Diltizem 30mg Tablet

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

DILTIAZEM HYDROCHLORIDE

Boleh didapati daripada:

MEDIDATA SDN BHD

INN (Nama Antarabangsa):

DILTIAZEM HYDROCHLORIDE

Unit dalam pakej:

100 Tablets; 32 Tablets; 48 Tablets; 112 Tablets

Dikeluarkan oleh:

Gensenta Ilac Sanayi ve Ticaret A.S.

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP_
_) _
DILTIZEM
_DILTIAZEM HYDROCHLORIDE 30MG TABLET _
1
WHAT IS IN THIS LEAFLET
1.
What DILTIZEM is used for
2.
How DILTIZEM works
3.
Before you take DILTIZEM
4.
How to take DILTIZEM
5.
While you are taking DILTIZEM
6.
Side effects
7.
Storage and disposal of DILTIZEM
8.
Product Description
9.
Manufacturer
and
Product
Registration
Holder
10.
Date of Revision
1.
WHAT DILTIZEM IS USED FOR
DILTIZEM is used to treat (long- term)
and prevent chest pain and mild to
moderate high blood pressure.
2.
HOW DILTIZEM WORKS
DILTIZEM contains the active substance
diltiazem hydrochloride, which belongs
to a group of medicines called ‘calcium
channel blockers’.
It works by making your blood vessels
wider, which makes it easier for your heart
to pump blood around the body. This helps
to prevent the chest pain.
3.
BEFORE YOU TAKE DILTIZEM
-
_When you must not use it _
Do
not
take
DILTIZEM
if
you
are
allergic to diltiazem hydrochloride or any
of the ingredients listed at the end of this
leaflet.
Do not take DILTIZEM with dantrolene
infusion (a muscle relaxant) because it
may cause a serious heart failure.
Do
not
take
DILTIZEM
if
you
have
galactose
intolerance,
the
Lapp
lactase
deficiency
or
glucose-galactose
malabsorption, as the medicine contains
lactose monohydrate.
Do
not
take
DILTIZEM
if
you
have
severe
blood
pressure,
have
a
heart
condition such as; a severe slow heartbeat
(bradycardia), disturbance in heart rhythm
(sick sinus syndrome), heart failure with
reduced
blood
flow
to
your
lungs,
congestive heart failure, heart block,
narrowing of the opening of the
aortic
valve
in
the
heart
(aortic
stenosis),
shock
caused
by
heart
problems (cardiogenic shock).
Do
not
take
DILTIZEM
if
you
have an inherited disorder of the
red
blood
pigment
haemoglobin
(porphyria).
Do not take DILTIZEM if you are
pregnant, might become pregnant
or breast feeding.
DILTIZEM
is not
recommended
in
children
and
adolescents
younger than 18 years. The safety
and
effectiveness
of
DILTIZEM
has not been establis

Ciri produk

DRUG INTERACTION:
Due to potential for additive effects, caution and careful titration
are warranted in
patients receiving diltiazem concomitantly with other agents known to
affect
cardiac contractility an/or conduction. Pharmacologic studies indicate
that there
may be additive effects in prolonging AV conduction when using
beta-blockers
or digitalis concomitantly with diltiazem.
As with all drugs, care should be exercised when treating patients
with multiple
medications. Diltiazem is both a substrate and an inhibitor of the
cytochrome P-
450 3A4 enzyme system. Other drugs that are specific substrates,
inhibitors, or
inducers of this enzyme system may have a significant impact on the
efficacy and
side effect profile of diltiazem. Patients taking other drugs that
are substrates of
CYP450, especially patients with renal and/or hepatic impairment, may
require
dosage adjustment when starting or stopping concomitantly administered
diltiazem
in order to maintain optimum therapeutic blood levels.
ANESTHETICS: The depression of cardiac contractility, conductivity,
and automaticity
as well as the vascular dilation associated with anesthetics may be
potentiated by
calcium channel blockers. When used concomitantly, anesthetic and
calcium
blockers should be titrated carefully.
BENZODIAZEPINES: Studies showed that diltiazem increased the AUC of
midazolam
and triazolam by 3- to 4- fold and the C
max
by 2-fold, compared to placebo. The
elimination half-life of midazolam and triazolam also increase (1.5 to
2.5 fold)
during coadministration with diltiazem. These pharmacokinetic effects
seen during
diltiazem coadministration can result in increased clinical effects
(e.g, prolonged
sedation) of both midazolam and triazolam.
BETA-BLOCKERS: Controlled and uncontrolled domestic studies suggest
that
concomitant use of diltiazem and beta-blockers is usually well
tolerated, but
available data are not sufficient to predict the effects of
concomitant treatment in
patients with left ventricular dysfunction or cardiac conduction
abnorma