Cotrikant - 960 Tablets 960 mg

국가: 탄자니아

언어: 영어

출처: Tanzania Medicinces & Medical Devices Authority

유효 성분:

Sulfamethazine , Trimethoprim

제공처:

S Kant Healthcare Limited, INDIA

ATC 코드:

Sulphonamide & Anti-infective in combination

INN (국제 이름):

Sulfamethazine + Trimethoprim

복용량:

960 mg

약제 형태:

Tablets

Manufactured by:

S Kant Healthcare Limited, INDIA

제품 요약:

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)

승인 상태:

Registered/Compliant

승인 날짜:

2021-11-26

제품 특성 요약

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: [phone]/+255
(22)
2450512/2450751/2452108, EMAIL: [e-mail], 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