Sural400 mg
Tablet
Ethambutol
Ambee Pharmaceuticals Ltd.
Product Code : 16406
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Medicine overview
Indications of Sural 400 mg
Sural 400 mg is indicated for the treatment of pulmonary tuberculosis. It should not be used as the sole antituberculous drug, but should be used in conjunction with at least one other antituberculous drug. Selection of the companion drug should be based on clinical experience, considerations of ... Read moreSural 400 mg is indicated for the treatment of pulmonary tuberculosis. It should not be used as the sole antituberculous drug, but should be used in conjunction with at least one other antituberculous drug. Selection of the companion drug should be based on clinical experience, considerations of comparative safety, and appropriate in vitro susceptibility studies. In patients who have not received previous antituberculous therapy, ie, initial treatment, the most frequently used regimens have been the following:
Sural 400 mg plus isoniazid
Sural 400 mg plus isoniazid plus streptomycin.
In patients who have received previous antituberculous therapy, mycobacterial resistance to other drugs used in initial therapy is frequent. Consequently, in such retreatment patients, Sural 400 mg should be combined with at least one of the second line drugs not previously administered to the patient and to which bacterial susceptibility has been indicated by appropriate in vitro studies. Antituberculous drugs used with Sural 400 mg have included cycloserine, ethionamide, pyrazinamide, viomycin and other drugs. Isoniazid, aminosalicylic acid, and streptomycin have also been used in multiple drug regimens. Alternating drug regimens have also been utilized.
Theropeutic Class
Anti-Tubercular Chemotherapeutics
Pharmacology
Sural 400 mg appears to inhibit the synthesis of 1 or more metabolites in susceptible bacteria resulting in impairment of cellular metabolism, arrest of multiplication, and cell death. It is active against susceptible bacteria only when they are undergoing cell division.
Dosage of Sural 400 mg
Sural 400 mg should not be used alone, in initial treatment or in retreatment. Sural 400 mg should be administered on a once every 24-hour basis only. Absorption is not significantly altered by administration with food. Therapy, in general, should be continued until bacteriological conversion has become permanent and maximal clinical improvement has occurred.Sural 400 mg is not recommended for use in pediatric patients under thirteen years of age since safe conditions for use have not been established.Initial Treatment: In patients who have not received previous antituberculous therapy, administer Sural 400 mg 15 mg/kg of body weight, as a single oral dose once every 24 hours. In the more recent studies, isoniazid has been administered concurrently in a single, daily, oral dose.Retreatment: In patients who have received previous antituberculous therapy, administer Sural 400 mg 25 mg/kg of body weight, as a single oral dose once every 24 hours. Concurrently administer at least one other antituberculous drug to which the organisms have been demonstrated to be susceptible by appropriate in vitro tests. Suitable drugs usually consist of those not previously used in the treatment of the patient. After 60 days of Sural 400 mg administration, decrease the dose to 15 mg/kg of body weight, and administer as a single oral dose once every 24 hours.During the period when a patient is on a daily dose of 25 mg/kg, monthly eye examinations are advised.Renal Impairment: Dose adjustment may be needed as determined by blood levels of Sural 400 mg.
Administration of Sural 400 mg
Should be taken with food.
Interaction of Sural 400 mg
Delayed or reduced absorption with aluminium hydroxide.
Contraindications
Sural 400 mg is contraindicated in patients who are known to be hypersensitive to this drug. It is also contraindicated in patients with known optic neuritis unless clinical judgment determines that it may be used. Sural 400 mg is contraindicated in patients who are unable to appreciate and report visual side effects or changes in vision
Side Effects of Sural 400 mg
Retrobulbar neuritis with reduction in visual acuity, constriction of visual field, central or peripheral scotoma and green-red colour blindness of 1 or both eyes. Reduced renal clearance of urate and may precipitate acute gout. Confusion, disorientation, hallucinations, headache, dizziness, malaise, jaundice or transient liver dysfunction, peripheral neuropathy, thrombocytopenia, pulmonary infiltrates, eosinophilia and GI disturbances (e.g. nausea, vomiting, anorexia, abdominal pain). Rarely, retinal haemorrhage, hypersensitivity reactions including rashes, pruritus, leucopenia, fever, and joint pains.
Pregnancy & Lactation
Category C: Either studies in animals have revealed adverse effects on the foetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the foetus.
Precautions & Warnings
Patient with ocular defects (e.g. cataracts, recurrent ocular inflammatory conditions, diabetic neuropathy). Renal impairment. Pregnancy and lactation.
Storage Conditions
Store between 20-25°C. Protect from light, moisture and excessive heat.
Drug Classes
Anti-Tubercular Chemotherapeutics
Mode Of Action
Sural 400 mg appears to inhibit the synthesis of 1 or more metabolites in susceptible bacteria resulting in impairment of cellular metabolism, arrest of multiplication, and cell death. It is active against susceptible bacteria only when they are undergoing cell division.
Pregnancy
Category C: Either studies in animals have revealed adverse effects on the foetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the foetus.
Disclaimer
The information provided is accurate to our best practices, but it does not replace professional medical advice. We cannot guarantee its completeness or accuracy. The absence of specific information about a drug should not be seen as an endorsement. We are not responsible for any consequences resulting from this information, so consult a healthcare professional for any concerns or questions.