ABRIDGED PRESCRIBING INFORMATION: ABEC-L

Composition:

Each film coated tablet contains Abacavir Sulphate IP equivalent to Abacair 600 mg and Lamivudine IP 300 mg.


Indication:

Treatment of HIV-1 infection in combination with other antiretroviral agents.


Dosage:

The recommended oral dose of ABEC-L for adults is one tablet daily, in combination with other antiretroviral agents. ABEC-L can be taken with or without food.


Adverse Reactions:

Serious and sometimes fatal hypersensitivity reactions have been associated with abacavir sulfate, a component of ABEC-L. Insomnia, depression, headache, migraine, fatigue / malaise, dizziness / vertigo, nausea, diarrhea, skin rash, fever, abdominal pain / gastritis, abnormal dreams and anxiety are the commonly reported side effects.


Warnings & Precautions:

Should not be administered concomitantly with other abacavir-containing and/or lamivudine-containing products. Serious and sometimes fatal hypersensitivity reactions have been associated with ABEC-L and other abacavir-containing products. Patients who carry the HLA-B*5701 allele are at high risk for experiencing a hypersensitvity reaction to abacavir. Prior to initiating therapy with abacavir, screening for the HLA-B*5701 allele is recommended; this approach has been found to decrease the risk of hypersensitivity reaction. Screening is also recommended prior to reinitiation of abacavir in patients of unknown HLA-B*5701 status who have previously tolerated abacavir. Treatment with ABEC-L should be suspended in any patient who develops clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity. Patients receiving interferon alfa with or without ribavirin and ABEC-L should be closely monitored for treatment-associated toxicities, especially hepatic decompensation. Discontinuation of ABEC-L should be considered as medically appropriate. Since ABEC-L is a fixed dose combination, should not be given to patients with creatinine clearance < 50 ml/min.


Drug Interactions:

Ethanol decreases the elimination of abacavir causing an increase in overall exposure. Lamivudine and zalcitabine may inhibit the intracellular phosphorylation of one another. Therefore, use of ABEC-L in combination with zalcitabine is not recommended.


Pregnancy:

Category C drug. ABEC-L should be used during pregnancy only if the potential benefits outweigh the risks.


Nursing Mothers:

Mothers should not breastfeed their infants to avoid risking postnatal transmission of HIV-1 infection.


Contraindications:

Patients with previously demonstrated hypersensitivity to abacavir or to any other component of the product. NEVER restart ABEC-L or any other abacavir-containing product following a hypersensitivity reaction to abacavir, regardless of HLA-B*5701 status. Patients with hepatic impairment.


Storage:

Store in a cool and dry place.


Presentation:

Container of 30 tablets. For further information, please consult the full prescribing information.