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CAPTOPRIL - REACH (Reach Pharmaceuticals Pty Ltd)

Product name
CAPTOPRIL - REACH
Date registered
Evaluation commenced
Decision date
Approval time
149 (255 working days)
Active ingredients
captopril
Registration type
New generic medicine
Indication

HYPERTENSION:

CAPTOPRIL-REACH (captopril) is indicated for the treatment of hypertension. In using CAPTOPRIL-REACH, consideration should be given to the risk of neutropenia/agranulocytosis (see section 4.4 Special warnings and precautions for use). CAPTOPRIL-REACH is effective alone and in combination with other antihypertensive agents, especially thiazide-type diuretics. The blood pressure lowering effects of captopril and thiazides are approximately additive.

MYOCARDIAL INFARCTION:

CAPTOPRIL-REACH is indicated to improve survival following myocardial infarction in clinically stable patients with left ventricular dysfunction, manifested as an ejection fraction less than or equal to 40% and to reduce the incidence of overt heart failure, and subsequent hospitalisations for congestive heart failure in these patients. The efficacy data for the use of CAPTOPRIL-REACH following myocardial infarction are strongest for initiation of therapy beyond 3 days post-infarct.

HEART FAILURE:

CAPTOPRIL-REACH (captopril) is indicated for the treatment of heart failure. In symptomatic patients it is recommended that CAPTOPRIL-REACH be administered together with a diuretic.

DIABETIC NEPHROPATHY:

CAPTOPRIL-REACH is indicated for the treatment of diabetic nephropathy in patients with Type 1 insulin-dependent diabetes mellitus.