Abridged Prescribing Information:

A- Bec Tablet


Therapeutic Category:

Antiretroviral./p>


Composition:

Each film-coated tablet contains Abacavir sulphate equivalent to Abacavir 300 mg.


Indication:

For the treatment of HIV- 1 infection in combination with other antiretroviral agents.


Dosage and administration:

The recommended oral dose for adults is 300 mg twice daily in combination with other antiretroviral agents. The recommended oral dose of abacavir for adolescents and pediatric patients 3 months to 16 years of age is 8 mg/kg twice daily (up to a maximum of 300 mg twice daily) in combination with other antiretroviral agents. The recommended dose of abacavir in patients with mild hepatic impairment (Child-Pugh score 5 to 6) is 200 mg twice daily. Dose adjustments in patients of renal impairment are not expected to be needed. May be taken with or without food.


Contraindications:

Contraindicated in patients with previously demonstrated hypersensitivity to abacavir or any other component of the formulation, patients with moderate to severe hepatic impairment.


Warnings and precautions:

Abacavir should be permanently discontinued if hypersensitivity can not be ruled out. Particular caution should be exercised in patients with known risk factors for liver disease as they are prone for lactic acidosis or hepatotoxicity. Should always be used in combination with other antiretroviral agents. The potential for cross resistance between abacavir and other NRTIs should be considered. Caution should be taken in elderly patients.


Pregnancy:

Category C.


Lactation:

It is recommended that HIV-infected mothers should not breastfeed their infants to avoid postnatal transmission of HIV infection. Drug Interactions: Abacavir does not inhibit cytochrome P450 isoforms; hence it is unlikely that clinically significant drug interactions will occur between abacavir and drugs metabolized through these pathways.


Adverse drug reactions:

Hypersensitivity reactions, laboratory abnormalities such as anemia, neutropenia, thrombocytopenia, altered liver function tests, CPK elevations, mild elevation of blood glucose, increased gamma glutamyl transferase, pancreatitis, Stevens- Johnson syndrome, toxic epidermal necrolysis, myocardial infarction, body fat redistribution, lactic acidosis, nausea, vomiting, abdominal pain, gastritis, diarrhea, headache, hepatomegaly, steatosis, sleep disorders, pharyngitis, dyspnoea, cough.


Overdosage:

No known antidote for abacavir. Not known weather abacavir can be removed by dialysis.


Presentation:

30 tablets in HDPE container / 60 tablets in HDPE container.


Storage:

Store in a cool, dry and dark place. For further information please consult full prescribing information.