Maa: Etelä-Afrikka
Kieli: englanti
Lähde: South African Health Products Regulatory Authority (SAHPRA)
Aspen-p
TRUVADA* Tablets SCHEDULING STATUS: S4 PROPRIETARY NAME (and dosage form): TRUVADA* Tablets COMPOSITION: Each film-coated tablet contains 200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate (which is equivalent to 245 mg tenofovir disoproxil ). WARNING LACTIC ACIDOSIS AND SEVERE HEPATOMEGALY WITH STEATOSIS, INCLUDING FATAL CASES, HAVE BEEN REPORTED WITH THE USE OF NUCLEOSIDE ANALOGS ALONE OR IN COMBINATION WITH OTHER ANTIRETROVIRALS (SEE WARNINGS). THE COMBINATION TABLET IS NOT INDICATED FOR THE TREATMENT OF CHRONIC HEPATITIS B VIRUS (HBV) INFECTION AND THE SAFETY AND EFFICACY OF THE COMBINATION TABLET HAVE NOT BEEN ESTABLISHED IN PATIENTS COINFECTED WITH HBV AND HIV. SEVERE ACUTE EXACERBATIONS OF HEPATITIS B HAVE BEEN REPORTED IN PATIENTS WHO HAVE DISCONTINUED EMTRICITABINE (200 MG) OR TENOFOVIR. HEPATIC FUNCTION SHOULD BE MONITORED CLOSELY WITH BOTH CLINICAL AND LABORATORY FOLLOW-UP FOR AT LEAST SEVERAL MONTHS IN PATIENTS WHO DISCONTINUE THE COMBINATION TABLET AND ARE COINFECTED WITH HIV AND HBV. IF APPROPRIATE, INITIATION OF ANTI- HEPATITIS B THERAPY MAY BE WARRANTED (SEE WARNINGS). PHARMACOLOGICAL CLASSIFICATION A 20.2.8 Antimicrobial (Chemotherapeutic) Agents. Antiviral Agents PHARMACOLOGICAL ACTION Mechanism of Action: Emtricitabine: Emtricitabine, a synthetic nucleoside analog of cytidine, is phosphorylated by cellular enzymes to form emtricitabine 5'-triphosphate. Emtricitabine 5'-triphosphate inhibits the activity of the HIV-1 reverse transcriptase (RT) by competing with the natural substrate deoxycytidine 5'-triphosphate and by being incorporated into nascent viral DNA which results in chain termination. Emtricitabine 5'-triphosphate is a weak inhibitor of mammalian DNA polymerase alpha, beta, e and mitochondrial DNA polymerase y. Tenofovir disoproxil fumarate Lue koko asiakirja