Composition
Each tablet contains:
Captopril 25 or 50 mg
Each tablet contains:
Captopril 25 or 50 mg
Properties and Mode of Action
CAPOTRIL is an ACE inhibitor which prevents the conversion of Ang.I to Ang.II resulting in peripheral vasodilatation and reducing peripheral resistance and after load and the reduction of aldosterone secretion promoting sodium excretion and potassium retention. It also reduces the angiotensin-mediated vasopressin release resulting in protection from volume overload with reduction of pre - load. The above action is of value in control of heart failure.
The inhibition of ACE, promotes accumulation of bradykinin with its vasodilator properties.
CAPOTRIL has been shown to be uricosuric and reduces hyperuricaemia.
CAPOTRIL is an ACE inhibitor which prevents the conversion of Ang.I to Ang.II resulting in peripheral vasodilatation and reducing peripheral resistance and after load and the reduction of aldosterone secretion promoting sodium excretion and potassium retention. It also reduces the angiotensin-mediated vasopressin release resulting in protection from volume overload with reduction of pre - load. The above action is of value in control of heart failure.
The inhibition of ACE, promotes accumulation of bradykinin with its vasodilator properties.
CAPOTRIL has been shown to be uricosuric and reduces hyperuricaemia.
Indications
Hypertension
CAPOTRIL is indicated for the treatment of hypertension in adults and children.
It may be used alone or in combination with other antihypertensive agents, especially thiazide - type diuretics. The blood pressure lowering effect of CAPOTRIL and thiazides are additive.
Heart failure CAPOTRIL is indicated for the treatment of heart failure. In such patients it is recommended that CAPOTRIL be administered together with a diuretic.
Hypertension
CAPOTRIL is indicated for the treatment of hypertension in adults and children.
It may be used alone or in combination with other antihypertensive agents, especially thiazide - type diuretics. The blood pressure lowering effect of CAPOTRIL and thiazides are additive.
Heart failure CAPOTRIL is indicated for the treatment of heart failure. In such patients it is recommended that CAPOTRIL be administered together with a diuretic.
Dosage and Administration
Dosage must be individualized.
Adults
Hypertension: The initial dose of CAPOTRIL is 50 mg daily in two divided doses. If a satisfactory reduction of blood pressure has not been achieved after 2 - 4 weeks, the dose of CAPOTRIL may be increased to 100mg daily in two divided doses. If after an additional 2 weeks, a further reduction in blood pressure is desirable, a dose of diuretic may be added.
For patients already receiving a diuretic, the initial dose of CAPOTRIL should be administered with care.
The usual effective dose of CAPOTRIL in mild to moderate hypertension does not exceed 100 mg per day. In severe hypertension where further blood pressure reduction is required, larger or more frequent dosing may be required.
A maximum daily dose of 450mg CAPOTRIL should not be exceeded. For patients with accelerated or malignant hypertension, particularly those unresponsive to conventional therapy, the dosage may be increased at 24 hours intervals or less, under continuous medical supervision, until a satisfactory blood pressure response is obtained or the maximum dose of CAPOTRIL is reached.
When CAPOTRIL is used alone, concomitant sodium restriction may be beneficial. CAPOTRIL may be used advantageously in conjunction with other antihypertensive agents, such as diuretics and calcium-channel blockers.
Heart Failure:
CAPOTRIL therapy must be started under close medical supervision.
The usual starting dose is 25 mg 3 times a day.
A starting dose of 6.25 mg or 12.5 mg 3 times a day may minimize the duration of any transient hypotensive effect. Usually it has been added to treatment with a diuretic or a diuretic and digitails. After a dose of 50 mg 3 times a day is reached, further increases in dosage should be delayed to determine if a satisfactory response occurs.
Twice daily dosage has been used.
A maximum daily dose of 150 mg should not be exceeded.
Dosage must be individualized.
Adults
Hypertension: The initial dose of CAPOTRIL is 50 mg daily in two divided doses. If a satisfactory reduction of blood pressure has not been achieved after 2 - 4 weeks, the dose of CAPOTRIL may be increased to 100mg daily in two divided doses. If after an additional 2 weeks, a further reduction in blood pressure is desirable, a dose of diuretic may be added.
For patients already receiving a diuretic, the initial dose of CAPOTRIL should be administered with care.
The usual effective dose of CAPOTRIL in mild to moderate hypertension does not exceed 100 mg per day. In severe hypertension where further blood pressure reduction is required, larger or more frequent dosing may be required.
A maximum daily dose of 450mg CAPOTRIL should not be exceeded. For patients with accelerated or malignant hypertension, particularly those unresponsive to conventional therapy, the dosage may be increased at 24 hours intervals or less, under continuous medical supervision, until a satisfactory blood pressure response is obtained or the maximum dose of CAPOTRIL is reached.
When CAPOTRIL is used alone, concomitant sodium restriction may be beneficial. CAPOTRIL may be used advantageously in conjunction with other antihypertensive agents, such as diuretics and calcium-channel blockers.
Heart Failure:
CAPOTRIL therapy must be started under close medical supervision.
The usual starting dose is 25 mg 3 times a day.
A starting dose of 6.25 mg or 12.5 mg 3 times a day may minimize the duration of any transient hypotensive effect. Usually it has been added to treatment with a diuretic or a diuretic and digitails. After a dose of 50 mg 3 times a day is reached, further increases in dosage should be delayed to determine if a satisfactory response occurs.
Twice daily dosage has been used.
A maximum daily dose of 150 mg should not be exceeded.
Children
The usual dose is 0.1 - 0.5 mg/kg every 8 - 12 hrs and can be increased if necessary to a maximum daily dose of 4 mg/kg.
The usual dose is 0.1 - 0.5 mg/kg every 8 - 12 hrs and can be increased if necessary to a maximum daily dose of 4 mg/kg.
Patients with Renal Impairment
CAPOTRIL excretion is reduced in the presence of ipaired renal function. After desired therapeutic effect has been achieved, the total daily dose should be reduced or the dose intervals increased.
CAPOTRIL is removed by haemodialysis.
When concomitant diuretic therapy is required, a loop diuretic (e.g. furosemide), rather than a thiazide diuretic, is preferred in patients with impaired renal function.
CAPOTRIL excretion is reduced in the presence of ipaired renal function. After desired therapeutic effect has been achieved, the total daily dose should be reduced or the dose intervals increased.
CAPOTRIL is removed by haemodialysis.
When concomitant diuretic therapy is required, a loop diuretic (e.g. furosemide), rather than a thiazide diuretic, is preferred in patients with impaired renal function.
Precautions
Patients with renal disease, particularly those with bilateral renal artery stenosis, may develop increases in BUN and serum creatinine after reduction of blood pressure with CAPOTRIL.
CAPOTRIL dosage reduction, discontinuation of diuretic, or both has been required in such patients. For these patients, it may not be possible to normalize blood pressure and maintain adequate renal perfusion. During long - term treatment some patients with heart failure have experienced a reduction in renal function that usually stabilized at the reduced level. A few patients have developed angioedema of the face, mucous membranes of the mouth, and the extremities which is reversible upon discontinuation of the drug. Laryngeal oedema and anaphylaxis have also been reported.
CAPOTRIL, as with any drug that reduces vascular resistance, should be used only with extreme caution in patients with aortic stenosis because of the potentially harmful consequences of reduced coronary perfusion secondary to the reduced blood pressure.
CAPOTRIL, as other ACE inhibitors, can cause fetal and neonatal morbidity and mortality when administered to pregnant women.
When pregnancy is detected, discontinue the drug as soon as possible.
Small amounts of CAPOTRIL are excreted in human breast milk. Therefore, breast-feeding should be avoided.
In patients undergoing major surgery or during anaesthesia, CAPOTRIL may cause hypotension which can be corrected by volume expansion.
Patients with renal disease, particularly those with bilateral renal artery stenosis, may develop increases in BUN and serum creatinine after reduction of blood pressure with CAPOTRIL.
CAPOTRIL dosage reduction, discontinuation of diuretic, or both has been required in such patients. For these patients, it may not be possible to normalize blood pressure and maintain adequate renal perfusion. During long - term treatment some patients with heart failure have experienced a reduction in renal function that usually stabilized at the reduced level. A few patients have developed angioedema of the face, mucous membranes of the mouth, and the extremities which is reversible upon discontinuation of the drug. Laryngeal oedema and anaphylaxis have also been reported.
CAPOTRIL, as with any drug that reduces vascular resistance, should be used only with extreme caution in patients with aortic stenosis because of the potentially harmful consequences of reduced coronary perfusion secondary to the reduced blood pressure.
CAPOTRIL, as other ACE inhibitors, can cause fetal and neonatal morbidity and mortality when administered to pregnant women.
When pregnancy is detected, discontinue the drug as soon as possible.
Small amounts of CAPOTRIL are excreted in human breast milk. Therefore, breast-feeding should be avoided.
In patients undergoing major surgery or during anaesthesia, CAPOTRIL may cause hypotension which can be corrected by volume expansion.
Drug Interactions
NSAIDs may reduce the effectiveness of CAPOTRIL.
If given with a diuretic (preferably thiazide - type), the dose of either agent is necessary to be reduced.
With K+ supplements, as serum K + level may be increased.
With other antihypertensive agents, as the hypotensive effect may be pronounced.
NSAIDs may reduce the effectiveness of CAPOTRIL.
If given with a diuretic (preferably thiazide - type), the dose of either agent is necessary to be reduced.
With K+ supplements, as serum K + level may be increased.
With other antihypertensive agents, as the hypotensive effect may be pronounced.
Contra_indications
A history of previous hypersensitivity to CAPOTRIL, bilateral renal artery stenosis and neutropenia, pregnancy, lactation.
A history of previous hypersensitivity to CAPOTRIL, bilateral renal artery stenosis and neutropenia, pregnancy, lactation.
Side effects
Headache, rash, dizziness, fatigue, malaise, taste alteration, gastric upset or diarrhoea and cough, hyperkalaemia, hyponatraemia.
Headache, rash, dizziness, fatigue, malaise, taste alteration, gastric upset or diarrhoea and cough, hyperkalaemia, hyponatraemia.
Presentation
CAPOTRIL 25 mg Tablets : Box of 2 blisters of 10 scored tablets each.
CAPOTRIL 25 mg Tablets : Box of 2 blisters of 10 scored tablets each.
CAPOTRIL 50 mg Tablets : Box of 2 blisters of 10 scored tablets each.
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