QUINIDINE SULFATE

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

QUINIDINE SULFATE

متاح من:

REKAH PHARMACEUTICAL INDUSTRY LTD, ISRAEL

ATC رمز:

C01BA

الشكل الصيدلاني:

TABLETS

تركيب:

QUINIDINE SULFATE 200 MG

طريقة التعاطي:

PER OS

نوع الوصفة الطبية :

Required

المصنعة من قبل:

REKAH PHARMACEUTICAL INDUSTRY LTD, ISRAEL

المجموعة العلاجية:

ANTIARRHYTHMICS, CLASS IA

الخصائص العلاجية:

Treatment of certain cardiac arrhythmias: atrial fibrillation / flutter and ventricular arrhythmias

تاريخ الترخيص:

2021-12-31

خصائص المنتج

SUMMARY OF PRODUCTS CHARACTERISTICS
Product Summary
1.
Trade name of the Medical Product
Quinidine sulfate 200 mg
2.
Qualitative and Quantitative Composition
Each tablets contains 200 mg of quinidine sulfate
For the full list of excipient, see 6.1
3 . Pharmaceutical Form
Tablet
4. Clinical Particulars
4.1 THERAPEUTIC INDICATIONS
Treatment
of
certain
cardiac
arrhythmias:
atrial
fibrillation,
atrial
flutter
and
ventricular
arrhythmias
4.2 POSOLOGY AND METHOD OF ADMINISTRATION

Adult dosage:
For Atrial fibrillation and flutter, Chronic therapy to reduce
recurrence: immediate-release
tablet, 200 mg ORALLY every 6 h; if needed and patient tolerates, may
raise dose cautiously.
For Ventricular arrhythmia, Life-threatening: immediate-release
tablet, 200 mg ORALLY every
6 h; if needed and patient tolerates, may raise dose cautiously.
The dosage should be adapted in renal or hepatic insufficiency.

Children dosage:
Quinidine is not recommended in children.
4.3 CONTRAINDICATIONS
Quinidine sulfate should not be given to patients with:
● Hypersensitivity to quinidine or cinchona alkaloids (quinine).
● have developed thrombocytopenic purpura during prior therapy with
quinidine or
quinine.
Quinidine is also contraindicated in patients who, like those with
myasthenia gravis, might
be adversely affected by an anticholinergic agent.
In the absence of a functioning artificial pacemaker, quinidine is
also contraindicated in any
patient whose cardiac rhythm is dependent upon a junctional or
idioventricular pacemaker,
including patients in complete atrioventricular block.
4.4 SPECIAL WARNING AND PRECAUTION FOR USE
MORTALITY
In many trials of antiarrhythmic therapy for non-life-threatening
arrhythmias, active
antiarrhythmic therapy has resulted in increased mortality; the risk
of active therapy is
probably greatest in patients with structural heart disease.
In the case of quinidine used to prevent or defer recurrence of atrial
flutter/fibrillation, the best
available data come from a meta-analysis
Pharmacological Properties
/