ISDIN 10mg Tablet

País: Malasia

Idioma: inglés

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

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Ficha técnica Ficha técnica (SPC)
05-09-2016

Ingredientes activos:

ISOSORBIDE DINITRATE

Disponible desde:

AVERROES PHARMACEUTICALS SDN. BHD.

Designación común internacional (DCI):

ISOSORBIDE DINITRATE

Unidades en paquete:

100tablet Tablets; 1000tablet Tablets

Fabricado por:

Maple Pharmaceuticals (Pvt.) Limited

Ficha técnica

                                ISDIN TABLET 10 MG
ISOSORBIDE DINITRATE 10 MG
DESCRIPTION
White round tablet mark maple leaf on one side and ISDIN and bisected
line on the other size.
COMPOSITION
Each Tablet contains Isosorbide Dinitrate 10mg.
MODE OF ACTION
Isosorbide dinitrate is a vasodilator.
SUMMARY OF PHARMACODYNAMICS AND PHARMACOKINETICS
Isosorbide
dinitrate
is
readily
absorbed
from
the
oral
mucosa
and
also
following
oral
administration. It undergoes extensive first pass metabolism, mainly
in the liver.
The major metabolites are isosorbide 2-mononitrate and isosorbide
5-mononitrate which both
possess vasodilatory activity and may contribute to the activity of
the parent compound.
INDICATIONS
Isosorbide dinitrate taken orally is used in the prophylaxis of angina
pectoris and as adjunctive
therapy in congestive heart failure.
ADVERSE REACTIONS/SIDE EFFECTS
As with nitroglycerin and other nitrates, vascular headache occurs and
it may be severe and
persistent. This adverse effect occurs most frequently at the
beginning of therapy. Headache
usually
can
be
controlled
by
temporary
dosage
reduction,
concomitant
administration
of
commonly used analgesics or by administering the drug during meals.
These headaches usually
disappear within one week of continous, uninterrupted therapy. It is
usually best to advise the
patient of their possible occurrence and of their importance in regard
to the prevention of angina.
Drug and/or exfoliative dermatitis occasionally occur. Signs of
cerebral ischemia associated
with postural hypotension such as weakness or transient episodes of
dizziness may occasionally
develop. Cutaneous vasodilatation with flushing may occur. Rarely a
marked sensitivity to the
hypotensive effects of the drug and severe response (nausea, vomiting,
restlessness, perspiration
and collapse) can occur and alcohol may enhance this effect.
Isosorbide dinitrate can antagonize
the effects of histamine or epinephrine, acetylcholine and similar
agents.
PRECAUTION/WARNINGS
Development of tolerance may occur with all forms of nitrate therapy
parti
                                
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Información para el usuario Información para el usuario malayo 05-09-2016

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