LANOGRAV Film-coated tablet Ref.[51100] Active ingredients: Dolutegravir Lamivudine Tenofovir disoproxil

Source: Health Products Regulatory Authority (ZA)  Revision Year: 2022  Publisher: Ranbaxy Pharmaceuticals (Pty) Ltd, 14 Lautre Road, Stormill, Ext.1, Roodepoort, 1724, South Africa

Product name and form

Lanograv.

Pharmaceutical Form

Film coated tablet.

White to off-white film coated, caplet shaped tablets plain on both side.

Qualitative and quantitative composition

Each film coated tablet contains:

Dolutegravir sodium equivalent to dolutegravir 50 mg
Lamivudine 300 mg
Tenofovir disoproxil fumarate 300 mg

Contains sugar: Mannitol 144,5 mg per tablet.

For full list of excipients, see section 6.1.

Active Ingredient Description
Dolutegravir

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

Lamivudine is a nucleoside analogue which has activity against human immunodeficiency virus (HIV) and hepatitis B virus (HBV). Its main mode of action is as a chain terminator of viral reverse transcription.

Tenofovir disoproxil

Tenofovir disoproxil is absorbed and converted to the active substance tenofovir, which is a nucleoside monophosphate analogue. Tenofovir is then converted to the active metabolite, tenofovir diphosphate, an obligate chain terminator, by constitutively expressed cellular enzymes. Tenofovir diphosphate inhibits HIV-1 reverse transcriptase and the HBV polymerase by direct binding competition with the natural deoxyribonucleotide substrate and, after incorporation into DNA, by DNA chain termination.

List of Excipients

Croscarmellose sodium
Magnesium stearate
Mannitol
Microcrystalline cellulose
Povidone
Sodium starch glycolate

Coating material: Opadry II 85F580019 (White)

Macrogol/PEG
Polyvinyl alcohol-part hydrolysed
Talc
Titanium dioxide

Pack sizes and marketing

The film coated tablets are packed in a white opaque HDPE bottle pack of 28’s, 30’s and 90’s with 3 g silica or 5 g silica as desiccant and a white opaque polypropylene screw cap with an induction seal liner; with or without a carton.

Marketing authorization holder

Ranbaxy Pharmaceuticals (Pty) Ltd, 14 Lautre Road, Stormill, Ext.1, Roodepoort, 1724, South Africa

Marketing authorization dates and numbers

52/20.2.8/0718

26 October 2018

Drugs

Drug Countries
LANOGRAV South Africa

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