EFAVIRENZ SANDOZ FILM COATED TABLET 600MG [SIN15719P]

Product Info

EFAVIRENZ SANDOZ FILM COATED TABLET 600MG

[SIN15719P]

Indication

4.1 Therapeutic indications
Efavirenz is indicated in antiviral combination treatment of human immunodeficiency virus-1 (HIV-1) infected adults, adolescents and children.

Dosing

4.2 Posology and method of administration
Adults: The recommended dosage of EFAVIRENZ in combination with a protease inhibitor and/or nucleoside analogue reverse transcriptase inhibitors (NRTIs) is 600 mg orally, once daily. It is recommended that EFAVIRENZ be taken on an empty stomach.

In order to improve the tolerability of nervous system side effects, bedtime dosing is recommended during the first two to four weeks of therapy and in patients who continue to experience these symptoms (see section 4.8 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Concomitant Antiretroviral Therapy: EFAVIRENZ must be given in combination with other antiretroviral medications (see section 4.5 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Adolescents and children (17 years and under): The recommended dose of EFAVIRENZ in combination with a protease inhibitor and/or NRTIs for patients 17 years of age and under is described in Table 1. EFAVIRENZ tablets should only be administered to children who are able to reliably swallow tablets. It is recommended that EFAVIRENZ be taken on an empty stomach. EFAVIRENZ has not been adequately studied in children under the age of 3 years or children weighing less than 13 kg.

PEDIATRIC USE
EFAVIRENZ has not been studied in pediatric patients below 3 years of age or who weigh less than 13 kg.

Contraindications

4.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

EFAVIRENZ is contraindicated with elbasvir/grazoprevir due to the expected significant decreases in elbasvir and grazoprevir plasma concentrations (see section 4.5 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). This effect is due to an induction of CYP3A4 by efavirenz and is expected to result in the loss of virologic response of elbasvir/grazoprevir.

EFAVIRENZ must not be administered concurrently with the standard doses of voriconazole because efavirenz significantly decreases voriconazole plasma concentrations while voriconazole also significantly increases efavirenz plasma concentrations (see section 4.5; for use of adjusted doses of voriconazole with adjusted doses of efavirenz, see section 4.5 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

St. John’s wort (Hypericum perforatum): Patients on efavirenz should not concomitantly use products containing St. John’s wort (Hypericum perforatum) since it may be expected to result in reduced plasma concentrations of efavirenz. This effect is due to an induction of CYP3A4 and may result in loss of therapeutic effect and development of resistance.