RITOVIR (Ritonavir Tablets 100 mg)

Страна: Малайзія

мова: англійська

Джерело: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Активний інгредієнт:

RITONAVIR

Доступна з:

CAMBER LABORATORIES SDN. BHD.

ІПН (Міжнародна Ім'я):

RITONAVIR

Одиниць в упаковці:

30tablet Tablets

Виробник:

Hetero Labs Limited

Характеристики продукта

RITONAVIR TABLETS 100 MG
HETERO
NAME OF THE PRODUCT
RITOVIR (Ritonavir Tablets 100 mg)
NAME AND STRENGTH OF ACTIVE INGREDIENT
Name
: Ritonavir
Strength
: 100 mg
DOSAGE FORM
Oral
PRODUCT DESCRIPTION
Ritonavir Tablets 100 mg
White to off white, capsule shaped, film coated tablets debossed with
‘H’ on one side and ‘R9’
on other side.
PHARMACOLOGY
PHARMACODYNAMICS:
MECHANISM OF ACTION
Ritonavir is an orally active peptidomimetic inhibitor of the HIV-1
and HIV-2 aspartyl proteases.
Inhibition of HIV protease renders the enzyme incapable of processing
the gag-pol polyprotein
precursor which leads to the production of HIV particles with immature
morphology that are
unable to initiate new rounds of infection. Ritonavir has selective
affinity for the HIV protease
and has little inhibitory activity against human aspartyl proteases.
PHARMACOKINETICS
Ritonavir is absorbed after oral doses and peak plasma concentrations
occur in about 2 to 4
hours. Absorption is enhanced when ritonavir is taken with food, and
is dose-related. Protein
binding is reported to be about 98% and penetration into the CNS is
minimal. Ritonavir is
extensively metabolised in the liver mainly by cytochrome P450
isoenzymes CYP3A4 and to a
lesser extent by CYP2D6. Five metabolites have been identified and the
major metabolite has
antiviral activity, but concentrations in plasma are low. Studies in
HIV-infected children 2 to 14
years of age indicate that ritonavir clearance is 1.5 to 1.7 times
greater than in adults.
RITONAVIR TABLETS 100 MG
HETERO
About 86% of a dose is eliminated through the faeces (both as
unchanged drug and as
metabolites) and about 11% is excreted in the urine (3.5% as unchanged
drug). The elimination
half-life is 3 to 5 hours.
INDICATIONS
Ritonavir is indicated alone or in combination with other
antiretroviral agents for the treatment of
patients with HIV infection when therapy is warranted based on
clinical and/or immunological
evidence of disease progression.
RECOMMENDED DOSE
Ritonavir tablets are administered orally and sh