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Reutren SR
Diclofenac Sodium
Reutren SR
Diclofenac Sodium
Indications
Tendonitis
Indication detailsView
Rheumatology: Inflammatory and degenerative forms of rheumatism, chronic involutive, polyarthritis, ankylosing spondylarthritis, osteoarthritis, spondylarthroses, acute gout, peri-articular rheumatic disorders.
Surgery and Traumatology: Sprain, bruises, dislocations, fractures, softtissue injuries, surgical interventions.
Obstetrics and Gynecology: Primary dysmenorrhoea, episiotomy, adnexitis, endometritis, parametritis, salpingitis, and mastitis.
Otorhinolaryngology: As pre-operative medication for the prevention of pain, inflammation, and swelling.
Dentistry: Post-operative and post-traumatic pain, inflammation, and swelling.
Other indications: For the prevention of pain and treatment of inflammation and swelling of patients operated in the urogenital tract, renal and biliary colic.
Surgery and Traumatology: Sprain, bruises, dislocations, fractures, softtissue injuries, surgical interventions.
Obstetrics and Gynecology: Primary dysmenorrhoea, episiotomy, adnexitis, endometritis, parametritis, salpingitis, and mastitis.
Otorhinolaryngology: As pre-operative medication for the prevention of pain, inflammation, and swelling.
Dentistry: Post-operative and post-traumatic pain, inflammation, and swelling.
Other indications: For the prevention of pain and treatment of inflammation and swelling of patients operated in the urogenital tract, renal and biliary colic.
Therapeutic classView
Drugs for Osteoarthritis, Drugs used for Rheumatoid Arthritis, Non-steroidal Anti-inflammatory Drugs (NSAIDs)
PharmacologyView
Dilofenac Sodium is a potent non-steroidal anti-inflammatory drug (NSAID) with pronounced anti-rheumatic, anti-inflammatory, analgesic and antipyretic properties. It has also some uricosuric effect. Diclofenac exerts its effect by inhibiting prostaglandin biosynthesis which plays a major role in causing inflammation, pain and fever. Diclofenac is rapidly and completely absorbed from the gastro-intestinal tract when taken with or after meal. Peak plasma concentrations are reached within an average of 2 hours after ingestion of it. At therapeutic concentrations, it is 99.7% bound to plasma proteins. Diclofenac is metabolized in the liver and undergoes first pass metabolism.
DosageView
Diclofenac FC Tablet: Adults: 75-150 mg daily in 2 to 3 divided doses, preferably after food. Dose should be reduced in long term use.
Diclofenac SR Tablet:
Diclofenac Suppository: For adults: 50 mg suppository 2-3 times daily. Maximum daily dose is 150 mg.
Diclofenac injection: For adults the usual dose is 1 ampoule daily. In serious cases this dose may be increased up to 2 ampoules daily.
Diclofenac Gel: For external use only. Depending on the size of area to be treated, 2-4 g of Diclofenac gel should be applied to the skin 3-4 times daily. To the affected area gel should be rubbed in lightly. This gel may also be given in addition to further treatment with other dosage forms of Diclofenac.
Diclofenac SR Tablet:
- Adult: 1 tablet daily, taken whole with liquid, preferably at meal times. If necessary, the daily dose can be increased to 150 mg by supplementation with conventional tablets.
- Children: 1-3 mg of diclofenac/kg body wt. daily in divided doses.
- Elderly patients: In elderly or debilitated patients, the lowest effective dosage is recommended, although the pharmacokinetics of diclofenac sodium is not impaired to any clinically relevant extent in elderly patients.
- Adults: The recommended daily dosage is 2-3 tablets and the maximum daily dose is 150 mg. In milder cases, 2 tablets of Diclofenac DT per day are sufficient. Diclofenac DT should preferably be taken before meals.
- Children: Diclofenac is not recommended in children for other indications except juvenile rheumatoid arthritis where the recommended dose is 1-3 mg/kg body weight. Diclofenac DT is to be dropped into a half-glass of water and the liquid is to be stirred to aid dispersion before swallowing. There is no information on the use of Diclofenac DT for more than 03 months.
Diclofenac Suppository: For adults: 50 mg suppository 2-3 times daily. Maximum daily dose is 150 mg.
Diclofenac injection: For adults the usual dose is 1 ampoule daily. In serious cases this dose may be increased up to 2 ampoules daily.
Diclofenac Gel: For external use only. Depending on the size of area to be treated, 2-4 g of Diclofenac gel should be applied to the skin 3-4 times daily. To the affected area gel should be rubbed in lightly. This gel may also be given in addition to further treatment with other dosage forms of Diclofenac.
Side effectsView
Diclofenac Sodium is generally well tolerated. Adverse effects are mild, rare and transient. At the starting of the treatment, however, patients may be sometimes complaining of epigastric pain, eructation, nausea and diarrhea or dizziness or headache. These effects are usually mild in nature. Peripheral edema and skin reactions, such as rash and eczema have also been encountered. Diclofenac Sodium Gel may cause local irritation and reddening of the skin and skin rash.
ContraindicationsView
Contraindicated to the patients hypersensitive to any ingredient of the products. Peptic ulcer, hypersensitivity to Diclofenac like other non-steroid anti-inflammatory agents, Diclofenac is also contra-indicated in asthmatic patient in whom attack with asthma, urticaria or acute rhinitis are precipitated by acetylsalicylic acid or by other drugs with prostaglandin synthetase inhibitor. This Gel should not be used under occlusive airtight dressings.
PrecautionsView
In rare instances where peptic ulceration or gastrointestinal bleeding occurs in patients under treatment with Diclofenac. In patients with advanced age should be kept under close observation. Diclofenac Sodium Gel should not be allowed to come in contact with the eyes or mucus membranes, after application the hands should be washed properly and not to be taken by mouth.
Pregnancy & lactationView
During pregnancy, Diclofenac should be employed only for compelling reasons. The lowest effective dose should be used. These types of drugs are not recommended during the first trimester of pregnancy. In view of insufficient clinical data, Diclofenac Sodium Gel is not recommended during pregnancy. A very insignificant quantity of Diclofenac may be detected in breast milk but no undesirable effects on the infant to be expected.
StorageView
Store in a cool and dry place, protected from light. Store below 30°C. Keep out of the reach of children.
Revacin
Levofloxacin (Ophthalmic)
Revacin
Levofloxacin (Ophthalmic)
Indications
Corneal ulcer
Indication detailsView
Levofloxacin eye drops is indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following bacteria:
Aerobic Gram-Positive bacteria-
Aerobic Gram-Positive bacteria-
- Corynebacterium species
- Staphylococcus oureus
- Staphylococcus epidermidis
- Streptococcus pneumoniae
- Streptococcus (Groups C/F)
- Streptococcus (Group G)
- Streptococcus viridons group
- Acinetobocter Iwoffii
- Haemophilus influenzae
- Serrotia morcescens
Therapeutic classView
4-Quinolone preparations
PharmacologyView
Levofloxacin eye drops is a sterile topical ophthalmic solution. It is a synthetic, broad spectrum, third generation fluoroquinolone bactericidal antibiotic, which active against a broad spectrum of Gram-positive & Gram-negative ocular pathogens. It functions by inhibiting bacterial topoisomerase IV and DNA gyrase enzymes required for DNA replication, transcription, repair and recombination.
DosageView
0.5% eye drop: Adults and children 1 year of age and older:
- Days 1 and 2: Instill 1-2 drops in the affected eye(s) every 2 hours while awake, up to 8 times per day.
- Days 3 through 7: Instill 1-2 drops in the affected eye(s) every 4 hours while awake, up to 4 times per day.
- Days 1 through 3: Instill one to two drops in the affected eye(s) every 30 minutes to 2 hours while awake and approximately 4 and 6 hours after retiring.
- Day 4 through treatment completion: Instill one to two drops in the affected eye(s) every 1 to 4 hours while awake.
Side effectsView
Side effects occurred only approximately 1-3% of patients that may include transient blurred vision, fever, foreign body sensation, headache, transient ocular burning, ocular pain or discomfort, pharyngitis and photophobia. In less than 1% of patients included allergic reactions, lid edema, ocular dryness and ocular itching.
ContraindicationsView
It is contraindicated in patients with a history of hypersensitivity to Levofloxacin, to other quinolones or to any of the components of this medication
PrecautionsView
Prolonged use may result in the overgrowth of non-susceptible organisms, including fungi. If superinfection occurs, discontinue use and institute alternative therapy.
InteractionsView
Specific drug interaction studies have not been conducted with levofloxacin eye drops. But the systemic administration of some quinolones has been shown to elevate plasma concentrations of theophylline, interfere with the metabolism of caffeine and enhance the effects of the oral anticoagulant warfarin and its derivatives.
Pregnancy & lactationView
Pregnancy Category C. Levofloxacin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Levofloxacin has not been measured in human milk. Caution should be exercised when Levofloxacin eye drops is administered to a nursing mother.
StorageView
Eye drops should be protected from light, store in a cool (15°-25° C) and dry place & keep out of reach of children.
Revalon
Moxifloxacin Hydrochloride (Tablet)
Revalon
Moxifloxacin Hydrochloride (Tablet)
Indications
Acute bacterial sinusitis
Indication detailsView
Moxifloxacin is indicated for the treatment of acute bacterial sinusitis, acute exacerbation of chronic bronchitis, community acquired pneumonia, uncomplicated & complicated skin and skin structure infections, complicated intra-abdominal infections and pelvic inflammatory disease.
Therapeutic classView
4-Quinolone preparations
PharmacologyView
Moxifloxacin is a 4th generation synthetic broad spectrum, fluoroquinolone class of antibacterial drug. It has activity against a wide range of gram-positive, gram-negative, anaerobic and atypical bacteria including Mycoplasma pneumoniae. It acts by inhibiting topoisomerase II (DNA gyrase) and topoisomerase IV which are necessary for bacterial DNA replication, transcription & repair.
DosageView
Acute bacterial sinusitis: 400 mg once daily 7-10 days.
Acute bacterial exacerbation of chronic bronchitis: 400 mg once daily 5-10 days.
Community-acquired pneumonia: 400 mg once daily 7-14 days.
Uncomplicated skin and skin structure infections: 400 mg once daily 7 days.
Complicated skin and skin structure infections: 400 mg once daily 7-21 days.
Complicated intra-abdominal infections: 400 mg once daily 5-14 days.
Pelvic inflammatory disease: 400 mg once daily 14 days.
Acute bacterial exacerbation of chronic bronchitis: 400 mg once daily 5-10 days.
Community-acquired pneumonia: 400 mg once daily 7-14 days.
Uncomplicated skin and skin structure infections: 400 mg once daily 7 days.
Complicated skin and skin structure infections: 400 mg once daily 7-21 days.
Complicated intra-abdominal infections: 400 mg once daily 5-14 days.
Pelvic inflammatory disease: 400 mg once daily 14 days.
Side effectsView
Common side effects of Moxifloxacin include nausea, vomiting, diarrhea, headache and dizziness.
ContraindicationsView
It is contraindicated in patients with a history of hypersensitivity to Moxifloxacin or other quinolones.
PrecautionsView
Moxifloxacin may cause an increased risk of tendinitis and tendon rupture. It should be discontinued if pain or inflammation in a tendon occurs. It should not be used in patients with known prolongation of the QT interval, patients with uncorrected hypokalemia, and patients with receiving Class IA or Class III antiarrhythmic agents
InteractionsView
Moxifloxacin absorption is decreased when administered with antacids, sucralfate, multivitamins, and multivalent cations (e.g. iron or zinc). Moxifloxacin may enhance the risk of convulsions with NSAIDs and bleeding with warfarin. So concomitant use of Moxifloxacin with them should be avoided.
Pregnancy & lactationView
US FDA pregnancy category C. Moxifloxacin is not recommended during pregnancy & lactation.
Pediatric usageView
Renal or hepatic impaired patients: No dose adjustment is necessary for patients with renal or hepatic impairment.
Pediatric patients: Safety and effectiveness of Moxifloxacin in pediatric patients and adolescent less than 18 years of age have not been established.
Pediatric patients: Safety and effectiveness of Moxifloxacin in pediatric patients and adolescent less than 18 years of age have not been established.
StorageView
Keep in a dry place, away from light and heat. Keep out of the reach of children.
Revam Gold
Multivitamin & Multimineral [A-Z gold preparation]
Revam Gold
Multivitamin & Multimineral [A-Z gold preparation]
Indications
Vitamin deficiency
Indication detailsView
This is indicated for the prevention and treatment of vitamins & minerals deficiencies. As a complete daily nutritional supplement, it is also indicated to meet the increased demand for vitamins and minerals in the conditions like physical and emotional stress, chronic diseases, infection illness, osteoporosis, injuries or wound, surgery, poor digestion, old age, pregnancy and lactation, poor appetite, excess dieting, exposure to environmental pollution, heavy exercise etc.
Therapeutic classView
Multi-vitamin & Multi-mineral combined preparations
PharmacologyView
This is a film coated tablet, which combines 32 high potency vitamins and minerals. This preparation maintains a healthy body and active life-style.
DosageView
One tablet daily or as recommended by the physician.
Side effectsView
Generally, this preparation is well tolerated. Diarrhoea may occasionally occur during treatment with beta carotene and the skin may assume a slightly yellow discoloration. Vitamin C and vitamin E may cause diarrhoea and other gastrointestinal disturbances.
ContraindicationsView
This product is contraindicated in patients with known hypersensitivity to any of the ingredients.
PrecautionsView
Long term intake of high level of vitamin A (excluding that sourced from beta carotene) may increase the risk of osteoporosis in postmenopausal women.
InteractionsView
No drug interactions have been reported.
Pregnancy & lactationView
Recommended by the consultation with physician.
StorageView
Keep in a dry place, away from light and heat. Keep out of the reach of children.
Revam Kids
Multivitamin & Cod Liver Oil
Revam Kids
Multivitamin & Cod Liver Oil
Indications
Vitamin deficiency
Indication detailsView
Multivitamin syrup with cod-liver oil is indicated for growing children-
- It helps in the development and proper functioning of their vital organs.
- It helps to prevent vitamin deficiency and restore lost vitality after illness, in case of lack of appetite or tiredness of growing children.
- It also increases immunity and helps to maintain healthy skin, hair, nail, teeth, bone, eye and nervous system.
- Increases the resistance against cough, cold, chest and bronchial troubles.
- Helps to optimize brain development.
- In adults it helps to treat and prevent chronic diseases like heart diseases, rheumatoid arthritis, COPD, cancer etc.
- In pregnant and nursing mother it helps in proper development of the baby.
Therapeutic classView
Specific combined vitamin preparations
PharmacologyView
This preparation contains 8 essential vitamins with Cod Liver Oil. This provides extra protection for the children. It ensures for getting enough vitamins for children that help them to be grown up strong & stay healthy. Cod Liver Oil contains Vitamin A, Vitamin D, EPA & DHA. Vitamin A is essential for the immune system, bone growth, night vision, cellular growth, testicular and ovarian function, Vitamin D is essential for the absorption and utilization of calcium, which is also required for skeletal growth. EPA and DHA; omega-3 fatty acids, which are converted in the body to produce prostaglandins that affect a wide variety of physiological processes due to their modulating effect on the action of hormones. Omega-3 fatty acids relieve the symptoms of osteoarthritis, rheumatoid arthritis which also enhances immune function and promotes healthy blood circulation. It is thought that EPA and DHA may reduce the risk of coronary heart disease. DHA seems essential for normal brain development in unborn babies.
DosageView
1-12 Months: 2.5 ml (½ teaspoon) daily
1-4 Years: 5 ml (1 teaspoon) daily
4 years up: 7.5 ml (1½ teaspoon) daily
Adult: 10 ml (2 teaspoons) daily.
This syrup can be taken with water or milk.
1-4 Years: 5 ml (1 teaspoon) daily
4 years up: 7.5 ml (1½ teaspoon) daily
Adult: 10 ml (2 teaspoons) daily.
This syrup can be taken with water or milk.
Side effectsView
Generally well tolerated. However, a few allergic reactions may be seen.
ContraindicationsView
This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.
PrecautionsView
This medicine may accumulate in the body. So, should not be taken in overdose.
InteractionsView
Some drug interaction may occur with- Erythromycin, Conjugated estrogens, Sodium bicarbonate, Chloramphenicol etc.
Pregnancy & lactationView
Should be taken on physician's advice.
StorageView
Keep in cool and dry place and away from light. Keep away from children
Revam Silver
Multivitamin & Multimineral [A-Z silver preparation]
Revam Silver
Multivitamin & Multimineral [A-Z silver preparation]
Indications
Vitamin deficiency
Indication detailsView
This is specially formulated for the prevention and treatment of vitamin and mineral deficiencies for adults over 45 years of age. This Silver is also indicated to meet the increase demands of vitamin and minerals for adults over 45 years of age.
Therapeutic classView
Multi-vitamin & Multi-mineral combined preparations
PharmacologyView
This preparation is a comprehensive well-balanced multivitamin and multimineral preparation scientifically adjusted and designed to serve as the complete nutritional program for the elderly people. This preparation maintains a healthy body and active lifestyle and keeps proper nutrition covered for elderly people
DosageView
One tablet once daily with food or as indicated by the physician.
Side effectsView
Generally, this preparation is well tolerated. Allergic sensitization has been reported following oral administration of folic acid. Vitamin C and vitamin E may cause diarrhea and other gastrointestinal disturbances.
ContraindicationsView
This product is contraindicated in patients with known hypersensitivity to any of the ingredients. Do not take this product if taking other vitamin A supplements.
PrecautionsView
Long term intake of high levels of vitamin A (excluding that sourced from beta carotene) may increase the risk of osteoporosis in postmenopausal women.
InteractionsView
No drug interactions have been reported.
Pregnancy & lactationView
Recommended by the consultation with physician.
StorageView
Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
Revatol
Mahadrakkharist [Grape extract]
Revatol
Mahadrakkharist [Grape extract]
Indications
Tuberculosis
Indication detailsView
- Chronic obstructive pulmonary diseases(COPD)
- Asthma (both allergic and cardiac asthma)
- Pulmonary fibrosis
- Pulmonary tuberculosis
Therapeutic classView
Herbal and Nutraceuticals
PharmacologyView
Grapes contain beneficial bioflaVonoid-like ingredients called "proanthocyanidins" (PCOs or OPCs). Proanthocyanidins are believed to protect cell membranes by neutralizing particularly harmful free radicals called "lipid peroxides". PCOs may strengthen the capillary walls and skin. It has been reported to inhibit the release of inflammatory chemicals, such as histamine and prostaglandins. PCOs have been used in allergies and asthma because of their reported ability to slow histamine release from mast cells. Resveratrol, a molecule has antioxidant and anti-inflammatory properties that may protect against COPD and asthma (Wood 2010). A cell culture study found that resveratrol inhibited the release of all measured inflammatory mediators (cytokines) from immune cells extracted from the alveoli of smokers and non-smokers with COPD. Moreover, while resveratrol attenuates the release of inflammatory mediators in airway smooth muscle cells, it preserves signaling of a protein called vascular endothelial growth factor (VEGF), which may be protective against emphysema. More recently, the anti-inflammatory effects of resveratrol have been associated with inhibition of the transcription factor NF-kB, possibly mediated via the inhibition of l-kB kinase.
Resveratrol has several activities that may account for its possible cardioprotective action. These include inhibition of the oxidation of low-density lipoprotein (LDL), inhibition of smooth muscle cell proliferation and inhibition of platelet aggregation. Resveratrol also has been found to exert a strong inhibitory effect on superoxide anion and hydrogen peroxide production by macrophages stimulated by lipopolysaccharides or phorbol esters. It also increases nitric oxide and decreases lactate dehydrogenase levels in the carotid blood and effective against ischemia-reperfusion induced arrythmias. Triterpenes roxburghiadiol A and B isolated from this plant Aglaia roxburghiana has the potent anti-inflammatory activity and mast cell degranulation induced by A. roxburghiana extracts and the triterpenes.
Pharmacokinetics: From animal and limited human studies,it appears that resveratrol is absorbed from the gastrointestinal tract following its ingestion. Resveratrol is found in the form of a glucuronide conjugate after crossing the small intestine and entering the blood circulation. In case of human, five metabolites of resveratrolTiave been detected in urine, such as resveratrol monosulphate, two isomeric forms of resveratrol monoglucuronide, dihydroresveratrol monosulphate and dihydroresveratrol monoglucuronide. 56% sulphate and glucuronide conjugates excrete through urine (Baur and Sinclair,2006)
Resveratrol has several activities that may account for its possible cardioprotective action. These include inhibition of the oxidation of low-density lipoprotein (LDL), inhibition of smooth muscle cell proliferation and inhibition of platelet aggregation. Resveratrol also has been found to exert a strong inhibitory effect on superoxide anion and hydrogen peroxide production by macrophages stimulated by lipopolysaccharides or phorbol esters. It also increases nitric oxide and decreases lactate dehydrogenase levels in the carotid blood and effective against ischemia-reperfusion induced arrythmias. Triterpenes roxburghiadiol A and B isolated from this plant Aglaia roxburghiana has the potent anti-inflammatory activity and mast cell degranulation induced by A. roxburghiana extracts and the triterpenes.
Pharmacokinetics: From animal and limited human studies,it appears that resveratrol is absorbed from the gastrointestinal tract following its ingestion. Resveratrol is found in the form of a glucuronide conjugate after crossing the small intestine and entering the blood circulation. In case of human, five metabolites of resveratrolTiave been detected in urine, such as resveratrol monosulphate, two isomeric forms of resveratrol monoglucuronide, dihydroresveratrol monosulphate and dihydroresveratrol monoglucuronide. 56% sulphate and glucuronide conjugates excrete through urine (Baur and Sinclair,2006)
DosageView
Mahadrakkharist content of grapes is partly responsible for the therapeutic effect. The Daily recommended dose of resveratrol is 8 mg/kg body weight. Each 5 ml syrup contains 36 mg resveratrol as a fluid extract. So the daily recommended dose is-
- Children under 12 years: 1-2 teaspoonfuls (5-10 ml) 2 times daily after meal.
- Above 12 years and Adult: 3-4 teaspoonfuls (15-20 ml) 2 times daily after meal for 4-8 weeks or as directed by the physician.
Side effectsView
There are no side effects associated with the use of Drakkha in the above-mentioned therapeutic doses. Drakkha has been used safely as an ayurvedic medicine for hundreds of years. But in very rare case stomach pain, headache and an allergic reaction have been reported.
PrecautionsView
Drakkha is well tolerated but caution should be taken in hypertension, liver disease, alcohol dependence and diabetes. Patients with any medical conditions should talk to their doctors before taking Mahadrakkharist. Lactobacillus products (e.g. Probiotics) should be taken 2 or more hours apart.
InteractionsView
It should be used cautiously in patients taking anticoagulants such as warfarin, aspirin, non-steroidal anti inflammatory drugs (NSAIDS), ACE inhibitors or anti-platelet agents. Based on animal studies, grape seed may increase the risk of bleeding. PCOs may theoretically alter the effectiveness of prescribed blood pressure medications that are angiotensin converting enzyme (ACE) inhibitors.
Pregnancy & lactationView
Women who are pregnant or nursing are advised to consult with a physician prior to use Mahadrakkharist. Although medical literature has no report of adverse effects related to fetal development during pregnancy or to infants who are breast-fed.
StorageView
Keep in a cool, dry place & away from direct sunlight. Keep the medicine out of the reach of children
Revenor
Tetrabenazine
Revenor
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.
Revenor
Tetrabenazine
Revenor
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.
Reversair
Montelukast Sodium
Reversair
Montelukast Sodium
Indications
Rhinitis
Indication detailsView
Montelukast Sodium is indicated for:
- Prophylaxis and chronic treatment of asthma
- Acute prevention of Exercise-Induced Bronchoconstriction (EIB)
- Relief of symptoms of Allergic Rhinitis (AR): Seasonal & Perennial Allergic Rhinitis
Therapeutic classView
Leukotriene receptor antagonists
PharmacologyView
Montelukast is a selective and orally active leukotriene receptor antagonist that inhibits the cysteinyl leukotriene receptor (CysLT1). The cysteinyl leukotrienes (LTC4, LTD4, LTE4) are products of arachidonic acid metabolism and are released from various cells, including mast cells and eosinophils. Cysteinyl leukotrienes and leukotriene receptor occupation have been correlated with the pathophysiology of asthma & allergic rhinitis, including airway edema, smooth muscle contraction, and altered cellular activity associated with the inflammatory process, which contribute to the signs and symptoms of asthma.
DosageView
Adults & adolescents (15 years & older)-
- Asthma & Allergic Rhinitis: 10 mg/day
- Exercise-Induced Bronchoconstriction: 10 mg/day
- Asthma & Allergic Rhinitis: 5 mg/day
- Exercise-Induced Bronchoconstriction: 5 mg/day
- Asthma & Allergic Rhinitis: 4 mg/day
- Exercise-Induced Bronchoconstriction: Not recommended
AdministrationView
Route of administration: Oral. Montelukast may be taken with or without food or as directed by the physician.
Side effectsView
Common: Diarrhoea, fever, gastrointestinal discomfort, headache, nausea, vomiting, skin reactions, upper respiratory tract infection.
Uncommon: Akathisia, anxiety, arthralgia, asthenia, abnormal behavior, depression, dizziness, drowsiness, dry mouth, haemorrhage, irritability, malaise, muscle complaints, oedema, seizure, abnormal sensation, sleep disorders.
Rare: Angioedema, concentration impaired, disorientation, eosinophilic granulomatosis with polyangiitis, erythema nodosum, hallucination, hepatic disorders, memory loss, palpitations, pulmonary eosinophilia, suicidal tendencies, tremor.
Uncommon: Akathisia, anxiety, arthralgia, asthenia, abnormal behavior, depression, dizziness, drowsiness, dry mouth, haemorrhage, irritability, malaise, muscle complaints, oedema, seizure, abnormal sensation, sleep disorders.
Rare: Angioedema, concentration impaired, disorientation, eosinophilic granulomatosis with polyangiitis, erythema nodosum, hallucination, hepatic disorders, memory loss, palpitations, pulmonary eosinophilia, suicidal tendencies, tremor.
ContraindicationsView
Montelukast is contraindicated in patients who are hypersensitive to any component of this product.
PrecautionsView
Montelukast is not indicated for use in the reversal of bronchospasm in acute asthma attacks, including status asthmatic. Neuropsychiatric events including agitation, hostility, anxiousness, depression, disorientation, disturbance in attention, dream abnormalities, hallucinations, insomnia, irritability, memory impairment, restlessness, somnambulism, suicidal thinking and behavior (including suicide) and tremor.
InteractionsView
With medicine: No dose adjustment is needed when montelukast is co-administered with theophylline, prednisone, prednisolone, terfenadine, digoxin, warfarin, gemfibrozil, itraconazole, thyroid hormones, sedative-hypnotics, non-steroidal anti-inflammatory agents, benzodiazepines, decongestants, oral contraceptives, and Cytochrome P450 (CYP) enzyme inducers.
With food and others: Bioavailability and other conditions were not significantly observed with food & other conditions.
With food and others: Bioavailability and other conditions were not significantly observed with food & other conditions.
Pregnancy & lactationView
There are no adequate and well-controlled studies in pregnant women. Montelukast should be used during pregnancy only if clearly needed. Montelukast is excreted in breast milk. So caution should be exercised when Montelukast is given to a nursing mother.
Overdose effectsView
There were no adverse experiences in the majority of overdosage reports. The most frequently occurring adverse experiences were consistent with the safety profile of Montelukast and included abdominal pain, somnolence, thirst, headache, vomiting and psychomotor hyperactivity. In the event of overdose, it is reasonable to employ the usual supportive measures; e.g., remove unabsorbed material from the gastrointestinal tract, employ clinical monitoring, and institute supportive therapy, if required.
StorageView
Store in cool & dry place below 30°C, protect from light & moisture. Keep out of reach of children.
Reversair
Montelukast Sodium
Reversair
Montelukast Sodium
Indications
Rhinitis
Indication detailsView
Montelukast Sodium is indicated for:
- Prophylaxis and chronic treatment of asthma
- Acute prevention of Exercise-Induced Bronchoconstriction (EIB)
- Relief of symptoms of Allergic Rhinitis (AR): Seasonal & Perennial Allergic Rhinitis
Therapeutic classView
Leukotriene receptor antagonists
PharmacologyView
Montelukast is a selective and orally active leukotriene receptor antagonist that inhibits the cysteinyl leukotriene receptor (CysLT1). The cysteinyl leukotrienes (LTC4, LTD4, LTE4) are products of arachidonic acid metabolism and are released from various cells, including mast cells and eosinophils. Cysteinyl leukotrienes and leukotriene receptor occupation have been correlated with the pathophysiology of asthma & allergic rhinitis, including airway edema, smooth muscle contraction, and altered cellular activity associated with the inflammatory process, which contribute to the signs and symptoms of asthma.
DosageView
Adults & adolescents (15 years & older)-
- Asthma & Allergic Rhinitis: 10 mg/day
- Exercise-Induced Bronchoconstriction: 10 mg/day
- Asthma & Allergic Rhinitis: 5 mg/day
- Exercise-Induced Bronchoconstriction: 5 mg/day
- Asthma & Allergic Rhinitis: 4 mg/day
- Exercise-Induced Bronchoconstriction: Not recommended
AdministrationView
Route of administration: Oral. Montelukast may be taken with or without food or as directed by the physician.
Side effectsView
Common: Diarrhoea, fever, gastrointestinal discomfort, headache, nausea, vomiting, skin reactions, upper respiratory tract infection.
Uncommon: Akathisia, anxiety, arthralgia, asthenia, abnormal behavior, depression, dizziness, drowsiness, dry mouth, haemorrhage, irritability, malaise, muscle complaints, oedema, seizure, abnormal sensation, sleep disorders.
Rare: Angioedema, concentration impaired, disorientation, eosinophilic granulomatosis with polyangiitis, erythema nodosum, hallucination, hepatic disorders, memory loss, palpitations, pulmonary eosinophilia, suicidal tendencies, tremor.
Uncommon: Akathisia, anxiety, arthralgia, asthenia, abnormal behavior, depression, dizziness, drowsiness, dry mouth, haemorrhage, irritability, malaise, muscle complaints, oedema, seizure, abnormal sensation, sleep disorders.
Rare: Angioedema, concentration impaired, disorientation, eosinophilic granulomatosis with polyangiitis, erythema nodosum, hallucination, hepatic disorders, memory loss, palpitations, pulmonary eosinophilia, suicidal tendencies, tremor.
ContraindicationsView
Montelukast is contraindicated in patients who are hypersensitive to any component of this product.
PrecautionsView
Montelukast is not indicated for use in the reversal of bronchospasm in acute asthma attacks, including status asthmatic. Neuropsychiatric events including agitation, hostility, anxiousness, depression, disorientation, disturbance in attention, dream abnormalities, hallucinations, insomnia, irritability, memory impairment, restlessness, somnambulism, suicidal thinking and behavior (including suicide) and tremor.
InteractionsView
With medicine: No dose adjustment is needed when montelukast is co-administered with theophylline, prednisone, prednisolone, terfenadine, digoxin, warfarin, gemfibrozil, itraconazole, thyroid hormones, sedative-hypnotics, non-steroidal anti-inflammatory agents, benzodiazepines, decongestants, oral contraceptives, and Cytochrome P450 (CYP) enzyme inducers.
With food and others: Bioavailability and other conditions were not significantly observed with food & other conditions.
With food and others: Bioavailability and other conditions were not significantly observed with food & other conditions.
Pregnancy & lactationView
There are no adequate and well-controlled studies in pregnant women. Montelukast should be used during pregnancy only if clearly needed. Montelukast is excreted in breast milk. So caution should be exercised when Montelukast is given to a nursing mother.
Overdose effectsView
There were no adverse experiences in the majority of overdosage reports. The most frequently occurring adverse experiences were consistent with the safety profile of Montelukast and included abdominal pain, somnolence, thirst, headache, vomiting and psychomotor hyperactivity. In the event of overdose, it is reasonable to employ the usual supportive measures; e.g., remove unabsorbed material from the gastrointestinal tract, employ clinical monitoring, and institute supportive therapy, if required.
StorageView
Store in cool & dry place below 30°C, protect from light & moisture. Keep out of reach of children.
Reversair
Montelukast Sodium
Reversair
Montelukast Sodium
Indications
Rhinitis
Indication detailsView
Montelukast Sodium is indicated for:
- Prophylaxis and chronic treatment of asthma
- Acute prevention of Exercise-Induced Bronchoconstriction (EIB)
- Relief of symptoms of Allergic Rhinitis (AR): Seasonal & Perennial Allergic Rhinitis
Therapeutic classView
Leukotriene receptor antagonists
PharmacologyView
Montelukast is a selective and orally active leukotriene receptor antagonist that inhibits the cysteinyl leukotriene receptor (CysLT1). The cysteinyl leukotrienes (LTC4, LTD4, LTE4) are products of arachidonic acid metabolism and are released from various cells, including mast cells and eosinophils. Cysteinyl leukotrienes and leukotriene receptor occupation have been correlated with the pathophysiology of asthma & allergic rhinitis, including airway edema, smooth muscle contraction, and altered cellular activity associated with the inflammatory process, which contribute to the signs and symptoms of asthma.
DosageView
Adults & adolescents (15 years & older)-
- Asthma & Allergic Rhinitis: 10 mg/day
- Exercise-Induced Bronchoconstriction: 10 mg/day
- Asthma & Allergic Rhinitis: 5 mg/day
- Exercise-Induced Bronchoconstriction: 5 mg/day
- Asthma & Allergic Rhinitis: 4 mg/day
- Exercise-Induced Bronchoconstriction: Not recommended
AdministrationView
Route of administration: Oral. Montelukast may be taken with or without food or as directed by the physician.
Side effectsView
Common: Diarrhoea, fever, gastrointestinal discomfort, headache, nausea, vomiting, skin reactions, upper respiratory tract infection.
Uncommon: Akathisia, anxiety, arthralgia, asthenia, abnormal behavior, depression, dizziness, drowsiness, dry mouth, haemorrhage, irritability, malaise, muscle complaints, oedema, seizure, abnormal sensation, sleep disorders.
Rare: Angioedema, concentration impaired, disorientation, eosinophilic granulomatosis with polyangiitis, erythema nodosum, hallucination, hepatic disorders, memory loss, palpitations, pulmonary eosinophilia, suicidal tendencies, tremor.
Uncommon: Akathisia, anxiety, arthralgia, asthenia, abnormal behavior, depression, dizziness, drowsiness, dry mouth, haemorrhage, irritability, malaise, muscle complaints, oedema, seizure, abnormal sensation, sleep disorders.
Rare: Angioedema, concentration impaired, disorientation, eosinophilic granulomatosis with polyangiitis, erythema nodosum, hallucination, hepatic disorders, memory loss, palpitations, pulmonary eosinophilia, suicidal tendencies, tremor.
ContraindicationsView
Montelukast is contraindicated in patients who are hypersensitive to any component of this product.
PrecautionsView
Montelukast is not indicated for use in the reversal of bronchospasm in acute asthma attacks, including status asthmatic. Neuropsychiatric events including agitation, hostility, anxiousness, depression, disorientation, disturbance in attention, dream abnormalities, hallucinations, insomnia, irritability, memory impairment, restlessness, somnambulism, suicidal thinking and behavior (including suicide) and tremor.
InteractionsView
With medicine: No dose adjustment is needed when montelukast is co-administered with theophylline, prednisone, prednisolone, terfenadine, digoxin, warfarin, gemfibrozil, itraconazole, thyroid hormones, sedative-hypnotics, non-steroidal anti-inflammatory agents, benzodiazepines, decongestants, oral contraceptives, and Cytochrome P450 (CYP) enzyme inducers.
With food and others: Bioavailability and other conditions were not significantly observed with food & other conditions.
With food and others: Bioavailability and other conditions were not significantly observed with food & other conditions.
Pregnancy & lactationView
There are no adequate and well-controlled studies in pregnant women. Montelukast should be used during pregnancy only if clearly needed. Montelukast is excreted in breast milk. So caution should be exercised when Montelukast is given to a nursing mother.
Overdose effectsView
There were no adverse experiences in the majority of overdosage reports. The most frequently occurring adverse experiences were consistent with the safety profile of Montelukast and included abdominal pain, somnolence, thirst, headache, vomiting and psychomotor hyperactivity. In the event of overdose, it is reasonable to employ the usual supportive measures; e.g., remove unabsorbed material from the gastrointestinal tract, employ clinical monitoring, and institute supportive therapy, if required.
StorageView
Store in cool & dry place below 30°C, protect from light & moisture. Keep out of reach of children.
Reverse
Clonazepam
Reverse
Clonazepam
Indication detailsView
It is indicated for the treatment of panic disorder, with or without agoraphobia. Panic disorder is characterized by the occurrence of unexpected panic attacks and associated concern about having additional attacks, worry about the implications or consequences of the attacks.
It is also indicated alone or as an adjunct in the treatment of the Lennox-Gastaut Syndrome (petit mal variant), akinetic and myoclonic seizures. It may be indicated in patients with absence seizures (petit mal) who have failed to respond to succinimides.
The effectiveness of Clonazepam in long-term use, that is, for more than 9 weeks, has not been systematically studied in controlled clinical trials. The physician who elects to use Clonazepam for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient.
It is also indicated alone or as an adjunct in the treatment of the Lennox-Gastaut Syndrome (petit mal variant), akinetic and myoclonic seizures. It may be indicated in patients with absence seizures (petit mal) who have failed to respond to succinimides.
The effectiveness of Clonazepam in long-term use, that is, for more than 9 weeks, has not been systematically studied in controlled clinical trials. The physician who elects to use Clonazepam for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient.
Therapeutic classView
Adjunct anti-epileptic drugs, Benzodiazepine hypnotics
PharmacologyView
Clonazepam exhibits pharmacological properties which are common to benzodiazepines and include anticonvulsive, sedative, muscle relaxing and anxiolytic effects. The central actions of benzodiazepines are mediated through an enhancement of the GABAergic neurotransmission at inhibitory synapses. In the presence of benzodiazepines the affinity of the GABA receptor for the neurotransmitter is enhanced through positive allosteric modulation resulting in an increased action of released GABA on the postsynaptic transmembrane chloride ion flux.
There are also animal data showing an effect of clonazepam on serotonin. Animal data and electroencephalographic investigations in man have shown that clonazepam rapidly suppresses many types of paroxysmal activity including the spike and wave discharge in absences seizures (petit mal), slow spike wave, generalized spike wave, spikes with temporal or other locations as well as irregular spikes and waves. Generalized EEG abnormalities are more regularly suppressed than focal abnormalities. According to these findings clonazepam has beneficial effects in generalized and focal epilepsies.
There are also animal data showing an effect of clonazepam on serotonin. Animal data and electroencephalographic investigations in man have shown that clonazepam rapidly suppresses many types of paroxysmal activity including the spike and wave discharge in absences seizures (petit mal), slow spike wave, generalized spike wave, spikes with temporal or other locations as well as irregular spikes and waves. Generalized EEG abnormalities are more regularly suppressed than focal abnormalities. According to these findings clonazepam has beneficial effects in generalized and focal epilepsies.
DosageView
Oral:
Injection:
- Adults: The initial dose for adults with seizure disorders should not exceed 1.5 mg/day divided into three doses. Dosage may be increased in increments of 0.5 to 1 mg every 3 days until seizures are adequately controlled or until side effects preclude any further increase. Maintenance dosage must be individualized for each patient depending upon response. Maximum recommended daily dose is 20 mg.
- The initial dose for adults with panic disorder is 0.25 mg given in two divided dose. An increase to the target dose for most patients of 1 mg/day may be made after 3 days.
- Pediatric Patients: In order to minimize drowsiness, the initial dose for infants and children (up to 10 years of age or 30 kg of body weight) should be between 0.01 and 0.03 mg/kg/day but not to exceed 0.05 mg/kg/day given in two or three divided doses.
Injection:
- Infants and children: half of a vial (0.5 mg) by slow IV injection or by IV infusion.
- Adults: 1 vial (1 mg) by slow IV injection or by IV infusion. This dose can be repeated as required (1-4 mg are usually sufficient to reverse the status). In adults, the rate of injection must not exceed 0.25 - 0.5 mg per minute (0.5-1.0 ml of the prepared solution) and a total dose of 10 mg should not be exceeded.
Side effectsView
The most frequently occurring side effects of Clonazepam are referable to CNS depression. Experience in treatment of seizures has shown that drowsiness has occurred in approximately 50% of patients and ataxia in approximately 30%. In some cases, these may diminish with time; behavior problems have been noted in approximately 25% of patients. Abnormal eye movements, aphonia, coma, tremor, vertigo, confusion, depression, amnesia, hallucinations, hysteria, increased libido, insomnia, psychosis & palpitations may also occur.
ContraindicationsView
It should not be used in patients with a history of hypersensitivity to benzodiazepines, nor in patients with clinical or biochemical evidence of significant liver disease. It may be used in patients with open angle glaucoma who are receiving appropriate therapy but is contraindicated in acute narrow angle glaucoma.
PrecautionsView
When used in patients in whom several different types of seizure disorders coexist, Clonazepam may increase the incidence or precipitate the onset of generalized tonic-clonic seizures. This may require the addition of appropriate anticonvulsants or an increase in their dosages. The concomitant use of valproic acid and Clonazepam may produce absence status.
InteractionsView
Clonazepam does not appear to alter the pharmacokinetics of phenytoin, carbamazepine or phenobarbital. The effect of Clonazepam on the metabolism of other drugs has not been investigated.
Pregnancy & lactationView
Pregnancy: From preclinical studies it cannot be excluded that clonazepam possesses the possibility of producing congenital malformations. From epidemiological evaluations there is evidence that anticonvulsant drugs act as teratogens. However, it is difficult to determine from published epidemiological reports which drug or combination of drugs is responsible for defects in the newborn. The possibility also exists that other factors e.g. genetic factors or the epileptic condition itself may be more important than drug therapy in leading to birth defects. Under these circumstances, the drug should only be administered to pregnant women if the potential benefits outweigh the risk to the foetus. During pregnancy, Clonazepam may be administered only if there is a compelling indication. Administration of high doses in the last trimester of pregnancy or during labour can cause irregularities in the heartbeat of the unborn child and hypothermia, hypotonia, mild respiratory depression and poor feeding in the neonate. It should be borne in mind that both pregnancy itself and abrupt discontinuation of the medication can cause exacerbation of epilepsy. Withdrawal symptoms in newborn infants have occasionally been reported with benzodiazepines.
Nursing Mothers: Although the active ingredient of Clonazepam has been found to pass into the maternal milk in small amounts only, mothers undergoing treatment with this drug should not breastfeed. If there is a compelling indication for Clonazepam, breastfeeding should be discontinued.
Nursing Mothers: Although the active ingredient of Clonazepam has been found to pass into the maternal milk in small amounts only, mothers undergoing treatment with this drug should not breastfeed. If there is a compelling indication for Clonazepam, breastfeeding should be discontinued.
Pediatric usageView
Pediatric Use: In infants and small children Rivotril may cause increased production of saliva and bronchial secretion. Therefore special attention must be paid to maintaining patency of the airways.
Geriatric Use: Benzodiazepine pharmacologic effects appear to be greater in elderly patients than in younger patients even at similar plasma benzodiazepine concentrations, possibly because of age-related changes in drug–receptor interactions, post-receptor mechanisms and organ function.
Renal Impairment: Renal impairment does not affect the pharmacokinetics of clonazepam. Based on pharmacokinetic criteria, no dose adjustment is required in patients with renal impairment.
Hepatic Impairment: Plasma protein binding of clonazepam in cirrhotic patients is significantly different from that in healthy subjects (free fraction 17.1±1.0% vs 13.9±0.2%). Although the influence of hepatic impairment on clonazepam pharmacokinetics has not been further investigated, experience with another closely related nitrobenzodiazepine (nitrazepam) indicates that clearance of unbound clonazepam might be reduced in liver cirrhosis.
Geriatric Use: Benzodiazepine pharmacologic effects appear to be greater in elderly patients than in younger patients even at similar plasma benzodiazepine concentrations, possibly because of age-related changes in drug–receptor interactions, post-receptor mechanisms and organ function.
Renal Impairment: Renal impairment does not affect the pharmacokinetics of clonazepam. Based on pharmacokinetic criteria, no dose adjustment is required in patients with renal impairment.
Hepatic Impairment: Plasma protein binding of clonazepam in cirrhotic patients is significantly different from that in healthy subjects (free fraction 17.1±1.0% vs 13.9±0.2%). Although the influence of hepatic impairment on clonazepam pharmacokinetics has not been further investigated, experience with another closely related nitrobenzodiazepine (nitrazepam) indicates that clearance of unbound clonazepam might be reduced in liver cirrhosis.
Overdose effectsView
Symptoms: Benzodiazepines commonly cause drowsiness, ataxia, dysarthria and nystagmus. Overdose of Clonazepam is seldom life-threatening if the drug is taken alone, but may lead to areflexia, apnoea, hypotension, cardiorespiratory depression and coma. Coma, if it occurs, usually lasts a few hours but it may be more protracted and cyclical, particularly in elderly patients. Increased frequency of seizures may occur in patients at supratherapeutic plasma concentrations. Benzodiazepine respiratory depressant effects are more serious in patients with respiratory disease. Benzodiazepines increase the effects of other central nervous system depressants, including alcohol.
Treatment: Monitor the patient’s vital signs and institute supportive measures as indicated by the patient’s clinical state. In particular, patients may require symptomatic treatment for cardiorespiratory effects or central nervous system effects. Further absorption should be prevented using an appropriate method e.g. treatment within 1-2 hours with activated charcoal. If activated charcoal is used airway protection is imperative for drowsy patients. In case of mixed ingestion gastric lavage may be considered, however not as a routine measure. If CNS depression is severe consider the use of flumazenil, a benzodiazepine antagonist. This should only be administered under closely monitored conditions. It has a short half-life (about an hour), therefore patients administered flumazenil will require monitoring after its effects have worn off. Flumazenil is to be used with extreme caution in the presence of drugs that reduce seizure threshold (e.g. tricyclic antidepressants). Refer to the prescribing information for flumazenil, for further information on the correct use of this drug.
Treatment: Monitor the patient’s vital signs and institute supportive measures as indicated by the patient’s clinical state. In particular, patients may require symptomatic treatment for cardiorespiratory effects or central nervous system effects. Further absorption should be prevented using an appropriate method e.g. treatment within 1-2 hours with activated charcoal. If activated charcoal is used airway protection is imperative for drowsy patients. In case of mixed ingestion gastric lavage may be considered, however not as a routine measure. If CNS depression is severe consider the use of flumazenil, a benzodiazepine antagonist. This should only be administered under closely monitored conditions. It has a short half-life (about an hour), therefore patients administered flumazenil will require monitoring after its effects have worn off. Flumazenil is to be used with extreme caution in the presence of drugs that reduce seizure threshold (e.g. tricyclic antidepressants). Refer to the prescribing information for flumazenil, for further information on the correct use of this drug.
ReconstitutionView
Slow intravenous injection: The contents of the vial must be diluted with 1 ml of water for injection prior to administration so as to avoid local irritation of the veins. The injection solution should be prepared immediately before use. IV injection should be administered slowly with continuous monitoring of EEG, respiration and blood pressure.
Intravenous infusion: Clonazepam (the vial) can be diluted for infusion in a ratio of 1 vial (1 mg) to at least 85 ml diluting media. The diluting media can be any of the following: sodium chloride 0.9%; sodium chloride 0.45% + glucose 2.5%; glucose 5% or glucose 10%. These mixtures are stable for 24 hours at room temperature. Infusion bags other than PVC should be used for infusing Clonazepam. If PVC infusion bags are used then the mixture should be infused immediately or within 4 hours. The infusion time should not exceed 8 hours. Do not prepare Clonazepam infusions using sodium bicarbonate solution, as precipitation of the solution may occur.
Intramuscular injection: The IM route should be used only in exceptional cases or if IV administration is not feasible.
Intravenous infusion: Clonazepam (the vial) can be diluted for infusion in a ratio of 1 vial (1 mg) to at least 85 ml diluting media. The diluting media can be any of the following: sodium chloride 0.9%; sodium chloride 0.45% + glucose 2.5%; glucose 5% or glucose 10%. These mixtures are stable for 24 hours at room temperature. Infusion bags other than PVC should be used for infusing Clonazepam. If PVC infusion bags are used then the mixture should be infused immediately or within 4 hours. The infusion time should not exceed 8 hours. Do not prepare Clonazepam infusions using sodium bicarbonate solution, as precipitation of the solution may occur.
Intramuscular injection: The IM route should be used only in exceptional cases or if IV administration is not feasible.
StorageView
Keep in a dry place away from light and heat. Keep out of the reach of children.
Reverse
Clonazepam
Reverse
Clonazepam
Indication detailsView
It is indicated for the treatment of panic disorder, with or without agoraphobia. Panic disorder is characterized by the occurrence of unexpected panic attacks and associated concern about having additional attacks, worry about the implications or consequences of the attacks.
It is also indicated alone or as an adjunct in the treatment of the Lennox-Gastaut Syndrome (petit mal variant), akinetic and myoclonic seizures. It may be indicated in patients with absence seizures (petit mal) who have failed to respond to succinimides.
The effectiveness of Clonazepam in long-term use, that is, for more than 9 weeks, has not been systematically studied in controlled clinical trials. The physician who elects to use Clonazepam for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient.
It is also indicated alone or as an adjunct in the treatment of the Lennox-Gastaut Syndrome (petit mal variant), akinetic and myoclonic seizures. It may be indicated in patients with absence seizures (petit mal) who have failed to respond to succinimides.
The effectiveness of Clonazepam in long-term use, that is, for more than 9 weeks, has not been systematically studied in controlled clinical trials. The physician who elects to use Clonazepam for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient.
Therapeutic classView
Adjunct anti-epileptic drugs, Benzodiazepine hypnotics
PharmacologyView
Clonazepam exhibits pharmacological properties which are common to benzodiazepines and include anticonvulsive, sedative, muscle relaxing and anxiolytic effects. The central actions of benzodiazepines are mediated through an enhancement of the GABAergic neurotransmission at inhibitory synapses. In the presence of benzodiazepines the affinity of the GABA receptor for the neurotransmitter is enhanced through positive allosteric modulation resulting in an increased action of released GABA on the postsynaptic transmembrane chloride ion flux.
There are also animal data showing an effect of clonazepam on serotonin. Animal data and electroencephalographic investigations in man have shown that clonazepam rapidly suppresses many types of paroxysmal activity including the spike and wave discharge in absences seizures (petit mal), slow spike wave, generalized spike wave, spikes with temporal or other locations as well as irregular spikes and waves. Generalized EEG abnormalities are more regularly suppressed than focal abnormalities. According to these findings clonazepam has beneficial effects in generalized and focal epilepsies.
There are also animal data showing an effect of clonazepam on serotonin. Animal data and electroencephalographic investigations in man have shown that clonazepam rapidly suppresses many types of paroxysmal activity including the spike and wave discharge in absences seizures (petit mal), slow spike wave, generalized spike wave, spikes with temporal or other locations as well as irregular spikes and waves. Generalized EEG abnormalities are more regularly suppressed than focal abnormalities. According to these findings clonazepam has beneficial effects in generalized and focal epilepsies.
DosageView
Oral:
Injection:
- Adults: The initial dose for adults with seizure disorders should not exceed 1.5 mg/day divided into three doses. Dosage may be increased in increments of 0.5 to 1 mg every 3 days until seizures are adequately controlled or until side effects preclude any further increase. Maintenance dosage must be individualized for each patient depending upon response. Maximum recommended daily dose is 20 mg.
- The initial dose for adults with panic disorder is 0.25 mg given in two divided dose. An increase to the target dose for most patients of 1 mg/day may be made after 3 days.
- Pediatric Patients: In order to minimize drowsiness, the initial dose for infants and children (up to 10 years of age or 30 kg of body weight) should be between 0.01 and 0.03 mg/kg/day but not to exceed 0.05 mg/kg/day given in two or three divided doses.
Injection:
- Infants and children: half of a vial (0.5 mg) by slow IV injection or by IV infusion.
- Adults: 1 vial (1 mg) by slow IV injection or by IV infusion. This dose can be repeated as required (1-4 mg are usually sufficient to reverse the status). In adults, the rate of injection must not exceed 0.25 - 0.5 mg per minute (0.5-1.0 ml of the prepared solution) and a total dose of 10 mg should not be exceeded.
Side effectsView
The most frequently occurring side effects of Clonazepam are referable to CNS depression. Experience in treatment of seizures has shown that drowsiness has occurred in approximately 50% of patients and ataxia in approximately 30%. In some cases, these may diminish with time; behavior problems have been noted in approximately 25% of patients. Abnormal eye movements, aphonia, coma, tremor, vertigo, confusion, depression, amnesia, hallucinations, hysteria, increased libido, insomnia, psychosis & palpitations may also occur.
ContraindicationsView
It should not be used in patients with a history of hypersensitivity to benzodiazepines, nor in patients with clinical or biochemical evidence of significant liver disease. It may be used in patients with open angle glaucoma who are receiving appropriate therapy but is contraindicated in acute narrow angle glaucoma.
PrecautionsView
When used in patients in whom several different types of seizure disorders coexist, Clonazepam may increase the incidence or precipitate the onset of generalized tonic-clonic seizures. This may require the addition of appropriate anticonvulsants or an increase in their dosages. The concomitant use of valproic acid and Clonazepam may produce absence status.
InteractionsView
Clonazepam does not appear to alter the pharmacokinetics of phenytoin, carbamazepine or phenobarbital. The effect of Clonazepam on the metabolism of other drugs has not been investigated.
Pregnancy & lactationView
Pregnancy: From preclinical studies it cannot be excluded that clonazepam possesses the possibility of producing congenital malformations. From epidemiological evaluations there is evidence that anticonvulsant drugs act as teratogens. However, it is difficult to determine from published epidemiological reports which drug or combination of drugs is responsible for defects in the newborn. The possibility also exists that other factors e.g. genetic factors or the epileptic condition itself may be more important than drug therapy in leading to birth defects. Under these circumstances, the drug should only be administered to pregnant women if the potential benefits outweigh the risk to the foetus. During pregnancy, Clonazepam may be administered only if there is a compelling indication. Administration of high doses in the last trimester of pregnancy or during labour can cause irregularities in the heartbeat of the unborn child and hypothermia, hypotonia, mild respiratory depression and poor feeding in the neonate. It should be borne in mind that both pregnancy itself and abrupt discontinuation of the medication can cause exacerbation of epilepsy. Withdrawal symptoms in newborn infants have occasionally been reported with benzodiazepines.
Nursing Mothers: Although the active ingredient of Clonazepam has been found to pass into the maternal milk in small amounts only, mothers undergoing treatment with this drug should not breastfeed. If there is a compelling indication for Clonazepam, breastfeeding should be discontinued.
Nursing Mothers: Although the active ingredient of Clonazepam has been found to pass into the maternal milk in small amounts only, mothers undergoing treatment with this drug should not breastfeed. If there is a compelling indication for Clonazepam, breastfeeding should be discontinued.
Pediatric usageView
Pediatric Use: In infants and small children Rivotril may cause increased production of saliva and bronchial secretion. Therefore special attention must be paid to maintaining patency of the airways.
Geriatric Use: Benzodiazepine pharmacologic effects appear to be greater in elderly patients than in younger patients even at similar plasma benzodiazepine concentrations, possibly because of age-related changes in drug–receptor interactions, post-receptor mechanisms and organ function.
Renal Impairment: Renal impairment does not affect the pharmacokinetics of clonazepam. Based on pharmacokinetic criteria, no dose adjustment is required in patients with renal impairment.
Hepatic Impairment: Plasma protein binding of clonazepam in cirrhotic patients is significantly different from that in healthy subjects (free fraction 17.1±1.0% vs 13.9±0.2%). Although the influence of hepatic impairment on clonazepam pharmacokinetics has not been further investigated, experience with another closely related nitrobenzodiazepine (nitrazepam) indicates that clearance of unbound clonazepam might be reduced in liver cirrhosis.
Geriatric Use: Benzodiazepine pharmacologic effects appear to be greater in elderly patients than in younger patients even at similar plasma benzodiazepine concentrations, possibly because of age-related changes in drug–receptor interactions, post-receptor mechanisms and organ function.
Renal Impairment: Renal impairment does not affect the pharmacokinetics of clonazepam. Based on pharmacokinetic criteria, no dose adjustment is required in patients with renal impairment.
Hepatic Impairment: Plasma protein binding of clonazepam in cirrhotic patients is significantly different from that in healthy subjects (free fraction 17.1±1.0% vs 13.9±0.2%). Although the influence of hepatic impairment on clonazepam pharmacokinetics has not been further investigated, experience with another closely related nitrobenzodiazepine (nitrazepam) indicates that clearance of unbound clonazepam might be reduced in liver cirrhosis.
Overdose effectsView
Symptoms: Benzodiazepines commonly cause drowsiness, ataxia, dysarthria and nystagmus. Overdose of Clonazepam is seldom life-threatening if the drug is taken alone, but may lead to areflexia, apnoea, hypotension, cardiorespiratory depression and coma. Coma, if it occurs, usually lasts a few hours but it may be more protracted and cyclical, particularly in elderly patients. Increased frequency of seizures may occur in patients at supratherapeutic plasma concentrations. Benzodiazepine respiratory depressant effects are more serious in patients with respiratory disease. Benzodiazepines increase the effects of other central nervous system depressants, including alcohol.
Treatment: Monitor the patient’s vital signs and institute supportive measures as indicated by the patient’s clinical state. In particular, patients may require symptomatic treatment for cardiorespiratory effects or central nervous system effects. Further absorption should be prevented using an appropriate method e.g. treatment within 1-2 hours with activated charcoal. If activated charcoal is used airway protection is imperative for drowsy patients. In case of mixed ingestion gastric lavage may be considered, however not as a routine measure. If CNS depression is severe consider the use of flumazenil, a benzodiazepine antagonist. This should only be administered under closely monitored conditions. It has a short half-life (about an hour), therefore patients administered flumazenil will require monitoring after its effects have worn off. Flumazenil is to be used with extreme caution in the presence of drugs that reduce seizure threshold (e.g. tricyclic antidepressants). Refer to the prescribing information for flumazenil, for further information on the correct use of this drug.
Treatment: Monitor the patient’s vital signs and institute supportive measures as indicated by the patient’s clinical state. In particular, patients may require symptomatic treatment for cardiorespiratory effects or central nervous system effects. Further absorption should be prevented using an appropriate method e.g. treatment within 1-2 hours with activated charcoal. If activated charcoal is used airway protection is imperative for drowsy patients. In case of mixed ingestion gastric lavage may be considered, however not as a routine measure. If CNS depression is severe consider the use of flumazenil, a benzodiazepine antagonist. This should only be administered under closely monitored conditions. It has a short half-life (about an hour), therefore patients administered flumazenil will require monitoring after its effects have worn off. Flumazenil is to be used with extreme caution in the presence of drugs that reduce seizure threshold (e.g. tricyclic antidepressants). Refer to the prescribing information for flumazenil, for further information on the correct use of this drug.
ReconstitutionView
Slow intravenous injection: The contents of the vial must be diluted with 1 ml of water for injection prior to administration so as to avoid local irritation of the veins. The injection solution should be prepared immediately before use. IV injection should be administered slowly with continuous monitoring of EEG, respiration and blood pressure.
Intravenous infusion: Clonazepam (the vial) can be diluted for infusion in a ratio of 1 vial (1 mg) to at least 85 ml diluting media. The diluting media can be any of the following: sodium chloride 0.9%; sodium chloride 0.45% + glucose 2.5%; glucose 5% or glucose 10%. These mixtures are stable for 24 hours at room temperature. Infusion bags other than PVC should be used for infusing Clonazepam. If PVC infusion bags are used then the mixture should be infused immediately or within 4 hours. The infusion time should not exceed 8 hours. Do not prepare Clonazepam infusions using sodium bicarbonate solution, as precipitation of the solution may occur.
Intramuscular injection: The IM route should be used only in exceptional cases or if IV administration is not feasible.
Intravenous infusion: Clonazepam (the vial) can be diluted for infusion in a ratio of 1 vial (1 mg) to at least 85 ml diluting media. The diluting media can be any of the following: sodium chloride 0.9%; sodium chloride 0.45% + glucose 2.5%; glucose 5% or glucose 10%. These mixtures are stable for 24 hours at room temperature. Infusion bags other than PVC should be used for infusing Clonazepam. If PVC infusion bags are used then the mixture should be infused immediately or within 4 hours. The infusion time should not exceed 8 hours. Do not prepare Clonazepam infusions using sodium bicarbonate solution, as precipitation of the solution may occur.
Intramuscular injection: The IM route should be used only in exceptional cases or if IV administration is not feasible.
StorageView
Keep in a dry place away from light and heat. Keep out of the reach of children.
Revert
Cinnarizine + Dimenhydrinate
Revert
Cinnarizine + Dimenhydrinate
Indications
Vertigo
Indication detailsView
Cerebral circulatory disorders:
Disorders of balance:
- Prophylaxis and maintenance therapy for symptoms of cerebral vascular spasms and arteriosclerosis such as: dizziness, ear buzzing (tinnitus), vascular headache, unsociability and irritability, fatigue, sleep rhythm disorders such as premature awakening, involutional depressions, loss of memory and lack of concentration, incontinence and other disorders due to aging.
- Sequelae of cerebral and cranial trauma.
- Postapoplectic disorders.
- Migraine.
Disorders of balance:
- Prophylaxis and maintenance therapy for symptoms of labyrinthine arteriosclerosis; vestibular irritability; Meniere's syndrome such as vertigo, dizziness, giddiness, syncopal attacks, tinnitus, nystagmus, nausea and vomiting.
- Prophylaxis of motion sickness.
Therapeutic classView
Anti vertigo drugs
PharmacologyView
This contains two active ingredients Cinnarizine and Dimenhydrinate. The two substances belong to different groups of medicines. Cinnarizine is part of a group called calcium antagonists. Dimenhydrinate belongs to a group called antihistamines. Both substances work by reducing symptoms of vertigo (a feeling of dizziness or spinning) and nausea (feeling sick). The combination product is more effective than the individual compounds.
DosageView
Adults: 1 tablet three times daily, to be taken after meals. Children and
adolescents under the age of 18 years: Not recommended
Elderly: Dosage as for adults.
adolescents under the age of 18 years: Not recommended
Elderly: Dosage as for adults.
Side effectsView
Drowsiness, dry mouth, headache, and stomach pain may occur. Rare side effects are impaired vision, allergic reactions, light sensitivity, and difficulty in urinating. Other possible reactions which may occur: weight gain, constipation, tightness of the chest, jaundice, worsening of angle-closure glaucoma, uncontrollable movements, unusual excitement and restlessness, severe skin reactions.
ContraindicationsView
Cinnarizine and Dimenhydrinate should not be used by patients with severe hepatic impairment. Cinnarizine and Dimenhydrinate is contra-indicated in patients with known hypersensitivity to the active substances or to any of the excipients. Cinnarizine and Dimenhydrinate should not be used in patients with angle-closure glaucoma, convulsions, suspicion of raised intracranial pressure, and alcohol abuse or urine retention due to urethroprostatic disorders.
PrecautionsView
Cinnarizine and Dimenhydrinate do not reduce blood pressure significantly; however, it should be used with caution in hypotensive patients. Cinnarizine and Dimenhydrinate should be taken after meals to minimize any gastric irritation. Caution should be exercised when administering Cinnarizine and Dimenhydrinate to patients with Parkinson’s disease.
InteractionsView
Concurrent use of alcohol, CNS depressants or tricyclic antidepressants may potentiate the sedative effects of either these drugs or of Cinnarizine and Dimenhydrinate. Therefore, it is advisable to avoid these drugs while taking Cinnarizine and Dimenhydrinate.
Pregnancy & lactationView
Dimenhydrinate and cinnarizine should not be used during pregnancy and lactation.
Overdose effectsView
Drowsiness, dizziness and ataxia with anticholinergic effects such as dry mouth, flushing of the face, dilated pupils, tachycardia, pyrexia, headache and urinary retention. General supportive measures should be used to treat respiratory insufficiency or circulatory failure. Gastric lavage with isotonic sodium chloride solution is recommended.
StorageView
Store in a cool (below 30°C) and dry place. Keep away from light and out of reach of children.
Revira
Valacyclovir
Revira
Valacyclovir
Indications
Varicella zoster (chickenpox)
Indication detailsView
Valacyclovir is indicated for the treatment of Herpes zoster (shingles). It is indicated for the treatment or suppression of genital herpes in immuno-competent individuals and for the suppression of recurrent genital herpes in HIV infected individuals. It is also indicated for the treatment of cold sores (Herpes labialis).
Therapeutic classView
Herpes simplex & Varicella-zoster virus infections
PharmacologyView
Valacyclovir is the hydrochloride salt of L-valyl ester of the antiviral drug acyclovir. Valacyclovir is an antiviral drug. It slows the growth and spread of the herpes virus so that the body can fight off the infection. Valacyclovir lessens the symptoms of infections and shortens the length of time of sickness. Valacyclovir is used in the treatment and suppression of genital herpes, shingles and cold sores.
DosageView
Adult Dosage:
Cold Sores: 2 grams every 12 hours for 1 dayGenital Herpes:
- Initial episode: 1 gram twice daily for 10 days
- Recurrent episodes: 500 mg twice daily for 3 days Suppressive therapy
- Immunocompetent patients: 1 gram once daily
- Alternate dose in patients with < 9 recurrences/year: 500 mg once daily
- HIV-infected patients: 500 mg twice daily
- Reduction of transmission: 500 mg once daily
Pediatric Dosage:
- Cold Sores (> 12 years of age): 2 grams every 12 hours for 1 day
- Chickenpox (2 to < 18 years of age): 20 mg/kg 3 times daily for 5 days; not to exceed 1 gram 3 times daily
Side effectsView
The most frequently reported adverse reactions were nausea (15%), headache (14%), vomiting (6%), dizziness (3%) and abdominal pain (3%).
ContraindicationsView
Valacyclovir is contraindicated in patients with a known hypersensitivity or intolerance to valacyclovir, acyclovir, or any component of the formulation.
PrecautionsView
Dosage reduction is recommended when administering valacyclovir to patients with renal impairment. Similar caution should be exercised when administering valacyclovir to geriatric patients and patients receiving potentially nephrotoxic agents. The safety and efficacy of valacyclovir have not been established in immuno compromised patients other than for the suppression of genital herpes in HIVinfected patients
InteractionsView
No dosage adjustment is recommended when valacyclovir is coadministered with digoxin, antacids, thiazide diuretics, cimetidine or probenecid in subjects with normal renal function.
Pregnancy & lactationView
Pregnancy category B. Valacyclovir was not teratogenic in rats or rabbits at 10 and 7 times human plasma levels, respectively, during the period of major organogenesis. There is no adequate and well-controlled studies of valacyclovir in pregnant women.
Nursing Mothers: Unchanged valacyclovir was not detected in maternal serum, breast milk, or infant urine. Valacyclovir should be administered to a nursing mother with caution and only when indicated.
Nursing Mothers: Unchanged valacyclovir was not detected in maternal serum, breast milk, or infant urine. Valacyclovir should be administered to a nursing mother with caution and only when indicated.
Pediatric usageView
Pediatric Use: Safety and effectiveness of valacyclovir in pre-pubertal pediatric patients have not been established.
Elderly Use (Over 65 yr.): Elderly patients may require a dose reduction of valacyclovir due to a low body weight or disorders (renal, CNS etc.) associated with aging.
Elderly Use (Over 65 yr.): Elderly patients may require a dose reduction of valacyclovir due to a low body weight or disorders (renal, CNS etc.) associated with aging.
StorageView
Store in cool & dry place, away from children.
Revira
Valacyclovir
Revira
Valacyclovir
Indications
Varicella zoster (chickenpox)
Indication detailsView
Valacyclovir is indicated for the treatment of Herpes zoster (shingles). It is indicated for the treatment or suppression of genital herpes in immuno-competent individuals and for the suppression of recurrent genital herpes in HIV infected individuals. It is also indicated for the treatment of cold sores (Herpes labialis).
Therapeutic classView
Herpes simplex & Varicella-zoster virus infections
PharmacologyView
Valacyclovir is the hydrochloride salt of L-valyl ester of the antiviral drug acyclovir. Valacyclovir is an antiviral drug. It slows the growth and spread of the herpes virus so that the body can fight off the infection. Valacyclovir lessens the symptoms of infections and shortens the length of time of sickness. Valacyclovir is used in the treatment and suppression of genital herpes, shingles and cold sores.
DosageView
Adult Dosage:
Cold Sores: 2 grams every 12 hours for 1 dayGenital Herpes:
- Initial episode: 1 gram twice daily for 10 days
- Recurrent episodes: 500 mg twice daily for 3 days Suppressive therapy
- Immunocompetent patients: 1 gram once daily
- Alternate dose in patients with < 9 recurrences/year: 500 mg once daily
- HIV-infected patients: 500 mg twice daily
- Reduction of transmission: 500 mg once daily
Pediatric Dosage:
- Cold Sores (> 12 years of age): 2 grams every 12 hours for 1 day
- Chickenpox (2 to < 18 years of age): 20 mg/kg 3 times daily for 5 days; not to exceed 1 gram 3 times daily
Side effectsView
The most frequently reported adverse reactions were nausea (15%), headache (14%), vomiting (6%), dizziness (3%) and abdominal pain (3%).
ContraindicationsView
Valacyclovir is contraindicated in patients with a known hypersensitivity or intolerance to valacyclovir, acyclovir, or any component of the formulation.
PrecautionsView
Dosage reduction is recommended when administering valacyclovir to patients with renal impairment. Similar caution should be exercised when administering valacyclovir to geriatric patients and patients receiving potentially nephrotoxic agents. The safety and efficacy of valacyclovir have not been established in immuno compromised patients other than for the suppression of genital herpes in HIVinfected patients
InteractionsView
No dosage adjustment is recommended when valacyclovir is coadministered with digoxin, antacids, thiazide diuretics, cimetidine or probenecid in subjects with normal renal function.
Pregnancy & lactationView
Pregnancy category B. Valacyclovir was not teratogenic in rats or rabbits at 10 and 7 times human plasma levels, respectively, during the period of major organogenesis. There is no adequate and well-controlled studies of valacyclovir in pregnant women.
Nursing Mothers: Unchanged valacyclovir was not detected in maternal serum, breast milk, or infant urine. Valacyclovir should be administered to a nursing mother with caution and only when indicated.
Nursing Mothers: Unchanged valacyclovir was not detected in maternal serum, breast milk, or infant urine. Valacyclovir should be administered to a nursing mother with caution and only when indicated.
Pediatric usageView
Pediatric Use: Safety and effectiveness of valacyclovir in pre-pubertal pediatric patients have not been established.
Elderly Use (Over 65 yr.): Elderly patients may require a dose reduction of valacyclovir due to a low body weight or disorders (renal, CNS etc.) associated with aging.
Elderly Use (Over 65 yr.): Elderly patients may require a dose reduction of valacyclovir due to a low body weight or disorders (renal, CNS etc.) associated with aging.
StorageView
Store in cool & dry place, away from children.
Revistar
Flucloxacillin Sodium
Revistar
Flucloxacillin Sodium
Indications
Wounds
Indication detailsView
Flucloxacillin is indicated for the treatment of infections due to Gram-positive organisms, including infections caused by penicillinase producing staphylococci. These indications include:
- Skin and soft tissue infections: Boils, abscess, carbuncles, infected skin conditions (e.g. ulcer, eczema, acne, furunculosis, cellulitis, infected wounds, infected burns, otitis media and externa, impetigo).
- Respiratory tract infections: Pneumonia, lung abscess, empyema, sinusitis, pharyngitis, tonsillitis, quinsy.
- It is also used for the treatment of other infections i.e. osteomyelitis, enteritis, endocarditis, urinary tract infection, meningitis, septicaemia caused by Flucloxacillin-sensitive organisms.
- As a prophylactic agent, it is used during major surgical procedures where appropriate; for example, cardiothoracic and orthopedic surgery.
Therapeutic classView
Penicillinase-resistant penicillins
PharmacologyView
Flucloxacillin is active against Gram-positive organisms including penicillinase producing strains. It has little activity against Gram-negative bacilli. Flucloxacillin acts by inhibiting the formation of cell wall of bacteria. Flucloxacillin is isoxazolyl penicillin which combined the properties of resistance to hydrolysis by penicillinase, gastric acid stability and activity against gram-positive bacteria. Flucloxacillin is a bactericidal antibiotic that is particularly useful against penicillinase-producing staphylococci. Flucloxacillin kills bacterial cellwall, thus interfering with peptidoglycan synthesis. Peptidoglycan is a heteropolymeric structure that provides the cell wall with its mechanical stability. The final stage of peptidoglycan synthesis involves the completion of the cross-linking with the terminal glycine residue of the pentaglycin bridge linking to the fourth residue of the pentapeptide (D-alanine). The transpeptidase enzyme that performs this step is inhibited by Flucloxacillin. As a result the bacterial cellwall is weakened, the cell swells and then ruptures. Flucloxacillin resists the action of bacterial penicillinase probably because of the steric hindrance induced by the acyl side chain which prevents the opening of the β- lactam ring.
DosageView
Oral administration:
Adult or Elderly:
- Adult: 250 mg four times daily. Dosage may be doubled in severe infections. In osteomyelitis and endocarditis, up to 8 gm daily is used in 6-8 hourly divided doses.
- Children (2-10 years): 1/2 of adult dose.
- Children (Under 2 years): 1/4 of adult dose.
Adult or Elderly:
- Intramuscular Injection: 250 mg four times daily.
- Intravenous Injection: 250 mg-1 g four times daily by slow injection over 3 to 4 minutes or by intravenous infusion.
- All systemic doses may be doubled in severe infections: doses up to 8 g daily have been suggested for endocarditis or osteomyelitis.
- 2-10 years: half of the adult dose.
- Under 2 years: a quarter of the adult dose.
AdministrationView
Oral doses should be administered 1 hour before meal.
Side effectsView
There have been some common side effects of gastrointestinal tract such as nausea, vomiting, diarrhoea, dyspepsia and other minor gastrointestinal disturbances. Besides these rashes, urticaria, purpura, fever, interstitial nephritis, hepatitis and cholestatic jaundice have been reported.
ContraindicationsView
Flucloxacillin is contraindicated in penicillin hypersensitive patients.
PrecautionsView
Flucloxacillin should be used with caution in patients with evidence of hepatic dysfunction. Caution should also be exercised in the treatment of patients with an allergic diathesis.
InteractionsView
Concurrent use of Flucloxacillin and may result in increased level of Flucloxacillin in blood for prolonged period.
Pregnancy & lactationView
US FDA Pregnancy Category of Flucloxacillin is B. There are, no adequate and well-controlled studies 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. Flucloxacillin have been shown to be excreted in human milk. So, caution should be exercised when Flucloxacillin is administered to a lactating mother.
Pediatric usageView
In severe renal failure (creatinine clearance <10 ml/min), a reduction in dose or an extension of dose interval should be considered.
ReconstitutionView
Flucloxacillin has been used in other routes in conjunction with systemic therapy. It has been administered in a dose of 250 mg to 500 mg daily by intraarticular injection, dissolved if necessary in a 0.5% solution of lignocaine hydrochloride, and by intrapleural injection in a dose of 250 mg daily. Using powder for injection, 125 mg-250 mg has been dissolved in 3 ml of sterile water and inhaled by nebuliser four times daily.
StorageView
Keep in a dry place away from light and heat. Keep out of the reach of children.
Revistar
Flucloxacillin Sodium
Revistar
Flucloxacillin Sodium
Indications
Wounds
Indication detailsView
Flucloxacillin is indicated for the treatment of infections due to Gram-positive organisms, including infections caused by penicillinase producing staphylococci. These indications include:
- Skin and soft tissue infections: Boils, abscess, carbuncles, infected skin conditions (e.g. ulcer, eczema, acne, furunculosis, cellulitis, infected wounds, infected burns, otitis media and externa, impetigo).
- Respiratory tract infections: Pneumonia, lung abscess, empyema, sinusitis, pharyngitis, tonsillitis, quinsy.
- It is also used for the treatment of other infections i.e. osteomyelitis, enteritis, endocarditis, urinary tract infection, meningitis, septicaemia caused by Flucloxacillin-sensitive organisms.
- As a prophylactic agent, it is used during major surgical procedures where appropriate; for example, cardiothoracic and orthopedic surgery.
Therapeutic classView
Penicillinase-resistant penicillins
PharmacologyView
Flucloxacillin is active against Gram-positive organisms including penicillinase producing strains. It has little activity against Gram-negative bacilli. Flucloxacillin acts by inhibiting the formation of cell wall of bacteria. Flucloxacillin is isoxazolyl penicillin which combined the properties of resistance to hydrolysis by penicillinase, gastric acid stability and activity against gram-positive bacteria. Flucloxacillin is a bactericidal antibiotic that is particularly useful against penicillinase-producing staphylococci. Flucloxacillin kills bacterial cellwall, thus interfering with peptidoglycan synthesis. Peptidoglycan is a heteropolymeric structure that provides the cell wall with its mechanical stability. The final stage of peptidoglycan synthesis involves the completion of the cross-linking with the terminal glycine residue of the pentaglycin bridge linking to the fourth residue of the pentapeptide (D-alanine). The transpeptidase enzyme that performs this step is inhibited by Flucloxacillin. As a result the bacterial cellwall is weakened, the cell swells and then ruptures. Flucloxacillin resists the action of bacterial penicillinase probably because of the steric hindrance induced by the acyl side chain which prevents the opening of the β- lactam ring.
DosageView
Oral administration:
Adult or Elderly:
- Adult: 250 mg four times daily. Dosage may be doubled in severe infections. In osteomyelitis and endocarditis, up to 8 gm daily is used in 6-8 hourly divided doses.
- Children (2-10 years): 1/2 of adult dose.
- Children (Under 2 years): 1/4 of adult dose.
Adult or Elderly:
- Intramuscular Injection: 250 mg four times daily.
- Intravenous Injection: 250 mg-1 g four times daily by slow injection over 3 to 4 minutes or by intravenous infusion.
- All systemic doses may be doubled in severe infections: doses up to 8 g daily have been suggested for endocarditis or osteomyelitis.
- 2-10 years: half of the adult dose.
- Under 2 years: a quarter of the adult dose.
AdministrationView
Oral doses should be administered 1 hour before meal.
Side effectsView
There have been some common side effects of gastrointestinal tract such as nausea, vomiting, diarrhoea, dyspepsia and other minor gastrointestinal disturbances. Besides these rashes, urticaria, purpura, fever, interstitial nephritis, hepatitis and cholestatic jaundice have been reported.
ContraindicationsView
Flucloxacillin is contraindicated in penicillin hypersensitive patients.
PrecautionsView
Flucloxacillin should be used with caution in patients with evidence of hepatic dysfunction. Caution should also be exercised in the treatment of patients with an allergic diathesis.
InteractionsView
Concurrent use of Flucloxacillin and may result in increased level of Flucloxacillin in blood for prolonged period.
Pregnancy & lactationView
US FDA Pregnancy Category of Flucloxacillin is B. There are, no adequate and well-controlled studies 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. Flucloxacillin have been shown to be excreted in human milk. So, caution should be exercised when Flucloxacillin is administered to a lactating mother.
Pediatric usageView
In severe renal failure (creatinine clearance <10 ml/min), a reduction in dose or an extension of dose interval should be considered.
ReconstitutionView
Flucloxacillin has been used in other routes in conjunction with systemic therapy. It has been administered in a dose of 250 mg to 500 mg daily by intraarticular injection, dissolved if necessary in a 0.5% solution of lignocaine hydrochloride, and by intrapleural injection in a dose of 250 mg daily. Using powder for injection, 125 mg-250 mg has been dissolved in 3 ml of sterile water and inhaled by nebuliser four times daily.
StorageView
Keep in a dry place away from light and heat. Keep out of the reach of children.
Revistar
Flucloxacillin Sodium
Revistar
Flucloxacillin Sodium
Indications
Wounds
Indication detailsView
Flucloxacillin is indicated for the treatment of infections due to Gram-positive organisms, including infections caused by penicillinase producing staphylococci. These indications include:
- Skin and soft tissue infections: Boils, abscess, carbuncles, infected skin conditions (e.g. ulcer, eczema, acne, furunculosis, cellulitis, infected wounds, infected burns, otitis media and externa, impetigo).
- Respiratory tract infections: Pneumonia, lung abscess, empyema, sinusitis, pharyngitis, tonsillitis, quinsy.
- It is also used for the treatment of other infections i.e. osteomyelitis, enteritis, endocarditis, urinary tract infection, meningitis, septicaemia caused by Flucloxacillin-sensitive organisms.
- As a prophylactic agent, it is used during major surgical procedures where appropriate; for example, cardiothoracic and orthopedic surgery.
Therapeutic classView
Penicillinase-resistant penicillins
PharmacologyView
Flucloxacillin is active against Gram-positive organisms including penicillinase producing strains. It has little activity against Gram-negative bacilli. Flucloxacillin acts by inhibiting the formation of cell wall of bacteria. Flucloxacillin is isoxazolyl penicillin which combined the properties of resistance to hydrolysis by penicillinase, gastric acid stability and activity against gram-positive bacteria. Flucloxacillin is a bactericidal antibiotic that is particularly useful against penicillinase-producing staphylococci. Flucloxacillin kills bacterial cellwall, thus interfering with peptidoglycan synthesis. Peptidoglycan is a heteropolymeric structure that provides the cell wall with its mechanical stability. The final stage of peptidoglycan synthesis involves the completion of the cross-linking with the terminal glycine residue of the pentaglycin bridge linking to the fourth residue of the pentapeptide (D-alanine). The transpeptidase enzyme that performs this step is inhibited by Flucloxacillin. As a result the bacterial cellwall is weakened, the cell swells and then ruptures. Flucloxacillin resists the action of bacterial penicillinase probably because of the steric hindrance induced by the acyl side chain which prevents the opening of the β- lactam ring.
DosageView
Oral administration:
Adult or Elderly:
- Adult: 250 mg four times daily. Dosage may be doubled in severe infections. In osteomyelitis and endocarditis, up to 8 gm daily is used in 6-8 hourly divided doses.
- Children (2-10 years): 1/2 of adult dose.
- Children (Under 2 years): 1/4 of adult dose.
Adult or Elderly:
- Intramuscular Injection: 250 mg four times daily.
- Intravenous Injection: 250 mg-1 g four times daily by slow injection over 3 to 4 minutes or by intravenous infusion.
- All systemic doses may be doubled in severe infections: doses up to 8 g daily have been suggested for endocarditis or osteomyelitis.
- 2-10 years: half of the adult dose.
- Under 2 years: a quarter of the adult dose.
AdministrationView
Oral doses should be administered 1 hour before meal.
Side effectsView
There have been some common side effects of gastrointestinal tract such as nausea, vomiting, diarrhoea, dyspepsia and other minor gastrointestinal disturbances. Besides these rashes, urticaria, purpura, fever, interstitial nephritis, hepatitis and cholestatic jaundice have been reported.
ContraindicationsView
Flucloxacillin is contraindicated in penicillin hypersensitive patients.
PrecautionsView
Flucloxacillin should be used with caution in patients with evidence of hepatic dysfunction. Caution should also be exercised in the treatment of patients with an allergic diathesis.
InteractionsView
Concurrent use of Flucloxacillin and may result in increased level of Flucloxacillin in blood for prolonged period.
Pregnancy & lactationView
US FDA Pregnancy Category of Flucloxacillin is B. There are, no adequate and well-controlled studies 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. Flucloxacillin have been shown to be excreted in human milk. So, caution should be exercised when Flucloxacillin is administered to a lactating mother.
Pediatric usageView
In severe renal failure (creatinine clearance <10 ml/min), a reduction in dose or an extension of dose interval should be considered.
ReconstitutionView
Flucloxacillin has been used in other routes in conjunction with systemic therapy. It has been administered in a dose of 250 mg to 500 mg daily by intraarticular injection, dissolved if necessary in a 0.5% solution of lignocaine hydrochloride, and by intrapleural injection in a dose of 250 mg daily. Using powder for injection, 125 mg-250 mg has been dissolved in 3 ml of sterile water and inhaled by nebuliser four times daily.
StorageView
Keep in a dry place away from light and heat. Keep out of the reach of children.