physician.
Film coated tablet: The recommended dose in adults is 100 mg, twice daily.
Side effectsView
Aceclofenac is a non-steroidal drug with anti-inflammatory and analgesic properties. It is a potent inhibitor of the enzyme cyclooxygenase, which is involved in the production of prostaglandin. After oral administration, it is rapidly and completely absorbed an unchanged drug.
ContraindicationsView
Aceclofenac is contraindicated in patients with known hypersensitivity to it or in whom aspirin or NSAIDs precipitate attacks of asthma.
PrecautionsView
Caution should be exercised to patients with active or suspected peptic ulcer or gastro-intestinal bleeding moderate to severe hepatic impairment and cardiac or renal impairment. Caution should also be exercised in patients suffering from dizziness or urticaria.
InteractionsView
No significant drug interactions has not been observed but close monitoring of patients is required when it is used with:
- Lithium and Digoxin: may increase plasma concentration of lithium and digoxin.
- Diuretics: may interact the activity of diuretics.
- Anticoagulants: may enhance the activity of anticoagulant.
- Methotrexate: may increase the plasma level of methotrexate.
Pregnancy & lactationView
The use of Aceclofenac should be avoided in pregnancy and lactation unless the potential benefits to the other outweigh the possible risks to the fetus.
Pediatric usageView
There are no clinical data on the use of Aceclofenac in children.
StorageView
keep in a dry place away from light and heat. Keep out of the reach of children.
Terovit
Folic Acid
Terovit
Folic Acid
Indications
Nutritional supplement
Indication detailsView
Folic acid is indicated for the treatment of-
- Folic acid deficiency
- Megaloblastic anemia
- Anemias of nutritional origins, pregnancy, infancy, or childhood.
Therapeutic classView
Drugs for Megaloblastic Anemia, Vitamin-B preparations
PharmacologyView
Folic acid, as it is biochemically inactive, is converted to tetrahydrofolic acid and methyltetrahydrofolate by dihydrofolate reductase (DHFR). These folic acid congeners are transported across cells by receptor-mediated endocytosis where they are needed to maintain normal erythropoiesis, synthesize purine and thymidylate nucleic acids, interconvert amino acids, methylate tRNA, and generate and use formate. Using vitamin B12 as a cofactor, folic acid can normalize high homocysteine levels by remethylation of homocysteine to methionine via methionine synthetase.
DosageView
Adults-
- Initially: 5 mg daily for 4 months.
- maintenance: 5 mg every 1-7 days depending on the underlying disease.
- Up to 1 year: 500 mcg/kg daily.
- Over 1 year: Same as adult dose.
Side effectsView
Folic acid is generally well tolerated. Gastro-intestinal disturbances may occur. Hypersensitivity reactions have been reported rarely.
ContraindicationsView
Folic acid is contraindicated in patients who have shown previous intolerance to the drug.
PrecautionsView
It should be used with caution in patients who may have folate dependent tumours. It should never be given alone or in conjunction with inadequate amounts of vitamin B12 for the treatment of undiagnosed megaloblastic anaemia. Although folic acid may produce a haematopoietic response in patients with a megaloblastic anaemia due to vitamin B12 deficiency it should not be given alone in vitamin B12 deficiency states as it may precipitate the onset of subacute combined degeneration of the cord. In elderly people a cobalamin absorption test should be done before long term folate. No harmful results found from short courses of folate.
InteractionsView
None has been reported.
Pregnancy & lactationView
No special precautions are known.
StorageView
Store below 30°C in a dry place, away from light. Keep out of the reach of children.
Terrell
Isoflurane
Terrell
Isoflurane
Indications
Obstetric analgesia
Indication detailsView
Isoflurane may be used for induction and maintenance of general anesthesia. Adequate data have not been developed to establish its application in obstetrical anesthesia.
Therapeutic classView
General (Inhalation) anesthetics
PharmacologyView
Isoflurane may be used for induction and maintenance of general anesthesia. Adequate data have not been developed to establish its application in obstetrical anesthesia.
Induction of and recovery from Isoflurane anesthesia are rapid. Isoflurane has a mild pungency, which limits the rate of induction, although excessive salivation or tracheobronchial secretions do not appear to be stimulated. Pharyngeal and laryngeal reflexes are readily obtunded. The level of anesthesia may be changed rapidly with Isoflurane. Isoflurane is a profound respiratory depressant. Respiration must be monitored closely and supported when necessary. As anesthetic dose is increased, tidal volume decreases and respiratory rate is unchanged. This depression is partially reversed by surgical stimulation, even at deeper levels of anesthesia. Isoflurane evokes a sigh response reminiscent of that seen with diethyl ether and enflurane, although the frequency is less than with enflurane.
Blood pressure decreases with induction of anesthesia but returns toward normal with surgical stimulation. Progressive increases in depth of anesthesia produce corresponding decreases in blood pressure. Nitrous oxide diminishes the inspiratory concentration of Isoflurane required to reach a desired level of anesthesia and may reduce the arterial hypotension seen with Isoflurane alone. Heart rhythm is remarkably stable. With controlled ventilation and normal PaCO2, cardiac output is maintained despite increasing depth of anesthesia, primarily through an increase in heart rate, which compensates for a reduction in stroke volume. The hypercapnia, which attends spontaneous ventilation during Isoflurane anesthesia further increases heart rate and raises cardiac output above awake levels. Isoflurane does not sensitize the myocardium to exogenously administered epinephrine in the dog. Limited data indicate that subcutaneous injection of 0.25 mg of epinephrine (50 mL of 1:200,000 solution) does not produce an increase in ventricular arrhythmias in patients anesthetized with Isoflurane.
Muscle relaxation is often adequate for intra-abdominal operations at normal levels of anesthesia. Complete muscle paralysis can be attained with small doses of muscle relaxants. All commonly used muscle relaxants are markedly potentiated with Isoflurane, the effect being most profound with the nondepolarizing type. Neostigmine reverses the effect of nondepolarizing muscle relaxants in the presence of Isoflurane. All commonly used muscle relaxants are compatible with Isoflurane.
Isoflurane can produce coronary vasodilation at the arteriolar level in selected animal models; the drug is probably also a coronary dilator in humans. Isoflurane, like some other coronary arteriolar dilators, has been shown to divert blood from collateral dependent myocardium to normally perfused areas in an animal model (“coronary steal”). Clinical studies to date evaluating myocardial ischemia, infarction and death as outcome parameters have not established that the coronary arteriolar dilation property of Isoflurane is associated with coronary steal or myocardial ischemia in patients with coronary artery disease
Induction of and recovery from Isoflurane anesthesia are rapid. Isoflurane has a mild pungency, which limits the rate of induction, although excessive salivation or tracheobronchial secretions do not appear to be stimulated. Pharyngeal and laryngeal reflexes are readily obtunded. The level of anesthesia may be changed rapidly with Isoflurane. Isoflurane is a profound respiratory depressant. Respiration must be monitored closely and supported when necessary. As anesthetic dose is increased, tidal volume decreases and respiratory rate is unchanged. This depression is partially reversed by surgical stimulation, even at deeper levels of anesthesia. Isoflurane evokes a sigh response reminiscent of that seen with diethyl ether and enflurane, although the frequency is less than with enflurane.
Blood pressure decreases with induction of anesthesia but returns toward normal with surgical stimulation. Progressive increases in depth of anesthesia produce corresponding decreases in blood pressure. Nitrous oxide diminishes the inspiratory concentration of Isoflurane required to reach a desired level of anesthesia and may reduce the arterial hypotension seen with Isoflurane alone. Heart rhythm is remarkably stable. With controlled ventilation and normal PaCO2, cardiac output is maintained despite increasing depth of anesthesia, primarily through an increase in heart rate, which compensates for a reduction in stroke volume. The hypercapnia, which attends spontaneous ventilation during Isoflurane anesthesia further increases heart rate and raises cardiac output above awake levels. Isoflurane does not sensitize the myocardium to exogenously administered epinephrine in the dog. Limited data indicate that subcutaneous injection of 0.25 mg of epinephrine (50 mL of 1:200,000 solution) does not produce an increase in ventricular arrhythmias in patients anesthetized with Isoflurane.
Muscle relaxation is often adequate for intra-abdominal operations at normal levels of anesthesia. Complete muscle paralysis can be attained with small doses of muscle relaxants. All commonly used muscle relaxants are markedly potentiated with Isoflurane, the effect being most profound with the nondepolarizing type. Neostigmine reverses the effect of nondepolarizing muscle relaxants in the presence of Isoflurane. All commonly used muscle relaxants are compatible with Isoflurane.
Isoflurane can produce coronary vasodilation at the arteriolar level in selected animal models; the drug is probably also a coronary dilator in humans. Isoflurane, like some other coronary arteriolar dilators, has been shown to divert blood from collateral dependent myocardium to normally perfused areas in an animal model (“coronary steal”). Clinical studies to date evaluating myocardial ischemia, infarction and death as outcome parameters have not established that the coronary arteriolar dilation property of Isoflurane is associated with coronary steal or myocardial ischemia in patients with coronary artery disease
DosageView
Premedication: Premedication should be selected according to the need of the individual patient, taking into account that secretions are weakly stimulated by Isoflurane, and the heart rate tends to be increased. The use of anticholinergic drugs is a matter of choice.
Inspired Concentration: The concentration of Isoflurane being delivered from a vaporizer during anesthesia should be known. This may be accomplished by using:
Vaporizers calibrated specifically for Isoflurane;
Vaporizers from which delivered flows can be calculated, such as vaporizers delivering a saturated vapor, which is then diluted. The delivered concentration from such a vaporizer may be calculated using the formula: % Isoflurane = 100 PvFv/FT (PA - PV)
Where:
Induction: Induction with Isoflurane in oxygen or in combination with oxygen-nitrous oxide mixtures may produce coughing, breath holding, or laryngospasm. These difficulties may be avoided by the use of a hypnotic dose of an ultra-short-acting barbiturate. Inspired concentrations of 1.5 to 3.0% Isoflurane usually produce surgical anesthesia in 7 to 10 minutes.
Maintenance: Surgical levels of anesthesia may be sustained with a 1.0 to 2.5% concentration when nitrous oxide is used concomitantly. An additional 0.5 to 1.0% may be required when Isoflurane is given using oxygen alone. If added relaxation is required, supplemental doses of muscle relaxants may be used.
The level of blood pressure during maintenance is an inverse function of Isoflurane concentration in the absence of other complicating problems. Excessive decreases may be due to depth of anesthesia and in such instances may be corrected by lightening anesthesia.
Inspired Concentration: The concentration of Isoflurane being delivered from a vaporizer during anesthesia should be known. This may be accomplished by using:
Vaporizers calibrated specifically for Isoflurane;
Vaporizers from which delivered flows can be calculated, such as vaporizers delivering a saturated vapor, which is then diluted. The delivered concentration from such a vaporizer may be calculated using the formula: % Isoflurane = 100 PvFv/FT (PA - PV)
Where:
- PA= Pressure of atmosphere
- PV= Vapor pressure of Isoflurane
- FV= Flow of gas through vaporizer (mL/min)
- FT= Total gas flow (mL/min)
Induction: Induction with Isoflurane in oxygen or in combination with oxygen-nitrous oxide mixtures may produce coughing, breath holding, or laryngospasm. These difficulties may be avoided by the use of a hypnotic dose of an ultra-short-acting barbiturate. Inspired concentrations of 1.5 to 3.0% Isoflurane usually produce surgical anesthesia in 7 to 10 minutes.
Maintenance: Surgical levels of anesthesia may be sustained with a 1.0 to 2.5% concentration when nitrous oxide is used concomitantly. An additional 0.5 to 1.0% may be required when Isoflurane is given using oxygen alone. If added relaxation is required, supplemental doses of muscle relaxants may be used.
The level of blood pressure during maintenance is an inverse function of Isoflurane concentration in the absence of other complicating problems. Excessive decreases may be due to depth of anesthesia and in such instances may be corrected by lightening anesthesia.
Side effectsView
Nausea, Vomiting, Shivering, Dose-dependent hypotension, Arrhythmias, Malignant hyperthermia (rare), Elevations in white blood count, May decrease creatinine and increase BUN, Ileus, severe (fatal), Hepatic dysfunction (postoperative period),Respiratory depression may occur
ContraindicationsView
Known or suspected susceptibility to malignant hyperthermia. Porphyria.
PrecautionsView
Perioperative hyperkalaemia; raised intracranial pressure. May impair ability to drive or operate machinery. Pregnancy and lactation. Do not allow carbon dioxide absorbents in anaesthetic apparatus to dry out when delivering isoflurane to minimise the risk of developing elevated carboxyhaemoglobin levels.
InteractionsView
Enhances effects of neuromuscular blockers. May sensitise the myocardium to adrenaline and other sympathomimetics. Enhances hypotensive effects of ACE inhibitors, TCAs, MAOIs, antihypertensives, antipsychotics or beta-blockers. May have synergistic effects with CNS depressants.
Pregnancy & lactationView
Pregnancy Category C. Isoflurane has been shown to have a possible anesthetic-related fetotoxic effect in mice when given in doses 6 times the human dose. There are no adequate and well-controlled studies in pregnant women. Isoflurane should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Nursing Mothers: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Isoflurane is administered to a nursing woman.
Nursing Mothers: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Isoflurane is administered to a nursing woman.
StorageView
Store at room temperature 15°-30°C. Isoflurane contains no additives and has been demonstrated to be stable at room temperature for periods in excess of five years.
Tervent
Terbutaline Sulfate
Tervent
Terbutaline Sulfate
Indications
Uncomplicated premature labour
Indication detailsView
Terbutaline sulfate is indicated for the prevention and reversal of bronchospasm in patients 12 years of age and older with asthma and reversible bronchospasm associated with bronchitis and emphysema.
Therapeutic classView
Short-acting selective & β2-adrenoceptor stimulants
PharmacologyView
Terbutaline is a relatively selective β2-adrenergic bronchodilator that has little or no effect on alpha-adrenergic receptors. The drug has exerts a preferential effect on β2-adrenergic receptors but stimulates beta-adrenergic receptors less selectively than relatively selective β2-agonists. Terbutaline appears to have a greater stimulating effect on beta-receptors of the bronchial, vascular, and uterine smooth muscles (β2 receptors) than on the beta-receptors of the heart (β1 receptors). This drug relaxes smooth muscle and inhibits uterine contractions, but may also cause some cardiostimulatory effects and CNS stimulation.
The pharmacologic effects of terbutaline are at least in part attributable to stimulation through beta-adrenergic receptors of intracellular adenyl cyclase, the enzyme that catalyzes the conversion of adenosine triphosphate (ATP) to cyclic- 3',5'- adenosine monophosphate (c-AMP). Increased c-AMP levels are associated with relaxation of bronchial smooth muscle and inhibition of release of mediators of immediate hypersensitivity from cells, especially from mast cells.
The pharmacologic effects of terbutaline are at least in part attributable to stimulation through beta-adrenergic receptors of intracellular adenyl cyclase, the enzyme that catalyzes the conversion of adenosine triphosphate (ATP) to cyclic- 3',5'- adenosine monophosphate (c-AMP). Increased c-AMP levels are associated with relaxation of bronchial smooth muscle and inhibition of release of mediators of immediate hypersensitivity from cells, especially from mast cells.
DosageView
Use in bronchospasm: Terbutaline tablets and syrup have a duration of action of 7 to 8 hours. The minimum recommended dosage interval is therefore 7 hours.
Adults/Elderly:
Adults/Elderly:
- Tablets: During the first 1-2 weeks 2.5 mg (1 tablet) 3 times in a 24 hour period is recommended. The dose may then be increased to 5 mg (2 tablets) 3 times in 24 hours to achieve adequate bronchodilation.
- Syrup: The starting dose should be 2×5 ml spoonfuls (3 mg) 3 times in 24 hours. The dose may then be increased to 3×5 ml spoonfuls (4.5 mg) 3 times in 24 hours if necessary.
- Tablets: 7-15 years, the starting dose should normally be 2.5 mg (1 tablet) 2 times in 24 hours. However, in some patients, the dose may need to be increased to 2.5 mg (1 tablet) 3 times in 24 hours.
- Syrup: 0.25 ml (0.075 mg)/kg body weight 3 times in a 24 hour period.
Side effectsView
The frequency of side-effects is low at the recommended doses. Side-effects which have been recorded such as tremor, headache, tonic cramp and palpitations are all characteristic of sympathomimetic amines. A few patients feel tense; this is also due to the effects on skeletal muscle and not to direct CNS stimulation. Whenever these side-effects have occurred the majority have usually been spontaneously reversible within the first week of treatment. Urticaria and exanthema may occur. In children sleep disturbances and disturbances of behavioural effects have been observed. Potentially serious hypokalaemia may result from β2-agonist therapy.
ContraindicationsView
Patients with known hypersensitivity to Terbutaline.
PrecautionsView
Care should be taken with patients suffering from myocardial insufficiency or thyrotoxicosis. Due to the hyperglycaemic effects of β2-stimulants, additional blood glucose measurements are initially recommended when Terbutaline therapy is commenced in diabetic patients. If a previously effective dosage regimen no longer gives the same symptomatic relief the patient should seek further medical advice, for reassessment of asthma therapy, as soon as possible. Potentially serious hypokalaemia may result from β2-agonist therapy. Particular caution is advised in severe asthma as this effect may be potentiated by concomitant treatment with xanthine derivatives, steroids, diuretics and by hypoxia. It is recommended that serum potassium levels are monitored in such situations. Due to the positive inotropic effect of β2-agonists, these drugs should not be used in patients with hypertophic cardiomyopathy.
InteractionsView
β-blocking agents, especially the non-selective ones such as propranolol may partially or totally inhibit the effect of β-stimulants. Therefore Terbutaline preparations and non-selective β-blockers should not normally be administered concurrently. Terbutaline should be used with caution in patients receiving other sympathomimetics.
Pregnancy & lactationView
Although no teratogenic effects have been observed in animals or in patients, Terbutaline should only be administered with caution during the first trimester of pregnancy. Terbutaline is secreted via breast milk, but effect on the infant is unlikely at therapeutic doses.
Overdose effectsView
Possible symptoms: Headache, anxiety, tremor, tonic cramp, palpitations, arrhythmia. A fall in blood pressure sometimes occurs.
Treatment:
Treatment:
- Mild and moderate cases: Reduce the dose.
- Severe cases: Gastric lavage, administration of activated charcoal.
StorageView
Store in a cool and dry place, protected from light.
Tervent
Terbutaline Sulfate
Tervent
Terbutaline Sulfate
Indications
Uncomplicated premature labour
Indication detailsView
Terbutaline sulfate is indicated for the prevention and reversal of bronchospasm in patients 12 years of age and older with asthma and reversible bronchospasm associated with bronchitis and emphysema.
Therapeutic classView
Short-acting selective & β2-adrenoceptor stimulants
PharmacologyView
Terbutaline is a relatively selective β2-adrenergic bronchodilator that has little or no effect on alpha-adrenergic receptors. The drug has exerts a preferential effect on β2-adrenergic receptors but stimulates beta-adrenergic receptors less selectively than relatively selective β2-agonists. Terbutaline appears to have a greater stimulating effect on beta-receptors of the bronchial, vascular, and uterine smooth muscles (β2 receptors) than on the beta-receptors of the heart (β1 receptors). This drug relaxes smooth muscle and inhibits uterine contractions, but may also cause some cardiostimulatory effects and CNS stimulation.
The pharmacologic effects of terbutaline are at least in part attributable to stimulation through beta-adrenergic receptors of intracellular adenyl cyclase, the enzyme that catalyzes the conversion of adenosine triphosphate (ATP) to cyclic- 3',5'- adenosine monophosphate (c-AMP). Increased c-AMP levels are associated with relaxation of bronchial smooth muscle and inhibition of release of mediators of immediate hypersensitivity from cells, especially from mast cells.
The pharmacologic effects of terbutaline are at least in part attributable to stimulation through beta-adrenergic receptors of intracellular adenyl cyclase, the enzyme that catalyzes the conversion of adenosine triphosphate (ATP) to cyclic- 3',5'- adenosine monophosphate (c-AMP). Increased c-AMP levels are associated with relaxation of bronchial smooth muscle and inhibition of release of mediators of immediate hypersensitivity from cells, especially from mast cells.
DosageView
Use in bronchospasm: Terbutaline tablets and syrup have a duration of action of 7 to 8 hours. The minimum recommended dosage interval is therefore 7 hours.
Adults/Elderly:
Adults/Elderly:
- Tablets: During the first 1-2 weeks 2.5 mg (1 tablet) 3 times in a 24 hour period is recommended. The dose may then be increased to 5 mg (2 tablets) 3 times in 24 hours to achieve adequate bronchodilation.
- Syrup: The starting dose should be 2×5 ml spoonfuls (3 mg) 3 times in 24 hours. The dose may then be increased to 3×5 ml spoonfuls (4.5 mg) 3 times in 24 hours if necessary.
- Tablets: 7-15 years, the starting dose should normally be 2.5 mg (1 tablet) 2 times in 24 hours. However, in some patients, the dose may need to be increased to 2.5 mg (1 tablet) 3 times in 24 hours.
- Syrup: 0.25 ml (0.075 mg)/kg body weight 3 times in a 24 hour period.
Side effectsView
The frequency of side-effects is low at the recommended doses. Side-effects which have been recorded such as tremor, headache, tonic cramp and palpitations are all characteristic of sympathomimetic amines. A few patients feel tense; this is also due to the effects on skeletal muscle and not to direct CNS stimulation. Whenever these side-effects have occurred the majority have usually been spontaneously reversible within the first week of treatment. Urticaria and exanthema may occur. In children sleep disturbances and disturbances of behavioural effects have been observed. Potentially serious hypokalaemia may result from β2-agonist therapy.
ContraindicationsView
Patients with known hypersensitivity to Terbutaline.
PrecautionsView
Care should be taken with patients suffering from myocardial insufficiency or thyrotoxicosis. Due to the hyperglycaemic effects of β2-stimulants, additional blood glucose measurements are initially recommended when Terbutaline therapy is commenced in diabetic patients. If a previously effective dosage regimen no longer gives the same symptomatic relief the patient should seek further medical advice, for reassessment of asthma therapy, as soon as possible. Potentially serious hypokalaemia may result from β2-agonist therapy. Particular caution is advised in severe asthma as this effect may be potentiated by concomitant treatment with xanthine derivatives, steroids, diuretics and by hypoxia. It is recommended that serum potassium levels are monitored in such situations. Due to the positive inotropic effect of β2-agonists, these drugs should not be used in patients with hypertophic cardiomyopathy.
InteractionsView
β-blocking agents, especially the non-selective ones such as propranolol may partially or totally inhibit the effect of β-stimulants. Therefore Terbutaline preparations and non-selective β-blockers should not normally be administered concurrently. Terbutaline should be used with caution in patients receiving other sympathomimetics.
Pregnancy & lactationView
Although no teratogenic effects have been observed in animals or in patients, Terbutaline should only be administered with caution during the first trimester of pregnancy. Terbutaline is secreted via breast milk, but effect on the infant is unlikely at therapeutic doses.
Overdose effectsView
Possible symptoms: Headache, anxiety, tremor, tonic cramp, palpitations, arrhythmia. A fall in blood pressure sometimes occurs.
Treatment:
Treatment:
- Mild and moderate cases: Reduce the dose.
- Severe cases: Gastric lavage, administration of activated charcoal.
StorageView
Store in a cool and dry place, protected from light.
Tesco DL
Diphenhydramine + Dextromethorphan + Levomenthol
Tesco DL
Diphenhydramine + Dextromethorphan + Levomenthol
Indications
Dry cough
Indication detailsView
This syrup is indicated as an antitussive, for the relief of persistent, dry, irritating cough and aids restful sleep.
Therapeutic classView
Combined cough expectorants, Combined cough suppressants
PharmacologyView
Dextromethorphan Hydrobromide is a non-opioid antitussive drug. It exerts its antitussive activity by acting on the cough center in the medulla oblongata, raising the threshold for the cough reflex. Levomenthol has mild local anesthetic and decongestant properties. Diphenhydramine Hydrochloride possesses antitussive, antihistaminic, anticholinergic properties.
DosageView
Adults and children over 12 years: 2 teaspoonfuls of syrup 4 times a day or as directed by the physicians. Do not take more than 8 teaspoonfuls of syrup in 24 hours.
Use in children & Adolescents: The efficacy and safely of Dextromethorphan Hydrobromide have not been established in pediatric patients and adolescents.
Use in children & Adolescents: The efficacy and safely of Dextromethorphan Hydrobromide have not been established in pediatric patients and adolescents.
Side effectsView
This syrup may cause drowsiness, dizziness, nausea, vomiting, gastrointestinal disturbance, dry mouth, nose and throat difficulty in urination, or blurred vision.
ContraindicationsView
This syrup is contraindicated in individuals with known hypersensitivity to the product or any of its components. This medicine is contraindicated in individuals who are taking, or have taken, monoamine oxidase inhibitor within the preceding two weeks. Dextromethorphan, In common with other centrally acting antitussive agents, should not be given to subjects in, or at risk of developing respiratory failure.
PrecautionsView
This syrup may cause drowsiness; if affected, individuals should not drive or operate machinery. Diphenhydramine Hydrochloride should not be taken by individuals with narrow-angle glaucoma or symptomatic prostatic hypertrophy. Caution is particularly recommended for adolescents and young adults as well as in patients with a history of drug abuse or psychoactive substances.
InteractionsView
This syrup contains Diphenhydramine Hydrochloride and therefore may potentiate the effects of alcohol, and other CNS depressants. As Diphenhydramine Hydrochloride possess some anticholinergic activity, the effects of anticholinergics (e.g. some psychotrophic drugs and atropine) may be potentiated by this product. This may result in tachycardia, mouth dryness, gastrointestinal disturbances (e.g. colic), urinary retention and headache. The concomitant use of a Dextromethorphan Hydrobromide containing product and monoamine oxidase inhibitors can occasionally result in symptoms such as hyperpyrexia, hallucinations, gross excitation or coma.
Pregnancy & lactationView
Pregnancy: Both Diphenhydramine Hydrochloride and Dextromethorphan Hydrobromide have been in widespread use for many years without apparent ill consequences. However, there is insufficient information on the effects of the administration of Dextromethorphan Hydrobromide during human pregnancy.
Lactation: It is not known whether dextromethorphan or its metabolites are excreted in breast milk. Diphenhydramine Hydrochloride is known to cross the placenta and has also been detected in breast milk. The syrup should therefore only be used when the potential benefit of treatment to the mother exceeds any possible hazards to the developing fetus or suckling infant.
Lactation: It is not known whether dextromethorphan or its metabolites are excreted in breast milk. Diphenhydramine Hydrochloride is known to cross the placenta and has also been detected in breast milk. The syrup should therefore only be used when the potential benefit of treatment to the mother exceeds any possible hazards to the developing fetus or suckling infant.
Overdose effectsView
With higher doses, and particularly in children, hallucinations and convulsions may appear; with massive doses, coma or cardiovascular collapse may follow. Treatment of overdose should be symptomatic and supportive. Measures to promote rapid gastric emptying and in cases of acute poisoning the use of activated charcoal may be useful. Naloxone has been used successfully as a specific antagonist to dextromethorphan toxicity in children. Convulsions may be controlled with diazepam and thiopental sodium.
StorageView
Store at a temperature not exceeding 30°C in a dry place. Protect from liqht & moisture. Keep out of the reach of children.
Tesco GL
Guaifenesin + Levomenthol + Diphenhydramine
Tesco GL
Guaifenesin + Levomenthol + Diphenhydramine
Indications
Productive cough
Indication detailsView
This syrup is indicated for the relief of cough, associated congestive symptoms and aiding restful sleep
Therapeutic classView
Combined cough expectorants
PharmacologyView
Guaifenesin is reported to reduce the viscosity of tenacious sputum end is used as an expectorant. Levomenthol has mild local anesthetic and decongestant properties. Diphenhydramine Hydrochloride possesses antitussive, antihistaminic, and anticholinergic properties.
DosageView
For adults and children over 12 years: 2 teaspoonfuls syrup 4 times a day or as directed by the physicians. Do not take more than 8 teaspoonful syrup in 24 hours.
Use in Children & Adolescents: The efficacy and safety of Guaifenesin have not been established in pediatric patients and adolescents.
Use in Children & Adolescents: The efficacy and safety of Guaifenesin have not been established in pediatric patients and adolescents.
Side effectsView
This syrup may cause drowsiness, dizziness, nausea and vomiting, gastro-intestinal disturbance, dry mouth, nose and throat difficulty in urination or blurred vision.
ContraindicationsView
This syrup is contraindicated in individuals with known hypersensitivity to the product or any of its components. This medicine should not be administered to patients who have received treatment with MAOIs within last two weeks.
PrecautionsView
This syrup may cause drowsiness; if affected, individuals should not drive or operate machinery. Diphenhydramine Hydrochloride should not be taken by individuals with narrow-angle glaucoma or symptomatic prostatic hypertrophy. This product should not be used for persistent or chronic cough, such as occurs with asthma, or where cough is accompanied by excessive secretions unless directed by a physician.
InteractionsView
This syrup contains Diphenhydramine Hydrochloride and therefore may potentiate the effects of alcohol, and other CNS depressants. As Diphenhydramine Hydrochloride possess some anticholinergic activity, the effects of anticholinergics (e.g. some psychotrophic drugs and atropine) may be potentiated by this product. This may result in tachycardia, mouth dryness, gastrointestinal disturbances (e.g. colic), urinary retention and headache.
Pregnancy & lactationView
As with any other medicine, care should be taken In administration during pregnancy. This product has not been associated with adverse effects in the human fetus or suckling infant.
Overdose effectsView
When taken in excess, Guaifenesin may cause renal calculi. Treatment of overdose should be symptomatic and supportive.
StorageView
Store at a temperature not exceeding 30° C in a dry place. Protect from light & moisture. Keep out of the reach of children.
Testanon
Testosterone Decanoate
Testanon
Testosterone Decanoate
Indications
Testosterone replacement therapy
Indication detailsView
Males: Testosterone is indicated for Testosterone replacement therapy for primary and secondary hypogonadal disorders, which include:
- After castration
- Eunuchoidism
- Hypopituitarism
- Endocrine impotence
- Certain types of infertility due to spermatogenic disorders
- Male climacteric symptoms as decreased libido and decreased feeling of general wellbeing and fitness
- Osteoporosis caused by androgen deficiency
Therapeutic classView
Male Sex hormones (Androgens)
PharmacologyView
Testosterone is the principal endogenous hormone essential for normal growth and development of the male sex organs and male secondary sex characteristics. During adult life testosterone is essential for the functioning of the testes and accessory structures and for the maintenance of libido, sense of well-being, erectile potency, prostate and seminal vesicle function.
Treatment of hypogonadal men with Testanon results in a clinically significant rise of plasma concentrations of testosterone, dihydrotestosterone and androstenedione, as well as a decrease of SHBG (sex hormone binding globulin). In males with primary (hypergonadotropic) hypogonadism treatment with Testosterone Decanoate results in a normalization of gonadotropin levels. Treatment of female-to-male transsexuals with Testosterone Decanoate results in a clinically significant rise of plasma testosterone levels, a decrease of LH and FSH levels and a decrease in SHBG level.
Treatment of hypogonadal men with Testanon results in a clinically significant rise of plasma concentrations of testosterone, dihydrotestosterone and androstenedione, as well as a decrease of SHBG (sex hormone binding globulin). In males with primary (hypergonadotropic) hypogonadism treatment with Testosterone Decanoate results in a normalization of gonadotropin levels. Treatment of female-to-male transsexuals with Testosterone Decanoate results in a clinically significant rise of plasma testosterone levels, a decrease of LH and FSH levels and a decrease in SHBG level.
DosageView
In general, the dose should be adjusted according to the response of the individual patient.
Adults: Usually, one injection of 1 ml per three weeks is adequate. Testosterone should be administered by deep intramuscular injection.
Children: Safety and efficacy have not been adequately determined in children and adolescents.
Testosterone contains benzyl alcohol and should not be given to children under 3 years of age.
Adults: Usually, one injection of 1 ml per three weeks is adequate. Testosterone should be administered by deep intramuscular injection.
Children: Safety and efficacy have not been adequately determined in children and adolescents.
Testosterone contains benzyl alcohol and should not be given to children under 3 years of age.
Side effectsView
The most common side effects of Testosterone therapy are precocious sexual development, increased frequency of erections, phallic enlargement and premature epiphyseal closure, priapism, oligospermia, decreased ejaculatory volume and fluid & sodium retention.
ContraindicationsView
Testosterone is contraindicated in case of known hypersensitivity to Testosterone or any of its components. It is also contraindicated in patient with known and suspected prostatic carcinoma or breast carcinoma in male.
PrecautionsView
Androgens should be used with caution in pre (pubertal) boys to avoid premature epiphyseal closure or precocious sexual development. Skeletal maturation should be monitored regularly. Patients with latent or overt cardiac failure, renal dysfunction, hypertension, epilepsy or migraine (or a history of these conditions) should be kept under close medical supervision, since aggravation or recurrence may occasionally be induced. Androgens should be used with caution in men suffering from benign prostatic hyperplasia. The use of steroids may influence the results of certain laboratory tests. The misuse of androgens to enhance ability in sports carries serious health risks and is to be discouraged.
InteractionsView
Enzyme inducing agents may exert increasing or decreasing effects on Testosterone levels. Therefore, adjustment of dose or intervals between injections may be required.
Pregnancy & lactationView
Pregnancy: There are no adequate data for the use of Testosterone in pregnant women. In view of the risk of virilization of the foetus, Testosterone should not be used during pregnancy. Treatment with Testosterone should be discontinued when pregnancy occurs.
Lactation: There are no adequate data for the use of Testosterone during lactation. Therefore, Testosterone should not be used during lactation.
Lactation: There are no adequate data for the use of Testosterone during lactation. Therefore, Testosterone should not be used during lactation.
Overdose effectsView
The acute intramuscular toxicity of Testosterone is very low. Priapism in men is a symptom of chronic over dosage. If this occurs, treatment should be interrupted and after disappearance of the symptom, be resumed at a lower dosage.
StorageView
Store in a cool (between 8º C to 30º C) and dry place protected from light. Keep out of the reach of children.
Testoren
Testosterone Decanoate
Testoren
Testosterone Decanoate
Indications
Testosterone replacement therapy
Indication detailsView
Males: Testosterone is indicated for Testosterone replacement therapy for primary and secondary hypogonadal disorders, which include:
- After castration
- Eunuchoidism
- Hypopituitarism
- Endocrine impotence
- Certain types of infertility due to spermatogenic disorders
- Male climacteric symptoms as decreased libido and decreased feeling of general wellbeing and fitness
- Osteoporosis caused by androgen deficiency
Therapeutic classView
Male Sex hormones (Androgens)
PharmacologyView
Testosterone is the principal endogenous hormone essential for normal growth and development of the male sex organs and male secondary sex characteristics. During adult life testosterone is essential for the functioning of the testes and accessory structures and for the maintenance of libido, sense of well-being, erectile potency, prostate and seminal vesicle function.
Treatment of hypogonadal men with Testanon results in a clinically significant rise of plasma concentrations of testosterone, dihydrotestosterone and androstenedione, as well as a decrease of SHBG (sex hormone binding globulin). In males with primary (hypergonadotropic) hypogonadism treatment with Testosterone Decanoate results in a normalization of gonadotropin levels. Treatment of female-to-male transsexuals with Testosterone Decanoate results in a clinically significant rise of plasma testosterone levels, a decrease of LH and FSH levels and a decrease in SHBG level.
Treatment of hypogonadal men with Testanon results in a clinically significant rise of plasma concentrations of testosterone, dihydrotestosterone and androstenedione, as well as a decrease of SHBG (sex hormone binding globulin). In males with primary (hypergonadotropic) hypogonadism treatment with Testosterone Decanoate results in a normalization of gonadotropin levels. Treatment of female-to-male transsexuals with Testosterone Decanoate results in a clinically significant rise of plasma testosterone levels, a decrease of LH and FSH levels and a decrease in SHBG level.
DosageView
In general, the dose should be adjusted according to the response of the individual patient.
Adults: Usually, one injection of 1 ml per three weeks is adequate. Testosterone should be administered by deep intramuscular injection.
Children: Safety and efficacy have not been adequately determined in children and adolescents.
Testosterone contains benzyl alcohol and should not be given to children under 3 years of age.
Adults: Usually, one injection of 1 ml per three weeks is adequate. Testosterone should be administered by deep intramuscular injection.
Children: Safety and efficacy have not been adequately determined in children and adolescents.
Testosterone contains benzyl alcohol and should not be given to children under 3 years of age.
Side effectsView
The most common side effects of Testosterone therapy are precocious sexual development, increased frequency of erections, phallic enlargement and premature epiphyseal closure, priapism, oligospermia, decreased ejaculatory volume and fluid & sodium retention.
ContraindicationsView
Testosterone is contraindicated in case of known hypersensitivity to Testosterone or any of its components. It is also contraindicated in patient with known and suspected prostatic carcinoma or breast carcinoma in male.
PrecautionsView
Androgens should be used with caution in pre (pubertal) boys to avoid premature epiphyseal closure or precocious sexual development. Skeletal maturation should be monitored regularly. Patients with latent or overt cardiac failure, renal dysfunction, hypertension, epilepsy or migraine (or a history of these conditions) should be kept under close medical supervision, since aggravation or recurrence may occasionally be induced. Androgens should be used with caution in men suffering from benign prostatic hyperplasia. The use of steroids may influence the results of certain laboratory tests. The misuse of androgens to enhance ability in sports carries serious health risks and is to be discouraged.
InteractionsView
Enzyme inducing agents may exert increasing or decreasing effects on Testosterone levels. Therefore, adjustment of dose or intervals between injections may be required.
Pregnancy & lactationView
Pregnancy: There are no adequate data for the use of Testosterone in pregnant women. In view of the risk of virilization of the foetus, Testosterone should not be used during pregnancy. Treatment with Testosterone should be discontinued when pregnancy occurs.
Lactation: There are no adequate data for the use of Testosterone during lactation. Therefore, Testosterone should not be used during lactation.
Lactation: There are no adequate data for the use of Testosterone during lactation. Therefore, Testosterone should not be used during lactation.
Overdose effectsView
The acute intramuscular toxicity of Testosterone is very low. Priapism in men is a symptom of chronic over dosage. If this occurs, treatment should be interrupted and after disappearance of the symptom, be resumed at a lower dosage.
StorageView
Store in a cool (between 8º C to 30º C) and dry place protected from light. Keep out of the reach of children.
Tetagam-P
Human Tetanus Immunoglobulin
Tetagam-P
Human Tetanus Immunoglobulin
Indications
Tetanus
Indication detailsView
Indications and uses Human Tetanus Immunoglobulin is indicated for -
- Prophylaxis of tetanus following injury in patients whose immunization is incomplete or uncertain.
- Therapeutically in the treatment of tetanus.
Therapeutic classView
Vaccines, Anti-sera & Immunoglobulin
PharmacologyView
Human clostridium tetani toxoid immune globulin prevents tetanus toxoid from damaging tissue and producing the symptoms associated with tetanus. The immune globulin binds to tetanus toxiod, interfering with the normal interaction of the toxoid with human tissue. This prevents the toxoid from invading the nervous system and producing painful muscle spasms as well as autonomic dysfunction. The Clostridium tetani bacterium is killed either via antibiotic treatment of the host's immune system and immune globulin-bound toxoid is likely broken down by phagocytic immune cells.
DosageView
Post-exposure prophylaxis of tetanus:
At the same time, 0.5 ml of tetanus vaccine in a different extremity with a separate syringe and complete immunization schedule is required to be administered.
Therapy of clinically manifest tetanus: For adults and children single doses of 3,000 to 6,000 IU (in combination with other appropriate clinical procedures).
- For adults and children single dose of 250 IU should be given. The dose may be increased to 500 IU in case of:
- Infected wounds where surgically appropriate treatment cannot be achieved within 24 hours
- Deep or contaminated wounds with tissue damage and reduced oxygen supply, as well as foreign body injury (e.g., bites, stings or shots)
- Burns, congelations
- Tissue necrosis
- Septicaemic abortion
- Adults weighing more than the average
At the same time, 0.5 ml of tetanus vaccine in a different extremity with a separate syringe and complete immunization schedule is required to be administered.
Therapy of clinically manifest tetanus: For adults and children single doses of 3,000 to 6,000 IU (in combination with other appropriate clinical procedures).
AdministrationView
Administrations: Human Tetanus Immunoglobulin should only be administered by intramuscular injection. Human tetanus immunoglobulin should not be administered by intravenously.
Do not use solutions which are cloudy or contain residues (deposits/particles)
Human tetanus immunoglobulin is a ready for use solution and should be administered at body temperature. If comparatively large total volumes are required, it is advisable to administer them in divided doses at different sites
In the presence of a severe coagulation disorder where intramuscular injections are contraindicated, human tetanus immunoglobulin may be given subcutaneously (under the skin) for prophylaxis. Afterwards the injection site should be compressed with a swab. However, it should be noted that there are no clinical efficacy data to support administration by the subcutaneous route
Co-administration: Immunoglobulin administration may impair the efficacy of live, attenuated virus vaccines such as measles, rubella, mumps and varicella vaccines for a period of up to three months.
After administration of human tetanus immunoglobulin an interval of at least three months should elapse before vaccination with live, attenuated virus vaccines. In the case of measles, this impairment may persist for up to five months. Therefore, patients receiving measles vaccine should have their antibody status checked.
Do not use solutions which are cloudy or contain residues (deposits/particles)
Human tetanus immunoglobulin is a ready for use solution and should be administered at body temperature. If comparatively large total volumes are required, it is advisable to administer them in divided doses at different sites
In the presence of a severe coagulation disorder where intramuscular injections are contraindicated, human tetanus immunoglobulin may be given subcutaneously (under the skin) for prophylaxis. Afterwards the injection site should be compressed with a swab. However, it should be noted that there are no clinical efficacy data to support administration by the subcutaneous route
Co-administration: Immunoglobulin administration may impair the efficacy of live, attenuated virus vaccines such as measles, rubella, mumps and varicella vaccines for a period of up to three months.
After administration of human tetanus immunoglobulin an interval of at least three months should elapse before vaccination with live, attenuated virus vaccines. In the case of measles, this impairment may persist for up to five months. Therefore, patients receiving measles vaccine should have their antibody status checked.
Side effectsView
Adverse reaction following administration of human tetanus immunoglobulin is infrequent and mild, but severe local and systemic reactions have occurred rarely.
- Local reactions at the injection site: Local pain, tenderness or swelling.
- Immune system disorders: Allergic reactions including fall in blood pressure, dyspnoea, cutaneous reactions, in isolated cases reaching as far as anaphylactic shock, even when the patient has shown no hypersensitivity to previous administration of immunoglobulins.
- Generalized reactions: Chills, fever, headache, malaise, nausea, vomiting, arthralgia and moderate back pain.
- Heart and vascular disorders: Cardiovascular reactions particularly if the product is inadvertently injected intravascularly.
ContraindicationsView
- Known hypersensitivity to any of the components of the product
- Known hypersensitivity to human immunoglobulins
- Like any other intramuscular injections, human tetanus immunoglobulin is not advocated for patients with bleeding disorders
- In patients with a history of immunoglobulin A (IgA) deficiency or severe anaphylactic reactions to plasma products, the risk-benefit ratio must be considered
PrecautionsView
Should not be administered intravenously
A separate sterile syringe must be used for each patient to prevent the possible transmission of hepatitis B and other infectious diseases.
Should be administered with caution to individuals who have exhibited systemic allergic reactions to immunoglobulin. Epinephrine (0.1~0.5ml, 1:1000) should be available for immediate treatment.
In patients who have severe thrombocytopenia or any coagulation disorder that would contra-indicated intramuscular injection, human tetanus immunoglobulin should be given only if the expected benefits out way the risks.
While administering human tetanus immunoglobulin care should be taken to drawback the plunger of the syringe before injection in order to be certain that the needle is not in blood vessel.
Human tetanus immunoglobulin is prepared from human plasma is pasteurized in its bulk condition to reduce the risk of viruses infections but freedom from the risk of unknown viruses (Parvovirus B-19, etc) cannot be assumed. The infused patient is continuously checked for long time after injection.
A separate sterile syringe must be used for each patient to prevent the possible transmission of hepatitis B and other infectious diseases.
Should be administered with caution to individuals who have exhibited systemic allergic reactions to immunoglobulin. Epinephrine (0.1~0.5ml, 1:1000) should be available for immediate treatment.
In patients who have severe thrombocytopenia or any coagulation disorder that would contra-indicated intramuscular injection, human tetanus immunoglobulin should be given only if the expected benefits out way the risks.
While administering human tetanus immunoglobulin care should be taken to drawback the plunger of the syringe before injection in order to be certain that the needle is not in blood vessel.
Human tetanus immunoglobulin is prepared from human plasma is pasteurized in its bulk condition to reduce the risk of viruses infections but freedom from the risk of unknown viruses (Parvovirus B-19, etc) cannot be assumed. The infused patient is continuously checked for long time after injection.
InteractionsView
May reduce the efficacy of live vaccines.
Pregnancy & lactationView
The safety for use of human tetanus immunoglobulin in human pregnancy has not been established in controlled clinical trials. Long lasting clinical experience with immunoglobulins suggests that no harmful effects on the course of pregnancy, or on the fetus and the neonate are to be expected.
Overdose effectsView
Not applicable.
StorageView
Keep out of the reach and sight of children. Store at +2 °C to +8 °C. Transportation should also be in designed packs to maintain the product temperature +2 °C to +8 °C. Do not freeze. Discard vaccine if frozen. Protect from light
Tetclin
Tetracycline Hydrochloride (Oral)
Tetclin
Tetracycline Hydrochloride (Oral)
Indications
Uncomplicated gonorrhoea
Indication detailsView
Tetracycline is the drug of choice in the following infections :
- Ricketsial infection (Rocky Mountain spotted fever, endemic and scrub typhus fever and human ehrlichiosis).
- Mycoplasma pneumoniae infections in adults. Outbreaks of pneumonia caused by this organism are common in barracks and institutions. Most cases occur in children and young adults. Maculopapular rashes, haemolytic anaemia and meningo-encephalitis occur rarely.
- Chlamydial Infections: Chlamydia psittaci: This organism is the cause of psittacosis (ornithosis), a systemic illness contracted from infected birds. The pneumonia associated with it may be extensive, and severe systemic upset and death are common.Headache is a prominent early symptom.
- Non-gonococcal or non specific urethritis: Inflammation of the urethra not resulting from gonococcal, chlamydial, or other specific infectious agents.
- Lyme disease
- Brucellosis
- Miscellaneous infections, including granuloma inguinale, cholera, glanders, relapsing fever and V. vulnifians.
- Urinary Tract Infections with susceptible organisms (including the acute urethral syndrome in women).
- Bronchitis in patients with known underlying chronic lung diseases.
- Pelvic inflammatory disease and other sexually transmitted diseases (STDs) regimen.
- Travelers diarrhoea.
- Acne vulgaris
- Prostatitis.
- As an alternative agent in the penicillin allergic patient with syphilis.
- Anaerobic infections with susceptible organisms.
Therapeutic classView
Tetracycline group of drugs
PharmacologyView
Tetracycline has its main mechanism of action on protein synthesis, and an energy-dependent active transport system pumps the drug through the inner cytoplasmic membrane of bacteria. Once inside the bacterial cell, Tetracycline binds specifically to the 30s ribosomes and inhibit bacterial protein synthesis.
Many Gram positive aerobic Cocci are susceptible, but many strains of staphylococci, streptococci and even some pneumococci are resistant to Tetracycline. Thus, tetracycline is not the drug of choice in infections due to gram positive aerobes.
Pseudomonas and many Enterobacteriaceae are resistant. Urinary concentrations are adequate for some community - acquired E. coli and consequently, Tetracycline is still used in uncomplicated initial UTIs. Tetracycline is also active against and is the drug of choice for Brucella species, Calymmatobacterium granulomatis, Vibrio cholerae and V. vulnificus.
Tetracycline is also active against anaerobic species of bacteria and since concentrations of the drug are quite high in the gastrointestinal contents, the enteric flora are usually altered by the drug.
Tetracycline is incompletely absorbed from the gastro-intestinal tract, about 60 to 80% of a dose of tetracycline usually being available. It is widely distributed through the body tissues and fluids.
Tetracycline has a half-life of about 12 hours. It is excreted in the urine and in the faeces.
Many Gram positive aerobic Cocci are susceptible, but many strains of staphylococci, streptococci and even some pneumococci are resistant to Tetracycline. Thus, tetracycline is not the drug of choice in infections due to gram positive aerobes.
Pseudomonas and many Enterobacteriaceae are resistant. Urinary concentrations are adequate for some community - acquired E. coli and consequently, Tetracycline is still used in uncomplicated initial UTIs. Tetracycline is also active against and is the drug of choice for Brucella species, Calymmatobacterium granulomatis, Vibrio cholerae and V. vulnificus.
Tetracycline is also active against anaerobic species of bacteria and since concentrations of the drug are quite high in the gastrointestinal contents, the enteric flora are usually altered by the drug.
Tetracycline is incompletely absorbed from the gastro-intestinal tract, about 60 to 80% of a dose of tetracycline usually being available. It is widely distributed through the body tissues and fluids.
Tetracycline has a half-life of about 12 hours. It is excreted in the urine and in the faeces.
DosageView
The usual adult oral dosage of Tetracycline is 1-2 g daily given in 2-4 divided doses. The usual oral dosage of Tetracycline for children older than 8 years of age in 25-50 mg/kg daily given in 2-4 divided doses. Alternatively some clinicians recommended that children should receive 0.6-1.2 g/m2 daily.
Tetracycline should be taken preferably one hour before or 2 hours after meals.
Some specific indications along with some information on dosage is given below:
Acne vulgaris: 250 mg four times daily or 500 mg 12 hourly for 1 week; 125-250 mg for several weeks or months. Duration of therapy is determined by individual progress
Acute staphylococcal infections: 1-2 g daily in divided doses for 10-14 days
Acute streptococcal infections: 1-2 g daily in divided doses for 10 days. Prolonged therapy is needed to avoid risk of rheumatic fever or glomerulonephritis
Amoebiasis: 1 g daily in four divided doses or 500 mg 12 hourly for 7 days. Given in association with amoebicidal agents
Brucellosis: 500 mg four times daily plus 1 g streptomycin twice daily for 1 week ; then 500 mg four times daily (no streptomycin) for 1 week. Prolonged therapy is necessary to avoid relapse
Subacute bacterial endocarditis: 1-2 g daily in divided doses for 6 weeks. Usually given in combination with a bactericidal agent
Syphilis: Total 30-40 g given in divided doses over 10-15 days. Serology and spinal fluid examination should follow the administration of tetracycline
Tetracycline should be taken preferably one hour before or 2 hours after meals.
Some specific indications along with some information on dosage is given below:
Acne vulgaris: 250 mg four times daily or 500 mg 12 hourly for 1 week; 125-250 mg for several weeks or months. Duration of therapy is determined by individual progress
Acute staphylococcal infections: 1-2 g daily in divided doses for 10-14 days
Acute streptococcal infections: 1-2 g daily in divided doses for 10 days. Prolonged therapy is needed to avoid risk of rheumatic fever or glomerulonephritis
Amoebiasis: 1 g daily in four divided doses or 500 mg 12 hourly for 7 days. Given in association with amoebicidal agents
Brucellosis: 500 mg four times daily plus 1 g streptomycin twice daily for 1 week ; then 500 mg four times daily (no streptomycin) for 1 week. Prolonged therapy is necessary to avoid relapse
Subacute bacterial endocarditis: 1-2 g daily in divided doses for 6 weeks. Usually given in combination with a bactericidal agent
Syphilis: Total 30-40 g given in divided doses over 10-15 days. Serology and spinal fluid examination should follow the administration of tetracycline
Side effectsView
Teeth and bone: Tetracycline can cause depression of bone growth, permanent graybrown discoloration of the teeth and enamel hypoplasia when given during tooth development (i.e. during the later half of pregnancy, during infancy and in childhood).
Hypersensitivity reactions such as anaphylaxis, urticaria and rashes are uncommon. Photosensitivity reactions consisting of a red rash on areas exposed to intense sunlight can occur with Tetracycline.
Gastrointestinal effects: Epigastric distress and nausea are commonly seen after oral administration, and these symptoms are somewhat dose related. Vomiting can occur.
Accentuated prerenal azotemia: Tetracycline appears to aggravate pre-existing renal failure by inhibiting protein synthesis, which increases the azotemia from amino acid metabolism.
Superinfections with oral and anogenital candidiasis are relatively common in patients taking Tetracycline.
Esophageal ulcerations: In most cases, the patients were taking the capsules with little or no fluid before going to bed. To help minimize this, oral doses should be given with adequate amounts of fluid.
Hypersensitivity reactions such as anaphylaxis, urticaria and rashes are uncommon. Photosensitivity reactions consisting of a red rash on areas exposed to intense sunlight can occur with Tetracycline.
Gastrointestinal effects: Epigastric distress and nausea are commonly seen after oral administration, and these symptoms are somewhat dose related. Vomiting can occur.
Accentuated prerenal azotemia: Tetracycline appears to aggravate pre-existing renal failure by inhibiting protein synthesis, which increases the azotemia from amino acid metabolism.
Superinfections with oral and anogenital candidiasis are relatively common in patients taking Tetracycline.
Esophageal ulcerations: In most cases, the patients were taking the capsules with little or no fluid before going to bed. To help minimize this, oral doses should be given with adequate amounts of fluid.
ContraindicationsView
Tetracycline Hydrochloride is contraindicated in patients hypersensitive to any of the member of tetracycline groups, since cross-sensitivity may occur Tetracycline Hydrochloride should be avoided in patients with systemic lupus erythematosus. Tetracycline Hydrochloride is considered to be contraindicated in renal impairment, particularly if severe ; if it must be given, doses should be reduced.
PrecautionsView
Care should be taken if Tetracycline Hydrochloride is given to patients with impaired liver function and high doses should be avoided. Potentiality hepatotoxic drugs (including erythromycin, chloramphenicol, isoniazide and sulphonamides) should not be given concomitantly.
InteractionsView
Impaired absorption with antacids containing divalent and trivalent cations (e.g. Al, Ca, Mg), Fe, Zn and Na bicarbonate preparations, kaolin-pectin, bismuth subsalicylate, sucralfate, strontium ranelate, colestipol and colestyramine. May interfere with the bactericidal action of penicillin. May potentiate the effect of anticoagulants. May decrease efficacy of oral contraceptives. Nephrotoxic effects may be exacerbated by diuretics or other nephrotoxic drugs. May increase the hypoglycaemic effect of insulin and sulfonylureas in patients with DM. May increase toxic effects of ergot alkaloids and methotrexate.
Pregnancy & lactationView
Tetracycline should not be used during pregnancy because of the risk of hypertoxicity in the mother as well as the effects on the developing foetus. Use in pregnancy potentially during breast-feeding and in children up to the age of 8, or some authorise say 12 years, may result in impaired bone growth and permanent discoloration of the child's teeth.
StorageView
Store between 20-25° C.
Tetraben
Tetrabenazine
Tetraben
Tetrabenazine
Indications
Moderate to severe tardive dyskinesia
Indication detailsView
Tetrabenazine is indicated for the treatment of chorea associated with Huntington's disease.
Therapeutic classView
Atypical neuroleptic drugs
PharmacologyView
Prolongation of the QTc interval has been observed at doses of 50 mg. In rats, it has been observed that tetrabenazine or its metabolites bind to melanin-containing tissues such as the eyes and skin. After a single oral dose of radiolabeled tetrabenazine, radioactivity was still detected in eye and fur at 21 days post dosing.
Tetrabenazine is a reversible human vesicular monoamine transporter type 2 inhibitor (Ki = 100 nM). It acts within the basal ganglia and promotes depletion of monoamine neurotransmitters serotonin, norepinephrine, and dopamine from stores. It also decreases uptake into synaptic vesicles. Dopamine is required for fine motor movement, so the inhibition of its transmission is efficacious for hyperkinetic movement. Tetrabenazine exhibits weak in vitro binding affinity at the dopamine D2 receptor (Ki = 2100 nM).
Tetrabenazine is a reversible human vesicular monoamine transporter type 2 inhibitor (Ki = 100 nM). It acts within the basal ganglia and promotes depletion of monoamine neurotransmitters serotonin, norepinephrine, and dopamine from stores. It also decreases uptake into synaptic vesicles. Dopamine is required for fine motor movement, so the inhibition of its transmission is efficacious for hyperkinetic movement. Tetrabenazine exhibits weak in vitro binding affinity at the dopamine D2 receptor (Ki = 2100 nM).
DosageView
General Dosing Considerations:
The chronic daily dose of Tetrabenazine used to treat chorea associated with Huntington's disease (HD) is determined individually for each patient. When first prescribed, Tetrabenazine therapy should be titrated slowly over several weeks to identify a dose of XENAXINE that reduces chorea and is tolerated. Tetrabenazine can be administered without regard to food.Individualization Of Dose:
Dosing Recommendations Up to 50 mg per day: The starting dose should be 12.5 mg per day given once in the morning. After one week, the dose should be increased to 25 mg per day given as 12.5 mg twice a day. Tetrabenazine should be titrated up slowly at weekly intervals by 12.5 mg daily, to allow the identification of a tolerated dose that reduces chorea. If a dose of 37.5 to 50 mg per day is needed, it should be given in a three times a day regimen. The maximum recommended single dose is 25 mg. If adverse reactions such as akathisia, restlessness, parkinsonism, depression, insomnia, anxiety or sedation occur, titration should be stopped and the dose should be reduced. If the adverse reaction does not resolve, consideration should be given to withdrawing Tetrabenazine treatment or initiating other specific treatment (e.g., antidepressants).Dosing Recommendations Above 50 mg per day: Patients who require doses of Tetrabenazine greater than 50 mg per day should be first tested and genotyped to determine if they are poor metabolizers (PMs) or extensive metabolizers (EMs) by their ability to express the drug metabolizing enzyme, CYP2D6. The dose of Tetrabenazine should then be individualized accordingly to their status as PMs or EMs
Extensive and Intermediate CYP2D6 Metabolizers:
Genotyped patients who are identified as extensive (EMs) or intermediate metabolizers (IMs) of CYP2D6, who need doses of Tetrabenazine above 50 mg per day, should be titrated up slowly at weekly intervals by 12.5 mg daily, to allow the identification of a tolerated dose that reduces chorea. Doses above 50 mg per day should be given in a three times a day regimen. The maximum recommended daily dose is 100 mg and the maximum recommended single dose is 37.5 mg. If adverse reactions such as akathisia, parkinsonism, depression, insomnia, anxiety or sedation occur, titration should be stopped and the dose should be reduced. If the adverse reaction does not resolve, consideration should be given to withdrawing Tetrabenazine treatment or initiating other specific treatment (e.g., antidepressants)Side effectsView
The following serious adverse reactions are Depression, Suicidality Akathisia, restlessness, and agitation, Parkinsonism, Dysphagia, Sedation and somnolence
ContraindicationsView
Tetrabenazine is contraindicated in patients:
- Who are actively suicidal, or in patients with untreated or inadequately treated depression
- With hepatic impairment
- Taking monoamine oxidase inhibitors (MAOIs). XENAZINE should not be used in combination with an MAOI, or within a minimum of 14 days of discontinuing therapy with an MAOI
PrecautionsView
May exacerbate symptoms of parkinsonism. Caution to be exercised when driving or performing skilled tasks. Pregnancy.
InteractionsView
Tetrabenazine should not be given with or within 14 days of discontinuation of MAOI therapy. Blocks action of reserpine. Decreases effects of levodopa and worsen parkinsonism. Increased risk of extrapyramidal side effects when given with amantadine, metoclopramide, antipsychotics.
Pregnancy & lactationView
Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. Tetrabenazine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Nursing Mothers: It is not known whether Tetrabenazine or its metabolites are excreted in human milk. Since many drugs are excreted into human milk and because of the potential for serious adverse reactions in nursing infants from Tetrabenazine, a decision should be made whether to discontinue nursing or to discontinue Tetrabenazine, taking into account the importance of the drug to the mother.
Nursing Mothers: It is not known whether Tetrabenazine or its metabolites are excreted in human milk. Since many drugs are excreted into human milk and because of the potential for serious adverse reactions in nursing infants from Tetrabenazine, a decision should be made whether to discontinue nursing or to discontinue Tetrabenazine, taking into account the importance of the drug to the mother.
Pediatric usageView
Pediatric Use: The safety and efficacy of Tetrabenazine in pediatric patients have not been established.
Geriatric Use: The pharmacokinetics of Tetrabenazine and its primary metabolites have not been formally studied in geriatric subjects.
Hepatic Impairment: Because the safety and efficacy of the increased exposure to Tetrabenazine and other circulating metabolites are unknown, it is not possible to adjust the dosage of Tetrabenazine in hepatic impairment to ensure safe use. The use of Tetrabenazine in patients with hepatic impairment is contraindicated
Geriatric Use: The pharmacokinetics of Tetrabenazine and its primary metabolites have not been formally studied in geriatric subjects.
Hepatic Impairment: Because the safety and efficacy of the increased exposure to Tetrabenazine and other circulating metabolites are unknown, it is not possible to adjust the dosage of Tetrabenazine in hepatic impairment to ensure safe use. The use of Tetrabenazine in patients with hepatic impairment is contraindicated
Overdose effectsView
Three episodes of overdose occurred in the open-label trials performed in support of registration. Eight cases of overdose with Tetrabenazine have been reported in the literature. The dose of Tetrabenazine in these patients ranged from 100 mg to 1g. Adverse reactions associated with Tetrabenazine overdose include acute dystonia, oculogyric crisis, nausea and vomiting, sweating, sedation, hypotension, confusion, diarrhea, hallucinations, rubor, and tremor.
Treatment should consist of those general measures employed in the management of overdosage with any CNS-active drug. General supportive and symptomatic measures are recommended. Cardiac rhythm and vital signs should be monitored. In managing overdosage, the possibility of multiple drug involvement should always be considered. The physician should consider contacting a poison control center on the treatment of any overdose.
Treatment should consist of those general measures employed in the management of overdosage with any CNS-active drug. General supportive and symptomatic measures are recommended. Cardiac rhythm and vital signs should be monitored. In managing overdosage, the possibility of multiple drug involvement should always be considered. The physician should consider contacting a poison control center on the treatment of any overdose.
Tetraben
Tetrabenazine
Tetraben
Tetrabenazine
Indications
Moderate to severe tardive dyskinesia
Indication detailsView
Tetrabenazine is indicated for the treatment of chorea associated with Huntington's disease.
Therapeutic classView
Atypical neuroleptic drugs
PharmacologyView
Prolongation of the QTc interval has been observed at doses of 50 mg. In rats, it has been observed that tetrabenazine or its metabolites bind to melanin-containing tissues such as the eyes and skin. After a single oral dose of radiolabeled tetrabenazine, radioactivity was still detected in eye and fur at 21 days post dosing.
Tetrabenazine is a reversible human vesicular monoamine transporter type 2 inhibitor (Ki = 100 nM). It acts within the basal ganglia and promotes depletion of monoamine neurotransmitters serotonin, norepinephrine, and dopamine from stores. It also decreases uptake into synaptic vesicles. Dopamine is required for fine motor movement, so the inhibition of its transmission is efficacious for hyperkinetic movement. Tetrabenazine exhibits weak in vitro binding affinity at the dopamine D2 receptor (Ki = 2100 nM).
Tetrabenazine is a reversible human vesicular monoamine transporter type 2 inhibitor (Ki = 100 nM). It acts within the basal ganglia and promotes depletion of monoamine neurotransmitters serotonin, norepinephrine, and dopamine from stores. It also decreases uptake into synaptic vesicles. Dopamine is required for fine motor movement, so the inhibition of its transmission is efficacious for hyperkinetic movement. Tetrabenazine exhibits weak in vitro binding affinity at the dopamine D2 receptor (Ki = 2100 nM).
DosageView
General Dosing Considerations:
The chronic daily dose of Tetrabenazine used to treat chorea associated with Huntington's disease (HD) is determined individually for each patient. When first prescribed, Tetrabenazine therapy should be titrated slowly over several weeks to identify a dose of XENAXINE that reduces chorea and is tolerated. Tetrabenazine can be administered without regard to food.Individualization Of Dose:
Dosing Recommendations Up to 50 mg per day: The starting dose should be 12.5 mg per day given once in the morning. After one week, the dose should be increased to 25 mg per day given as 12.5 mg twice a day. Tetrabenazine should be titrated up slowly at weekly intervals by 12.5 mg daily, to allow the identification of a tolerated dose that reduces chorea. If a dose of 37.5 to 50 mg per day is needed, it should be given in a three times a day regimen. The maximum recommended single dose is 25 mg. If adverse reactions such as akathisia, restlessness, parkinsonism, depression, insomnia, anxiety or sedation occur, titration should be stopped and the dose should be reduced. If the adverse reaction does not resolve, consideration should be given to withdrawing Tetrabenazine treatment or initiating other specific treatment (e.g., antidepressants).Dosing Recommendations Above 50 mg per day: Patients who require doses of Tetrabenazine greater than 50 mg per day should be first tested and genotyped to determine if they are poor metabolizers (PMs) or extensive metabolizers (EMs) by their ability to express the drug metabolizing enzyme, CYP2D6. The dose of Tetrabenazine should then be individualized accordingly to their status as PMs or EMs
Extensive and Intermediate CYP2D6 Metabolizers:
Genotyped patients who are identified as extensive (EMs) or intermediate metabolizers (IMs) of CYP2D6, who need doses of Tetrabenazine above 50 mg per day, should be titrated up slowly at weekly intervals by 12.5 mg daily, to allow the identification of a tolerated dose that reduces chorea. Doses above 50 mg per day should be given in a three times a day regimen. The maximum recommended daily dose is 100 mg and the maximum recommended single dose is 37.5 mg. If adverse reactions such as akathisia, parkinsonism, depression, insomnia, anxiety or sedation occur, titration should be stopped and the dose should be reduced. If the adverse reaction does not resolve, consideration should be given to withdrawing Tetrabenazine treatment or initiating other specific treatment (e.g., antidepressants)Side effectsView
The following serious adverse reactions are Depression, Suicidality Akathisia, restlessness, and agitation, Parkinsonism, Dysphagia, Sedation and somnolence
ContraindicationsView
Tetrabenazine is contraindicated in patients:
- Who are actively suicidal, or in patients with untreated or inadequately treated depression
- With hepatic impairment
- Taking monoamine oxidase inhibitors (MAOIs). XENAZINE should not be used in combination with an MAOI, or within a minimum of 14 days of discontinuing therapy with an MAOI
PrecautionsView
May exacerbate symptoms of parkinsonism. Caution to be exercised when driving or performing skilled tasks. Pregnancy.
InteractionsView
Tetrabenazine should not be given with or within 14 days of discontinuation of MAOI therapy. Blocks action of reserpine. Decreases effects of levodopa and worsen parkinsonism. Increased risk of extrapyramidal side effects when given with amantadine, metoclopramide, antipsychotics.
Pregnancy & lactationView
Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. Tetrabenazine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Nursing Mothers: It is not known whether Tetrabenazine or its metabolites are excreted in human milk. Since many drugs are excreted into human milk and because of the potential for serious adverse reactions in nursing infants from Tetrabenazine, a decision should be made whether to discontinue nursing or to discontinue Tetrabenazine, taking into account the importance of the drug to the mother.
Nursing Mothers: It is not known whether Tetrabenazine or its metabolites are excreted in human milk. Since many drugs are excreted into human milk and because of the potential for serious adverse reactions in nursing infants from Tetrabenazine, a decision should be made whether to discontinue nursing or to discontinue Tetrabenazine, taking into account the importance of the drug to the mother.
Pediatric usageView
Pediatric Use: The safety and efficacy of Tetrabenazine in pediatric patients have not been established.
Geriatric Use: The pharmacokinetics of Tetrabenazine and its primary metabolites have not been formally studied in geriatric subjects.
Hepatic Impairment: Because the safety and efficacy of the increased exposure to Tetrabenazine and other circulating metabolites are unknown, it is not possible to adjust the dosage of Tetrabenazine in hepatic impairment to ensure safe use. The use of Tetrabenazine in patients with hepatic impairment is contraindicated
Geriatric Use: The pharmacokinetics of Tetrabenazine and its primary metabolites have not been formally studied in geriatric subjects.
Hepatic Impairment: Because the safety and efficacy of the increased exposure to Tetrabenazine and other circulating metabolites are unknown, it is not possible to adjust the dosage of Tetrabenazine in hepatic impairment to ensure safe use. The use of Tetrabenazine in patients with hepatic impairment is contraindicated
Overdose effectsView
Three episodes of overdose occurred in the open-label trials performed in support of registration. Eight cases of overdose with Tetrabenazine have been reported in the literature. The dose of Tetrabenazine in these patients ranged from 100 mg to 1g. Adverse reactions associated with Tetrabenazine overdose include acute dystonia, oculogyric crisis, nausea and vomiting, sweating, sedation, hypotension, confusion, diarrhea, hallucinations, rubor, and tremor.
Treatment should consist of those general measures employed in the management of overdosage with any CNS-active drug. General supportive and symptomatic measures are recommended. Cardiac rhythm and vital signs should be monitored. In managing overdosage, the possibility of multiple drug involvement should always be considered. The physician should consider contacting a poison control center on the treatment of any overdose.
Treatment should consist of those general measures employed in the management of overdosage with any CNS-active drug. General supportive and symptomatic measures are recommended. Cardiac rhythm and vital signs should be monitored. In managing overdosage, the possibility of multiple drug involvement should always be considered. The physician should consider contacting a poison control center on the treatment of any overdose.
Tetrabez
Tetrabenazine
Tetrabez
Tetrabenazine
Indications
Moderate to severe tardive dyskinesia
Indication detailsView
Tetrabenazine is indicated for the treatment of chorea associated with Huntington's disease.
Therapeutic classView
Atypical neuroleptic drugs
PharmacologyView
Prolongation of the QTc interval has been observed at doses of 50 mg. In rats, it has been observed that tetrabenazine or its metabolites bind to melanin-containing tissues such as the eyes and skin. After a single oral dose of radiolabeled tetrabenazine, radioactivity was still detected in eye and fur at 21 days post dosing.
Tetrabenazine is a reversible human vesicular monoamine transporter type 2 inhibitor (Ki = 100 nM). It acts within the basal ganglia and promotes depletion of monoamine neurotransmitters serotonin, norepinephrine, and dopamine from stores. It also decreases uptake into synaptic vesicles. Dopamine is required for fine motor movement, so the inhibition of its transmission is efficacious for hyperkinetic movement. Tetrabenazine exhibits weak in vitro binding affinity at the dopamine D2 receptor (Ki = 2100 nM).
Tetrabenazine is a reversible human vesicular monoamine transporter type 2 inhibitor (Ki = 100 nM). It acts within the basal ganglia and promotes depletion of monoamine neurotransmitters serotonin, norepinephrine, and dopamine from stores. It also decreases uptake into synaptic vesicles. Dopamine is required for fine motor movement, so the inhibition of its transmission is efficacious for hyperkinetic movement. Tetrabenazine exhibits weak in vitro binding affinity at the dopamine D2 receptor (Ki = 2100 nM).
DosageView
General Dosing Considerations:
The chronic daily dose of Tetrabenazine used to treat chorea associated with Huntington's disease (HD) is determined individually for each patient. When first prescribed, Tetrabenazine therapy should be titrated slowly over several weeks to identify a dose of XENAXINE that reduces chorea and is tolerated. Tetrabenazine can be administered without regard to food.Individualization Of Dose:
Dosing Recommendations Up to 50 mg per day: The starting dose should be 12.5 mg per day given once in the morning. After one week, the dose should be increased to 25 mg per day given as 12.5 mg twice a day. Tetrabenazine should be titrated up slowly at weekly intervals by 12.5 mg daily, to allow the identification of a tolerated dose that reduces chorea. If a dose of 37.5 to 50 mg per day is needed, it should be given in a three times a day regimen. The maximum recommended single dose is 25 mg. If adverse reactions such as akathisia, restlessness, parkinsonism, depression, insomnia, anxiety or sedation occur, titration should be stopped and the dose should be reduced. If the adverse reaction does not resolve, consideration should be given to withdrawing Tetrabenazine treatment or initiating other specific treatment (e.g., antidepressants).Dosing Recommendations Above 50 mg per day: Patients who require doses of Tetrabenazine greater than 50 mg per day should be first tested and genotyped to determine if they are poor metabolizers (PMs) or extensive metabolizers (EMs) by their ability to express the drug metabolizing enzyme, CYP2D6. The dose of Tetrabenazine should then be individualized accordingly to their status as PMs or EMs
Extensive and Intermediate CYP2D6 Metabolizers:
Genotyped patients who are identified as extensive (EMs) or intermediate metabolizers (IMs) of CYP2D6, who need doses of Tetrabenazine above 50 mg per day, should be titrated up slowly at weekly intervals by 12.5 mg daily, to allow the identification of a tolerated dose that reduces chorea. Doses above 50 mg per day should be given in a three times a day regimen. The maximum recommended daily dose is 100 mg and the maximum recommended single dose is 37.5 mg. If adverse reactions such as akathisia, parkinsonism, depression, insomnia, anxiety or sedation occur, titration should be stopped and the dose should be reduced. If the adverse reaction does not resolve, consideration should be given to withdrawing Tetrabenazine treatment or initiating other specific treatment (e.g., antidepressants)Side effectsView
The following serious adverse reactions are Depression, Suicidality Akathisia, restlessness, and agitation, Parkinsonism, Dysphagia, Sedation and somnolence
ContraindicationsView
Tetrabenazine is contraindicated in patients:
- Who are actively suicidal, or in patients with untreated or inadequately treated depression
- With hepatic impairment
- Taking monoamine oxidase inhibitors (MAOIs). XENAZINE should not be used in combination with an MAOI, or within a minimum of 14 days of discontinuing therapy with an MAOI
PrecautionsView
May exacerbate symptoms of parkinsonism. Caution to be exercised when driving or performing skilled tasks. Pregnancy.
InteractionsView
Tetrabenazine should not be given with or within 14 days of discontinuation of MAOI therapy. Blocks action of reserpine. Decreases effects of levodopa and worsen parkinsonism. Increased risk of extrapyramidal side effects when given with amantadine, metoclopramide, antipsychotics.
Pregnancy & lactationView
Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. Tetrabenazine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Nursing Mothers: It is not known whether Tetrabenazine or its metabolites are excreted in human milk. Since many drugs are excreted into human milk and because of the potential for serious adverse reactions in nursing infants from Tetrabenazine, a decision should be made whether to discontinue nursing or to discontinue Tetrabenazine, taking into account the importance of the drug to the mother.
Nursing Mothers: It is not known whether Tetrabenazine or its metabolites are excreted in human milk. Since many drugs are excreted into human milk and because of the potential for serious adverse reactions in nursing infants from Tetrabenazine, a decision should be made whether to discontinue nursing or to discontinue Tetrabenazine, taking into account the importance of the drug to the mother.
Pediatric usageView
Pediatric Use: The safety and efficacy of Tetrabenazine in pediatric patients have not been established.
Geriatric Use: The pharmacokinetics of Tetrabenazine and its primary metabolites have not been formally studied in geriatric subjects.
Hepatic Impairment: Because the safety and efficacy of the increased exposure to Tetrabenazine and other circulating metabolites are unknown, it is not possible to adjust the dosage of Tetrabenazine in hepatic impairment to ensure safe use. The use of Tetrabenazine in patients with hepatic impairment is contraindicated
Geriatric Use: The pharmacokinetics of Tetrabenazine and its primary metabolites have not been formally studied in geriatric subjects.
Hepatic Impairment: Because the safety and efficacy of the increased exposure to Tetrabenazine and other circulating metabolites are unknown, it is not possible to adjust the dosage of Tetrabenazine in hepatic impairment to ensure safe use. The use of Tetrabenazine in patients with hepatic impairment is contraindicated
Overdose effectsView
Three episodes of overdose occurred in the open-label trials performed in support of registration. Eight cases of overdose with Tetrabenazine have been reported in the literature. The dose of Tetrabenazine in these patients ranged from 100 mg to 1g. Adverse reactions associated with Tetrabenazine overdose include acute dystonia, oculogyric crisis, nausea and vomiting, sweating, sedation, hypotension, confusion, diarrhea, hallucinations, rubor, and tremor.
Treatment should consist of those general measures employed in the management of overdosage with any CNS-active drug. General supportive and symptomatic measures are recommended. Cardiac rhythm and vital signs should be monitored. In managing overdosage, the possibility of multiple drug involvement should always be considered. The physician should consider contacting a poison control center on the treatment of any overdose.
Treatment should consist of those general measures employed in the management of overdosage with any CNS-active drug. General supportive and symptomatic measures are recommended. Cardiac rhythm and vital signs should be monitored. In managing overdosage, the possibility of multiple drug involvement should always be considered. The physician should consider contacting a poison control center on the treatment of any overdose.
Tetrabez
Tetrabenazine
Tetrabez
Tetrabenazine
Indications
Moderate to severe tardive dyskinesia
Indication detailsView
Tetrabenazine is indicated for the treatment of chorea associated with Huntington's disease.
Therapeutic classView
Atypical neuroleptic drugs
PharmacologyView
Prolongation of the QTc interval has been observed at doses of 50 mg. In rats, it has been observed that tetrabenazine or its metabolites bind to melanin-containing tissues such as the eyes and skin. After a single oral dose of radiolabeled tetrabenazine, radioactivity was still detected in eye and fur at 21 days post dosing.
Tetrabenazine is a reversible human vesicular monoamine transporter type 2 inhibitor (Ki = 100 nM). It acts within the basal ganglia and promotes depletion of monoamine neurotransmitters serotonin, norepinephrine, and dopamine from stores. It also decreases uptake into synaptic vesicles. Dopamine is required for fine motor movement, so the inhibition of its transmission is efficacious for hyperkinetic movement. Tetrabenazine exhibits weak in vitro binding affinity at the dopamine D2 receptor (Ki = 2100 nM).
Tetrabenazine is a reversible human vesicular monoamine transporter type 2 inhibitor (Ki = 100 nM). It acts within the basal ganglia and promotes depletion of monoamine neurotransmitters serotonin, norepinephrine, and dopamine from stores. It also decreases uptake into synaptic vesicles. Dopamine is required for fine motor movement, so the inhibition of its transmission is efficacious for hyperkinetic movement. Tetrabenazine exhibits weak in vitro binding affinity at the dopamine D2 receptor (Ki = 2100 nM).
DosageView
General Dosing Considerations:
The chronic daily dose of Tetrabenazine used to treat chorea associated with Huntington's disease (HD) is determined individually for each patient. When first prescribed, Tetrabenazine therapy should be titrated slowly over several weeks to identify a dose of XENAXINE that reduces chorea and is tolerated. Tetrabenazine can be administered without regard to food.Individualization Of Dose:
Dosing Recommendations Up to 50 mg per day: The starting dose should be 12.5 mg per day given once in the morning. After one week, the dose should be increased to 25 mg per day given as 12.5 mg twice a day. Tetrabenazine should be titrated up slowly at weekly intervals by 12.5 mg daily, to allow the identification of a tolerated dose that reduces chorea. If a dose of 37.5 to 50 mg per day is needed, it should be given in a three times a day regimen. The maximum recommended single dose is 25 mg. If adverse reactions such as akathisia, restlessness, parkinsonism, depression, insomnia, anxiety or sedation occur, titration should be stopped and the dose should be reduced. If the adverse reaction does not resolve, consideration should be given to withdrawing Tetrabenazine treatment or initiating other specific treatment (e.g., antidepressants).Dosing Recommendations Above 50 mg per day: Patients who require doses of Tetrabenazine greater than 50 mg per day should be first tested and genotyped to determine if they are poor metabolizers (PMs) or extensive metabolizers (EMs) by their ability to express the drug metabolizing enzyme, CYP2D6. The dose of Tetrabenazine should then be individualized accordingly to their status as PMs or EMs
Extensive and Intermediate CYP2D6 Metabolizers:
Genotyped patients who are identified as extensive (EMs) or intermediate metabolizers (IMs) of CYP2D6, who need doses of Tetrabenazine above 50 mg per day, should be titrated up slowly at weekly intervals by 12.5 mg daily, to allow the identification of a tolerated dose that reduces chorea. Doses above 50 mg per day should be given in a three times a day regimen. The maximum recommended daily dose is 100 mg and the maximum recommended single dose is 37.5 mg. If adverse reactions such as akathisia, parkinsonism, depression, insomnia, anxiety or sedation occur, titration should be stopped and the dose should be reduced. If the adverse reaction does not resolve, consideration should be given to withdrawing Tetrabenazine treatment or initiating other specific treatment (e.g., antidepressants)Side effectsView
The following serious adverse reactions are Depression, Suicidality Akathisia, restlessness, and agitation, Parkinsonism, Dysphagia, Sedation and somnolence
ContraindicationsView
Tetrabenazine is contraindicated in patients:
- Who are actively suicidal, or in patients with untreated or inadequately treated depression
- With hepatic impairment
- Taking monoamine oxidase inhibitors (MAOIs). XENAZINE should not be used in combination with an MAOI, or within a minimum of 14 days of discontinuing therapy with an MAOI
PrecautionsView
May exacerbate symptoms of parkinsonism. Caution to be exercised when driving or performing skilled tasks. Pregnancy.
InteractionsView
Tetrabenazine should not be given with or within 14 days of discontinuation of MAOI therapy. Blocks action of reserpine. Decreases effects of levodopa and worsen parkinsonism. Increased risk of extrapyramidal side effects when given with amantadine, metoclopramide, antipsychotics.
Pregnancy & lactationView
Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. Tetrabenazine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Nursing Mothers: It is not known whether Tetrabenazine or its metabolites are excreted in human milk. Since many drugs are excreted into human milk and because of the potential for serious adverse reactions in nursing infants from Tetrabenazine, a decision should be made whether to discontinue nursing or to discontinue Tetrabenazine, taking into account the importance of the drug to the mother.
Nursing Mothers: It is not known whether Tetrabenazine or its metabolites are excreted in human milk. Since many drugs are excreted into human milk and because of the potential for serious adverse reactions in nursing infants from Tetrabenazine, a decision should be made whether to discontinue nursing or to discontinue Tetrabenazine, taking into account the importance of the drug to the mother.
Pediatric usageView
Pediatric Use: The safety and efficacy of Tetrabenazine in pediatric patients have not been established.
Geriatric Use: The pharmacokinetics of Tetrabenazine and its primary metabolites have not been formally studied in geriatric subjects.
Hepatic Impairment: Because the safety and efficacy of the increased exposure to Tetrabenazine and other circulating metabolites are unknown, it is not possible to adjust the dosage of Tetrabenazine in hepatic impairment to ensure safe use. The use of Tetrabenazine in patients with hepatic impairment is contraindicated
Geriatric Use: The pharmacokinetics of Tetrabenazine and its primary metabolites have not been formally studied in geriatric subjects.
Hepatic Impairment: Because the safety and efficacy of the increased exposure to Tetrabenazine and other circulating metabolites are unknown, it is not possible to adjust the dosage of Tetrabenazine in hepatic impairment to ensure safe use. The use of Tetrabenazine in patients with hepatic impairment is contraindicated
Overdose effectsView
Three episodes of overdose occurred in the open-label trials performed in support of registration. Eight cases of overdose with Tetrabenazine have been reported in the literature. The dose of Tetrabenazine in these patients ranged from 100 mg to 1g. Adverse reactions associated with Tetrabenazine overdose include acute dystonia, oculogyric crisis, nausea and vomiting, sweating, sedation, hypotension, confusion, diarrhea, hallucinations, rubor, and tremor.
Treatment should consist of those general measures employed in the management of overdosage with any CNS-active drug. General supportive and symptomatic measures are recommended. Cardiac rhythm and vital signs should be monitored. In managing overdosage, the possibility of multiple drug involvement should always be considered. The physician should consider contacting a poison control center on the treatment of any overdose.
Treatment should consist of those general measures employed in the management of overdosage with any CNS-active drug. General supportive and symptomatic measures are recommended. Cardiac rhythm and vital signs should be monitored. In managing overdosage, the possibility of multiple drug involvement should always be considered. The physician should consider contacting a poison control center on the treatment of any overdose.
Tetracef
Cefepime Hydrochloride
Tetracef
Cefepime Hydrochloride
Indications
Urinary tract infection
Indication detailsView
Cefepime is indicated for the treatment of the following infections caused by susceptible strains of the microorganisms:
- Pneumonia (moderate to severe): caused by Streptococcus pneumoniae, including cases associated with concurrent bacteremia, Pseudomonas aeruginosa, Klebsiella pneumoniae, or Enterobacter species.
- Febrile Neutropenia: Cefepime as monotherapy is indicated for empiric treatment of febrile neutropenic patients. In patients at high risk for severe infection (including patients with a history of recent bone marrow transplantation, with hypotension at presentation, with an underlying hematologic malignancy, or with severe or prolonged neutropenia), antimicrobial monotherapy may not be appropriate. Insufficient data exist to support the efficacy of cefepime monotherapy in such patients.
- Uncomplicated and Complicated Urinary Tract Infections (including pyelonephritis): caused by Escherichia coli or Klebsiella pneumoniae, when the infection is severe, or caused by Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis, when the infection is mild to moderate, including cases associated with concurrent bacteremia with these microorganisms.
- Uncomplicated Skin and Skin Structure Infections: caused by Staphylococcus aureus (methicillin- susceptible strains only) or Streptococcus pyogenes.
- Complicated Intra-abdominal Infections (used in combination with metronidazole): caused by Escherichia coli, viridians group streptococci, Pseudomonas aeruginosa, Klebsiella pneumoniae, Enterobacter species, or Bacteroides fragilis.
Therapeutic classView
Fourth generation Cephalosporins
PharmacologyView
Cephalosporins are bactericidal and have the same mode of action as other beta-lactam antibiotics (such as penicillins). Cephalosporins disrupt the synthesis of the peptidoglycan layer of bacterial cell walls. The peptidoglycan layer is important for cell wall structural integrity, especially in Gram-positive organisms. The final transpeptidation step in the synthesis of the peptidoglycan is facilitated by transpeptidases known as penicillin binding proteins (PBPs).
DosageView
Cefepime should be administered intravenously over approximately 30 minutes.
*including cases associated with concurrent bacteremia.
**or until resolution of neutropenia. In patients whose fever resolves but who remain neutropenic for more than 7 days, the need for continued antimicrobial therapy should be re evaluated frequently.
*** IM route of administration is indicated only for mild to moderate, uncomplicated or complicated UTls due to E. coli when the IM route is considered to be a more appropriate route of drug administration.
- Moderate to Severe Pneumonia due to S. pneumoniae, *P. aeruginosa, K. pneumoniae, or Enterobacter species: 1-2 gm IV 12 hourly for 10 days.
- Empiric therapy for febrile neutropenic patients: 2 gm IV 8 hourly for 7** days.
- Mild to Moderate Uncomplicated or Complicated Urinary Tract Infections, including pyelonephritis, due to E. coli, K. pneumoniae, or P. mirabilis*: 0.5-1 gm IV/IM*** 12 hourly for 7-10 days.
- Severe Uncomplicated or Complicated Urinary Tract Infections, including pyelonephritis, due to E. coli or K. pneumoniae*: 2 gm IV 12 hourly for 10 days.
- Moderate to Severe Uncomplicated Skin and Skin Structure Infections due to S. aureus or S. pyogenes: 2 gm IV 12 hourly for 10 days.
- Complicated Intra-abdominal Infections (used in combination with metronidazole) caused by E. coli, viridans group streptococci, P. aeruginosa, K. pneumoniae, Enterobacter species, or B. fragilis: 2 gm IV 12 hourly for 7-10 days.
*including cases associated with concurrent bacteremia.
**or until resolution of neutropenia. In patients whose fever resolves but who remain neutropenic for more than 7 days, the need for continued antimicrobial therapy should be re evaluated frequently.
*** IM route of administration is indicated only for mild to moderate, uncomplicated or complicated UTls due to E. coli when the IM route is considered to be a more appropriate route of drug administration.
Side effectsView
Cefepime is contraindicated in patients who have shown immediate hypersensitivity reactions to cefepime or the cephalosporin class of antibiotics, penicillin, or other betalactum antibiotics.
ContraindicationsView
Cefepime is contraindicated in patients who have shown immediate hypersensitivity reactions to cefepime or the cephalosporin class of antibiotics, penicillin, or other betalactum antibiotics.
PrecautionsView
- Prescribing Cefepime in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.
- As with other antimicrobials, prolonged use of Cefepime may result in overgrowth of non susceptible microorganisms. Repeated evaluation of the patient's condition is essential.
- Many cephalosporins, including cefepime, have been associated with a fall in prothrombin activity. Those at risk include patients with renal or hepatic impairment, or poor nutritional state, as well as patients receiving a protracted course of antimicrobial therapy. Prothrombin time should be monitored in patients at risk.
- Cefepime should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis.
- Arginine has been shown to alter glucose metabolism and elevate serum potassium transiently when administered at 33 times the amount provided by the maximum recommended human dose of Cefepime. The effect of lower doses is not presently known.
InteractionsView
Renal function should be monitored carefully if high doses of aminoglycosides are to be administered with Cefepime because of the increased potential of nephrotoxicity and ototoxicity of aminoglycoside antibiotics. Nephrotoxicity has been reported following concomitant administration of other cephalosporins with potent diuretics such as furosemide.
Pregnancy & lactationView
Pregnancy Category B. There are, however, no adequate and well-controlled studies of cefepime use in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Cefepime is excreted in human breast milk in very low concentrations (0.5 pg/ml). Caution should be exercised when cefepime is administered to a nursing woman.
Pediatric usageView
Pediatric Use (2 months up to 16 years): The maximum dose for pediatric patients should not exceed the recommended adult dose. The usual recommended dosage in pediatric patients up to 40 kg in weight for uncomplicated and complicated urinary tract infections (including pyelonephritis), uncomplicated skin and skin structure infections, and pneumonia is 50 mg/kg/dose, administered every 12 hours (50 mg/kg/dose, every 8 hours for febrile neutropenic patients), for durations as given above.
Geriatric Use: Serious adverse events have occurred in geriatric patients with renal insufficiency given unadjusted doses of cefepime, including life-threatening or fatal occurrences of the following: encephalopathy, myoclonus, and seizures. This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and renal function should be monitored.
Impaired Hepatic Function: No adjustment is necessary for patients with impaired hepatic function.
Impaired Renal Function: In patients with impaired renal function (creatinine clearance<60 ml/min), the dose of Cefepime should be adjusted to compensate for the slower rate of renal elimination.
Geriatric Use: Serious adverse events have occurred in geriatric patients with renal insufficiency given unadjusted doses of cefepime, including life-threatening or fatal occurrences of the following: encephalopathy, myoclonus, and seizures. This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and renal function should be monitored.
Impaired Hepatic Function: No adjustment is necessary for patients with impaired hepatic function.
Impaired Renal Function: In patients with impaired renal function (creatinine clearance<60 ml/min), the dose of Cefepime should be adjusted to compensate for the slower rate of renal elimination.
Overdose effectsView
Patients who receive an overdose should be carefully observed and given supportive treatment. In the presence of renal insufficiency, hemodialysis, not peritoneal dialysis, is recommended to aid the removal of cefepime from the body. Accidental overdosing has occurred when large doses were given to patients with impaired renal function. Symptoms of overdose include encephalopathy (disturbance of consciousness including confusion, hallucinations, stupor, and coma), myoclonus, seizures, and neuromuscular excitability.
ReconstitutionView
For IV the resulting solution should be injected directly into the vein over a period of three to five minutes or injected into the tubing of an administration set while the patient is receiving a compatible IV fluid.
Intravenous: Cefepime is compatible with Sterile Water for Injection. It is also compatible at concentrations between 1 mg/ml and 40 mg/ml with the following IV infusion fluids: 0.9% Sodium Chloride Injection, 5% and 10% Dextrose Injection, M/6 Sodium Lactate Injection, 5% Dextrose and 0.9% Sodium Chloride Injection, Lactated Ringers and 5% Dextrose Injection.
Intramuscular: Cefepime is compatible with the following diluent such as: Sterile Water for Injection, 0.9% Sodium Chloride Injection, 5% Dextrose Injection, Sterile Bacteriostatic Water for Injection with Parabens or Benzyl Alcohol or 0.5% or 1% Lidocaine Hydrochloride.
500 mg (IV) vials for intravenous administration:
Intravenous: Cefepime is compatible with Sterile Water for Injection. It is also compatible at concentrations between 1 mg/ml and 40 mg/ml with the following IV infusion fluids: 0.9% Sodium Chloride Injection, 5% and 10% Dextrose Injection, M/6 Sodium Lactate Injection, 5% Dextrose and 0.9% Sodium Chloride Injection, Lactated Ringers and 5% Dextrose Injection.
Intramuscular: Cefepime is compatible with the following diluent such as: Sterile Water for Injection, 0.9% Sodium Chloride Injection, 5% Dextrose Injection, Sterile Bacteriostatic Water for Injection with Parabens or Benzyl Alcohol or 0.5% or 1% Lidocaine Hydrochloride.
500 mg (IV) vials for intravenous administration:
- Amount of WFI to be added: 5 ml
- Approximate available volume: 5.6 ml
- Amount of WFI to be added: 1.3 ml
- Approximate available volume: 1.8 ml
- Amount of WFI to be added: 10 ml
- Approximate available volume: 11.3 ml
- Amount of WFI to be added: 2.4 ml
- Approximate available volume: 3.6 ml
- Amount of WFI to be added: 10 ml
- Approximate available volume: 12.5 ml
StorageView
Do not use later than the date of expiry. Keep all medicines out of the reach of children. To be dispensed only on the prescription of a registered physician.
Tetracef
Cefepime Hydrochloride
Tetracef
Cefepime Hydrochloride
Indications
Urinary tract infection
Indication detailsView
Cefepime is indicated for the treatment of the following infections caused by susceptible strains of the microorganisms:
- Pneumonia (moderate to severe): caused by Streptococcus pneumoniae, including cases associated with concurrent bacteremia, Pseudomonas aeruginosa, Klebsiella pneumoniae, or Enterobacter species.
- Febrile Neutropenia: Cefepime as monotherapy is indicated for empiric treatment of febrile neutropenic patients. In patients at high risk for severe infection (including patients with a history of recent bone marrow transplantation, with hypotension at presentation, with an underlying hematologic malignancy, or with severe or prolonged neutropenia), antimicrobial monotherapy may not be appropriate. Insufficient data exist to support the efficacy of cefepime monotherapy in such patients.
- Uncomplicated and Complicated Urinary Tract Infections (including pyelonephritis): caused by Escherichia coli or Klebsiella pneumoniae, when the infection is severe, or caused by Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis, when the infection is mild to moderate, including cases associated with concurrent bacteremia with these microorganisms.
- Uncomplicated Skin and Skin Structure Infections: caused by Staphylococcus aureus (methicillin- susceptible strains only) or Streptococcus pyogenes.
- Complicated Intra-abdominal Infections (used in combination with metronidazole): caused by Escherichia coli, viridians group streptococci, Pseudomonas aeruginosa, Klebsiella pneumoniae, Enterobacter species, or Bacteroides fragilis.
Therapeutic classView
Fourth generation Cephalosporins
PharmacologyView
Cephalosporins are bactericidal and have the same mode of action as other beta-lactam antibiotics (such as penicillins). Cephalosporins disrupt the synthesis of the peptidoglycan layer of bacterial cell walls. The peptidoglycan layer is important for cell wall structural integrity, especially in Gram-positive organisms. The final transpeptidation step in the synthesis of the peptidoglycan is facilitated by transpeptidases known as penicillin binding proteins (PBPs).
DosageView
Cefepime should be administered intravenously over approximately 30 minutes.
*including cases associated with concurrent bacteremia.
**or until resolution of neutropenia. In patients whose fever resolves but who remain neutropenic for more than 7 days, the need for continued antimicrobial therapy should be re evaluated frequently.
*** IM route of administration is indicated only for mild to moderate, uncomplicated or complicated UTls due to E. coli when the IM route is considered to be a more appropriate route of drug administration.
- Moderate to Severe Pneumonia due to S. pneumoniae, *P. aeruginosa, K. pneumoniae, or Enterobacter species: 1-2 gm IV 12 hourly for 10 days.
- Empiric therapy for febrile neutropenic patients: 2 gm IV 8 hourly for 7** days.
- Mild to Moderate Uncomplicated or Complicated Urinary Tract Infections, including pyelonephritis, due to E. coli, K. pneumoniae, or P. mirabilis*: 0.5-1 gm IV/IM*** 12 hourly for 7-10 days.
- Severe Uncomplicated or Complicated Urinary Tract Infections, including pyelonephritis, due to E. coli or K. pneumoniae*: 2 gm IV 12 hourly for 10 days.
- Moderate to Severe Uncomplicated Skin and Skin Structure Infections due to S. aureus or S. pyogenes: 2 gm IV 12 hourly for 10 days.
- Complicated Intra-abdominal Infections (used in combination with metronidazole) caused by E. coli, viridans group streptococci, P. aeruginosa, K. pneumoniae, Enterobacter species, or B. fragilis: 2 gm IV 12 hourly for 7-10 days.
*including cases associated with concurrent bacteremia.
**or until resolution of neutropenia. In patients whose fever resolves but who remain neutropenic for more than 7 days, the need for continued antimicrobial therapy should be re evaluated frequently.
*** IM route of administration is indicated only for mild to moderate, uncomplicated or complicated UTls due to E. coli when the IM route is considered to be a more appropriate route of drug administration.
Side effectsView
Cefepime is contraindicated in patients who have shown immediate hypersensitivity reactions to cefepime or the cephalosporin class of antibiotics, penicillin, or other betalactum antibiotics.
ContraindicationsView
Cefepime is contraindicated in patients who have shown immediate hypersensitivity reactions to cefepime or the cephalosporin class of antibiotics, penicillin, or other betalactum antibiotics.
PrecautionsView
- Prescribing Cefepime in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.
- As with other antimicrobials, prolonged use of Cefepime may result in overgrowth of non susceptible microorganisms. Repeated evaluation of the patient's condition is essential.
- Many cephalosporins, including cefepime, have been associated with a fall in prothrombin activity. Those at risk include patients with renal or hepatic impairment, or poor nutritional state, as well as patients receiving a protracted course of antimicrobial therapy. Prothrombin time should be monitored in patients at risk.
- Cefepime should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis.
- Arginine has been shown to alter glucose metabolism and elevate serum potassium transiently when administered at 33 times the amount provided by the maximum recommended human dose of Cefepime. The effect of lower doses is not presently known.
InteractionsView
Renal function should be monitored carefully if high doses of aminoglycosides are to be administered with Cefepime because of the increased potential of nephrotoxicity and ototoxicity of aminoglycoside antibiotics. Nephrotoxicity has been reported following concomitant administration of other cephalosporins with potent diuretics such as furosemide.
Pregnancy & lactationView
Pregnancy Category B. There are, however, no adequate and well-controlled studies of cefepime use in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Cefepime is excreted in human breast milk in very low concentrations (0.5 pg/ml). Caution should be exercised when cefepime is administered to a nursing woman.
Pediatric usageView
Pediatric Use (2 months up to 16 years): The maximum dose for pediatric patients should not exceed the recommended adult dose. The usual recommended dosage in pediatric patients up to 40 kg in weight for uncomplicated and complicated urinary tract infections (including pyelonephritis), uncomplicated skin and skin structure infections, and pneumonia is 50 mg/kg/dose, administered every 12 hours (50 mg/kg/dose, every 8 hours for febrile neutropenic patients), for durations as given above.
Geriatric Use: Serious adverse events have occurred in geriatric patients with renal insufficiency given unadjusted doses of cefepime, including life-threatening or fatal occurrences of the following: encephalopathy, myoclonus, and seizures. This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and renal function should be monitored.
Impaired Hepatic Function: No adjustment is necessary for patients with impaired hepatic function.
Impaired Renal Function: In patients with impaired renal function (creatinine clearance<60 ml/min), the dose of Cefepime should be adjusted to compensate for the slower rate of renal elimination.
Geriatric Use: Serious adverse events have occurred in geriatric patients with renal insufficiency given unadjusted doses of cefepime, including life-threatening or fatal occurrences of the following: encephalopathy, myoclonus, and seizures. This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and renal function should be monitored.
Impaired Hepatic Function: No adjustment is necessary for patients with impaired hepatic function.
Impaired Renal Function: In patients with impaired renal function (creatinine clearance<60 ml/min), the dose of Cefepime should be adjusted to compensate for the slower rate of renal elimination.
Overdose effectsView
Patients who receive an overdose should be carefully observed and given supportive treatment. In the presence of renal insufficiency, hemodialysis, not peritoneal dialysis, is recommended to aid the removal of cefepime from the body. Accidental overdosing has occurred when large doses were given to patients with impaired renal function. Symptoms of overdose include encephalopathy (disturbance of consciousness including confusion, hallucinations, stupor, and coma), myoclonus, seizures, and neuromuscular excitability.
ReconstitutionView
For IV the resulting solution should be injected directly into the vein over a period of three to five minutes or injected into the tubing of an administration set while the patient is receiving a compatible IV fluid.
Intravenous: Cefepime is compatible with Sterile Water for Injection. It is also compatible at concentrations between 1 mg/ml and 40 mg/ml with the following IV infusion fluids: 0.9% Sodium Chloride Injection, 5% and 10% Dextrose Injection, M/6 Sodium Lactate Injection, 5% Dextrose and 0.9% Sodium Chloride Injection, Lactated Ringers and 5% Dextrose Injection.
Intramuscular: Cefepime is compatible with the following diluent such as: Sterile Water for Injection, 0.9% Sodium Chloride Injection, 5% Dextrose Injection, Sterile Bacteriostatic Water for Injection with Parabens or Benzyl Alcohol or 0.5% or 1% Lidocaine Hydrochloride.
500 mg (IV) vials for intravenous administration:
Intravenous: Cefepime is compatible with Sterile Water for Injection. It is also compatible at concentrations between 1 mg/ml and 40 mg/ml with the following IV infusion fluids: 0.9% Sodium Chloride Injection, 5% and 10% Dextrose Injection, M/6 Sodium Lactate Injection, 5% Dextrose and 0.9% Sodium Chloride Injection, Lactated Ringers and 5% Dextrose Injection.
Intramuscular: Cefepime is compatible with the following diluent such as: Sterile Water for Injection, 0.9% Sodium Chloride Injection, 5% Dextrose Injection, Sterile Bacteriostatic Water for Injection with Parabens or Benzyl Alcohol or 0.5% or 1% Lidocaine Hydrochloride.
500 mg (IV) vials for intravenous administration:
- Amount of WFI to be added: 5 ml
- Approximate available volume: 5.6 ml
- Amount of WFI to be added: 1.3 ml
- Approximate available volume: 1.8 ml
- Amount of WFI to be added: 10 ml
- Approximate available volume: 11.3 ml
- Amount of WFI to be added: 2.4 ml
- Approximate available volume: 3.6 ml
- Amount of WFI to be added: 10 ml
- Approximate available volume: 12.5 ml
StorageView
Do not use later than the date of expiry. Keep all medicines out of the reach of children. To be dispensed only on the prescription of a registered physician.
Tetracef
Cefepime Hydrochloride
Tetracef
Cefepime Hydrochloride
Indications
Urinary tract infection
Indication detailsView
Cefepime is indicated for the treatment of the following infections caused by susceptible strains of the microorganisms:
- Pneumonia (moderate to severe): caused by Streptococcus pneumoniae, including cases associated with concurrent bacteremia, Pseudomonas aeruginosa, Klebsiella pneumoniae, or Enterobacter species.
- Febrile Neutropenia: Cefepime as monotherapy is indicated for empiric treatment of febrile neutropenic patients. In patients at high risk for severe infection (including patients with a history of recent bone marrow transplantation, with hypotension at presentation, with an underlying hematologic malignancy, or with severe or prolonged neutropenia), antimicrobial monotherapy may not be appropriate. Insufficient data exist to support the efficacy of cefepime monotherapy in such patients.
- Uncomplicated and Complicated Urinary Tract Infections (including pyelonephritis): caused by Escherichia coli or Klebsiella pneumoniae, when the infection is severe, or caused by Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis, when the infection is mild to moderate, including cases associated with concurrent bacteremia with these microorganisms.
- Uncomplicated Skin and Skin Structure Infections: caused by Staphylococcus aureus (methicillin- susceptible strains only) or Streptococcus pyogenes.
- Complicated Intra-abdominal Infections (used in combination with metronidazole): caused by Escherichia coli, viridians group streptococci, Pseudomonas aeruginosa, Klebsiella pneumoniae, Enterobacter species, or Bacteroides fragilis.
Therapeutic classView
Fourth generation Cephalosporins
PharmacologyView
Cephalosporins are bactericidal and have the same mode of action as other beta-lactam antibiotics (such as penicillins). Cephalosporins disrupt the synthesis of the peptidoglycan layer of bacterial cell walls. The peptidoglycan layer is important for cell wall structural integrity, especially in Gram-positive organisms. The final transpeptidation step in the synthesis of the peptidoglycan is facilitated by transpeptidases known as penicillin binding proteins (PBPs).
DosageView
Cefepime should be administered intravenously over approximately 30 minutes.
*including cases associated with concurrent bacteremia.
**or until resolution of neutropenia. In patients whose fever resolves but who remain neutropenic for more than 7 days, the need for continued antimicrobial therapy should be re evaluated frequently.
*** IM route of administration is indicated only for mild to moderate, uncomplicated or complicated UTls due to E. coli when the IM route is considered to be a more appropriate route of drug administration.
- Moderate to Severe Pneumonia due to S. pneumoniae, *P. aeruginosa, K. pneumoniae, or Enterobacter species: 1-2 gm IV 12 hourly for 10 days.
- Empiric therapy for febrile neutropenic patients: 2 gm IV 8 hourly for 7** days.
- Mild to Moderate Uncomplicated or Complicated Urinary Tract Infections, including pyelonephritis, due to E. coli, K. pneumoniae, or P. mirabilis*: 0.5-1 gm IV/IM*** 12 hourly for 7-10 days.
- Severe Uncomplicated or Complicated Urinary Tract Infections, including pyelonephritis, due to E. coli or K. pneumoniae*: 2 gm IV 12 hourly for 10 days.
- Moderate to Severe Uncomplicated Skin and Skin Structure Infections due to S. aureus or S. pyogenes: 2 gm IV 12 hourly for 10 days.
- Complicated Intra-abdominal Infections (used in combination with metronidazole) caused by E. coli, viridans group streptococci, P. aeruginosa, K. pneumoniae, Enterobacter species, or B. fragilis: 2 gm IV 12 hourly for 7-10 days.
*including cases associated with concurrent bacteremia.
**or until resolution of neutropenia. In patients whose fever resolves but who remain neutropenic for more than 7 days, the need for continued antimicrobial therapy should be re evaluated frequently.
*** IM route of administration is indicated only for mild to moderate, uncomplicated or complicated UTls due to E. coli when the IM route is considered to be a more appropriate route of drug administration.
Side effectsView
Cefepime is contraindicated in patients who have shown immediate hypersensitivity reactions to cefepime or the cephalosporin class of antibiotics, penicillin, or other betalactum antibiotics.
ContraindicationsView
Cefepime is contraindicated in patients who have shown immediate hypersensitivity reactions to cefepime or the cephalosporin class of antibiotics, penicillin, or other betalactum antibiotics.
PrecautionsView
- Prescribing Cefepime in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.
- As with other antimicrobials, prolonged use of Cefepime may result in overgrowth of non susceptible microorganisms. Repeated evaluation of the patient's condition is essential.
- Many cephalosporins, including cefepime, have been associated with a fall in prothrombin activity. Those at risk include patients with renal or hepatic impairment, or poor nutritional state, as well as patients receiving a protracted course of antimicrobial therapy. Prothrombin time should be monitored in patients at risk.
- Cefepime should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis.
- Arginine has been shown to alter glucose metabolism and elevate serum potassium transiently when administered at 33 times the amount provided by the maximum recommended human dose of Cefepime. The effect of lower doses is not presently known.
InteractionsView
Renal function should be monitored carefully if high doses of aminoglycosides are to be administered with Cefepime because of the increased potential of nephrotoxicity and ototoxicity of aminoglycoside antibiotics. Nephrotoxicity has been reported following concomitant administration of other cephalosporins with potent diuretics such as furosemide.
Pregnancy & lactationView
Pregnancy Category B. There are, however, no adequate and well-controlled studies of cefepime use in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Cefepime is excreted in human breast milk in very low concentrations (0.5 pg/ml). Caution should be exercised when cefepime is administered to a nursing woman.
Pediatric usageView
Pediatric Use (2 months up to 16 years): The maximum dose for pediatric patients should not exceed the recommended adult dose. The usual recommended dosage in pediatric patients up to 40 kg in weight for uncomplicated and complicated urinary tract infections (including pyelonephritis), uncomplicated skin and skin structure infections, and pneumonia is 50 mg/kg/dose, administered every 12 hours (50 mg/kg/dose, every 8 hours for febrile neutropenic patients), for durations as given above.
Geriatric Use: Serious adverse events have occurred in geriatric patients with renal insufficiency given unadjusted doses of cefepime, including life-threatening or fatal occurrences of the following: encephalopathy, myoclonus, and seizures. This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and renal function should be monitored.
Impaired Hepatic Function: No adjustment is necessary for patients with impaired hepatic function.
Impaired Renal Function: In patients with impaired renal function (creatinine clearance<60 ml/min), the dose of Cefepime should be adjusted to compensate for the slower rate of renal elimination.
Geriatric Use: Serious adverse events have occurred in geriatric patients with renal insufficiency given unadjusted doses of cefepime, including life-threatening or fatal occurrences of the following: encephalopathy, myoclonus, and seizures. This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and renal function should be monitored.
Impaired Hepatic Function: No adjustment is necessary for patients with impaired hepatic function.
Impaired Renal Function: In patients with impaired renal function (creatinine clearance<60 ml/min), the dose of Cefepime should be adjusted to compensate for the slower rate of renal elimination.
Overdose effectsView
Patients who receive an overdose should be carefully observed and given supportive treatment. In the presence of renal insufficiency, hemodialysis, not peritoneal dialysis, is recommended to aid the removal of cefepime from the body. Accidental overdosing has occurred when large doses were given to patients with impaired renal function. Symptoms of overdose include encephalopathy (disturbance of consciousness including confusion, hallucinations, stupor, and coma), myoclonus, seizures, and neuromuscular excitability.
ReconstitutionView
For IV the resulting solution should be injected directly into the vein over a period of three to five minutes or injected into the tubing of an administration set while the patient is receiving a compatible IV fluid.
Intravenous: Cefepime is compatible with Sterile Water for Injection. It is also compatible at concentrations between 1 mg/ml and 40 mg/ml with the following IV infusion fluids: 0.9% Sodium Chloride Injection, 5% and 10% Dextrose Injection, M/6 Sodium Lactate Injection, 5% Dextrose and 0.9% Sodium Chloride Injection, Lactated Ringers and 5% Dextrose Injection.
Intramuscular: Cefepime is compatible with the following diluent such as: Sterile Water for Injection, 0.9% Sodium Chloride Injection, 5% Dextrose Injection, Sterile Bacteriostatic Water for Injection with Parabens or Benzyl Alcohol or 0.5% or 1% Lidocaine Hydrochloride.
500 mg (IV) vials for intravenous administration:
Intravenous: Cefepime is compatible with Sterile Water for Injection. It is also compatible at concentrations between 1 mg/ml and 40 mg/ml with the following IV infusion fluids: 0.9% Sodium Chloride Injection, 5% and 10% Dextrose Injection, M/6 Sodium Lactate Injection, 5% Dextrose and 0.9% Sodium Chloride Injection, Lactated Ringers and 5% Dextrose Injection.
Intramuscular: Cefepime is compatible with the following diluent such as: Sterile Water for Injection, 0.9% Sodium Chloride Injection, 5% Dextrose Injection, Sterile Bacteriostatic Water for Injection with Parabens or Benzyl Alcohol or 0.5% or 1% Lidocaine Hydrochloride.
500 mg (IV) vials for intravenous administration:
- Amount of WFI to be added: 5 ml
- Approximate available volume: 5.6 ml
- Amount of WFI to be added: 1.3 ml
- Approximate available volume: 1.8 ml
- Amount of WFI to be added: 10 ml
- Approximate available volume: 11.3 ml
- Amount of WFI to be added: 2.4 ml
- Approximate available volume: 3.6 ml
- Amount of WFI to be added: 10 ml
- Approximate available volume: 12.5 ml
StorageView
Do not use later than the date of expiry. Keep all medicines out of the reach of children. To be dispensed only on the prescription of a registered physician.
Tetracillin
Tetracycline Hydrochloride (Oral)
Tetracillin
Tetracycline Hydrochloride (Oral)
Indications
Uncomplicated gonorrhoea
Indication detailsView
Tetracycline is the drug of choice in the following infections :
- Ricketsial infection (Rocky Mountain spotted fever, endemic and scrub typhus fever and human ehrlichiosis).
- Mycoplasma pneumoniae infections in adults. Outbreaks of pneumonia caused by this organism are common in barracks and institutions. Most cases occur in children and young adults. Maculopapular rashes, haemolytic anaemia and meningo-encephalitis occur rarely.
- Chlamydial Infections: Chlamydia psittaci: This organism is the cause of psittacosis (ornithosis), a systemic illness contracted from infected birds. The pneumonia associated with it may be extensive, and severe systemic upset and death are common.Headache is a prominent early symptom.
- Non-gonococcal or non specific urethritis: Inflammation of the urethra not resulting from gonococcal, chlamydial, or other specific infectious agents.
- Lyme disease
- Brucellosis
- Miscellaneous infections, including granuloma inguinale, cholera, glanders, relapsing fever and V. vulnifians.
- Urinary Tract Infections with susceptible organisms (including the acute urethral syndrome in women).
- Bronchitis in patients with known underlying chronic lung diseases.
- Pelvic inflammatory disease and other sexually transmitted diseases (STDs) regimen.
- Travelers diarrhoea.
- Acne vulgaris
- Prostatitis.
- As an alternative agent in the penicillin allergic patient with syphilis.
- Anaerobic infections with susceptible organisms.
Therapeutic classView
Tetracycline group of drugs
PharmacologyView
Tetracycline has its main mechanism of action on protein synthesis, and an energy-dependent active transport system pumps the drug through the inner cytoplasmic membrane of bacteria. Once inside the bacterial cell, Tetracycline binds specifically to the 30s ribosomes and inhibit bacterial protein synthesis.
Many Gram positive aerobic Cocci are susceptible, but many strains of staphylococci, streptococci and even some pneumococci are resistant to Tetracycline. Thus, tetracycline is not the drug of choice in infections due to gram positive aerobes.
Pseudomonas and many Enterobacteriaceae are resistant. Urinary concentrations are adequate for some community - acquired E. coli and consequently, Tetracycline is still used in uncomplicated initial UTIs. Tetracycline is also active against and is the drug of choice for Brucella species, Calymmatobacterium granulomatis, Vibrio cholerae and V. vulnificus.
Tetracycline is also active against anaerobic species of bacteria and since concentrations of the drug are quite high in the gastrointestinal contents, the enteric flora are usually altered by the drug.
Tetracycline is incompletely absorbed from the gastro-intestinal tract, about 60 to 80% of a dose of tetracycline usually being available. It is widely distributed through the body tissues and fluids.
Tetracycline has a half-life of about 12 hours. It is excreted in the urine and in the faeces.
Many Gram positive aerobic Cocci are susceptible, but many strains of staphylococci, streptococci and even some pneumococci are resistant to Tetracycline. Thus, tetracycline is not the drug of choice in infections due to gram positive aerobes.
Pseudomonas and many Enterobacteriaceae are resistant. Urinary concentrations are adequate for some community - acquired E. coli and consequently, Tetracycline is still used in uncomplicated initial UTIs. Tetracycline is also active against and is the drug of choice for Brucella species, Calymmatobacterium granulomatis, Vibrio cholerae and V. vulnificus.
Tetracycline is also active against anaerobic species of bacteria and since concentrations of the drug are quite high in the gastrointestinal contents, the enteric flora are usually altered by the drug.
Tetracycline is incompletely absorbed from the gastro-intestinal tract, about 60 to 80% of a dose of tetracycline usually being available. It is widely distributed through the body tissues and fluids.
Tetracycline has a half-life of about 12 hours. It is excreted in the urine and in the faeces.
DosageView
The usual adult oral dosage of Tetracycline is 1-2 g daily given in 2-4 divided doses. The usual oral dosage of Tetracycline for children older than 8 years of age in 25-50 mg/kg daily given in 2-4 divided doses. Alternatively some clinicians recommended that children should receive 0.6-1.2 g/m2 daily.
Tetracycline should be taken preferably one hour before or 2 hours after meals.
Some specific indications along with some information on dosage is given below:
Acne vulgaris: 250 mg four times daily or 500 mg 12 hourly for 1 week; 125-250 mg for several weeks or months. Duration of therapy is determined by individual progress
Acute staphylococcal infections: 1-2 g daily in divided doses for 10-14 days
Acute streptococcal infections: 1-2 g daily in divided doses for 10 days. Prolonged therapy is needed to avoid risk of rheumatic fever or glomerulonephritis
Amoebiasis: 1 g daily in four divided doses or 500 mg 12 hourly for 7 days. Given in association with amoebicidal agents
Brucellosis: 500 mg four times daily plus 1 g streptomycin twice daily for 1 week ; then 500 mg four times daily (no streptomycin) for 1 week. Prolonged therapy is necessary to avoid relapse
Subacute bacterial endocarditis: 1-2 g daily in divided doses for 6 weeks. Usually given in combination with a bactericidal agent
Syphilis: Total 30-40 g given in divided doses over 10-15 days. Serology and spinal fluid examination should follow the administration of tetracycline
Tetracycline should be taken preferably one hour before or 2 hours after meals.
Some specific indications along with some information on dosage is given below:
Acne vulgaris: 250 mg four times daily or 500 mg 12 hourly for 1 week; 125-250 mg for several weeks or months. Duration of therapy is determined by individual progress
Acute staphylococcal infections: 1-2 g daily in divided doses for 10-14 days
Acute streptococcal infections: 1-2 g daily in divided doses for 10 days. Prolonged therapy is needed to avoid risk of rheumatic fever or glomerulonephritis
Amoebiasis: 1 g daily in four divided doses or 500 mg 12 hourly for 7 days. Given in association with amoebicidal agents
Brucellosis: 500 mg four times daily plus 1 g streptomycin twice daily for 1 week ; then 500 mg four times daily (no streptomycin) for 1 week. Prolonged therapy is necessary to avoid relapse
Subacute bacterial endocarditis: 1-2 g daily in divided doses for 6 weeks. Usually given in combination with a bactericidal agent
Syphilis: Total 30-40 g given in divided doses over 10-15 days. Serology and spinal fluid examination should follow the administration of tetracycline
Side effectsView
Teeth and bone: Tetracycline can cause depression of bone growth, permanent graybrown discoloration of the teeth and enamel hypoplasia when given during tooth development (i.e. during the later half of pregnancy, during infancy and in childhood).
Hypersensitivity reactions such as anaphylaxis, urticaria and rashes are uncommon. Photosensitivity reactions consisting of a red rash on areas exposed to intense sunlight can occur with Tetracycline.
Gastrointestinal effects: Epigastric distress and nausea are commonly seen after oral administration, and these symptoms are somewhat dose related. Vomiting can occur.
Accentuated prerenal azotemia: Tetracycline appears to aggravate pre-existing renal failure by inhibiting protein synthesis, which increases the azotemia from amino acid metabolism.
Superinfections with oral and anogenital candidiasis are relatively common in patients taking Tetracycline.
Esophageal ulcerations: In most cases, the patients were taking the capsules with little or no fluid before going to bed. To help minimize this, oral doses should be given with adequate amounts of fluid.
Hypersensitivity reactions such as anaphylaxis, urticaria and rashes are uncommon. Photosensitivity reactions consisting of a red rash on areas exposed to intense sunlight can occur with Tetracycline.
Gastrointestinal effects: Epigastric distress and nausea are commonly seen after oral administration, and these symptoms are somewhat dose related. Vomiting can occur.
Accentuated prerenal azotemia: Tetracycline appears to aggravate pre-existing renal failure by inhibiting protein synthesis, which increases the azotemia from amino acid metabolism.
Superinfections with oral and anogenital candidiasis are relatively common in patients taking Tetracycline.
Esophageal ulcerations: In most cases, the patients were taking the capsules with little or no fluid before going to bed. To help minimize this, oral doses should be given with adequate amounts of fluid.
ContraindicationsView
Tetracycline Hydrochloride is contraindicated in patients hypersensitive to any of the member of tetracycline groups, since cross-sensitivity may occur Tetracycline Hydrochloride should be avoided in patients with systemic lupus erythematosus. Tetracycline Hydrochloride is considered to be contraindicated in renal impairment, particularly if severe ; if it must be given, doses should be reduced.
PrecautionsView
Care should be taken if Tetracycline Hydrochloride is given to patients with impaired liver function and high doses should be avoided. Potentiality hepatotoxic drugs (including erythromycin, chloramphenicol, isoniazide and sulphonamides) should not be given concomitantly.
InteractionsView
Impaired absorption with antacids containing divalent and trivalent cations (e.g. Al, Ca, Mg), Fe, Zn and Na bicarbonate preparations, kaolin-pectin, bismuth subsalicylate, sucralfate, strontium ranelate, colestipol and colestyramine. May interfere with the bactericidal action of penicillin. May potentiate the effect of anticoagulants. May decrease efficacy of oral contraceptives. Nephrotoxic effects may be exacerbated by diuretics or other nephrotoxic drugs. May increase the hypoglycaemic effect of insulin and sulfonylureas in patients with DM. May increase toxic effects of ergot alkaloids and methotrexate.
Pregnancy & lactationView
Tetracycline should not be used during pregnancy because of the risk of hypertoxicity in the mother as well as the effects on the developing foetus. Use in pregnancy potentially during breast-feeding and in children up to the age of 8, or some authorise say 12 years, may result in impaired bone growth and permanent discoloration of the child's teeth.
StorageView
Store between 20-25° C.