PVC/Al foil blister presentation:
48 months
PVC/PVDC/Al foil blister presentation:
36 months
None.
Lactose monohydrate, maize starch, microcrystalline cellulose, stearic acid.
Animal studies performed during organogenesis with captopril have not shown any teratogenic effect but captopril has produced foetal toxicity in several species, including foetal mortality during late pregnancy, growth retardation and postnatal mortality in the rat. Preclinical data reveal no other specific hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicology, genotoxicity and carcinogenicity.
Captopril is an orally active agent that does not require biotransformation for activity. The average minimal absorption is approximately 75%. Peak plasma concentrations are reached within 60-90 minutes. The presence of food in the gastrointestinal tract reduces absorption by about 30-40%. Approximately 25-30% of the circulating drug is bound to plasma proteins.
The apparent elimination half-life of unchanged captopril in blood is about 2 hours. Greater than 95% of the absorbed dose is eliminated in the urine within 24 hours; 40-50% is unchanged drug and the remainder are inactive disulphide metabolites (captopril disulphide and captopril cysteine disulphide). Impaired renal function could result in drug accumulation. Therefore, in patients with impaired renal function the dose should be reduced and/or dosage interval prolonged.
Studies in animals indicate that captopril does not cross the blood-brain barrier to any significant extent.
Lactation:
In the report of twelve women taking oral captopril 100mg 3 times daily, the average peak milk level was 4.7μg/L and occurred 3.8 hours after the dose. Based on these data, the maximum daily dosage that a nursing infant would receive is less than 0.002% of the maternal daily dosage.
January 2017
E.R. Squibb & Sons Limited
Uxbridge Business Park
Sanderson Road
Uxbridge
Middlesex UB8 1DH
PVC/Al foil blister presentation:
Store below 30°C.
Protect from moisture.
PVC/PVDC/Al foil blister presentation:
Do not store above 25°C.
Store in the original package to protect from moisture.
The tablets are packaged in PVC/aluminium blisters or PVC/PVdC/aluminium blisters in packs of 28 or 84 tablets.
Not all pack sizes may be marketed.
PL 00034/0193
No special instructions.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Date of first authorisation: 27th March 1981
Date of latest renewal: 26th November 1996
