ZIAGEN (ABACAVIR) 300MG 60`S

Abacavir is indicated in antiretroviral combination therapy for the treatment of Human Immunodeficiency Virus (HIV) infection in adults, adolescents and children.

Before initiating treatment with abacavir, screening for carriage of the allele should be performed in any HIV-infected patient, irrespective of racial origin . Abacavir should not be used in patients known to carry the HLA-B*5701 allele.

Posology and method of administration

Adults, adolescents and children (weighing at least 25 kg):

The recommended dose of abacavir is 600 mg daily. This may be administered as either 300 mg (one tablet) twice daily or 600 mg (two tablets) once daily.

Children (weighing less than 25 kg):

Children weighing ? 20 kg to < 25 kg: The recommended dose is 450 mg daily. This may be administered as either one 150 mg (one half of a tablet) taken in the morning and 300 mg (one whole tablet) taken in the evening, or 450 mg (one and a half tablets) taken once daily.

Patients changing from the twice daily dosing regimen to the once daily dosing regimen should take the recommended once daily dose (as described above) approximately 12 hours after the last twice daily dose, and then continue to take the recommended once daily dose (as described above) approximately every 24 hours. When changing back to a twice daily regimen, patients should take the recommended twice daily dose approximately 24 hours after the last once daily dose.

Method of administration

Abacavir can be taken with or without food.

To ensure administration of the entire dose, the tablet(s) should ideally be swallowed without crushing.

Alternatively, for patients who are unable to swallow tablets, the tablet(s) may be crushed and added to a small amount of semi-solid food or liquid, all of which should be consumed immediately.

Adverse drug reactions

Metabolism and nutrition disorders

Common: anorexia

Very rare: lactic acidosis

Nervous system disorders

Common: headache

Gastrointestinal disorders

Common: nausea, vomiting, diarrhoea

Rare: pancreatitis

 

Skin and subcutaneous tissue disorders

Common: rash (without systemic symptoms)

Very rare: erythema multiforme, Stevens-Johnson syndrome and toxic epidermal necrolysis

General disorders and administration site conditions

Common: fever, lethargy, fatigue