COMBIVIR TABLETS

GLAXOSMITHKLINE PTE LTD

GLAXOSMITHKLINE PTE LTD

Therapeutic

Prescription Only

TABLET, FILM COATED

**Dosage and Administration** Pharmaceutical Form: Film-coated tablets. _COMBIVIR_ therapy should be initiated and monitored by a physician experienced in the management of HIV infection. _COMBIVIR_ may be administered with or without food. **Populations** Adults and children over the age of 12 years: The recommended dose of _COMBIVIR_ is one tablet twice daily. If a reduction in dose of _COMBIVIR_ appears clinically indicated, or if one of the components of _COMBIVIR_ (lamivudine or zidovudine) requires reduction or discontinuation, separate preparations of lamivudine ( _EPIVIR_) and zidovudine ( _RETROVIR_) are available in tablets/capsules and oral solution. - **Elderly** No specific data are available, however special care is advised in this age group due to age associated changes such as the decrease in renal function and alteration of haematological parameters. - **Renal impairment** Dosage adjustment of lamivudine is required in patients with a creatinine clearance of less than 30 mL/min ( _see Pharmacokinetics and Warnings and Precautions_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). It is therefore recommended that separate preparations of lamivudine and zidovudine should be administered to these patients. - **Hepatic impairment** Dosage adjustments for zidovudine may be necessary in patients with hepatic impairment ( _see Pharmacokinetics_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). It is therefore recommended that separate preparations of lamivudine and zidovudine should be administered to patients with severe hepatic impairment. - **Dosage adjustments in patients with haematological adverse reactions** Dosage adjustment of zidovudine may be necessary if the haemoglobin level falls below 9 g/dL or 5.59 mmol/L or the neutrophil count falls below 1.0 x 109 /L ( _see Contraindications and Warnings and Precautions_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). As dosage adjustment of _COMBIVIR_ is not possible, separate preparations of zidovudine and lamivudine should be used. Physicians should refer to the individual prescribing information for these drugs.