Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2022 Publisher: ViiV Healthcare UK Limited, 980 Great West Road, Brentford, Middlesex, TW8 9GS
Retrovir oral formulations are indicated in anti-retroviral combination therapy for Human Immunodeficiency Virus (HIV) infected adults and children.
Retrovir chemoprophylaxis is indicated for use in HIV-positive pregnant women (over 14 weeks of gestation) for prevention of maternal-foetal HIV transmission and for primary prophylaxis of HIV infection in newborn infants.
Retrovir should be prescribed by physicians who are experienced in the treatment of HIV infection.
The usual recommended dose of Retrovir in combination with other anti-retroviral agents is 250 or 300 mg twice daily.
Retrovir 100 mg capsules and Retrovir 100 mg/10 ml oral solution are available for use in children.
| Weight (kg) | In the morning | In the evening | Daily dose (mg) |
|---|---|---|---|
| 8-13 | one 100 mg capsule | one 100 mg capsule | 200 |
| 14-21 | one 100 mg capsule | two 100 mg capsules | 300 |
| 22-30 | two 100 mg capsules | two 100 mg capsules | 400 |
| Alternatively children weighing at least 28 kg to 30 kg (included) could take: | |||
| 28-30 | one 250 mg capsule | one 250 mg capsule | 500 |
Oral solution is available for dosing children less than 8 kg and for those children above 8 kg unable to swallow capsules (see Oral Solution SPC).
Pregnant women (over 14 weeks of gestation) should be given 500 mg/day orally (100 mg five times per day) until the beginning of labour. During labour and delivery Retrovir should be administered intravenously at 2 mg/kg bodyweight given over one hour followed by a continuous intravenous infusion at 1 mg/kg/h until the umbilical cord is clamped.
Neonates should be given 0.2 mL/kg (2 mg/kg) bodyweight orally every 6 hours starting within 12 hours after birth and continuing until 6 weeks old.
Care should be taken when calculating doses for neonates due to the small volumes of oral solution required. To facilitate dosing precision, an appropriately sized syringe with 0.1 mL graduation should be used to ensure accurate oral dosing of neonates (see oral solution SPC).
Infants unable to receive oral dosing should be given Retrovir intravenously at 1.5 mg/kg bodyweight infused over 30 minutes every 6 hours.
In case of planned caesarean, the infusion should be started 4 hours before the operation. In the event of a false labour, the Retrovir infusion should be stopped and oral dosing restarted.
Substitution of zidovudine should be considered in patients whose haemoglobin level or neutrophil count fall to clinically significant levels. Other potential causes of anaemia or neutropenia should be excluded. Retrovir dose reduction or interruption should be considered in the absence of alternative treatments (see sections 4.3 and 4.4).
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.
The recommended dose for patients with severe renal impairment (creatinine clearance <10 ml/min) and patients with end-stage renal disease maintained on haemodialysis or peritoneal dialysis is 100 mg every 6 to 8 hrs (300-400 mg daily). Haematological parameters and clinical response may influence the need for subsequent dosage adjustment (see section 5.2).
Data in patients with cirrhosis suggest that accumulation of zidovudine may occur in patients with hepatic impairment because of decreased glucuronidation. Dosage reductions may be necessary but, due to the large variability in zidovudine exposures in patients with moderate to severe liver disease, precise recommendations cannot be made. If monitoring of plasma zidovudine levels is not feasible, physicians will need to monitor for signs of intolerance, such as the development of haematological adverse reactions (anaemia, leucopenia, neutropenia) and reduce the dose and/or increase the interval between doses as appropriate (see section 4.4).
No specific symptoms or signs have been identified following acute overdose with zidovudine apart from those listed as undesirable effects.
Patients should be observed closely for evidence of toxicity (see section 4.8) and given the necessary supportive therapy.
Haemodialysis and peritoneal dialysis appear to have a limited effect on elimination of zidovudine but enhance the elimination of the glucuronide metabolite.
Further management should be as clinically indicated or as recommended by the national poisons centre, where available.
5 years.
Do not store above 30°C.
Store in the original package.
PVC/aluminium foil blister pack containing 40 capsules.
No special requirements for disposal.
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