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Public Summary
Summary for ARTG Entry:
56651
WL-CAPTOPRIL 12.5 captopril 12.5mg tablet bottle
ARTG entry for
Medicine Registered
Sponsor
Biotech Pharmaceuticals Pty Ltd
Postal Address
83 Cherry Lane,LAVERTON NORTH, VIC, 3026
Australia
ARTG Start Date
19/02/1997
Product category
Medicine
Status
Active
Approval area
Drug Safety Evaluation Branch
Conditions
Conditions applicable to all therapeutic goods as specified in the document "Standard Conditions Applying to Registered or Listed Therapeutic Goods
Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.
Conditions applicable to the relevant category and class of therapeutic goods as specified in the document "Standard Conditions Applying to Registered
or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.
Products
1. WL-CAPTOPRIL 12.5 captopril 12.5mg tablet bottle
Product Type
Effective date
Single Medicine Product
3/07/2002
Warnings
See Product Information and Consumer Medicine Information for this product
Specific Indications
Hypertension: Treatment of hypertension. In using WL-Captopril, consideration should be given to the risk of neutropenia/agranulocytosis. WL-Captopril
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: 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 following myocardial infarction are
strongest for initiation of therapy beyond three days post-infarction. Heart Failure: Treatment of heart failure. In symptomatic patients it is recommended
that WL-Captopril be administered together with a diuretic. Diabetic Nephropathy: Treatment of diabetic nephropathy in patients with type 1 insulin
dependent diabetes mellitus.
Additional Product information
Container information
Type
Material
Life Time
Temperature
Closure
Conditions
Bottle
Not recorded
2 Years
Store below 30
degrees Celsius
Not recorded
Protect from Moisture
Pack Size/Poison information
Pack Size
Poison Schedule
90 tablets
(S4) Prescription Only Medicine
Components
1. Medicine Component
Dosage Form
Tablet, uncoated
Route of Administration
Oral
Visual Identification
white 3.2 x 6.35mm, oval flat bevelled edge tablet - debossed "355", score
line and "12.5" on one side and a stylised "R" logo on the other.
Active Ingredients
Captopril
12.5 mg
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Public Summary
Standard Indications