Cotrikant - 960 Tablets 960 mg

Страна: Танзания

Език: английски

Източник: Tanzania Medicinces & Medical Devices Authority

Активна съставка:

Sulfamethazine , Trimethoprim

Предлага се от:

S Kant Healthcare Limited, INDIA

АТС код:

Sulphonamide & Anti-infective in combination

INN (Международно Name):

Sulfamethazine + Trimethoprim

дозиране:

960 mg

Лекарствена форма:

Tablets

Произведено от:

S Kant Healthcare Limited, INDIA

Каталог на резюме:

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)

Статус Оторизация:

Registered/Compliant

Дата Оторизация:

2021-11-26

Данни за продукта

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