Abalam

Abalam Dosage/Direction for Use

abacavir + lamivudine

Manufacturer:

Hetero Labs

Distributor:

Medicell Pharma
Full Prescribing Info
Dosage/Direction for Use
Therapy should be initiated by a physician experienced in the management of HIV infection.
Abacavir sulfate and Lamivudine tablets should not be administered to patients who weigh less than 25 kg because it is a fixed-dose tablet that cannot be dose reduced. Separate preparations of abacavir and lamivudine should be administered to patients weighing less than 25 kg.
Abacavir sulfate and Lamivudine tablets can be taken with or without food.
Abacavir sulfate and Lamivudine tablets is a fixed-dose tablet and should not be prescribed for patients requiring dosage adjustments, such as those with creatinine clearance less than 50 ml/min or with mild hepatic impairment. Separate preparations of abacavir or lamivudine should be administered in cases where discontinuation or dose adjustment is indicated. In these cases, the physician should refer to the individual product information for these medicinal products.
Populations: Adults and children weighing at least 25 kg: The recommended dose of Abacavir sulfate and Lamivudine tablets in adults and children weighing 25 kg or more is one tablet once daily.
Children weighing less than 25 kg: Abacavir sulfate and Lamivudine tablets is not recommended for treatment of children weighing less than 25 kg as the necessary dose adjustment cannot be made. Physicians should refer to the individual product information for lamivudine and abacavir.
Elderly: The pharmacokinetics of abacavir and lamivudine have not been studied in patients over 65 years of age. When treating elderly patients, consideration needs to be given to the greater frequency of decreased hepatic, renal and cardiac function, concomitant medicinal products or disease.
Renal impairment: Whilst no dosage adjustment of abacavir is necessary in patients with renal impairment, a dose reduction of lamivudine is required due to decreased clearance. Therefore Abacavir sulfate and Lamivudine tablets is not recommended for use in patients with a creatinine clearance less than 50 ml/min (see Pharmacology: Pharmacokinetics under Actions).
Hepatic impairment: Abacavir is contraindicated in patients with moderate to severe hepatic impairment and dose reduction is required in patients with mild hepatic impairment (Child-Pugh grade A). As dose reduction is not possible with Abacavir sulfate and Lamivudine tablets, the separate preparations of Abacavir and Lamivudine should be used when this is judged necessary. Abacavir sulfate and Lamivudine tablets is contraindicated for patients with moderate and severe hepatic impairment (see Pharmacology: Pharmacokinetics: Special Patient Populations under Actions).
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