Adpharm Pharmaceuticals Limited
60, Ajao Road, Surulere, Lagos State, Nigeria
Tel: +234(0)818-839-0519, +234(0)807-408-4334. Mobile: 08033481022

Brand Name



Globela Pharma Pvt. Ltd. 357, G.I.D.C., Sachin Surat -394 230. Gujarat. (India) Mfg. Lic. No.: G/25/1749

Therapeutic Class

Angiotensin converting enzyme (ACE) inhibitors

Dosage Form, Composition & NAFDAC Registration Number (NRN)

Tablet(NRN:   ): Each tablet contains 25 mg Captopril.

Pack size: 10 Tablets Alu-PVC Blister pack, such 10 blister packed in one carton.



Captopril inhibits angiotensin-converting-enzyme (ACE), the enzyme involved in the conversion of angiotensin I to angiotensin II; this enzyme is identical to bradykininase or kininase II and captopril may also reduce the degradation of bradykinin. The pharmacological actions of captopril are thought to be primarily due to the inhibition of the renin-angiotensin-aldosterone system, but as it also effectively reduces blood pressure in patients with low renin concentrations, other mechanisms are probably also involved.

Captopril produces a reduction in total peripheral arterial resistance and, in patients with congestive heart failure, a reduction in both preload and afterload. Normally renal blood flow is increased without a change in glomerular filtration rate.

Following oral administration, captopril produces a maximum effect within 1 to 2 hours, although the full effect may not develop for several weeks during chronic dosing. The duration of action is dose-dependant and may persist for 6-12 hours. About 60-75% of a dose of captopril is absorbed from the gastro-intestinal tract. It is about 30% bound to plasma proteins. It crosses the placenta and is found in breast milk at about 1% of maternal blood concentrations. It is largely excreted in the urine, 40 to 50% as unchanged drug, the rest as disulphide and other metabolites.

The elimination half-life has been reported to be 2-3 hours, but this is increased in renal failure. Captopril is removed by dialysis.


Sivocaptopril is indicated for the treatment of mild to moderate hypertension in adults. It may be used alone or in combination with other antihypertensive agents, especially thiazide-type diuretics, where the blood pressure lowering effects of captopril and thiazides are additive.

Sivocaptopril is indicated for the treatment of patients with congestive heart failure and when indicated, in combination with diuretics and/or digitalis.


Hypersensitivity to captopril or the other components of Sivocaptopril or other ACE-inhibitors.

Safety and efficacy in individuals younger than 18 years of age have not been established.

Patients with a history of angioneurotic oedema relating to previous treatment with an ACE- inhibitor. Severe renal and/or hepatic insufficiency.


Captopril should not be used in patients with aortic stenosis or outflow tract obstruction.



Captopril should not generally be used in patients with impaired renal function particularly if renovascular disease is present or suspected but is occasionally necessary for severe resistant hypertension in such patients, when it should only be given with great caution and under close specialist supervision. Some authorities consider patients with peripheral vascular diseases or generalised atherosclerosis may be at high risk of renovascular disease.

Captopril should also be used with caution in patients with collagen vascular disorders such as systemic lupus erythematosus or scleroderma. Renal function should be assessed in all patients prior to administration of captopril. Patients with existing renal disease or taking high doses of captopril should be monitored regularly for proteinuria. Regular white blood cell counts should be made during the initial stages of therapy particularly in patients with collagen vascular disorders or impaired renal function and in patients receiving immunosuppressive therapy.

Patients with congestive heart failure and patients who are likely to be salt or water depleted, may experience symptomatic hypotension during the initial stages of captopril therapy - this may be minimised by starting with a low dose, preferably on retiring. Should a woman become pregnant while receiving an ACE-inhibitor, the treatment must be stopped promptly and the patient switched to a different medicine. Should a woman contemplate pregnancy, the doctor should consider alternative medication.

Angioedema involving the extremities, face, eyes, lips, mucous membranes, tongue, glottis or larynx has been seen in patients treated with captopril. Patients should be advised to immediately report to their doctor, any signs or symptoms suggesting angioedema (e.g., swelling of face, eyes, lips, tongue, larynx and extremities, difficulty in swallowing or breathing, hoarseness) and to discontinue therapy. If angioedema involves the tongue, glottis or larynx, airway obstruction may occur, which may be fatal.

Emergency therapy including but not necessarily limited to, subcutaneous administration of 1:1000 solution of adrenalin should be promptly instituted. Swelling confined to the face, mucous membranes of the mouth, lips and extremities has usually resolved with discontinuation of captopril, some cases required medical therapy (see side effects and special precautions).

Proteinuria has been seen in patients receiving captopril, but this has been predominantly in those receiving relatively high doses (in excess of 150 mg per day), or those with compromised renal function, or both. Alterations in renal function (as assessed by blood urea and serum creatinine) were infrequent in these patients and did not occur in those who had prior renal disease. Nephrotic syndrome (hypoalbuminemia, edema and protein excretion greater than 3 grams per day) has also occurred.

In most cases, proteinuria subsided or cleared within 6 months whether or not captopril was continued.


Since raised serum potassium concentrations may develop , potassium sparing diuretics , potassium supplements and potassium containing salt substitutes should be used with caution .

The hypotensive effect of captopril is enhanced by diuretics and other antihypertensive agents.

Indomethacin has been shown to reduce or abolish the hypotensive effect of captopril and salicylates have been shown to produce a similar effect. 

Captopril may cause false positive results in the test for acetone in urine . 

Adverse Effects


The most common adverse effects are skin rashes which may be accompanied by pruritus, fever and eosinophilia; a persistent dry cough; and taste disturbances, which may sometimes be associated with weight loss.

Proteinuria has occurred mainly in patients with existing renal disease and some of these patients develop the nephrotic syndrome.

Evidence of deterioration in renal function, including increasing blood concentrations of urea and creatinine, and reversible acute renal failure have been reported in patients with existing renal or renovascular dysfunction and may be aggravated by hypovolaemia.

Captopril administration has also been associated with increases in blood-potassium concentrations.

Neutropenia and agranulocytosis occur less frequently, again mostly in patients with renal failure, and in those with collagen vascular disorders such as systemic lupus erythematosus and scleroderma. 

Thrombocytopenia and anaemias ,  including aplastic anaemia have also been reported . Transient hypotension may occur at the start of therapy ,  particularly in patients with congestive heart failure and in sodium or volume depleted patients . This can be minimized by starting with a low dose of captopril and giving the initial dose at night . 

Other adverse effects reported include angiooedema,  tachycardia, paraesthesia, lymphoadenopathy,  photosensitivity,  stomatitis, gastrointestinal irritation and disturbances,  abdominal pain,  and cases of hepatocellular injury and jaundice. 



Dosage & Administration


Dosage must be individualised. Sivocaptopril should be taken an hour before food intake.

Hypertension: An initial dose of 12.5 mg twice daily, which may be increased gradually at intervals of 2-4 weeks according to the response. The usual maintenance dose is 25 to 50 mg twice daily and should not normally exceed 50 mg three times daily, even in more severe hypertension. Since there may be a precipitous fall in blood pressure in some patients, the first dose of captopril should preferably be given at bedtime, and if possible diuretic therapy should cease a few days before introducing captopril. An initial dose of 6,25 mg twice daily is recommended if captopril is given in addition to a diuretic, to elderly patients, or to those with renal impairment.

Congestive heart failure: In the treatment of congestive heart failure severe first-dose hypotension on introduction to captopril is common in patients on loop diuretics, but their temporary withdrawal may cause rebound pulmonary oedema.

Thus an initial dose of 6,25 to 12,5 mg of captopril is given under close medical supervision; the usual maintenance dose is 25 mg two or three times daily, and doses should not normally exceed 50 mg three times daily. Higher doses have occasionally been given under close supervision.

In the event of an overdosage ,  volume expansion with an intravenous infusion of sodium chloride has been recommended 

Storage/Handling Recommendations

Store in cool and dry place, protect from light.


Review Date

2017-09-30 04:22:58