Dolutegravir, Lamivudine and TENOFOVOR DISOPROXIL Tablets
Country: Tanzania
Language: English
Source: Tanzania Medicinces & Medical Devices Authority
Summary of Product characteristics
(SPC)
08-03-2023
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Active ingredient:
Dolutegravir Sodium, Lamivudine , Tenofovovir Disoproxil Fumarate
Available from:
CIPLA QUALITY CHEMICAL INDUSTRIES Limited, UGANDA
INN (International Name):
Dolutegravir Sodium+ Lamivudine + Tenofovovir Disoproxil Fumarate
Pharmaceutical form:
Tablets
Manufactured by:
CIPLA QUALITY CHEMICAL INDUSTRIES LIMITED, UGANDA
Product summary:
Physical description: Blue coloured, capsule shaped biconvex film coated tablet, debossed with 'C' on one side and plain on other side; Local technical representative: Salama Pharmaceuticals Limited (9410)
Authorization status:
Registered/Compliant
Authorization date:
2021-06-03
Summary of Product characteristics
TMDA/DMC/MRE/F/016
REV #:02
THEUNITEDREPUBLICOFTANZANIA
MINISTRYOFHEALTH
TANZANIAMEDICINES ANDMEDICALDEVICESAUTHORITY
PUBLIC ASSESSMENT REPORT FOR DOLUTEGRAVIR SODIUM/ LAMIVUDINE
AND TENOFOVIR DISOPROXIL FUMARATE (DOLUTEGRAVIR SODIUM 50 MG,
LAMIVUDINE 300 MG, TENOFOVIR DISOPROXIL FUMARATE 300 MG) FILM
COATED TABLETS
VERSION NUMBER 1.0
3
RD JANUARY, 2023
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
Dolutegravir Sodium, Lamivudine/Tenofovir Disoproxil Fumarate is a
generic medicine
of Tivicay film-coated tablets, Viread 245 mg film-coated tablets and
Epivir 300 mg film-
coated tablets. Dolutegravir Sodium, Lamivudine/Tenofovir Disoproxil
Fumarate is an
Antiviral
medicine
belonging
to
J05AF07
(nucleoside
and
nucleotide
reverse
transcriptase inhibitors), J05AF0 (nucleoside analogue) and J05AJ03
(other antivirals)
group.
Dolutegravir inhibits HIV integrase by binding to the integrase active
site and blocking
the strand transfer step of retroviral Deoxyribonucleic acid (DNA)
integration which is
essential for the HIV replication cycle.
Lamivudine
is
a
nucleoside
analogue
which
has
activity
against
human
immunodeficiency
virus
(HIV)
and
hepatitis
B
virus
(HBV).
It
is
metabolised
intracellularly to the active moiety, lamivudine 5'-triphosphate. Its
main mode of action is
as a chain terminator of viral reverse transcription. The triphosphate
has selective
inhibitory activity against HIV-1 and HIV-2 replication in vitro, it
is also active against
zidovudine-resistant clinical isolates of HIV. No antagonistic effects
in vitro were seen
with
lamivudine
and
other
anti
retrovirals
(tested
agents:
abacavir,
didanosine,
nevirapine and zidovudine
Tenofovir disoproxil fumarate is the fumarate salt of the prodrug
tenofovir disoproxil.
Tenofovir disoproxil is absorbed and converted to th
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