TRIMETHOPRIM AND SULFAMETHOXAZOLE TABLETS 120 mg 1. COMPOSITIONEach tablet contains: 2. PHARMACEUTICAL FORMTablet. 3. THERAPEUTIC CLASSAntibacterial Combination / Folate Antagonist. 4. INDICATIONSTreatment of susceptible bacterial infections. Urinary tract infections caused by susceptible organisms. Certain respiratory and gastrointestinal bacterial infections when indicated. Other susceptible infections as determined by the physician.
5. CONTRAINDICATIONSHypersensitivity to Trimethoprim, Sulfonamides, or any component of the formulation. Severe hepatic impairment. Severe renal impairment when renal function cannot be monitored. Megaloblastic anaemia due to folate deficiency. Concomitant use with dofetilide. Not recommended in infants below 2 months of age unless specifically prescribed.
6. DRUG INTERACTIONSMay interact with: Warfarin and other anticoagulants — may increase anticoagulant effect. Methotrexate — may increase the risk of bone-marrow toxicity. Phenytoin — may increase phenytoin exposure. ACE inhibitors/ARBs and potassium-sparing medicines — may increase the risk of hyperkalaemia. Cyclosporine — may increase the risk of nephrotoxicity. Dofetilide — concomitant use is contraindicated.
7. ADMINISTRATIONTake orally with a sufficient quantity of water, preferably after food, or as directed by a physician. The dosage and duration depend on the type and severity of infection, age and renal function. Complete the prescribed course of treatment. Maintain adequate fluid intake during treatment. Do not discontinue treatment prematurely unless advised by a physician.
8. STORAGEStore below 25°C, protected from moisture and excessive heat. Keep the tablets in the original package. Keep out of reach of children. Do not use after the expiry date. Market : international export Private Label : Available Registration Support : Available Regulatory documents : Available on request |