COMPOSITION :

Each tablet contains : Captopril USP 25 mg and 50 mg.

DESCRIPTION :

Captopril Shiba is an antihypertensive agent. It is a specific competitive inhibitor of angiotensin converting enzyme

(ACE), the enzyme responsible for the conversion of angiotensin I to angiotensin II. Its beneficial effects in

hypertension and heart failure appear to result primarly from suppression of rennin – angiotensin – aldosteron system.

Captopril is rapidly absorbed from gastrointestinal tract after oral administration and peak plasma concentrations are

achieved within about an hour. Absorption has been reported to be reduced in the presence of food .

INDICATIONS :

- Antihypertension : Captopril Shiba is indicated for treatment of hypertension. It is effective either alone or in

combination with other antihypertensive agents especially thiazide type diuretics .

- Heart failure : It is indicated in the treatment of congestive heart failure in combination with diuretic and digitalis.

DOSAGE AND ADMINISTRATION :

Dosage must be individualized and should be taken one hour before meals. The dose shouldn’t be changed without

consulting your doctor.

- In case of hypertension : The initial dose is 25 mg twice or three times daily. The dose may be increased to 50 mg

twice or three times daily if satisfactory reduction of blood pressure has not been achieved after one or two weeks.

The dose of Captopril should not exceed 50 mg three times daily as antihypertensive. If the blood pressure has not

been satisfactorily controlled after one to two weeks at this dose a modest dose of thiazide type diuretic may be

co-administered .

- In the case of heart failure : The usual initial daily dose is 25 mg three times. Increment in dose may be instituted at

intervals of at least 2 weeks. Total daily dose should not exceed 450 mg .

RESTRICTIONS ON USE :

Contraindication

Hypersensitivity to Captopril.

Precautions

- Captopril should be used with caution in patient with aortic stenosis .

- Captopril should be used with great caution in patients with impaired renal function.

Use in pregnancy and lactation

This drug should not be used during pregnancy or breast feeding.

DRUG INTERACTIONS :

- Concurrent use of Captopril with diuretic and other antihypertensive may cause excessive hypotension .

- An additive hyperkalemic effect is possible when Captopril or other ACE inhibitors are concomitantly administered

with potassium-sparing diuretics, potassium supplements or other drugs that can cause hyperkalemia.

- The adverse effects of Captopril or any ACE inhibitor on the kidneys may be potentiated by other drugs such as

NSAIDS.

ADVERSE EFFECTS :

Few side effects were reported on using Captopril such as:

- Headache, tiredness, vertigo, malaise, low blood pressure, skin rash, itching , nausea, loss of appetite,

gastrointestinal pain, taste change, dry cough .

- If the following cases occur stop taking Captopril and contact your doctor: swelling of the face, lips, tongue and / or

larynx which entail difficulties in breathing or swallowing .

STORAGE INSTRUCTIONS :

Store below 30°C , in dry place.

PRESENTATION :

Captopril Shiba 25 : pack of 20 tablets and hospital packs of different sizes .

Captopril Shiba 50 : pack of 20 tablets and hospital packs of different sizes .