Země: Malajsie
Jazyk: angličtina
Zdroj: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
EFAVIRENZ
MERCK SHARP & DOHME (MALAYSIA) SDN BHD
EFAVIRENZ
30tablet Tablets
ZHEJIANG HUAHAI PHARMACEUTICAL CO., LTD.
CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) STOCRIN ® TABLET Efavirenz (600mg) 1 WHAT IS IN THIS LEAFLET 1. What STOCRIN is used for 2. How STOCRIN works 3. Before you take STOCRIN 4. How to take STOCRIN 5. While you are taking STOCRIN 6. Side effects 7. Storage and disposal of STOCRIN 8. Product description 9. Manufacturer and Product Registration Holder 10. Date of Revision Please read this leaflet carefully before you start to take your medicine, even if you have just refilled your prescription. Some of the information in the previous leaflet may have changed. Remember that your doctor has prescribed this medicine only for you. Never give it to anyone else. WHAT STOCRIN IS USED FOR STOCRIN contains an active ingredient efavirenz. Your doctor has prescribed STOCRIN for you because you have HIV infection. STOCRIN taken in combina tion with other antiretroviral medicines reduces the amount of the virus in the blood. HOW STOCRIN WORKS STOCRIN is a member of a class of antiretroviral medicines called non - nucleoside reverse transcriptase inhibitors (NNRTIs). It is an antiretroviral m edicine that fights HIV infection by reducing the amount of virus in blood. BEFORE YOU TAKE STOCRIN -When you must not take it Do not take STOCRIN if you know you are allergic to any of the ingredients in STOCRIN tablets. STOCRIN should not be taken with some other medicines. (See Taking other medicines) -Before you start take it Inform your doctor about any past or present medical problems, including liver disease (for example, chronic hepatitis B or C) or allergies, seizures, mental illness, or substance or alcohol abuse. Also inform your doctor about any medications, vitamins, or nutritional supplements including St. John ’ s wort (Hypericum perforatum) that you are currently taking or intend to take. Inform your doctor if you are breast- feeding a baby, pregnant, or intend to become pregnant. Tell your doctor if you are taking a medicine that contains efavirenz. STOCRIN should not be taken together with other medicines that Přečtěte si celý dokument
LPC-MK0831-MF-062022 LOCAL PRODUCT CIRCULAR STOCRIN® (EFAVIRENZ) TABLETS 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. COMPOSITION IIIA. ACTIVE INGREDIENTS STOCRIN is available as: - Tablets contai ning either 200 mg or 600 mg of efavirenz IV. CLINICAL PHARMACOLOGY IVA. MECHA NISM OF ACTION Efavirenz is a selective non- nucleoside reverse transcriptase inhibitor of human immunode ficiency virus type 1 (HIV -1). Efavirenz is a non - competitive inhibitor of HIV - 1 reverse transcriptase (RT) with respect to template, primer or nucleoside triphosphates, with a small component of competitive inhibition. HIV-2 RT and human cellular DNA polymerases α, β, γ and δ are not inhibited by concentrations of efavirenz well in excess of those achieved clinically. IV B. PHARMACOKINETICS IVB- 1. ABSORPTION Peak efavirenz plasma concentrations of 1.6-9.1 µM were attained by 5 hours following single oral doses of 100 mg to 1600 mg administered to uninfected volunteers. Dose-related increases in C max and AUC were seen for doses up to 1600 mg; the increases were less than proportional suggesting diminished absorption at higher doses. Time to peak plasma concentrations (3-5 hours) did not change following multiple dosing and steady-state plasma concentrations were reached in 6 -7 days. In HIV-infected patients at steady-state, mean C max , mean C min , and mean AUC were linear with 200 mg, 400 mg, and 600 mg daily dose s. In 35 patients receiving STOCRIN 600 mg once daily, steady -state C max was 12.9 µM, steady-state C min was 5.6 µ M, and AUC was 184 µMh. Effect of Food on Oral Absorption The bioavailability of a single 600 - mg dose of efavirenz in uninfected v olunteers wa s increased 22% and 17%, respectively, when given with a meal of high fat or normal composition, relative to the bioavailability of a 600-mg Přečtěte si celý dokument