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Film Coated Tablets
30 X 600 mg
Concomitant antiretroviral therapy: STOCRIN must be given in combination with other antiretroviral medicines.
It is recommended that STOCRIN be taken on an empty stomach. The increased efavirenz concentrations observed following administration of STOCRIN with food may lead to an increase in frequency of adverse reactions.
In order to improve the tolerability of nervous system undesirable effects, bedtime dosing is recommended.
Adults: the recommended dose of STOCRIN in combination with nucleoside analogue reverse transcriptase inhibitors (NRTIs) with or without a PI is 600 mg orally, once daily.
Drug interactions: As STOCRIN 600 mg tablet is the only dose form available in the local marketplace, the recommended dose adjustments for voriconazole and rifampicin are not possible.
Renal impairment: the pharmacokinetics of efavirenz have not been studied in patients with renal insufficiency; however, less than 1 % of an efavirenz dose is excreted unchanged in the urine, so the impact of renal impairment on efavirenz elimination should be minimal.
Hepatic impairment: patients with mild liver disease may be treated with their normally recommended dose of efavirenz. Patients should be monitored carefully for dose-related adverse reactions, especially nervous system symptoms.
Paediatric population (3 to 17 years): Due to the local marketplace availability of 600 mg tablets only, this medication can only be administered to children ≥3 years of age and weighing greater than 40kg.
In combination with other antiretroviral agents for the treatment of HIV-1 infections.
Clinically significant hypersensitivity to any of the components. Should not be administered concurrently with astermizole, cisapride, midazolam, triazolam, or ergot derivatives because competition for CYP3A4 by efavirenz could result in inhibition of metabolism of these drugs and create the potential for serious and/or life-threatening adverse events (e.g. cardiac arrhythmias, prolonged sedation or respiratory depression).
Must not be used as a single agent to treat HIV or added on as a sole agent to a failing regimen. Therapy should always be initiated in combination with at least one other new antiretroviral agent to which the patient has not been previously exposed. Barrier contraception should always be used in combination with other methods of contraception. Women of childbearing potential should undergo pregnancy testing prior to initiation of Stocrin. Should not be administered concurrently with astemizole, cisapride, midazolam, triazolam, or ergot derivatives.
Dizziness, somnolence, insomnia, abnormal dreaming, confusion, abnormal thinking, impaired concentration, amnesia, agitation, depersonalization, hallucinations and euphoria. Rashes are usually mild-to-moderate maculopapular skin eruptions that occur within the first two weeks of initiating therapy. In most patients, rash resolves with continuing Stocrin therapy within one month.
Astemizole, midazolam, triazolam, cisapride, ergot derivatives. Clarithromycin, indinavir, methadone, ethinyl estradiol, rifabutin, rifampin, ritonavir, saquinavir. Warfarin, phenytoin, phenobarbital, carbamezepine, itraconazole, saquinavir/ritonavir combination, amprenavir.
See prescribing information for full details.