LOMIDA Film-coated tablet Ref.[115179] Active ingredients: Dolutegravir Lamivudine

Source: Health Products Regulatory Authority (ZA)  Revision Year: 2024  Publisher: CIPLA MEDPRO MANUFACTURING (PTY) LTD., 1474 South Coast Road, Mobeni, Durban, 4052, Customer care: 080 222 6662

Product name and form

LOMIDA (50/300 mg film-coated tablets).

Pharmaceutical Form

Film-coated tablets.

LOMIDA are grey coloured, capsule shaped, biconvex, film-coated tablets debossed with “C” on one side and plain on other side.

Qualitative and quantitative composition

Each film-coated tablet contains dolutegravir sodium equivalent to dolutegravir 50 mg and lamivudine 300 mg.

Contains sugar: mannitol 145,00 mg.

For the full list of excipients, see section 6.1.

Active Ingredient

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). Its main mode of action is as a chain terminator of viral reverse transcription.

List of Excipients

Colloidal silicon dioxide
Mannitol
Microcrystalline cellulose
Opadry Gray YS-1-17506-A
Povidone
Sodium starch glycolate
Sodium stearyl fumarate

Contents of the film-coating (Opadry Gray):

Ferrosoferric oxide/Black iron oxide
Hypromellose 3mPas
Hypromellose 6mPas
Macrogol
Polysorbate 80
Titanium dioxide

Pack sizes and marketing

LOMIDA is packed in a 50 cc white round high density polyethylene (HDPE) bottle with 33 mm blue child resistant cap. Pack sizes are 28’s and 30’s.

Marketing authorization holder

CIPLA MEDPRO MANUFACTURING (PTY) LTD., 1474 South Coast Road, Mobeni, Durban, 4052, Customer care: 080 222 6662

Marketing authorization dates and numbers

54/20.2.8/0642.641

25 May 2021

Drugs

Drug Countries
LOMIDA South Africa

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