Description

Abacavir: In a trial of 11 HIV-1-infected subjects receiving methadone-maintenance therapy with 600 mg twice daily (twice the currently recommended dose), oral methadone clearance increased. This alteration will not result in a methadone dose modification in the majority of patients; however, an increased methadone dose may be required in a small number of patients. Lamivudine: Coadministration of single doses of lamivudine and sorbitol resulted in a sorbitol dose-dependent reduction in lamivudine exposures. When possible, avoid use of sorbitol-containing medicines with lamivudine-containing medicines Zidovudine: Concomitant use of zidovudine with the following drugs should be avoided since an antagonistic relationship has been demonstrated in vitro: Stavudine, Doxorubicin, Nucleoside analogues, e.g., ribavirin

The most commonly reported adverse reactions (incidence at least 10%) in clinical trials were nausea, headache, malaise and fatigue, and nausea and vomiting.

Pregnancy Category C. There are no adequate and well-controlled studies of this preparation in pregnant women. This drug should be used during pregnancy only if the potential benefits outweigh the risks. Women infected with HIV should be instructed not to breastfeed due to potential for HIV transmission.

Serious and sometimes fatal hypersensitivity reactions have occurred with abacavir, a component of this preparation. These hypersensitivity reactions have included multi-organ failure and anaphylaxis and typically occurred within the first 6 weeks of treatment with abacavir (median time to onset was 9 days); although abacavir hypersensitivity reactions have occurred any time during. Patients who carry the HLA-B*5701 allele are at a higher risk of abacavir hypersensitivity reactions; although, patients who do not carry the HLA-B*5701 allele have developed hypersensitivity reactions. Hypersensitivity to abacavir was reported in approximately 206 (8%) of 2,670 patients in 9 clinical trials with abacavir-containing products where HLA-B*5701 screening was not performed. The incidence of suspected abacavir hypersensitivity reactions in clinical trials was 1% when subjects carrying the HLA-B*5701 allele were excluded. In any patient treated with abacavir, the clinical diagnosis of hypersensitivity reaction must remain the basis of clinical decision making.

There is no known specific treatment for overdose with this preparation. If overdose occurs, the patient should be monitored and standard supportive treatment applied as required.

Drugs for HIV / Anti-retroviral drugs

Store at a dry and cool place. Protect from light and moisture. Keep the medicine out of the reach of children.