DOLTELAM Film-coated tablet Ref.[50525] Active ingredients: Dolutegravir Lamivudine Tenofovir disoproxil

Source: Health Products Regulatory Authority (ZA)  Revision Year: 2022  Publisher: Austell Pharmaceuticals (Pty) Ltd, 1 Sherborne Road, Parktown, JOHANNESBURG, 2193, South Africa Tel: 0860287835 Manufactured by Lupin Ltd, imported and distributed by Austell Pharmaceuticals (Pty) Ltd. ...

Product name and form

DOLTELAM FILM-COATED TABLETS.

Pharmaceutical Form

White, biconvex modified capsule shaped bevelled edge film coated tablets debossed with ‘L 160’ on one side and plain on the other side.

Qualitative and quantitative composition

Each DOLTELAM film coated tablet contains dolutegravir sodium equivalent to 50 mg dolutegravir, 300 mg lamivudine and tenofovir disoproxil fumarate equivalent to 300 mg tenofovir disoproxil.

DOLTELAM contains sugar as mannitol 157 mg per tablet.

Contains lactose monohydrate 140 mg per tablet.

For the 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

Tablet core:

Colloidal silicone dioxide
Croscarmellose sodium
Hypromellose
Lactose monohydrate
Magnesium stearate (vegetable grade)
Mannitol
Microcrystalline cellulose (Avicel PH101)
Povidone
Sodium starch glycolate
Talc

Tablet coating:

Opadry II Pink 85F94172:

Ferrosoferric oxide
Iron oxide red
Polyethylene glycol
Polyvinyl alcohol
Talc
Titanium dioxide

Pack sizes and marketing

Round opaque white HDPE bottle with 38 mm child resistant closure of polypropylene with HS 12335 printed liner with one molecular sieve sachet of 5g containing 30 tablets.

Round opaque white HDPE bottle with 38 mm child resistant closure of polypropylene with HS 12335 printed liner with two molecular sieve sachets of 5g containing 60 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Austell Pharmaceuticals (Pty) Ltd, 1 Sherborne Road, Parktown, JOHANNESBURG, 2193, South Africa
Tel: 0860287835

Manufactured by Lupin Ltd, imported and distributed by Austell Pharmaceuticals (Pty) Ltd.

Marketing authorization dates and numbers

55/20.2.8/0349

07 September 2021

Drugs

Drug Countries
DOLTELAM South Africa

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.