Country: Tanzania
Language: English
Source: Tanzania Medicinces & Medical Devices Authority
Sulfamethazine , Trimethoprim
S Kant Healthcare Limited, INDIA
Sulphonamide & Anti-infective in combination
Sulfamethazine + Trimethoprim
960 mg
Tablets
S Kant Healthcare Limited, INDIA
Physical description: White coloured, uncoated, oval shaped, biconvex tablet having central break line on one side and plain on other side; Local technical representative: Abacus Pharma Africa Limited (8473)
Registered/Compliant
2021-11-26
Effective date: 03/10/2022 TMDA/DMC/MRE/F/016 REV #:02 THE UNITED REPUBLIC OF TANZANIA MINISTRY OF HEALTH TANZANIA MEDICINES AND MEDICAL DEVICES AUTHORITY PUBLIC ASSESSMENT REPORT FOR COTRIKANT-960 (SULFAMETHOXAZOLE 800MG AND TRIMETHOPRIM 160MG) TABLETS VERSION NUMBER 1 03 JANUARY, 2022 TMDA HEADQUARTERS, PLOT NO. 56/1, BLOCK E, KISASA B CENTRE, SWASWA ROAD, P. O. BOX 1253, DODOMA – TANZANIA, TELEPHONE: +255 (26) 2961989/2061990/+255 (22) 2450512/2450751/2452108, EMAIL: INFO@TMDA.OG.TZ, Website: WWW.TMDA.GO.TZ Toll free: 0800110084 Effective date: 03/10/2022 1. INTRODUCTION Cotrikant-960 is a generic medicine of Septrin forte tablets of Aspen Pharma Trading Limited, Dublin, Ireland. Cotrikant-960 is an antibacterial drug composed of two active principles, sulfamethoxazole and trimethoprim. Sulfamethoxazole is a competitive inhibitor of dihydropteroate synthetase enzyme. Sulfamethoxazole competitively inhibits the utilisation of para-aminobenzoic acid (PABA) in the synthesis of dihydrofolate by the bacterial cell resulting in bacteriostasis. Trimethoprim reversibly inhibits bacterial dihydrofolate reductase (DHFR), an enzyme active in the folate metabolic pathway converting dihydrofolate to tetrahydrofolate. Depending on the conditions the effect may be bactericidal. Thus, trimethoprim and sulfamethoxazole block two consecutive steps in the biosynthesis of purines and therefore nucleic acids essential to many bacteria. This action produces marked potentiation of activity in vitro between the two agents. Cotrikant-960 is approved in Tanzania for use in adults and children (>12 to <18 years old) and adults (>18 years old). 1.1 PRODUCT DETAILS Registration number TAN 21 HM 0440 Brand name Cotrikant-960 Generic name, strength, and form Each tablet contains Sulfamethoxazole 800mg and trimethoprim 160mg ATC classification Antibacterials for systemic use, combinations of sulfonamides and trimethoprim (sulfamethoxazole and trimethoprim: J01EE01) Distribution category POM Country of origin India Associated product N/A Ma Read the complete document