Captopril STELLA 25 mg

Rx

Indications

– Hypertension.

– Congestive heart failure.

– Type I diabetic nephropathy.

– Myocardial infarction.

• Short-term (4 weeks) treatment: Captopril is indicated in any clinically stable patient within the first 24 hours of an infarction.
• Long-term prevention of symptomatic heart failure: Captopril is indicated in clinically stable patients with asymptomatic left ventricular dysfunction (ejection fraction ≤ 40%) following myocardial infarction to improve survival.

Dosage

Hypertension: Start with 25-50 mg daily in two divided doses. The dose may be increased incrementally, with intervals of at least 2 weeks, to 100-150 mg/day in two divided doses as needed to reach target blood pressure.

Patients with a strongly active renin-angiotensin-aldosterone system (hypovolaemia, renovascular hypertension, cardiac decompensation) commence with a single dose of 6.25 mg or 12.5 mg. These doses will then be used at a rate of two per day. The dosage can be gradually increased to 50 mg per day in one or two doses, if necessary to 100 mg per day in one or two doses.

Congestive heart failure: Start with 6.25 mg – 12.5 mg BID or TID. Titration to the maintenance dose should be carried out based on patient’s response, clinical status and tolerability, up to a maximum of 150 mg per day in divided doses. The dose should be increased incrementally, with intervals of at least 2 weeks to evaluate patient’s response.

Myocardial infarction:

• Short-term treatment: Treatment should begin in hospital as soon as possible. A 6.25 mg test dose should be administered, with a 12.5 mg dose being administered 2 hours afterwards and a 25 mg dose 12 hours later. From the following day, use dose of 100 mg/day, in two daily administrations, for 4 weeks, if warranted by the absence of adverse haemodynamic reactions. At the end of the 4 weeks of treatment, the patient’s state should be reassessed before a decision is taken concerning treatment for the post-myocardial infarction stage.
• Chronic treatment: If captopril treatment has not begun during the first 24 hours of the acute myocardial infarction stage, it is suggested that treatment be instigated between the 3rd and 16th day post-infarction once stable haemodynamics and management of any residual ischaemia have been attained. Initiate with a dose of 6.25 mg followed by 12.5 mg 3 times daily for 2 days and then 25 mg 3 times daily if warranted by the absence of adverse haemodynamic reactions. The recommended dose for effective cardio protection during long-term treatment is 75 to 150 mg daily in two or three doses.

Type I diabetic nephropathy: The recommended dose is 75 – 100 mg daily in divided doses.

Patients with renal impairment: The following daily dose may be recommended:

Elderly: Initiate with 6.25 mg BID.

Children and adolescents: Children > 20 kg: Start with 0.3 mg per kg body weight. Captopril is administered to children 3 times a day, but dose and interval of dose should be adapted individually according to patient’s response.

Usage

Captopril STELLA 25 mg is administered orally,  may be taken before, during and after meals.

• Hypersensitivity to captopril and other ACE inhibitors, or any of the excipients.
• History of angioedema associated with previous ACE inhibitor therapy.
• Hereditary or idiopathic angioneurotic oedema.
• Post-myocardial infarction (hemodynamic instability patients).
• Bilateral renal artery stenosis, unilateral renal artery stenosis in a solitary kidney.
• Pre-existing hypotension, aortic stenosis and severe obstructive cardiomyopathy.
• Pregnancy and lactation.
• Concomitant therapy with aliskiren-containing products in patients with diabetes mellitus or moderate and severe renal failure (GFR < 60 ml/min 1.73 m²).

• Sleep disorders.
• Reversible and self-limiting taste impairment and dizziness.
• Dry, irritating (non-productive) cough and dyspnoea.
• Nausea, vomiting, loss of taste (usually reversible on stopping treatment), abdominal pain, dry mouth, diarrhoea or constipation and gastric irritations.
• Pruritus with or without a rash, rash, and alopecia.

• Symptomatic hypotension is likely to occur in hypertensive patients who are volume and/or sodium depleted by vigorous diuretic therapy, dietary salt restriction, diarrhoea, vomiting or haemodialysis. Volume and/or sodium depletion should be corrected before the administration of an ACE inhibitor and a lower starting dose should be considered.
• There is an increased risk of hypotension and renal insufficiency when patients with bilateral renal artery stenosis or stenosis of the artery to a single functioning kidney are treated with ACE inhibitors.
• Patients with renal impairment should not normally be treated with captopril. Proteinuria may occur particularly in patients with existing renal function impairment or on relatively high doses of ACE inhibitors.
• Captopril should be used with caution in patients with left ventricular valvular and outflow tract obstruction.
• Angioedema of the extremities, face, lips, mucous membranes, tongue, glottis or larynx may occur particularly during the first weeks of treatment. Treatment should be discontinued promptly. Angioedema involving the tongue, glottis or larynx may be fatal. Emergency therapy should be instituted. The patient should be hospitalised and observed for at least 12 to 24 hours and should not be discharged until complete resolution of symptoms has occurred.
• Characteristically, the cough is non-productive, persistent and resolves after discontinuation of therapy.
• Dual blockade of RAAS through the combined use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren is therefore not recommended.
• Patients receiving ACE inhibitors who develop jaundice or marked elevations of hepatic enzymes should discontinue the ACE inhibitor and receive appropriate medical follow-up.
• Patients at risk for the development of hyperkalaemia include those with renal insufficiency, diabetes mellitus, or those using concomitant potassium-sparing diuretics, potassium supplements or potassium-containing salt substitutes; or those patients taking other drugs associated with increases in serum potassium (e.g. heparin). If concomitant use of the above mentioned agents is deemed appropriate, regular monitoring of serum potassium is recommended.
• The combination of lithium and captopril is not recommended.
• Anaphylactoid reactions during desensitisation were avoided when the ACE inhibitor was temporarily withheld, but they reappeared upon inadvertent rechallenge. Therefore caution should be used in patients treated with ACE inhibitors undergoing such desensitisation procedures.
• Combination of anaphylactoid reactions during high-flux dialysis / lipoprotein apheresis membrane exposure and captopril should be avoided. Consideration should be given to use a different type of dialysis, membrane or a different class of medication.
• The glycaemia levels should be closely monitored in diabetic patients previously treated with oral antidiabetic drugs or insulin, namely during the first month of treatment with an ACE inhibitor.
• Captopril should be used with extreme caution in patients with pre-existing impaired renal function, collagen vascular disease, immunosuppressant therapy, treatment with allopurinol or procainamide, or a combination of these complicating factors. During treatment all patients should be instructed to report any sign of infection (e.g. sore throat, fever), when a differential white blood cell count should be performed. Captopril and other concomitant medication should be withdrawn if neutropenia (neutrophils less than 1000/mm³) is detected or suspected. In most patients neutrophil counts rapidly returned to normal upon discontinuing captopril.
• In patients undergoing major surgery, or during anaesthesia with agents which produce hypotension, captopril will block angiotensin II formation secondary to compensatory renin release. This may lead to hypotension which can be corrected by volume expansion.
• Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
• Patients should be aware of how they react to drug before driving or operating machinery.