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Sertraline is indicated for the treatment of-

• Major depressive disorder (MDD)
• Obsessive-compulsive disorder (OCD)
• Panic disorder (PD)
• Post-traumatic stress disorder (PTSD)
• Social anxiety disorder (SAD)
• Premenstrual dysphoric disorder (PMDD).

SSRIs & related anti-depressant drugs

Sertraline has potent and selective inhibitory action on CNS neuronal reuptake of 5-HT resulting in increased 5-HT concentrations at the synaptic clefts, leading to facilitation of its sustained activity at the postsynaptic receptor sites. It ultimately results in an improvement of depression. Reduction of Serotonin turnover in brain by Sertraline is also another contributing fact implicated in its action. Its prolonged elimination half-life offers a benefit of once daily administration.

Adults-
Major depressive disorder:

• Starting Dose: 50 mg
• Therapeutic Range: 50-200 mg

Obsessive-compulsive disorder:

• Starting Dose: 50 mg
• Therapeutic Range: 50-200 mg

Panic disorder, Post-traumatic stress disorder, Social anxiety disorder:

• Starting Dose: 25 mg
• Therapeutic Range: 50-200 mg

Pediatric Patients (ages 6-12 years old)-
Obsessive-compulsive disorder:

• Starting Dose: 25 mg
• Therapeutic Range: 50-200 mg

The recommended interval between dose changes is one week.

Premenstrual dysphoric disorder (PMDD): Starting dosage for PMDD is 50 mg/day. Sertraline may be administered either continuously (every day throughout the menstrual cycle) or intermittently (starting the daily dosage 14 days prior to the anticipated onset of menstruation and continuing through the onset of menses). Intermittent dosing would be repeated with each new cycle.

• Continuous: Patients not responding to a 50 mg dosage may benefit from dosage increases at 50 mg increments per menstrual cycle up to 150 mg per day.
• Intermittent: Patients not responding to a 50 mg dosage may benefit from increasing the dosage up to a maximum of 100 mg per day during the next menstrual cycle (and subsequent cycles).

Sertraline may cause side effects like upset stomach, diarrhoea, constipation, vomiting, dry mouth, loss of appetite, weight changes, drowsiness, dizziness, headache, pain, burning or tingling in the hands or feet, excitement, sore throat etc.

Sertraline is contraindicated in patients with a known hypersensitivity to Sertraline or any of the excipients of drug. In patients with moderate to severe hepatic impairment is not recommended.

Precaution should be taken in case of liver problems, kidney diseases, seizures, heart problems and any allergies. This drug may cause dizziness or drowsiness. Caution should be taken in activities requiring alertness such as driving or using machinery. Caution is advised while using this product in the elderly because they may be more sensitive to the effects of the drug. Do not take this drug if you have taken monoamine oxidase inhibitor in the last five weeks. Risk of suicidal thinking and change of behavior may occur (close monitoring of the patient after 2 to 3 weeks of use is required).

Potential effects of co-administration of drugs that are highly bound to plasma proteins- As Sertraline is tightly bound to plasma protein, the administration of Sertraline to a patient taking another drug which is tightly bound to protein, (e.g. warfarin, digitoxin) may cause a shift in plasma concentrations potentially resulting in an adverse effect. Conversely adverse effects may result from displacement of protein bound Sertraline by other tightly bound drugs. Sertraline may interact with other drugs such as Cimetidine, CNS active drugs like Diazepam, Hypoglycemic drugs, Atenolol etc.

Although animal studies did not provide any evidence of teratogenicity, the safety of Sertraline during human pregnancy has not been established. Sertraline is known to be excreted in breast milk. Its effects on the nursing infant have not yet been established. If treatment with Sertraline is considered necessary, discontinuation of breast-feeding should be considered.

Do not store above 30°C. Keep out of the reach of children.

Sertraline is indicated for the treatment of-

• Major depressive disorder (MDD)
• Obsessive-compulsive disorder (OCD)
• Panic disorder (PD)
• Post-traumatic stress disorder (PTSD)
• Social anxiety disorder (SAD)
• Premenstrual dysphoric disorder (PMDD).

SSRIs & related anti-depressant drugs

Sertraline has potent and selective inhibitory action on CNS neuronal reuptake of 5-HT resulting in increased 5-HT concentrations at the synaptic clefts, leading to facilitation of its sustained activity at the postsynaptic receptor sites. It ultimately results in an improvement of depression. Reduction of Serotonin turnover in brain by Sertraline is also another contributing fact implicated in its action. Its prolonged elimination half-life offers a benefit of once daily administration.

Adults-
Major depressive disorder:

• Starting Dose: 50 mg
• Therapeutic Range: 50-200 mg

Obsessive-compulsive disorder:

• Starting Dose: 50 mg
• Therapeutic Range: 50-200 mg

Panic disorder, Post-traumatic stress disorder, Social anxiety disorder:

• Starting Dose: 25 mg
• Therapeutic Range: 50-200 mg

Pediatric Patients (ages 6-12 years old)-
Obsessive-compulsive disorder:

• Starting Dose: 25 mg
• Therapeutic Range: 50-200 mg

The recommended interval between dose changes is one week.

Premenstrual dysphoric disorder (PMDD): Starting dosage for PMDD is 50 mg/day. Sertraline may be administered either continuously (every day throughout the menstrual cycle) or intermittently (starting the daily dosage 14 days prior to the anticipated onset of menstruation and continuing through the onset of menses). Intermittent dosing would be repeated with each new cycle.

• Continuous: Patients not responding to a 50 mg dosage may benefit from dosage increases at 50 mg increments per menstrual cycle up to 150 mg per day.
• Intermittent: Patients not responding to a 50 mg dosage may benefit from increasing the dosage up to a maximum of 100 mg per day during the next menstrual cycle (and subsequent cycles).

Sertraline may cause side effects like upset stomach, diarrhoea, constipation, vomiting, dry mouth, loss of appetite, weight changes, drowsiness, dizziness, headache, pain, burning or tingling in the hands or feet, excitement, sore throat etc.

Sertraline is contraindicated in patients with a known hypersensitivity to Sertraline or any of the excipients of drug. In patients with moderate to severe hepatic impairment is not recommended.

Precaution should be taken in case of liver problems, kidney diseases, seizures, heart problems and any allergies. This drug may cause dizziness or drowsiness. Caution should be taken in activities requiring alertness such as driving or using machinery. Caution is advised while using this product in the elderly because they may be more sensitive to the effects of the drug. Do not take this drug if you have taken monoamine oxidase inhibitor in the last five weeks. Risk of suicidal thinking and change of behavior may occur (close monitoring of the patient after 2 to 3 weeks of use is required).

Potential effects of co-administration of drugs that are highly bound to plasma proteins- As Sertraline is tightly bound to plasma protein, the administration of Sertraline to a patient taking another drug which is tightly bound to protein, (e.g. warfarin, digitoxin) may cause a shift in plasma concentrations potentially resulting in an adverse effect. Conversely adverse effects may result from displacement of protein bound Sertraline by other tightly bound drugs. Sertraline may interact with other drugs such as Cimetidine, CNS active drugs like Diazepam, Hypoglycemic drugs, Atenolol etc.

Although animal studies did not provide any evidence of teratogenicity, the safety of Sertraline during human pregnancy has not been established. Sertraline is known to be excreted in breast milk. Its effects on the nursing infant have not yet been established. If treatment with Sertraline is considered necessary, discontinuation of breast-feeding should be considered.

Do not store above 30°C. Keep out of the reach of children.

Deferasirox is indicated for the treatment of chronic iron overload due to blood transfusions in adult and paediatric patients (aged 2 years and over).

Antidote preparations

Deferasirox is an orally active chelator that is selective for iron (as Fe3+ ). It is a tridentate ligand that binds iron with high affinity in a 2:1 ratio. Although deferasirox has very low affinity for zinc and copper there are variable decreases in the serum concentration of these trace metals after the administration of deferasirox. The clinical significance of these decreases is uncertain.

2 years children & Adult Dose:

Chronic Iron overload: Initially, 20 mg/kg daily. Adjust dosage every 3-6 months as needed based on trends in serum ferritin concentrations (monitor monthly). Adjust dosage in increments of 5 or 10 mg/kg daily (up to maximum dosage of 30 mg/kg daily) according to the patient’s clinical response and therapeutic goals. Consider temporarily interrupting therapy if serum ferritin concentrations are consistently <500 mcg/L.

Deferasirox must be taken once daily on an empty stomach at least 30 minutes before food, preferably at the same time each day. The tablets are dispersed by stirring in a glass of water or apple or orange juice (100 to 200 mL) until a line suspension is obtained. After the suspension has been swallowed, any residue must be resuspended in a small volume of water or juice and swallowed. The tablets must not be chewed or swallowed whole. Dispersion in carbonated drinks or milk is not recommended due to foaming and slow dispersion, respectively.

Serum creatinine increase, Abdominal pain, Nausea, Vomiting, Diarrhea, Proteinuria, Pyrexia, Headache, Cough , Nasopharyngitis, Pharyngolaryngeal pain, Influenza, Rash, Respiratory tract infection, Bronchitis, ALT increased, Arthralgia, back pain, Acute tonsillitis, Rhinitis, Fatigue, Ear infection, Transaminitis, Urticaria, Anaphylaxis, Angioedema, Cytopenias, including agranulocytosis, neutropenia and thrombocytopenia; leukocytoclastic vasculitis

Creatinine clearance <40 mL/min or serum creatinine >2 times the age-appropriate upper limit of normal. High risk myelodysplastic syndrome (MDS) patients and patients with other hematological and non-hematological malignancies who are not expected to benefit from chelation therapy due to the rapid progression of their disease. Hypersensitivity to the active substance or to any of the excipients.

Moderate hepatic impairment. Children. Pregnancy and lactation.

May chelate Al when used with Al-containing antacids. Decreased exposure with colestyramine and potent inducers of UGT enzymes (e.g. carbamazepine, rifampicin, phenytoin). May increase serum concentration of CYP1A2 (e.g. duloxetine, theophylline) and CYP2C8 (e.g. repaglinide, paclitaxel) substrates, and decrease serum concentrations of CYP3A4 substrates (e.g. ciclosporin, hormonal contraceptives, simvastatin).

Pregnancy: No clinical data on exposed pregnancies are available for deferasirox. Studies in animals have shown some reproductive toxicity at maternally toxic doses. The potential risk for humans is unknown. As a precaution, it is recommended that Deferasirox not be used during pregnancy unless clearly necessary.

Breast-feeding: In animal studies, Deferasirox was found to be rapidly and extensively secreted into maternal milk. No effect on the offspring was noted. It is not known if Deferasirox is secreted into human milk. Breast-feeding while taking Deferasirox is not recommended.

Dosage Modification for Adverse Renal Effects: Interrupt therapy if a progressive increase in SCR (Serum Creatinine Concentration) beyond the ULN occurs. Once SCR returns to within normal limits, reinitiate therapy at a lower dosage followed by gradual dosage escalation if clinical beneht is expected to outweigh potential risks. Reduce dosage by 10 mg/kg daily if SCR at 2 consecutive visits increases to a level >33% above the average pretreatment value and the increase cannot be attributed to other causes.

Dosage Modifcation for Adverse Hepatic Effects: Consider dosage adjustment or interruption of therapy in patients with severe, persistent, progressive, or unexplained elevations of liver function test results.

Single doses up to 40 mg/kg in normal subjects have been well tolerated. Acute signs of overdose may include nausea, vomiting, headache, and diarrhea. Overdose may be treated by induction of emesis or by gastric lavage, and by symptomatic treatment.

Completely disperse tab by stirring in water, orange or apple juice. Disperse 1 gm in 210 ml of liq. Following admin, any residue should be resuspended in a small vol of liq.

Store at 25° C. Protect from moisture.

Deferasirox is indicated for the treatment of chronic iron overload due to blood transfusions in adult and paediatric patients (aged 2 years and over).

Antidote preparations

Deferasirox is an orally active chelator that is selective for iron (as Fe3+ ). It is a tridentate ligand that binds iron with high affinity in a 2:1 ratio. Although deferasirox has very low affinity for zinc and copper there are variable decreases in the serum concentration of these trace metals after the administration of deferasirox. The clinical significance of these decreases is uncertain.

2 years children & Adult Dose:

Chronic Iron overload: Initially, 20 mg/kg daily. Adjust dosage every 3-6 months as needed based on trends in serum ferritin concentrations (monitor monthly). Adjust dosage in increments of 5 or 10 mg/kg daily (up to maximum dosage of 30 mg/kg daily) according to the patient’s clinical response and therapeutic goals. Consider temporarily interrupting therapy if serum ferritin concentrations are consistently <500 mcg/L.

Deferasirox must be taken once daily on an empty stomach at least 30 minutes before food, preferably at the same time each day. The tablets are dispersed by stirring in a glass of water or apple or orange juice (100 to 200 mL) until a line suspension is obtained. After the suspension has been swallowed, any residue must be resuspended in a small volume of water or juice and swallowed. The tablets must not be chewed or swallowed whole. Dispersion in carbonated drinks or milk is not recommended due to foaming and slow dispersion, respectively.

Serum creatinine increase, Abdominal pain, Nausea, Vomiting, Diarrhea, Proteinuria, Pyrexia, Headache, Cough , Nasopharyngitis, Pharyngolaryngeal pain, Influenza, Rash, Respiratory tract infection, Bronchitis, ALT increased, Arthralgia, back pain, Acute tonsillitis, Rhinitis, Fatigue, Ear infection, Transaminitis, Urticaria, Anaphylaxis, Angioedema, Cytopenias, including agranulocytosis, neutropenia and thrombocytopenia; leukocytoclastic vasculitis

Creatinine clearance <40 mL/min or serum creatinine >2 times the age-appropriate upper limit of normal. High risk myelodysplastic syndrome (MDS) patients and patients with other hematological and non-hematological malignancies who are not expected to benefit from chelation therapy due to the rapid progression of their disease. Hypersensitivity to the active substance or to any of the excipients.

Moderate hepatic impairment. Children. Pregnancy and lactation.

May chelate Al when used with Al-containing antacids. Decreased exposure with colestyramine and potent inducers of UGT enzymes (e.g. carbamazepine, rifampicin, phenytoin). May increase serum concentration of CYP1A2 (e.g. duloxetine, theophylline) and CYP2C8 (e.g. repaglinide, paclitaxel) substrates, and decrease serum concentrations of CYP3A4 substrates (e.g. ciclosporin, hormonal contraceptives, simvastatin).

Pregnancy: No clinical data on exposed pregnancies are available for deferasirox. Studies in animals have shown some reproductive toxicity at maternally toxic doses. The potential risk for humans is unknown. As a precaution, it is recommended that Deferasirox not be used during pregnancy unless clearly necessary.

Breast-feeding: In animal studies, Deferasirox was found to be rapidly and extensively secreted into maternal milk. No effect on the offspring was noted. It is not known if Deferasirox is secreted into human milk. Breast-feeding while taking Deferasirox is not recommended.

Dosage Modification for Adverse Renal Effects: Interrupt therapy if a progressive increase in SCR (Serum Creatinine Concentration) beyond the ULN occurs. Once SCR returns to within normal limits, reinitiate therapy at a lower dosage followed by gradual dosage escalation if clinical beneht is expected to outweigh potential risks. Reduce dosage by 10 mg/kg daily if SCR at 2 consecutive visits increases to a level >33% above the average pretreatment value and the increase cannot be attributed to other causes.

Dosage Modifcation for Adverse Hepatic Effects: Consider dosage adjustment or interruption of therapy in patients with severe, persistent, progressive, or unexplained elevations of liver function test results.

Single doses up to 40 mg/kg in normal subjects have been well tolerated. Acute signs of overdose may include nausea, vomiting, headache, and diarrhea. Overdose may be treated by induction of emesis or by gastric lavage, and by symptomatic treatment.

Completely disperse tab by stirring in water, orange or apple juice. Disperse 1 gm in 210 ml of liq. Following admin, any residue should be resuspended in a small vol of liq.

Store at 25° C. Protect from moisture.

Lidocaine Injection is indicated-

• As a local anaesthetic for use in infiltration blockade and intravenous regional analgesia.
• For the prevention and treatment of ventricular tachyarrhythmias

Local & Surface anesthesia

Lidocaine acts mainly by inhibiting sodium influx through sodium specific ion channels in the neuronal cell membrane, in particular the so called voltage-gated sodium channels. When the influx of sodium is interrupted, an action potential cannot arise and signal conduction is inhibited. The receptor site is thought to be located at the cytoplasmic (inner) portion of the sodium channel. Lidocaine binds more readily to sodium channels in activated state, thus onset of neuronal blockade is faster in neurons that are rapidly firing. This is referred to as state dependent blockade.

The dosage is adjusted according to the response of the patient and site of administration.

Adult: For healthy adults, the maximum individual dose should not exceed 4.5mg/kg of body weight and in general it is recommended that the maximum total dose does not exceed 300 mg. Recommended doses given in the below serve only as a guide to the amount of anaesthetic required for most routine procedures.

Infiltration-

• Percutaneous: Total dose 5-300 mg
• Intravenous regional: Total dose 50-300 mg

Peripheral Nerve Blocks-

• Brachial: Total dose 225-300 mg
• Dental: Total dose 20-100 mg
• Intercostal: Total dose 30 mg
• Paravertebral: Total dose 30-50 mg

Pudenal (each side): 

• Paracervical Obstetrical analgesia: Total dose 100 mg

Sympathetic Nerve Blocks

• Cervical: Total dose 50 mg
• Lumbar: Total dose 50-100 mg

Central Neural Blocks

• Epidural: Total dose 200-300 mg [Dose determined by number of dermatomes to be anesthetized (2-3 mL/dermatome) periodically.]
• Thoracic: Total dose 200-300 mg

Lumbar

• Analgesia: Total dose 250-300 mg
• Anesthesia: Total dose 200-300 mg

Caudal

• Obstetrical analgesia: Total dose 200-300 mg
• Surgical anesthesia: Total dose 225-300 mg.

Antiarrhythmic treatment: An intravenous dose of 1 mg.kg^-1 may be given over 2 min and repeated after 5 min, but giving an infusion of 2-4 mg.min^-1 to produce a plasma level of 2-4 mg. l^-1 is a more satisfactory technique. To avoid a long delay in achieving a steady state, a loading dose of approximately 1 mg.kg^-1 is usually given intravenously over 2 min at the outset.

In common with other local anaesthetics, adverse reactions to lidocaine are rare and are usually the result of excessively high blood concentrations due to inadvertent intravascular injection, excessive dosage, rapid absorption or occasionally to hypersensitivity, idiosyncracy or diminished tolerance on the part of the patient. In such circumstances systemic effects occur involving the central nervous system and/or the cardiovascular system. CNS reactions are excitatory and/or depressant and may be characterized by nervousness, dizziness, blurred vision and tremors, followed by drowsiness, convulsions, unconsciousness and possibly respiratory arrest. Cardiovascular reactions are hypotension, myocardial depression, bradycardia and possibly cardiac arrest. Allergic reactions are extremely rare. They may be characterized by cutaneous lesions, urticaria, oedema or anaphylactoid reactions.

Known hypersensitivity to anaesthetics of the amide type.

Lidocaine for infiltration and nerve block should be employed only by clinicians who are well versed in diagnosis and management of dose-related toxicity. The safety and effectiveness of lidocaine depend on proper dosage, correct technique, adequate precautions, and readiness for emergencies. Standard text books should be consulted for specific techniques and precautions for various regional anaesthetic procedures. Resuscitative equipment, oxygen and other resuscitative drugs should be available for immediate use.

It should be used cautiously in patients with epilepsy, impaired cardiac conduction, bradycardia, impaired respiratory function and in patients with impaired hepatic function, if the dose or site of administration is likely to result in high blood levels. The effect of local anaesthetics may be reduced if an injection is made into an inflamed or infected area. Repeated doses of lidocaine may cause significant increases in blood levels with each repeated dose because of slow accumulation of the drug or its metabolites. Tolerance to elevated blood levels varies with the status of the patient. Careful and constant monitoring of cardiovascular and respiratory vital signs and the patient's state of consciousness should be accomplished after each local anaesthetic injection.

Cimetidine can impair the metabolism of lidocaine absorbed into the circulation. Elimination will be delayed and the risk of adverse reactions increased. Significant increases in plasma lidocaine concentrations have occurred during concomitant therapy with beta blockers such as propranolol, metoprolol or nadolol. It prolongs the duration of action of suxamethonium.

Although there is no evidence from animal studies of harm to the foetus, as with all drugs, it should not be given during early pregnancy unless the benefits are considered to outweigh the risks. Caution should be exercised when it is administered to a nursing woman.

Dosages in children should be reduced, commensurate with age, body-weight and physical condition. Elderly patients may be more sensitive to systemic effects and may require dose reductions.

Keep below 25°C temperature, away from light & moisture. Keep out of the reach of children.

This drug is indicated for production of local or regional anesthesia by infiltration techniques such as percutaneous injection, by peripheral nerve block techniques such as brachial plexus and intercostal and by central neural techniques such as lumbar and caudal epidural blocks, when the accepted procedures for these techniques as described in standard textbooks are observed.

Local & Surface anesthesia

Lidocaine is a local anaesthetic which decreases permeability of sodium ions, blocking induction and conduction of nerve impulses. Combination with epinephrine restricts systemic spread of lidocaine, vascular absorption and its duration of local anaesthetic effect.

Dosage depends on several factors such as route, type and extent of surgical procedure, duration of anaesthesia and patient's condition and age.

Adult: Max dose of lidocaine given with epinephrine: 7 mg/kg and not >500 mg.
Child: 3 mth-12 yr: Max dose 3 mg/kg. Ideal body weight should be used in children with high body weight.

More common side effects: Minor redness, burning, irritation, or numbness at the application site; lightheadedness; nausea.

Severe side effects: Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); confusion; dizziness; fainting; fast, slow, or irregular heartbeat; loss of consciousness; mental or mood changes; nervousness; paleness; redness or warmth of skin; ringing in the ears or hearing changes; seizures; sensation of heat or cold; shortness of breath; swelling or blistering of skin; tremors or twitching; vision changes or double vision; vomiting.

Tachycardia, hypertension, cerebral arteriosclerosis, ischaemic heart disease, IV admin, anaesthetise digits or appendages, myasthenia gravis.

Epilepsy, impaired cardiac conduction, CHE DM, closed angle glaucoma, impaired liver function (if site of admin is likely to result in high blood levels), severe renal dysfunction. Local anaesthetic effect may be reduced if injected into an inflamed or infected area. Cerebrovascular insufficiency, hyperthyroidism. Neonates, elderly, patients in poor general condition (optimise patient's condition before major block), pregnancy.

Halogenated inhalation anaesthetics; alpha or beta blocking agents; methyldopa, guanethidine; drugs with vasoconstrictor and pressor effects; antihypertensives; adrenergic neuron blockers; potassium-depleting drugs; cardiac glycosides; ephedra, yohimbe. TCAs may induce hypertension and arrhythmia.

Pregnancy Category C+B. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using epinephrine/lidocaine iontophoretic patch while you are pregnant. Epinephrine/lidocaine iontophoretic patch is found in breast milk. If you are or will be breast-feeding while you use epinephrine/lidocaine iontophoretic patch, check with your doctor. Discuss any possible risks to your baby.

Can be diluted if necessary in glucose 5%, sodium chloride 0.9% and lactated Ringer's solution.

Store at room temperature, between 20℃ to 25℃. Store away from heat and light. Keep the child-resistant envelope sealed at all times when not in use. Keep out of the reach of children and away from pets.

Eye Anti-Infectives & Antiseptics, Tetracycline group of drugs, Topical antibiotics for Acne

Oxytetracycline inhibits cell growth by inhibiting translation. It binds to the 30S ribosomal subunit and prevents the amino-acyl tRNA from binding to the A site of the ribosome. The binding is reversible in nature. Oxytetracycline is lipophilic and can easily pass through the cell membrane or passively diffuses through porin channels in the bacterial membrane.

Adults: 250-500 mg every 6 hours. Food, milk and some dairy products interfere with the absorption of Tetracyclines. So Tetracyclines should be given one hour before or two hours after meals.

Side effects of Oxytetracycline, which have been reported in some patients, are anorexia, nausea, vomiting, diarrhoea, glossitis, skin rashes and urticaria.

Oxytetracycline should not be used with patients who are hypersensitive to Tetracyclines. It should not be used in children under 12 years of age. It is contraindicated in pregnant women because of tooth staining in the fetus and possible growth retardation effects.

Oxytetracycline should be used with caution in renal impairment.

Antacids containing Aluminium, Calcium, Magnesium, Zinc or Iron salts may impair the absorption of Oxytetracycline. In long term therapy, Tetracyclines depress plasma prothrombin activity and reduced doses of concomitant anticoagulants may be necessary. A few cases of pregnancy or breakthrough bleeding have been attributed to the concurrent use of Tetracyclines or Oxytetracyclines with oral contraceptives.

Results of animal studies indicate that tetracyclines cross the placenta, are found in fetal tissues and can have toxic effects on the developing fetus. Evidence of embryotoxicity has also been noted in animals treated early in pregnancy. Tetracyclines are present in the milk of lactating women who are taking a drug in this class.

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.

Vitamin-C Preparations

vitamin C, the water-soluble vitamin, is readily absorbed from the gastrointestinal tract and is widely distributed in the body tissues. It is believed to be involved in biological oxidations and reductions used in cellular respiration. It is essential for the synthesis of collagen and intracellular material. Vitamin C deficiency develops when the dietary intake is inadequate and when increased demand is not fulfilled. Deficiency leads to the development of well defined syndrome known as scurvy, which is characterized by capillary fragility, bleeding (especially from small blood vessels and the gums), anaemia, cartilage and bone lesions and slow healing of wounds.

Oral administration-

• For the prevention of scurvy: 1 tablet daily
• For the treatment of scurvy: 1-2 tablets daily; but dose may be increased depending on the severity of the condition.
• For the reduction of risk of stroke in the elderly: 1-2 tablets daily.
• In other cases: 1 tablet daily or as directed by the physician.
• Maximum safe dose is 2000 mg daily in divided doses.

Parenteral administration-

• Vitamin C is usually administered orally. When oral administration is not feasible or when malabsorption is suspected, the drug may be administered IM, IV, or subcutaneously. When given parenterally, utilization of the vitamin reportedly is best after IM administration and that is the preferred parenteral route.
• For intravenous injection, dilution into a large volume parenteral such as Normal Saline, Water for Injection, or Glucose is recommended to minimize the adverse reactions associated with intravenous injection.
• The average protective dose of vitamin C for adults is 70 to 150 mg daily. In the presence of scurvy, doses of 300 mg to 1 g daily are recommended. However, as much as 6 g has been administered parenterally to normal adults without evidence of toxicity.
• To enhance wound healing, doses of 300 to 500 mg daily for a week or ten days both preoperatively and postoperatively are generally considered adequate, although considerably larger amounts have been recommended. In the treatment of burns, doses are governed by the extent of tissue injury. For severe burns, daily doses of 1 to 2 g are recommended. In other conditions in which the need for vitamin C is increased, three to five times the daily optimum allowances appear to be adequate.
• Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever the solution and container permit.

Vitamin C has little toxicity and only mega-doses of vitamin C may cause diarrhoea, abdominal bloating, iron over-absorption that is harmful in patients with thalassaemia, sideroblastic anemia, and haemochromatosis; hyperoxaluria, hyperuricosuria, and hemolysis in patients with glucose-6 phosphate dehydrogenase deficiency. A pregnant woman taking more than 5 gm/day may suffer fetal abortion.

Ingestion of megadose (more than 1000 mg daily) of vitamin C during pregnancy has resulted in scurvy in neonates. Vitamin C in mega-doses has been contraindicated for patients with hyperoxaluria. Vitamin C itself is a reactive substance in the redox system and can give rise to false positive reactions in certain analytical tests for glucose, uric acid, creatine and occult blood.

Potentially hazardous interactions: Ascorbic acid is incompatible in solution with aminophylline, bleomycin, erythromycin, lactobionate, nafcillin, nitrofurantoin sodium, conjugated oestrogen, sodium bicarbonate, sulphafurazole diethanolamine, chloramphenicol sodium succinate, chlorthiazide sodium and hydrocortisone sodium succinate.

Useful interactions: Ascorbic acid increases the apparent half-life of paracetamol and enhances iron absorption from the gastrointestinal tract.

The drug is safe in normal doses in pregnant women, but a daily intake of 5 gm or more is reported to have caused abortion. The drug may be taken safely during lactation.

Should be stored in a dry place below 30˚C.

Albendazole is indicated in single and mixed infestations of-

• Hookworm (Ancylostoma, Necator)
• Roundworm (Ascaris)
• Threadworm (Enterobius)
• Whipworm (Trichuris)
• Strongyloides
• Tapeworm
• Opisthorchi
• Hydatid.

Anthelmintic

Albendazole is a broad spectrum anthelmintic. Albendazole exhibits vermicidal, ovicidal and larvicidal activities. The drug is thought to exert its anthelmintic effect by blocking glucose uptake in the susceptible helminths, thereby depleting the energy level until it becomes inadequate for survival. Immobilization is followed by the parasite. These events may be a consequence of the binding and subsequent inhibition of parasite tubulin polymerization by Albendazole and its metabolites, although the drug also binds to human tubulin. Albendazole is extensively metabolized, probably in the liver. Albendazole is poorly absorbed from the gastrointestinal tract but rapidly undergoes extensive first-pass metabolism. The principal metabolite albendazole sulphoxide has anthelmintic activity and a plasma half-life of about 8.5 hrs. It is excreted in the urine together with other metabolites.

Adults & children over 2 years:

• 400 mg (1 tablet or 10 ml suspension) as a single dose in cases of Enterobius vermicularis, Trichuris trichiura, Ascaris lumbricoides, Ancylostoma duodenale and Necator americanus.
• In cases of strongyloidiasis or taeniasis, 400 mg (1 tablet or 10 ml suspension) daily should be given for 3 consecutive days. If the patient is not cured on follow-up after three weeks, a second course of treatment is indicated. 

Children of 1-2 years: Recommended dose is a single dose of 200 mg (5 ml suspension).

Children under 1 year: Not recommended.

In Hydatid disease (Echinococcosis):

• Albendazole is given by mouth with meals in a dose of 400 mg twice daily for 28 days for patients weighing over 60 kg.
• A dose of 15 mg/kg body weight daily in two divided doses (to a maximum total daily dose of 800 mg) is used for patients weighing less than 60 kg.
• For cystic echinococcosis, the 28 days course may be repeated after 14 days without treatment, to a total of 3 treatment cycles.
• For alveolar echinococcosis, cycles of 28 days of treatment followed by 14 days without treatment, may need to continue for months or years.
• In giardiasis, 400 mg (1 tablet or 10 ml suspension) once daily for five days is used.

Gastrointestinal disturbances, headache, dizziness, changes in liver enzymes, rarely reversible alopecia; rash, fever, blood disorders including leucopenia and pancytopenia reported; allergic shock if cyst leakage; convulsion and meningism in cerebral disease.

Neonates: Albendazole is not normally used in neonates.

Children: Reduction of the dose from 400 mg to 200 mg may be indicated in children weighing less than 10 kg but there are no grounds for a general reduction in dosage to children.

Pregnant woman: Albendazole should not be given during pregnancy or women thought to be pregnant. No information is available on placental transfer.

Concurrent disease: There is no evidence to suggest that dose should be altered in renal, hepatic or cardiac failure.

Blood counts and liver function tests before treatment and twice during each cycle; breastfeeding; exclude pregnancy before starting treatment. Albendazole should only be used in the treatment of Echinococcosis if there is constant medical supervision with regular monitoring of serum-transaminase concentrations and of leucocyte and platelet counts

No interaction involving Albendazole, either pharmacodynamic or pharmacokinetic, has been reported.

US FDA Pregnancy category of Albendazole is C. So, Albendazole should be avoided in pregnancy and lactation unless the potential benefits to the other outweigh the possible risks to the fetus.

Keep in a dry place, away from light and heat. Keep out of the reach of children.

D-chiro-inositol capsule is indicated for the treatment and prevention of-

• Polycystic ovary syndrome (PCOS)
• Anovulation
• Menstrual disorders such as amenorrhea
• Hyperandrogenism complaints such as hirsutism,
• Alopecia, acanthosis nigricans, acne
• Ovarian hyperthecosis.

Trophic Hormones & Related Synthetic Drugs

D-chiro-inositol is extracted by a patented process from Carob (Ceratonia siliqua) pod that mostly found in Southern Europe. Deficiency of D-chiro-inositol in peripheral tissue causes insulin resistance that leads to hyperandrogenism in ovaries which results polycystic ovary syndrome (PCOS). D-chiro-inositol helps to regulate the balance between androgen and estrogen by decreasing luteinizing hormone and serum testosterone level. It improves glucose tolerance and reduces circulating insulin. It reduces oxidative stress on follicle and decreases total cholesterol and triglyceride levels. D-chiro-inositol has been clinically proven as an effective treatment of ovarian cyst and PCOS associated metabolic disorders. It helps to improve and regulate normal ovulation after two weeks of administration. It also reduces hyperandrogenism related skin disorders like hirsutism, alopecia, acanthosis nigricans and acne. It lowers cardiovascular risk in women who are suffering from PCOS by controlling arterial pressure.

Orally 1-2 capsules daily or as advised by the physician. Duration of the treatment should be minimum 2 months.

Well tolerated in recommended dose.

Contraindicated in patient with known hypersensitivity to D-chiro-inositol.

Concurrent use with digoxin may result in increased digoxin toxicity.

Several human studies have been conducted with inositol has no clinically relevant adverse effects.

Store at temperature of below 30˚C, protect from light & moisture. Keep out of reach of children.

It is a blood purifier. Prevents itch, boils, pimples, and other skin eruptions. Also useful in syphilis and gonorrhea.

Herbal and Nutraceuticals

50 ml to be mixed with water and take once in a day.

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.

It is a blood purifier. Prevents itch, boils, pimples, and other skin eruptions. Also useful in syphilis and gonorrhea.

Herbal and Nutraceuticals

50 ml to be mixed with water and take once in a day.

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.

Macrolides

In vitro, chloramphenicol exerts mainly a bacteriostatic effect on a wide range of Gram-negative and Gram positive bacteria and is active against rickettsiae, the lymphogranuloma-psittacosis group and Vibrio cholerae. It is particularly active against Salmonella typhi and Haemophilus influenzae. The mode of actions is through interference or inhibition of protein synthesis in intact cells and cell-free systems. Antagonism has been demonstrated in vitro between chloramphenicol, erythromycin, clindamycin and lincomycin. Chloramphenicol is rapidly absorbed from the GI tract. Chloramphenicol palmitate is hydrolyzed in the GI tract and is absorbed as free chloramphenicol.

Following oral administration of a single one gram dose of chloramphenicol base to healthy adults, average peak plasma chloramphenicol concentrations of about 11 mcg/ml were attained with 1-3 hours. Cumulative dosing gave a peak of 18 mcg/ml after the fifth dose of one gram, every 6 hours. Mean serum levels were 8-14 mcg/ml over a 48 hour period.

Most of the drug is excreted in the urine. Despite the small proportion of unchanged drug excreted in the urine, the concentration of free chloramphenicol in the urine is relatively high. From 8% to 12% of the antibiotic is excreted as free chloramphenicol. The remainder is excreted as inert metabolites, mainly glucuronate. Small amounts of active drug are found in bile and feces. Chloramphenicol diffuses rapidly, but its distribution is not uniform. Highest concentrations are found in liver and kidney, and lowest concentrations are found in brain and cerebrospinal fluid (CSF). Chloramphenicol enters CSF even in the absence of meningeal inflammation, appearing in concentrations about half of those found in the blood.

Chloramphenicol, like other potent drugs, should be prescribed at recommended doses known to have therapeutic activity. Inhibition of the majority of sensitive organisms may be expected at concentrations of 5 to 20 mcg/ml. The desired concentration of active drug in serum should fall within this range over most of the treatment period. Dosage of 50 mg/kg/day divided into 4 doses at intervals of 6 hours will usually achieve and sustain levels of this order.

Except in certain circumstances (e.g. premature infants and neonates and individuals with hepatic or renal impairment) lower doses may not achieve these concentrations. Close observation of the patient should be maintained and in the event of any adverse reactions, dosage should be reduced or the drug discontinued, if other factors in the clinical situation permit.

Adults: should receive 50 mg/kg/day in divided doses [approximately one 250 mg capsule per each 4.5 kg (10 lbs) of body weight or one 500 mg capsule per each 9 kg (20 lbs) of body weight] in divided doses at 6 hour intervals. In exceptional cases, patients with infections due to moderately resistant organisms may require increased dosage up to 100 mg/kg/day to achieve serum levels inhibiting the pathogen, but these high doses should be decreased as soon as possible.

Adults with impairment of hepatic or renal function, or both, may have reduced ability to metabolize and excrete the drug. In instances of impaired metabolic processes, dosages should be adjusted accordingly.

Pediatric patients: Dosage of 50 mg/kg/day divided at 6 hour intervals is effective against most susceptible organisms. Severe infections (eg., bacteremia or meningitis), especially when adequate cerebrospinal fluid concentrations are desired, may require dosage up to 100 mg/kg/day; however, it is recommended that dosage be reduced to 50 mg/kg/day as soon as possible. Children with impaired hepatic or renal function may retain excessive amounts of the drug.

Newborn infants: A total of 25 mg/kg/day in 4 equal doses at 6-hour intervals usually produces and maintains concentrations in serum and tissues adequate to control most infections for which the drug is indicated.

Chloramphenicol is contraindicated in individuals with a history of hypersensitivity and/or toxic reaction to the product or its components. It must not be used in the treatment of trivial infections or where it is not indicated, as in colds, viral influenza, infections of the throat or as a prophylactic agent to prevent bacterial infections.

It is essential that adequate hematologic functions be closely monitored during treatment with the drug. While hematologic determinations may detect early peripheral hematologic changes, such as leukopenia, reticulocytopenia, or granulocytopenia, before they become irreversible, such determinations cannot be relied on to detect bone marrow depression prior to development of aplastic anemia

Chloramphenicol has been shown to retard the biotransformation of tolbutamide, phenytoin, and dicoumarol in man. Chloramphenicol should be used with caution if administered concomitantly with lincomycin, clindamycin, or erythromycin. In vitro experiments have demonstrated that binding sites for erythromycin, lincomycin, clindamycin and chloramphenicol overlap and competitive inhibition may occur. Rifampin therapy can reduce Chloramphenicol concentrations.

Levels exceeding 25 mcg/ml are frequently considered toxic. Chloramphenicol toxicity can be evidenced by serious hemopoietic effects such as aplastic anemia, thrombocytopenia, leukopenia, as well as increasing serum iron levels, nausea, vomiting and diarrhea. In the case of serious overdosage, charcoal hemoperfusion may be effective in removing chloramphenicol from plasma. Exchange transfusion is of questionable value following massive overdosage, especially in neonates and infants.

Store in a cool dry place. Keep bottle securely closed. Protect from light.

Ophthalmic steroid - antibiotic combined preparations

Dexamethasone is a glucocorticoid. It has an anti-inflammatory and anti-allergic action. It is used topically in the treatment of inflammatory conditions of the anterior segment of the eye. Dexamethasone is absorbed rapidly after oral administration with a half-life of about 190 minutes. Sufficient absorption may occur after topical application to the skin and eye to produce systemic effects.

Chloramphenicol is a broad spectrum bacteriostatic antibiotic active against a wide variety of gram-negative and gram-positive organisms. Chloramphenicol exerts its antibacterial effect by binding to bacterial ribosomes and inhibiting bacterial protein synthesis at an early stage

Eye:

• Bacterial Conjunctivitis: The recommended dosage regimen for the treatment of bacterial conjunctivitis is 1 to 2 drops instilled into the conjunctival sac (s) every 2 hours for 2 days and 1 or 2 drops every 4 hours for the next 5(five days) while awake.
• Corneal Ulcers: The recommended dosage regimen for the treatment of comeal ulcer is 2 drops in the affected eye (s) every 15 minutes for the first 6 hours then 2 drops into the affected eye(s) every 30 minutes for the remainder of first day. On the second day, instill 2 drops in the affected eye (s) hourly. On the 3 to 14 days, place 2 drops in the affected eye (s) every 4 hours. Treatment may be continued after 14 days if corneal re-epithelialization has not occurred.

Ear: For all infections, 2 to 3 drops every 2 to 3 hours initially. Frequency should be decreased gradually as warranted by improvement in clinical signs. Care should be taken not to discontinue therapy prematurely.

Adverse reactions seen with Chloramphenicol are transient ocular burning or discomfort and other reported reactions include stinging, redness, itching, conjunctivitis, foreign body sensation, photophobia, blurred vision, dryness and eye pain. Allergic sensitization may occur with the local use of Chloramphenicol. Elevation of intraocular pressure with possible development of glaucoma, infrequent optic nerve damage and posterior subcapsular cataract formation.

The combination is contraindicated in epithelial herpes simplex cornealis, fungal, viral, tuberculous and other infections of the eye and in glaucoma. Myelosuppression during previous exposure to Chloramphenicol. Hypersensitivity to Chloramphenicol & Dexamethasone Phosphate or to any other ingredients of the preparations.

The possibility of persistent fungal infections of the cornea should be considered after prolonged corticosteroid dosing. Prolonged use of steroids containing products may result in posterior subcapsular cataract formation and glaucoma with optic nerve damage. Intraocular pressure monitoring is needed. Prolonged use of antibiotics may result in the overgrowth of non-susceptible organisms, including fungi. If new infections appear during treatment, the drug should be discontinued and alternative therapy should be instituted.

If Chloramphenicol is absorbed from eye when taking anticoagulants e.g. warfarin, there may be an increase in the effect of this medicine. Action of Chloramphenicol will be inhibited if given simultaneously with Phenobarbital. The therapeutic efficacy of Dexamethasone may be reduced with the concomitant administration of phenytoin, phenobarbitone, ephedrine and rifampicin.

There are no adequate and well-controlled studies in pregnant women. This drug should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Caution should be exercised when Chloramphenicol and Dexamethasone ophthalmic solution is administered to a nursing mother.

Keep in a cool and dry place, away from light & keep out of the reach of children. Do not use after 30 days of first opening.

Ophthalmic steroid - antibiotic combined preparations

Dexamethasone is a glucocorticoid. It has an anti-inflammatory and anti-allergic action. It is used topically in the treatment of inflammatory conditions of the anterior segment of the eye. Dexamethasone is absorbed rapidly after oral administration with a half-life of about 190 minutes. Sufficient absorption may occur after topical application to the skin and eye to produce systemic effects.

Chloramphenicol is a broad spectrum bacteriostatic antibiotic active against a wide variety of gram-negative and gram-positive organisms. Chloramphenicol exerts its antibacterial effect by binding to bacterial ribosomes and inhibiting bacterial protein synthesis at an early stage

Eye:

• Bacterial Conjunctivitis: The recommended dosage regimen for the treatment of bacterial conjunctivitis is 1 to 2 drops instilled into the conjunctival sac (s) every 2 hours for 2 days and 1 or 2 drops every 4 hours for the next 5(five days) while awake.
• Corneal Ulcers: The recommended dosage regimen for the treatment of comeal ulcer is 2 drops in the affected eye (s) every 15 minutes for the first 6 hours then 2 drops into the affected eye(s) every 30 minutes for the remainder of first day. On the second day, instill 2 drops in the affected eye (s) hourly. On the 3 to 14 days, place 2 drops in the affected eye (s) every 4 hours. Treatment may be continued after 14 days if corneal re-epithelialization has not occurred.

Ear: For all infections, 2 to 3 drops every 2 to 3 hours initially. Frequency should be decreased gradually as warranted by improvement in clinical signs. Care should be taken not to discontinue therapy prematurely.

Adverse reactions seen with Chloramphenicol are transient ocular burning or discomfort and other reported reactions include stinging, redness, itching, conjunctivitis, foreign body sensation, photophobia, blurred vision, dryness and eye pain. Allergic sensitization may occur with the local use of Chloramphenicol. Elevation of intraocular pressure with possible development of glaucoma, infrequent optic nerve damage and posterior subcapsular cataract formation.

The combination is contraindicated in epithelial herpes simplex cornealis, fungal, viral, tuberculous and other infections of the eye and in glaucoma. Myelosuppression during previous exposure to Chloramphenicol. Hypersensitivity to Chloramphenicol & Dexamethasone Phosphate or to any other ingredients of the preparations.

The possibility of persistent fungal infections of the cornea should be considered after prolonged corticosteroid dosing. Prolonged use of steroids containing products may result in posterior subcapsular cataract formation and glaucoma with optic nerve damage. Intraocular pressure monitoring is needed. Prolonged use of antibiotics may result in the overgrowth of non-susceptible organisms, including fungi. If new infections appear during treatment, the drug should be discontinued and alternative therapy should be instituted.

If Chloramphenicol is absorbed from eye when taking anticoagulants e.g. warfarin, there may be an increase in the effect of this medicine. Action of Chloramphenicol will be inhibited if given simultaneously with Phenobarbital. The therapeutic efficacy of Dexamethasone may be reduced with the concomitant administration of phenytoin, phenobarbitone, ephedrine and rifampicin.

There are no adequate and well-controlled studies in pregnant women. This drug should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Caution should be exercised when Chloramphenicol and Dexamethasone ophthalmic solution is administered to a nursing mother.

Keep in a cool and dry place, away from light & keep out of the reach of children. Do not use after 30 days of first opening.

Macrolides

In vitro, chloramphenicol exerts mainly a bacteriostatic effect on a wide range of Gram-negative and Gram positive bacteria and is active against rickettsiae, the lymphogranuloma-psittacosis group and Vibrio cholerae. It is particularly active against Salmonella typhi and Haemophilus influenzae. The mode of actions is through interference or inhibition of protein synthesis in intact cells and cell-free systems. Antagonism has been demonstrated in vitro between chloramphenicol, erythromycin, clindamycin and lincomycin. Chloramphenicol is rapidly absorbed from the GI tract. Chloramphenicol palmitate is hydrolyzed in the GI tract and is absorbed as free chloramphenicol.

Following oral administration of a single one gram dose of chloramphenicol base to healthy adults, average peak plasma chloramphenicol concentrations of about 11 mcg/ml were attained with 1-3 hours. Cumulative dosing gave a peak of 18 mcg/ml after the fifth dose of one gram, every 6 hours. Mean serum levels were 8-14 mcg/ml over a 48 hour period.

Most of the drug is excreted in the urine. Despite the small proportion of unchanged drug excreted in the urine, the concentration of free chloramphenicol in the urine is relatively high. From 8% to 12% of the antibiotic is excreted as free chloramphenicol. The remainder is excreted as inert metabolites, mainly glucuronate. Small amounts of active drug are found in bile and feces. Chloramphenicol diffuses rapidly, but its distribution is not uniform. Highest concentrations are found in liver and kidney, and lowest concentrations are found in brain and cerebrospinal fluid (CSF). Chloramphenicol enters CSF even in the absence of meningeal inflammation, appearing in concentrations about half of those found in the blood.

Chloramphenicol, like other potent drugs, should be prescribed at recommended doses known to have therapeutic activity. Inhibition of the majority of sensitive organisms may be expected at concentrations of 5 to 20 mcg/ml. The desired concentration of active drug in serum should fall within this range over most of the treatment period. Dosage of 50 mg/kg/day divided into 4 doses at intervals of 6 hours will usually achieve and sustain levels of this order.

Except in certain circumstances (e.g. premature infants and neonates and individuals with hepatic or renal impairment) lower doses may not achieve these concentrations. Close observation of the patient should be maintained and in the event of any adverse reactions, dosage should be reduced or the drug discontinued, if other factors in the clinical situation permit.

Adults: should receive 50 mg/kg/day in divided doses [approximately one 250 mg capsule per each 4.5 kg (10 lbs) of body weight or one 500 mg capsule per each 9 kg (20 lbs) of body weight] in divided doses at 6 hour intervals. In exceptional cases, patients with infections due to moderately resistant organisms may require increased dosage up to 100 mg/kg/day to achieve serum levels inhibiting the pathogen, but these high doses should be decreased as soon as possible.

Adults with impairment of hepatic or renal function, or both, may have reduced ability to metabolize and excrete the drug. In instances of impaired metabolic processes, dosages should be adjusted accordingly.

Pediatric patients: Dosage of 50 mg/kg/day divided at 6 hour intervals is effective against most susceptible organisms. Severe infections (eg., bacteremia or meningitis), especially when adequate cerebrospinal fluid concentrations are desired, may require dosage up to 100 mg/kg/day; however, it is recommended that dosage be reduced to 50 mg/kg/day as soon as possible. Children with impaired hepatic or renal function may retain excessive amounts of the drug.

Newborn infants: A total of 25 mg/kg/day in 4 equal doses at 6-hour intervals usually produces and maintains concentrations in serum and tissues adequate to control most infections for which the drug is indicated.

Chloramphenicol is contraindicated in individuals with a history of hypersensitivity and/or toxic reaction to the product or its components. It must not be used in the treatment of trivial infections or where it is not indicated, as in colds, viral influenza, infections of the throat or as a prophylactic agent to prevent bacterial infections.

It is essential that adequate hematologic functions be closely monitored during treatment with the drug. While hematologic determinations may detect early peripheral hematologic changes, such as leukopenia, reticulocytopenia, or granulocytopenia, before they become irreversible, such determinations cannot be relied on to detect bone marrow depression prior to development of aplastic anemia

Chloramphenicol has been shown to retard the biotransformation of tolbutamide, phenytoin, and dicoumarol in man. Chloramphenicol should be used with caution if administered concomitantly with lincomycin, clindamycin, or erythromycin. In vitro experiments have demonstrated that binding sites for erythromycin, lincomycin, clindamycin and chloramphenicol overlap and competitive inhibition may occur. Rifampin therapy can reduce Chloramphenicol concentrations.

Levels exceeding 25 mcg/ml are frequently considered toxic. Chloramphenicol toxicity can be evidenced by serious hemopoietic effects such as aplastic anemia, thrombocytopenia, leukopenia, as well as increasing serum iron levels, nausea, vomiting and diarrhea. In the case of serious overdosage, charcoal hemoperfusion may be effective in removing chloramphenicol from plasma. Exchange transfusion is of questionable value following massive overdosage, especially in neonates and infants.

Store in a cool dry place. Keep bottle securely closed. Protect from light.

Macrolides

In vitro, chloramphenicol exerts mainly a bacteriostatic effect on a wide range of Gram-negative and Gram positive bacteria and is active against rickettsiae, the lymphogranuloma-psittacosis group and Vibrio cholerae. It is particularly active against Salmonella typhi and Haemophilus influenzae. The mode of actions is through interference or inhibition of protein synthesis in intact cells and cell-free systems. Antagonism has been demonstrated in vitro between chloramphenicol, erythromycin, clindamycin and lincomycin. Chloramphenicol is rapidly absorbed from the GI tract. Chloramphenicol palmitate is hydrolyzed in the GI tract and is absorbed as free chloramphenicol.

Following oral administration of a single one gram dose of chloramphenicol base to healthy adults, average peak plasma chloramphenicol concentrations of about 11 mcg/ml were attained with 1-3 hours. Cumulative dosing gave a peak of 18 mcg/ml after the fifth dose of one gram, every 6 hours. Mean serum levels were 8-14 mcg/ml over a 48 hour period.

Most of the drug is excreted in the urine. Despite the small proportion of unchanged drug excreted in the urine, the concentration of free chloramphenicol in the urine is relatively high. From 8% to 12% of the antibiotic is excreted as free chloramphenicol. The remainder is excreted as inert metabolites, mainly glucuronate. Small amounts of active drug are found in bile and feces. Chloramphenicol diffuses rapidly, but its distribution is not uniform. Highest concentrations are found in liver and kidney, and lowest concentrations are found in brain and cerebrospinal fluid (CSF). Chloramphenicol enters CSF even in the absence of meningeal inflammation, appearing in concentrations about half of those found in the blood.

Chloramphenicol, like other potent drugs, should be prescribed at recommended doses known to have therapeutic activity. Inhibition of the majority of sensitive organisms may be expected at concentrations of 5 to 20 mcg/ml. The desired concentration of active drug in serum should fall within this range over most of the treatment period. Dosage of 50 mg/kg/day divided into 4 doses at intervals of 6 hours will usually achieve and sustain levels of this order.

Except in certain circumstances (e.g. premature infants and neonates and individuals with hepatic or renal impairment) lower doses may not achieve these concentrations. Close observation of the patient should be maintained and in the event of any adverse reactions, dosage should be reduced or the drug discontinued, if other factors in the clinical situation permit.

Adults: should receive 50 mg/kg/day in divided doses [approximately one 250 mg capsule per each 4.5 kg (10 lbs) of body weight or one 500 mg capsule per each 9 kg (20 lbs) of body weight] in divided doses at 6 hour intervals. In exceptional cases, patients with infections due to moderately resistant organisms may require increased dosage up to 100 mg/kg/day to achieve serum levels inhibiting the pathogen, but these high doses should be decreased as soon as possible.

Adults with impairment of hepatic or renal function, or both, may have reduced ability to metabolize and excrete the drug. In instances of impaired metabolic processes, dosages should be adjusted accordingly.

Pediatric patients: Dosage of 50 mg/kg/day divided at 6 hour intervals is effective against most susceptible organisms. Severe infections (eg., bacteremia or meningitis), especially when adequate cerebrospinal fluid concentrations are desired, may require dosage up to 100 mg/kg/day; however, it is recommended that dosage be reduced to 50 mg/kg/day as soon as possible. Children with impaired hepatic or renal function may retain excessive amounts of the drug.

Newborn infants: A total of 25 mg/kg/day in 4 equal doses at 6-hour intervals usually produces and maintains concentrations in serum and tissues adequate to control most infections for which the drug is indicated.

Chloramphenicol is contraindicated in individuals with a history of hypersensitivity and/or toxic reaction to the product or its components. It must not be used in the treatment of trivial infections or where it is not indicated, as in colds, viral influenza, infections of the throat or as a prophylactic agent to prevent bacterial infections.

It is essential that adequate hematologic functions be closely monitored during treatment with the drug. While hematologic determinations may detect early peripheral hematologic changes, such as leukopenia, reticulocytopenia, or granulocytopenia, before they become irreversible, such determinations cannot be relied on to detect bone marrow depression prior to development of aplastic anemia

Chloramphenicol has been shown to retard the biotransformation of tolbutamide, phenytoin, and dicoumarol in man. Chloramphenicol should be used with caution if administered concomitantly with lincomycin, clindamycin, or erythromycin. In vitro experiments have demonstrated that binding sites for erythromycin, lincomycin, clindamycin and chloramphenicol overlap and competitive inhibition may occur. Rifampin therapy can reduce Chloramphenicol concentrations.

Levels exceeding 25 mcg/ml are frequently considered toxic. Chloramphenicol toxicity can be evidenced by serious hemopoietic effects such as aplastic anemia, thrombocytopenia, leukopenia, as well as increasing serum iron levels, nausea, vomiting and diarrhea. In the case of serious overdosage, charcoal hemoperfusion may be effective in removing chloramphenicol from plasma. Exchange transfusion is of questionable value following massive overdosage, especially in neonates and infants.

Store in a cool dry place. Keep bottle securely closed. Protect from light.

For the disinfection of clean and intact skin. For pre-operative surgical hand disinfection, hand disinfection on the ward prior to aseptic procedures or after handling contaminated materials. For disinfection of the patients’ skin prior to surgery or other invasive procedures

Chlorhexidine & Chloroxylenol preparations

Chlorhexidine is a very potent cationic chemoprophylactic agent that has a broad-spectrum of activity against gm+ve and gm-ve bacteria. It is both bacteriostatic and bactericidal depending on its concentration. The bactericidal effect, which is achieved at high concentrations, is due to the binding of the cationic to negatively charged bacterial cell walls and extramicrobial complexes. Bacteriostatic effect is achieved at low concentrations which causes an alteration of bacterial cell osmotic equilibrium and leakage of potassium and phosphorus.

Pre-operative surgical hand disinfection: Dispense 5 ml of solution and spread thoroughly over both hands and forearms, rubbing vigorously. When dry apply a further 5 ml and repeat the procedure.

Antiseptic hand disinfection on the ward: Dispense 3 ml of solution and spread thoroughly over the hands and wrists rubbing vigorously until dry.

Disinfection of patients skin: Prior to surgery apply the solution to a sterile swab and rub vigorously over the operation site for a minimum of 2 minutes. Chlorhexidine Gluconate is also used for preparation of the skin prior to invasive procedures such as venepuncture.

Irritative skin reactions can occasionally occur. Generalised allergic reactions have also been reported but are extremely rare

Chlorhexidine Gluconate is contraindicated for persons who have previously shown a hypersensitivity reaction to chlorhexidine. However, such reactions are extremely rare.

Avoid contact with brain, meninges, middle ear or sensitive tissues and eyes. Do not inject or use in body cavities.

Chlorhexidine is incompatible with soaps and other anionic agents. Hypochlorite bleaches may cause brown stains to develop in fabrics which have previously been in contact with chlorhexidine solutions.

No untoward effects are known

Symptoms: Pharyngeal oedema, necrotic lesions of the esophagus and elevated serum aminotransferase concentrations.

Management: Gastric lavage using milk, raw egg, gelatin or mild soap, or employ appropriate supportive measures.

Do not store above 25° C.

Chloramphenicol is indicated for the treatment of ocular infections involving the conjunctiva and/or cornea caused by chloramphenicol-susceptible organisms. Such as Staphylococcus aureus, Streptococcus pneumoniae, E.coli, H. influenzae, Klebsiella/Enterobacter spp, Moraxella lacunata, and Neisseria species.

Ear Anti-Infectives & Antiseptics, Eye Anti-Infectives & Antiseptics, Macrolides

Chloramphenicol is a broad-spectrum bacteriostatic antibiotic which acts through the inhibition of bacterial protein synthesis by interfering with the transfer of activated amino acids from soluble RNA to ribosomes.

Adult and Children: Instill 1 or 2 drops in the conjunctival sac 4-6 times per day for the first 72 hours and then every 4 hours thereafter. Treatment should be continued for approximately 7 days, but should not be continued for more than 3 weeks without re-evaluation by the physician.

The systemic adverse reaction has not been observed within short-term topical use of Chloramphenicol. The most frequently reported adverse reactions have been burning, stinging, conjunctival hyperemia, blood dyscrasia, allergic or inflammatory reactions, vesicular and maculopapular dermatitis.

It is contraindicated in individuals with a history of hypersensitivity to Chloramphenicol or any ingredients of the preparation.

Chloramphenicol ophthalmic solution should never be given for minor infections or for prophylaxis. Repeated course and prolonged treatment should be avoided. Blood dyscrasias (granulocytopenia, thrombocytopenia and moderate anaemia) may occur after prolonged ophthalmic use.

Chymotrypsin may be inhibited if given simultaneously with Chloramphenicol.

Safety for use in pregnancy and lactation has not been established. Therefore, use only when considered essential by the physicians.

Accidental ingestion of the medicine is unlikely to cause any toxicity due to low content of antibiotic.

Store in a cool (between 2°C-8°C) and dry place, protect from light, keep out of reach of children. Do not touch the dropper tip to the surface since this may contaminate the solution. Do not use after 30 days of the first opening.

Chloramphenicol is indicated for the treatment of ocular infections involving the conjunctiva and/or cornea caused by chloramphenicol-susceptible organisms. Such as Staphylococcus aureus, Streptococcus pneumoniae, E.coli, H. influenzae, Klebsiella/Enterobacter spp, Moraxella lacunata, and Neisseria species.

Ear Anti-Infectives & Antiseptics, Eye Anti-Infectives & Antiseptics, Macrolides

Chloramphenicol is a broad-spectrum bacteriostatic antibiotic which acts through the inhibition of bacterial protein synthesis by interfering with the transfer of activated amino acids from soluble RNA to ribosomes.

Adult and Children: Instill 1 or 2 drops in the conjunctival sac 4-6 times per day for the first 72 hours and then every 4 hours thereafter. Treatment should be continued for approximately 7 days, but should not be continued for more than 3 weeks without re-evaluation by the physician.

The systemic adverse reaction has not been observed within short-term topical use of Chloramphenicol. The most frequently reported adverse reactions have been burning, stinging, conjunctival hyperemia, blood dyscrasia, allergic or inflammatory reactions, vesicular and maculopapular dermatitis.

It is contraindicated in individuals with a history of hypersensitivity to Chloramphenicol or any ingredients of the preparation.

Chloramphenicol ophthalmic solution should never be given for minor infections or for prophylaxis. Repeated course and prolonged treatment should be avoided. Blood dyscrasias (granulocytopenia, thrombocytopenia and moderate anaemia) may occur after prolonged ophthalmic use.

Chymotrypsin may be inhibited if given simultaneously with Chloramphenicol.

Safety for use in pregnancy and lactation has not been established. Therefore, use only when considered essential by the physicians.

Accidental ingestion of the medicine is unlikely to cause any toxicity due to low content of antibiotic.

Store in a cool (between 2°C-8°C) and dry place, protect from light, keep out of reach of children. Do not touch the dropper tip to the surface since this may contaminate the solution. Do not use after 30 days of the first opening.