TRIZIVIR Film-coated tablet Ref.[107709] Active ingredients: Abacavir Lamivudine Zidovudine Zidovudine, Lamivudine and Abacavir

Source: European Medicines Agency (EU)  Revision Year: 2022  Publisher: ViiV Healthcare BV, Van Asch van Wijckstraat 55H, 3811 LP Amersfoort, Netherlands

Product name and form

TRIZIVIR 300 mg/150 mg/300 mg film-coated tablets.

Pharmaceutical Form

Film-coated tablet (tablet).

Blue-green capsule-shaped film-coated tablets engraved with “GX LL1” on one side.

Qualitative and quantitative composition

Each film-coated tablet contains 300 mg of abacavir (as sulfate), 150 mg lamivudine and 300 mg zidovudine.

Excipient(s) with known effect: Each 300 mg/150 mg/300 mg tablet contains 2.7 mg sodium.

For the full list of excipients see section 6.1.

Active Ingredient Description
Abacavir

Abacavir is a NRTI. It is a potent selective inhibitor of HIV-1 and HIV-2. Abacavir is metabolised intracellularly to the active moiety, carbovir 5'-triphosphate (TP). In vitro studies have demonstrated that its mechanism of action in relation to HIV is inhibition of the HIV reverse transcriptase enzyme, an event which results in chain termination and interruption of the viral 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.

Zidovudine

Zidovudine is an antiviral agent which is highly active in vitro against retroviruses including the Human Immunodeficiency Virus (HIV).

Zidovudine, Lamivudine and Abacavir

Abacavir, lamivudine and zidovudine are all NRTIs, and are potent selective inhibitors of HIV-1 and HIV-2.All three medicinal products are metabolised sequentially by intracellular kinases to the respective 5′-triphosphate (TP). Lamivudine-TP, carbovir-TP (the active triphosphate form of abacavir) and zidovudine-TP are substrates for and competitive inhibitors of HIV reverse transcriptase (RT). However, their main antiviral activity is through incorporation of the monophosphate form into the viral DNA chain, resulting in chain termination. Abacavir, lamivudine and zidovudine triphosphates show significantly less affinity for host cell DNA polymerases.

List of Excipients

Tablet core:

Microcrystalline cellulose
Sodium starch glycollate (type A)
Magnesium stearate

Tablet coating

Opadry Green 03B11434 containing: hypromellose, titanium dioxide, polyethylene glycol, indigo carmine aluminium lake, iron oxide yellow.

Pack sizes and marketing

Trizivir tablets are available in opaque white PCTFE/PVC-Al blister packs or child-resistant foil PVC/PCTFE/PVC-Al/Paper blister packs containing 60 tablets, or child resistant HDPE bottles containing 60 tablets.

Marketing authorization holder

ViiV Healthcare BV, Van Asch van Wijckstraat 55H, 3811 LP Amersfoort, Netherlands

Marketing authorization dates and numbers

EU/1/00/156/002 – opaque white PCTFE/PVC-Al Blister pack (60 Tablets)

EU/1/00/156/003 – Bottle pack (60 Tablets)

EU/1/00/156/004 – child-resistant foil PVC/PCTFE/PVC-Al/Paper Blister pack (60 Tablets)

Date of first authorisation: 28 December 2000
Date of latest renewal: 29 November 2010

Drugs

Drug Countries
TRIZIVIR Austria, Australia, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Italy, Lithuania, Netherlands, Poland, Romania, United Kingdom, United States

© 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.