STOCRIN TABLET 200MG

国: マレーシア

言語: 英語

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

有効成分:

EFAVIRENZ

から入手可能:

MERCK SHARP & DOHME (MALAYSIA) SDN BHD

INN（国際名）:

EFAVIRENZ

パッケージ内のユニット:

90tablet Tablets

製:

ZHEJIANG HUAHAI PHARMACEUTICAL CO., LTD.

情報リーフレット

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
STOCRIN
® TABLET
Efavirenz (200mg and 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
Strocrin contains an active ingredient
efavirenz.
Your doctor has prescribed
STOCRIN for you because you have
HIV infection. STOCRIN taken in
combination 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 medicine 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 con
tains
efavirenz.
_STOCRI

製品の特徴

LPC-MK0831-MF-042020
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 containing either 200 mg or 600 mg of efavirenz
IV. CLINICAL PHARMACOLOGY
IVa. Mechanism of Action
Efavirenz
is
a
selective
non-nucleoside
reverse
transcriptase
inhibitor
of
human
immunodeficiency 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.
2
IVb. 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 doses. In 35 patients receiving
STOCRIN
600 mg once
daily, steady-state C
max
was 12.9 µM, steady-state C
min
was 5.6 µM, and AUC was 184 µMh.
Effect of Food on Oral Absorption
The bioavailability of a single 600-mg dose of efavirenz in uninfected
volunteers was increased
22% and 17%, respectively, when given with a meal of high fat or
normal composition, relative
to the bioavailability of a 600-mg dose given under