COMBIVIR TABLETS [SIN10795P]

Product Info

COMBIVIR TABLETS

[SIN10795P]

Indications

COMBIVIR is indicated for the treatment of HIV-infected adults and adolescents > 12 years, with progressive immunodeficiency (CD4+ Count =< 500 cells/mm³).

Lamivudine in combination with zidovudine reduces HIV-1 viral load and increases CD4+ cell count. Clinical endpoint data indicate that lamivudine in combination with zidovudine alone, or in combination with zidovudine containing treatment regimens result in a significant reduction in the risk of disease progression and mortality.

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.

Contraindications

The use of COMBIVIR is contraindicated in patients with known hypersensitivity to lamivudine, zidovudine or to any ingredient of the preparation.

Zidovudine is contraindicated in patients with abnormally low neutrophil counts (less than 0.75 x 10⁹/L), or abnormally low haemoglobin levels (less than 7.5 g/dL or 4.65 mmol/L). COMBIVIR is therefore contraindicated in these patients (see Warnings and Precautions – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).