EMTROC Film-coated tablet Ref.[50541] Active ingredients: Emtricitabine Tenofovir disoproxil

Source: Health Products Regulatory Authority (ZA)  Revision Year: 2015  Publisher: Macleods Pharmaceuticals SA (Pty) Ltd, Stand 6 D & E, Growthpoint Business Park, Halfway House, Midrand, South Africa

Product name and form

EMTROC TABLETS (film-coated tablet).

Pharmaceutical Form

Film-coated tablet.

Blue coloured capsule shaped, biconvex, film coated tablets debossed “L 24” on one side of the tablet and plain on other surface.

Qualitative and quantitative composition

Each film coated tablet contains 200 mg emtricitabine and 300 mg of tenofovir disoproxil fumarate.

Contains lactose.

Active Ingredient Description
Emtricitabine

Emtricitabine is a synthetic nucleoside analogue of cytidine with activity that is specific to HIV-1, HIV-2 and HBV. Emtricitabine is phosphorylated by cellular enzymes to form emtricitabine 5'-triphosphate, which competitively inhibits HIV-1 reverse transcriptase, resulting in DNA chain termination. Emtricitabine is a weak inhibitor of mammalian DNA polymerase α, β and ε and mitochondrial DNA polymerase γ.

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

Lactose monohydrate, microcrystalline cellulose, pre-gelatinized starch, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate, Opadry II Blue 30K505002 coating containing lactose monohydrate, hydroxypropylmethylcellulose, titanium dioxide (Colour Index No. 77891), triacetin, FD&C Blue No.2 (Colour Index No. 73015).

Pack sizes and marketing

HDPE Container. Pack of 28 or 30 tablets: 75 ml white, heavy weight, round white HDPE bottle with 38-400 neck finish with a 38 mm white child resistant closure with pulp and heat seal liner containing a 3 g silica gel sachet.

Alu-Alu blister pack (10 × 10) tablets: Cold form laminate 25 micron OPA/45 micron Aluminium foil/60 micron PVC and plain 25 micron aluminium foil with 6-8 GSM HSL.

Marketing authorization holder

Macleods Pharmaceuticals SA (Pty) Ltd, Stand 6 D & E, Growthpoint Business Park, Halfway House, Midrand, South Africa

Marketing authorization dates and numbers

47/20.2.8/0188

Date of registration: 7 December 2012

Drugs

Drug Countries
EMTROC South Africa

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