STOCRIN Film-coated tablet Ref.[2777] Active ingredients: Efavirenz

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

Posology

Efavirenz must be given in combination with other antiretroviral medicines (see section 4.5).

In order to improve the tolerability of nervous system adverse reactions, bedtime dosing is recommended (see section 4.8).

Adults

The recommended dose of efavirenz in combination with nucleoside analogue reverse transcriptase inhibitors (NRTIs) with or without a PI (see section 4.5) is 600 mg orally, once daily.

Dose adjustment

If efavirenz is coadministered with voriconazole, the voriconazole maintenance dose must be increased to 400 mg every 12 hours and the efavirenz dose must be reduced by 50%, i.e., to 300 mg once daily. When treatment with voriconazole is stopped, the initial dose of efavirenz should be restored (see section 4.5).

If efavirenz is coadministered with rifampicin to patients weighing 50 kg or more, an increase in the dose of efavirenz to 800 mg/day may be considered (see section 4.5).

Children and adolescents (3 to 17 years)

The recommended dose of efavirenz in combination with a PI and/or NRTIs for patients between 3 and 17 years of age is described in Table 1. Efavirenz tablets must only be administered to children who are able to reliably swallow tablets.

Table 1. Paediatric dose to be administered once daily:

^* For information on the bioavailability of the capsule contents mixed with food vehicles, see section 5.2.

Special populations

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 (see section 4.4).

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 (see sections 4.3 and 4.4).

Paediatric population

The safety and efficacy of efavirenz in children below the age of 3 years or weighing less than 13 kg have not yet been established. Currently available data are described in sections 4.8, 5.1 and 5.2, but no recommendation on a posology can be made.

Method of administration

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 (see sections 4.4 and 5.2).

Some patients accidentally taking 600 mg twice daily have reported increased nervous system symptoms. One patient experienced involuntary muscle contractions.

Treatment of overdose with efavirenz should consist of general supportive measures, including monitoring of vital signs and observation of the patient’s clinical status. Administration of activated charcoal may be used to aid removal of unabsorbed efavirenz. There is no specific antidote for overdose with efavirenz. Since efavirenz is highly protein bound, dialysis is unlikely to remove significant quantities of it from blood.

For bottles: 3 years.

This medicinal product does not require any special storage conditions.

STOCRIN 600 mg film-coated tablets: HDPE bottles with a child-resistant polypropylene closure. Each carton contains 1 bottle of 30 film-coated tablets.

STOCRIN 50 mg film-coated tablets: HDPE bottles with a child-resistant polypropylene closure. Each carton contains 1 bottle of 30 film-coated tablets.

STOCRIN 200 mg film-coated tablets: HDPE bottles with a child-resistant polypropylene closure. Each carton contains 1 bottle of 90 film-coated tablets.

No special requirements for disposal.