Dolutegravir, Lamivudine and Tenofovir Disoproxil Fumarate Tablets 50mg/300mg/300mg Oral tablet 50/300/300

Country: Tanzania

Language: English

Source: Tanzania Medicinces & Medical Devices Authority

Active ingredient:

Dolutegravir, Lamivudine , Tenofovir Disoproxil Fumarate Tablets 50mg/300mg/300mg

Available from:

Hetero Laboratories Limited, INDIA

INN (International Name):

Dolutegravir, Lamivudine and Tenofovir Disoproxil Fumarate Tablets 50mg/300mg/300mg

Dosage:

50/300/300

Pharmaceutical form:

Oral tablet

Manufactured by:

HETERO LABS LIMITED (UNIT V), INDIA

Product summary:

Physical description: Orange coloured, modified capsule shaped, biconvex film coated tablets debossed with 'H' on one side and 'D17' on the other side; Local technical representative: KAS MEDICS LIMITED

Authorization status:

Registered/Compliant

Authorization date:

2021-10-09

Summary of Product characteristics

PRODUCT INFORMATION: SUMMARY OF PRODUCT CHARACTERISTICS (SMPC)
1. NAME OF THE FINISHED PHARMACEUTICAL PRODUCT
INN NAME:
Dolutegravir, Lamivudine and Tenofovir Disoproxil Fumarate Tablets
50mg / 300mg / 300mg
TRADE NAME:
Dolutegravir, Lamivudine and Tenofovir Disoproxil Fumarate Tablets
50mg / 300mg / 300mg
STRENGTH:
50/300/300 mg
PHARMACEUTICAL FORM: Film coated tablet
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film coated tablet contains: 52.6 mg of Dolutegravir Sodium
Equivalent to 50 mg of
Dolutegravir,
300
mg
of
Lamivudine
USP
and
300
mg
of
Tenofovir
Disoproxil
fumarate
(Equivalent to 245 mg of Tenofovir Disoproxil).
3.
PHARMACEUTICAL FORM
DOSAGE FORM: Film coated tablet
DESCRIPTION: Orange colored, modified capsule shaped, biconvex film
coated tablets
debossed with 'H 'on one side and 'D17' on the other side.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Dolutegravir, lamivudine and tenofovir disoproxil fumarate tablets are
indicated for the treatment
of human immunodeficiency virus type 1 (HIV-1) infection in adults and
adolescents.
LIMITATIONS OF USE:
•
Use of dolutegravir, lamivudine and tenofovir disoproxil fumarate
tablets in integrase
strand transfer inhibitor (INSTI)-experienced patients should be
guided by the number and type
of
baseline INSTI substitutions. The efficacy of dolutegravir, lamivudine
and tenofovir disoproxil
fumarate tablets 50 mg twice daily is reduced in patients with an
INSTI-resistance Q148
substitution plus 2 or more additional INSTI-resistance substitutions,
including T66A, L74I/M,
E138A/K/T,
G140S/A/C,
Y143R/C/H,
E157Q,
G163S/E/K/Q,
or
G193E/R
_[see _
_Microbiology _
_(12.4)]_.
•
The dosage of this product is for HIV-1 and not for HBV.
The following points should be considered when initiating therapy with
dolutegravir, lamivudine
and tenofovir disoproxil fumarate tablets for the treatment of HIV-1
infection:
Dolutegravir,
lamivudine
and
tenofovir
disoproxil
fumarate
tablets
should
not
be
used
in
combination with ATRIPLA
®
, COMPLERA
®
, DESCOVY
®
, GENVOYA
®