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Capoten

Capoten contains captopril, an agent acting in the renin-angiotensin system, and is registered in 19 countries spanning Europe, Latin America, the Middle East, and the Asia-Pacific region. It is one of the longer-established brand names within this pharmacological class, and travellers familiar with it from one market will often find that the same active ingredient is available elsewhere, even where the Capoten brand itself is not.

Capoten is prescribed in the management of hypertension, heart failure, left ventricular dysfunction following a heart attack, and certain forms of kidney disease associated with diabetes. The structured indication block further down this page lists each registered use in detail, as recognised by the national regulators in the markets where the brand is sold. Captopril belongs to a broader category of antihypertensive and vasodilator medications that act on the renin-angiotensin pathway, a mechanism widely used in cardiovascular and renal therapy.

The country footprint is geographically mixed rather than clustered: Brazil, Australia, Italy, Egypt, and China all appear among the markets where Capoten is registered, alongside several smaller European and Middle Eastern jurisdictions. Brand availability, packaging, and prescription pathways vary considerably from one country to another, so a traveller or expatriate who relies on Capoten at home should not assume the same brand will be on the shelf abroad.

Other medications acting on the renin-angiotensin system are sold in essentially every regulated market in the world, under a range of active ingredients and brand names. A local pharmacist is well placed to identify which captopril-containing or class-equivalent products are available regionally. Any decision to start, stop, switch, or substitute a cardiovascular medication of this kind belongs with a healthcare provider who knows the patient's history.

Countries
Australia Belgium Brazil China Cyprus Egypt Greece Ireland Italy Lebanon New Zealand Oman Peru Portugal Russia Spain Taiwan United Kingdom Venezuela
Diseases
Hypertension Diabetic Kidney Disease Diabetes Mellitus Heart Failure Heart Attack Nephropathy Left ventricular dysfunction
Ingredients
Captopril
Drug Actions
Agents acting in the renin-angiotensin system Antihypertensive Hypotensive Vasodilator

Drugs with the same active ingredients

Captarsan Captohasan comp Captohexal Captopril domesco Captopril sandoz Terry white chemists captopril Zedace Cabudan Ecadiu Kai fu lin Kai fu te Ya ning Capozide forte Captopril ratiopharm Captopril-hct forte ratiopharm Captopril-hct mite ratiopharm Captopril-hct ratiopharm Acediur (captopril) Ace-hemmer-ratiopharm comp Aceplus

Shelf life

PVC/Al foil blister presentation:

48 months

PVC/PVDC/Al foil blister presentation:

36 months

Incompatibilities

None.

List of excipients

Lactose monohydrate, maize starch, microcrystalline cellulose, stearic acid.

Preclinical safety data

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.

Pharmacotherapeutic group

ACE inhibitors, plain, ATC code: C09AA01.

Pharmacokinetic properties

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.

Date of revision of the text

January 2017

Marketing authorisation holder

E.R. Squibb & Sons Limited

Uxbridge Business Park

Sanderson Road

Uxbridge

Middlesex UB8 1DH

Special precautions for storage

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.

Nature and contents of container

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.

Marketing authorisation number(s)

PL 00034/0193

Special precautions for disposal and other handling

No special instructions.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

Date of first authorisation/renewal of the authorisation

Date of first authorisation: 27th March 1981

Date of latest renewal: 26th November 1996

Frequently asked questions

What conditions does Capoten treat?

Capoten is prescribed in the management of hypertension, heart failure, left ventricular dysfunction following a heart attack, and certain forms of kidney disease, including diabetic nephropathy. The active ingredient belongs to the class of agents acting on the renin-angiotensin system, which is widely used across cardiovascular and renal therapy. The structured indication section below this introduction lists each registered use as recognised in the markets where Capoten is sold.

Which active substance is in Capoten?

Capoten contains captopril, classified among agents acting on the renin-angiotensin system and used as an antihypertensive and vasodilator. Captopril is the same molecule whether sold under the Capoten brand or as a generic, and internationally the same active ingredient circulates under several different commercial names, particularly in markets where multiple manufacturers produce captopril products in parallel.

In how many countries is Capoten available?

Capoten is registered in 19 countries, with a geographically mixed footprint that includes Brazil, Australia, Italy, Egypt, China, Russia, and New Zealand among others. Smaller European and Middle Eastern markets such as Cyprus, Greece, Lebanon, and Oman also appear on the list. If your country is not represented here, a local pharmacist can usually confirm whether captopril is available locally under a different brand name or as a generic.

Are there other medications with the same active ingredient as Capoten?

Captopril is sold under several brand names worldwide, particularly in markets where the original patent has long expired and multiple manufacturers produce the molecule in parallel. Other medications acting on the renin-angiotensin system also exist as a broader class, although molecules within that class are not freely interchangeable without medical guidance. To identify a regional captopril-containing product, search the active ingredient on Pill2Trip or ask a local pharmacist.

Should I consult a doctor before taking Capoten?

Yes. Capoten is a prescription cardiovascular medication, and therapy with agents acting on the renin-angiotensin system is calibrated to the patient's full clinical picture, including blood pressure, kidney function, and concurrent medications. This is particularly relevant for travellers and people relocating between countries, where prescription rules, available brands, and generics differ. Any decision to begin, continue, change, or substitute this medication should involve a qualified healthcare provider.

Capoten

Available in 19 countries