Nchi: Ayalandi
Lugha: Kiingereza
Chanzo: HPRA (Health Products Regulatory Authority)
CAPTOPRIL
Stada Arzneimittel AG
CAPTOPRIL
12.5mg Milligram
Tablets
Withdrawn
2008-05-06
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 Soma hati kamili