COMPOSITION: Amprenavir 50mg and 150mg.
PRESENTATION: Soft capsules, off-white to cream.
STORAGE AND STABILITY: Do not store above 30C.
ACTION: Protease inhibitor.
INDICATIONS: Treatment of protease inhibitor experienced HIV-1 infected adults and children above the age of four years, in combination with other antiretroviral agents.
CONTRAINDICATIONS: Known hypersensitivity to active substance or excipients.
DOSAGE AND ADMINISTRATION: Amprenavir can be taken with or without food. Amprenavir should be used in combination with at least two other antiretrovirals.
Adults and adolescents aged 12 years and over and >50kg body weight, 1,200mg twice daily in combination with other antiretrovirals. In combination with ritonavir, reduced doses of amprenavir (600mg twice daily) and ritonavir (100-200mg twice daily) are recommended (see SPC).
Children (four to 12 years) and patients with a body weight <50kg, recommended dose of capsules is 20mg/kg body weight twice daily.
Children (under four years), not recommended.
Elderly (over 65 years), pharmacokinetics, efficacy and safety not studied.
Renal impairment, no dose adjustment necessary.
Hepatic impairment, use with caution. In adult patients with moderate hepatic impairment, the dose should be reduced to 450mg twice a day. In adult patients with severe hepatic impairment, the dose should be reduced to 300mg twice a day. No dose recommendation in children.
Pregnancy, use only after careful weighing of potential benefits compared with potential risk to foetus (see SPC).
Lactation, recommended that mothers being treated with amprenavir do not breastfeed their infants.
OVERDOSAGE: Monitor for evidence of toxicity and providedstandard supportive treatment as necessary.
PRECAUTIONS: When amprenavir is used as monotherapy, resistant viruses rapidly emerge. Discontinue use permanently if rash appears that is accompanied by systemic or allergic symptoms or mucosal involvement.
DRUG INTERACTIONS: Terfenadine, cisapride, pimozide, triazolam, diazepam, midazolam, flurazepam, ergotamine, dihydroergotamine, astemizole, ritonavir, nevirapine, delavirdine, rifampicin, rifabutin, antacids, benzodiazepines, calcium channel blockers, erectile dysfunction agents, lipid-lowering drugs, methadone and opiate derivatives, steroids, St John's wort. See SPC for further details.
SIDE EFFECTS: Gastrointestinal symptoms, rash and oral/peri-oral paraesthesia (see SPC).
NET PRICE: 50mg 480 £150, 150mg 240 £225.
SUPPLIER: Glaxo Wellcome UK, Stockley Park West, Uxbridge, Middlesex UB11 1BT. Tel 020 8990 9000, fax 020 8990 4321.
LEGAL CLASS: POM.