RETROVIR ORAL SOLUTION 10 MG/ML [SIN07527P]

Product Info

RETROVIR ORAL SOLUTION 10 MG/ML

[SIN07527P]

Indications

RETROVIR is indicated in combination with other antiretroviral agents for the treatment of Human Immunodeficiency Virus (HIV) infection in adults and children.

Dosage and Administration

Pharmaceutical form:

Oral solution.

RETROVIR therapy should be initiated by a physician experienced in the management of HIV infection.

• Adults and adolescents weighing at least 30 kg

  The recommended dose of RETROVIR in combination with other antiretroviral agents is 250 or 300 mg twice daily.

• Children

  Children weighing at least 9 kg and less than 30 kg:

  The recommended dose of RETROVIR is 0.9 mL/kg (9 mg/kg) twice daily in combination with other antiretroviral agents (e.g. a 15 kg child would require a 13.5 mL dose of oral solution twice daily). The maximum dosage should not exceed 300 mg (30 mL) twice daily.

  Children weighing at least 4 kg and less than 9 kg:

  The recommended dose of RETROVIR is 1.2 mL/kg (12 mg/kg) twice daily in combination with other antiretroviral agents (e.g. a 5 kg neonate would require a 6 mL dose of oral solution twice daily).

  Available data are insufficient to propose specific dosage recommendations for children weighing less than 4 kg (see below – Pregnancy and Lactation and Pharmacokinetics – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

• Elderly

  Zidovudine pharmacokinetics have not been studied in patients over 65 years of age and no specific data are available. However, since special care is advised in this age group due to age-associated changes such as the decrease in renal function and alterations in haematological parameters, appropriate monitoring of patients before and during use of RETROVIR is advised.

• Renal impairment

  In patients with severe renal impairment, daily dosages of 300 to 400 mg should be appropriate. Haematological parameters and clinical response may influence the need for subsequent dosage adjustment. Haemodialysis and peritoneal dialysis have no significant effect on RETROVIR elimination whereas elimination of the glucuronide metabolite is increased. For patients with end-stage renal disease maintained on haemodialysis or peritoneal dialysis, the recommended dose is 100 mg every 6 to 8 h (see Pharmacokinetics – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

• Hepatic impairment

  Limited data in patients with cirrhosis suggest that accumulation of zidovudine may occur in patients with hepatic impairment because of decreased glucuronidation. Dosage adjustments may be necessary but precise recommendations cannot be made at present. If monitoring of plasma zidovudine levels is not feasible, physicians will need to pay particular attention to signs of intolerance and increase the interval between doses as appropriate.

• Patients with haematological adverse reactions

  Dosage adjustments may be necessary in patients with haematological adverse reactions. This is more likely in patients with poor bone marrow reserve prior to treatment, particularly in patients with advanced HIV disease. If the haemoglobin level falls to between 7.5 g/dl (4.65 mmol/l) and 9 g/dl (5.59 mmol/l) or the neutrophil count falls to between 0.75 x 10⁹/l and 1.0 x 10⁹/l, the daily dosage may be reduced until there is evidence of marrow recovery; alternatively, recovery may be enhanced by a brief (2–4 weeks) interruption of RETROVIR therapy. If dosage reduction is considered, the daily dosage may, for example, be halved and subsequently increased, depending on patient tolerance, up to the original dosage. Therapy with RETROVIR should be interrupted if the haemoglobin level falls below 7.5 g/dl (4.65 mmol/l) or the neutrophil count falls to less than 0.75 x 10⁹/l (see Contraindications, Warnings and Precautions – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Marrow recovery is usually observed within 2 weeks after which time RETROVIR therapy at a reduced dosage may be reinstituted. After a further 2–4 weeks the dosage may be gradually increased, depending on patient tolerance, up to the original dosage.

Contraindications

RETROVIR is contraindicated in patients known to be hypersensitive to zidovudine, or to any of the components of the formulations.

RETROVIR should not be given to 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) (see Warnings and Precautions – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).