ACTOPRIL TABLETS 12.5MG. 12.5mg Milligram Tablets

Land: Irland

Språk: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv ingrediens:

CAPTOPRIL

Tilgjengelig fra:

Stada Arzneimittel AG

INN (International Name):

CAPTOPRIL

Dosering :

12.5mg Milligram

Legemiddelform:

Tablets

Autorisasjon status:

Withdrawn

Autorisasjon dato:

2008-05-06

Preparatomtale

PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Actopril Tablets 12.5mg.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains captopril 12.5 mg.
For excipients, see 6.1.
3 PHARMACEUTICAL FORM
Tablet.
White, round, flat, uncoated tablets, scored on both sides, 6mm in
diameter.
4 CLINICAL PARTICULARS 
4.1 THERAPEUTIC INDICATIONS
_Hypertension:_ Captopril is indicated
for the first line treatment 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, where appropriate, digitalis.
4.2 POSOLOGY AND METHOD OF ADMINSTRATION
For oral administration only.
Captopril is best taken about an hour before meals and should
be taken at the same times each day to improve 
compliance.
Treatment with captopril should be started
at the lowest effective dose and titrated to
the individual according to their 
needs.
Initiation of therapy requires, if possible, correction
of salt and/or body fluids deficiencies, discontinuation
of existing 
diuretic therapy for two
or three days before ACE inhibitors are introduced, and
use of the lowest starting dose. If this 
is not possible, the initial dose should
be half of the recommended starting dose.
In patients with malignant hypertension,
or severe cardiac insufficiency, initiation of therapy and
dose adjustment 
should be performed in a hospital.
_Mild to moderate hypertension:_ The starting dose is 12.5mg
twice daily or 25mg daily. The usual maintenance dose is 
25mg twice daily, which can be increased incrementally every 14 to
28 days until a suitable response has been 
achieved, to a maximum dose of 50mg twice daily.
A thiazide diuretic may be added to Captopril