Ország: Szingapúr
Nyelv: angol
Forrás: HSA (Health Sciences Authority)
Efavirenz
MSD PHARMA (SINGAPORE) PTE. LTD.
J05AG03
200.0 mg
TABLET
Efavirenz 200.0 mg
ORAL
Prescription Only
Zhejiang Huahai Pharmaceutical Co., Ltd.
ACTIVE
2008-07-31
STOCRIN SG-MK0831-MF-112013 (efavirenz) PRODUCT CIRCULAR TABLETS STOCRIN ® (EFAVIRENZ) I. THERAPEUTIC CLASS STOCRIN * [/sg_wm_1296.html#1] [/sg_wm_1296.html#1]is a non-nucleoside reverse transcriptase inhibitor of human immunodeficiency virus type 1 (HIV-1). II. INDICATIONS STOCRIN is indicated in antiviral combination treatment of HIV-1 infected adults, adolescents and children. III. DOSAGE AND ADMINISTRATION ADULTS: The recommended dosage of STOCRIN in combination with a protease inhibitor and/or nucleoside analogue reverse transcriptase inhibitors (NRTIs) is 600 mg orally, once daily. It is recommended that STOCRIN 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 SIDE EFFECTS). CONCOMITANT ANTIRETROVIRAL THERAPY: STOCRIN must be given in combination with other antiretroviral medications (see DRUG INTERACTIONS). ADOLESCENTS AND CHILDREN (17 YEARS AND UNDER): The recommended dose of STOCRIN in combination with a protease inhibitor and/or NRTIs for patients 17 years of age and under is described in Table 1. STOCRIN tablets should only be administered to children who are able to reliably swallow tablets. It is recommended that STOCRIN be taken on an empty stomach. STOCRIN has not been adequately studied in children under the age of 3 years or children weighing less than 13 kg. TABLE 1 PEDIATRIC DOSE TO BE ADMINISTERED ONCE DAILY STOCRIN TABLETS DOSE (MG) BODY WEIGHT KG 13 to <15 200 15 to < 20 250 20 to < 25 300 25 to < 32.5 350 32.5 to < Olvassa el a teljes dokumentumot
STOCRIN S-SG-MK0831-MF-042020 (efavirenz) PRODUCT CIRCULAR Tablets STOCRIN® (efavirenz) I. THERAPEUTIC CLASS STOCRIN is a non-nucleoside reverse transcriptase inhibitor of human immunodeficiency virus type 1 (HIV-1). II. INDICATIONS STOCRIN is indicated in antiviral combination treatment of HIV-1 infected adults, adolescents and children. III. DOSAGE AND ADMINISTRATION Adults: The recommended dosage of STOCRIN in combination with a protease inhibitor and/or nucleoside analogue reverse transcriptase inhibitors (NRTIs) is 600 mg orally, once daily. It is recommended that STOCRIN 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 SIDE EFFECTS). Concomitant Antiretroviral Therapy: STOCRIN must be given in combination with other antiretroviral medications (see DRUG INTERACTIONS). Adolescents and Children (17 years and under): The recommended dose of STOCRIN in combination with a protease inhibitor and/or NRTIs for patients 17 years of age and under is described in Table 1. STOCRIN tablets should only be administered to children who are able to reliably swallow tablets. It is recommended that STOCRIN be taken on an empty stomach. STOCRIN tablets have not been adequately studied in children under the age of 3 years or children weighing less than 13 kg (see PRECAUTIONS and PEDIATRIC USE). Table 1 Pediatric Dose to be Administered Once Daily STOCRIN Tablets Dose (mg) Body Weight kg 13 to < 15 200 15 to < 20 250 20 to < 25 300 25 to < 32.5 350 32.5 to < 40 400 ≥ 40 600 IV. CONTRAINDICATIONS STOCRIN is contraindicated in patients with clinically significant hypersensitivity to any of its components. STOCRIN is contraindicated with elbasvir/grazoprevir due to the expected significant decreases in elbasvir and grazoprevir plasma concentrations (see DRUG INTERACTIONS). This effect is due to an induction of CYP3A4 by efavirenz and is expecte Olvassa el a teljes dokumentumot