NEVIRAPINE TEVA Tablet Ref.[8787] Active ingredients: Nevirapine

Nevirapine Teva should be administered by physicians who are experienced in the treatment of HIV infection.

Posology

Patients 16 years and older The recommended dose of Nevirapine Teva is one 200 mg tablet daily for the first 14 days (this lead-in period should be used because it has been found to lessen the frequency of rash), followed by one 200 mg tablet twice daily, in combination with at least two additional antiretroviral agents.

For patients who are unable to swallow tablets or who weigh less than 50 kg or whose body surface area is below 1.25 m² according to the Mosteller formula, other nevirapine containing oral formulations are available and should be used if appropriate.

If a dose is recognized as missed within 8 hours of when it was due, the patient should take the missed dose as soon as possible. If a dose is missed and it is more than 8 hours later, the patient should only take the next dose at the usual time.

Dose management considerations

Patients experiencing rash during the 14-day lead-in period of 200 mg/day should not have their Nevirapine Teva dose increased until the rash has resolved. The isolated rash should be closely monitored (see section 4.4). The 200 mg once daily dosing regimen should not be continued beyond 28 days at which point in time an alternative treatment should be sought due to the possible risk of underexposure and resistance.

Patients who interrupt nevirapine dosing for more than 7 days should restart the recommended dosing regimen using the two week lead-in period.

There are toxicities that require interruption of Nevirapine Teva therapy (see section 4.4).

Special populations

Elderly

Nevirapine has not been specifically investigated in patients over the age of 65.

Renal impairment

For patients with renal dysfunction requiring dialysis an additional 200 mg dose of nevirapine following each dialysis treatment is recommended. Patients with CLcr ≥20 ml/min do not require a dose adjustment, see section 5.2.

Hepatic impairment

Nevirapine should not be used in patients with severe hepatic impairment (Child-Pugh C, see section 4.3). No dose adjustment is necessary in patients with mild to moderate hepatic impairment (see sections 4.4 and 5.2).

Paediatric population

Nevirapine Teva 200 mg tablets, following the dosing schedule described above, are suitable for larger children, particularly adolescents, below the age of 16 who weigh more than 50 kg or whose body surface area is above 1.25 m² according to the Mosteller formula.

Method of administration

The tablets shall be taken with

There is no known antidote for nevirapine overdose. Cases of nevirapine overdose at doses ranging from 800 to 6,000 mg per day for up to 15 days have been reported. Patients have experienced oedema, erythema nodosum, fatigue, fever, headache, insomnia, nausea, pulmonary infiltrates, rash, vertigo, vomiting, increase in transaminases and weight decrease. All of these effects subsided following discontinuation of nevirapine.

Paediatric population

One case of massive accidental overdose in a newborn was reported. The ingested dose was 40 times the recommended dose of 2 mg/kg/day. Mild isolated neutropenia and hyperlactataemia was observed, which spontaneously disappeared within one week without any clinical complications. One year later, the child’s development remained normal.

Shelf life: 2 years.

This medicinal product does not require any special storage conditions.

Treatment initiation pack: White opaque PVC/PE/PVdC – Aluminium blisters or OPA/Alu/PVC – Aluminium blisters. Cartons containing 14 tablets (Calendar Pack).

Maintenance packs: White opaque PVC/PE/PVdC – Aluminium blisters or OPA/Alu/PVC – Aluminium blisters. Cartons containing 60 or 120 tablets.

Not all pack sizes may be marketed.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.