Kaptopril tablets

Nchi: Armenia

Lugha: Kiingereza

Chanzo: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Viambatanisho vya kazi:

captopril

Inapatikana kutoka:

KRKA d.d.

ATC kanuni:

C09AA01

INN (Jina la Kimataifa):

captopril

Kipimo:

50mg

Dawa fomu:

tablets

Vitengo katika mfuko:

(20/2x10/) in blister

Dawa ya aina:

Prescription

Idhini hali ya:

Registered

Idhini ya tarehe:

2020-12-30

Tabia za bidhaa

Summary of product characteristics
CONFIDENTIAL
Kaptopril tablet 25 mg, 50 mg
VOL: 1; P: 6 / 44
PI_Text057855_1
– Updated:
Page 1 of 17
1.
NAME OF THE MEDICINAL PRODUCT
Kaptopril 25 mg tablets
Kaptopril 50 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 25 mg or 50 mg captopril.
Excipient:
25 mg tablets
50 mg tablets
lactose
47.50 mg/tablet
95.00 mg/tablet
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
The tablets of 25 mg are white, round, slightly biconvex tablets with
bevelled edges and scored on one
side. The score line is not intended for breaking the tablet.
The tablets of 50 mg are white, round, slightly biconvex tablets with
bevelled edges and a score on one
side. The score line is not intended is not intended for breaking the
tablet.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
-
Hypertension:
The management of mild to moderate hypertension. In severe
hypertension it should be used
where standard therapy is ineffective or inappropriate.
-
Congestive heart failure:
Captopril is indicated for the treatment of congestive heart failure.
The drug should be used
together with diuretics, and when appropriate, digitalis and
beta-blockers. In patients on doses
of over 100 mg daily plus or minus a diuretic, in those with severe
renal impairment or those
with severe congestive heart failure use of captopril should be under
specialist supervision.
-
Myocardial infarction:
Short-term (4 weeks) treatment: Captopril is indicated in any
clinically stable patient within
the first 24 hours of an infarction. Long-term prevention of
symptomatic heart failure:
Captopril is indicated in clinically stable patients with asymptomatic
and symptomatic left
ventricular dysfunction (ejection fraction < 40%) following myocardial
infarction to improve
survival, delay the onset of symptomatic heart failure, reduce
hospitalisations for heart failure
and reduce recurrent myocardial infarction and coronary
revascularisation procedures.
Before starting therapy, cardiac fu