VIRANZ 200

Negara: Indonesia

Bahasa: Bahasa Indonesia

Sumber: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

Bahan aktif:

EFAVIRENZ

Tersedia dari:

INDOFARMA - Indonesia

INN (Nama Internasional):

EFAVIRENZ

Dosis:

200 MG

Bentuk farmasi:

KAPSUL

Unit dalam paket:

DUS, 1 BOTOL PLASTIK @ 90 KAPSUL

Diproduksi oleh:

AUROBINDO PHARMA LIMITED - India

Tanggal Otorisasi:

2020-03-26

Karakteristik produk

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