STOCRIN TABLETS 600MG

מדינה: מלזיה

שפה: אנגלית

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

מרכיב פעיל:

EFAVIRENZ

זמין מ:

MERCK SHARP & DOHME (MALAYSIA) SDN BHD

INN (שם בינלאומי):

EFAVIRENZ

יחידות באריזה:

30tablet Tablets

תוצרת:

ZHEJIANG HUAHAI PHARMACEUTICAL CO., LTD.

עלון מידע

CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)
STOCRIN
® TABLET
Efavirenz (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
STOCRIN
contains an active ingredient
efavirenz.
Your doctor has prescribed
STOCRIN
for you because you have
HIV infection.
STOCRIN taken in
combina
tion 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 m
edicine 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 contains
efavirenz. STOCRIN should not be taken
together with other medicines that

מאפייני מוצר

LPC-MK0831-MF-062022
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 contai
ning either 200 mg or 600 mg
of efavirenz
IV. CLINICAL
PHARMACOLOGY
IVA. MECHA
NISM OF ACTION
Efavirenz
is
a
selective
non-
nucleoside
reverse
transcriptase
inhibitor
of
human
immunode
ficiency 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.
IV
B. 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 dose
s. In 35 patients receiving STOCRIN
600 mg once
daily, steady
-state C
max
was 12.9 µM, steady-state C
min
was 5.6 µ
M, and AUC was 184
µMh.
Effect of Food on Oral Absorption
The bioavailability of a single 600
-
mg dose of efavirenz in uninfected v
olunteers wa
s increased
22% and 17%,
respectively,
when given with a meal of high fat or
normal composition,
relative
to the
bioavailability
of a 600-mg