País: Indonèsia
Idioma: indonesi
Font: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
EFAVIRENZ
INDOFARMA - Indonesia
EFAVIRENZ
200 MG
KAPSUL
DUS, 1 BOTOL PLASTIK @ 90 KAPSUL
AUROBINDO PHARMA LIMITED - India
2020-03-26
VIRANZ 200 Efavirenz 200 mg COMPOSITION Each capsule contains efavirenz 200 mg and excipients as listed below: - Capsule contents: lactose, sodium starch glycolate, sodium lauryl sulphate, and magnesium stearate. - Capsule shell: gelatin, sodium lauryl sulphate, titanium dioxide, and silicon dioxide. The shells also contain yellow iron oxide. - Edible black printing ink: shellac, propylene glycol, potassium hydroxide, and black iron oxide. MECHANISM OF ACTIONS PHARMACODYNAMIC PROPERTIES Pharmacotherapeutic group: Human Immunodeficiency Virus (HIV-1) specific NNRTI. ATC code: J05A G03. Efavirenz is a NNRTI of HIV-1. Efavirenz is a non-competitive inhibitor of HIV-1 reverse transcriptase (RT) and does not significantly inhibit HIV-2 RT or cellular DNA polymerases (α, β, γ, or δ). Antiviral activity The concentration of efavirenz inhibiting replication of wild-type laboratory adapted strains and clinical isolates in cell culture by 90-95% (EC90-95) ranged from 1.7 to 25 nM in lymphoblastoid cell lines, peripheral blood mononuclear cells (PBMCs), and macrophage/monocyte cultures. Efavirenz demonstrated antiviral activity against clade B and most non-clade B isolates (subtypes A, AE, AG, C, D, F, G, J, N), but had reduced antiviral activity against group O viruses. Efavirenz demonstrated additive antiviral activity without cytotoxicity against HIV-1 in cell culture when combined with the NNRTIs delavirdine and nevirapine, NRTIs (abacavir, didanosine, emtricitabine, lamivudine, stavudine, tenofovir, zalcitabine, zidovudine), PIs (amprenavir, indinavir, lopinavir, nelfinavir, ritonavir, saquinavir), and the fusion inhibitor enfuvirtide. Efavirenz demonstrated additive to antagonistic antiviral activity in cell culture with atazanavir. Efavirenz was not antagonistic with adefovir, used for the treatment of hepatitis B virus infection, or ribavirin, used in combination with interferon for the treatment of hepatitis C virus infection. Resistance The potency of efavirenz in cell culture against viral variants with amino Llegiu el document complet