Verapamil Alkaloid tablets coated

Negara: Armenia

Bahasa: Inggris

Sumber: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Bahan aktif:

verapamil (verapamil hydrochloride)

Tersedia dari:

Alkaloid AD Skopje

Kode ATC:

C08DA01

INN (Nama Internasional):

verapamil (verapamil hydrochloride)

Dosis:

40mg

Bentuk farmasi:

tablets coated

Unit dalam paket:

(30/2x15/) in blister

Jenis Resep:

Prescription

Status otorisasi:

Registered

Tanggal Otorisasi:

2022-03-23

Karakteristik produk

Verapamil Alkaloid 40 mg and 80 mg coated tablets
_Summary of Product Characteristics _
_ _
_- _
1
_ -_
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF MEDICINAL PRODUCT
Verapamil Alkaloid, 40 mg coated tablets.
Verapamil Alkaloid, 80 mg coated tablets.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each coated tablet contains 40 mg verapamil hydrochloride.
Each coated tablet contains 80 mg verapamil hydrochloride.
Excipients with known effect: lactose monohydrate, sucrose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
*
Coated tablets
Yellow, glossy, biconvex coated tablets.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
_ _
Verapamil is indicated for the treatment and prophylaxis of angina
pectoris. It may be used in
the treatment and prophylaxis of paroxysmal supraventricular
tachycardia, atrial fibrillation
and atrial flutter; (verapamil should not be used where atrial
flutter/fibrillation complicates
Wolff-Parkinson-White syndrome). Verapamil may also be used in the
management of mild
to moderate hypertension and renal hypertension.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
For oral administration.
Angina Pectoris
_Adults:_
The usual dosage is 120 mg three times daily.
80 mg three times daily may be satisfactory in some patients with
angina of
effort. Less than 120 mg three times daily is not likely to be
effective in angina
at rest and variant angina.
_Children:_
No data are available.
Verapamil Alkaloid 40 mg and 80 mg coated tablets
_Summary of Product Characteristics _
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2
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Supraventricular tachycardia
_Adults:_
40 - 120 mg three times daily according to the severity of the
condition.
_ _
_Children:_
2 years and above: 40 – 120 mg tablets two to three times daily
according to
age and effectiveness.
Hypertension
_Adults:_
The usual dosage is 160 mg twice a day. However, a minority of
patients may
be successfully controlled on 120 mg twice a day while others may
require up
to 480 mg daily given in divided doses.
_Children: _
Up to 10 mg/kg/day, in divided doses, acco