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CAPTOPRIL is a brand name for Captopril. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Captopril oral solution is indicated for: Hypertension: the treatment of essential hypertension. Heart Failure: for the treatment of chronic heart failure. Myocardial Infarction: - short-term (4 weeks) treatment: Captopril Oral Solution is indicated in any clinically stable patient within the first 24 hours of an…
Verbatim from this product's MHRA label. Tap a section to expand.
4) and blood pressure response. The recommended maximum daily dose is 150 mg. Captopril oral solution may be taken before, during and after meals. Hypertension: the recommended starting dose is 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.
Captopril oral solution may be used alone or with other antihypertensive agents, especially thiazide diuretics. 1). 5 mg. The inauguration of this treatment should preferably take place under close medical supervision. These doses will then be administered at a rate of two per day.
The dosage can be gradually increased to 50 mg per day in one or two doses and if necessary to 100 mg per day in one or two doses. Heart failure: treatment with captopril for heart failure should be initiated under close medical supervision.
5 mg BID or TID. Titration to the maintenance dose (75 - 150 mg per day) 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:
Captopril treatment should begin in hospital as soon as possible following the appearance of the signs and/or symptoms in patients with stable haemodynamics. 5 mg dose being administered 2 hours afterwards and a 25 mg dose 12 hours later.
From the following day, captopril should be administered in a 100 mg/day dose, 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 the necessary treatment conditions have been attained (stable haemodynamics and management of any residual ischaemia).
Treatment should be started in hospital under strict surveillance (particularly of blood pressure) until the 75 mg dose is reached. 4), particularly if the patient exhibits normal or low blood pressure at the initiation of therapy. 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 table below lists adverse reactions reported with Captopril, ranked under the following frequency classification: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).
Within each frequency, adverse reactions are presented in order of decreasing seriousness. Table 1. Adverse reactions with Captopril in clinical trials and post-marketing experience Frequency System organ class Common Uncommon Rare Very rare Not Known Blood and lymphatic system disorders Neutropenia/ agranulocytosis, pancytopenia particularly in patients with renal dysfunction, anaemia (including aplastic and haemolytic), thrombocytopenia, lymphadenopathy, eosinophilia, auto- immune diseases and/or positive ANA-titres Metabolism and nutrition disorders Decreased appetite Hyperkalaemia, hyponatremia, hypoglycemia Psychiatric disorders Sleep disorders Confusion, depression Nervous system disorders Taste impairment, dizziness Headache, paraesthesia Drowsiness Cerebrovascular accident, cerebrovascular insufficiency, syncope Eye disorders Blurred vision Cardiac disorders Tachycardia or arrhythmia, angina pectoris, palpitations Cardiac arrest, cardiogenic shock Vascular Disorders Hypotension, Raynaud syndrome, flush, pallor, orthostatic hypotension Frequency System organ class Common Uncommon Rare Very rare Not Known Respiratory, thoracic and mediastinal disorders Dry, irritating (non- productive) cough and dyspnoea Bronchospasm, rhinitis, allergic alveolitis/ eosinophilic pneumonia Gastrointestinal disorders Nausea, vomiting, gastric irritations, abdominal pain, diarrhoea, constipation, dry mouth, peptic ulcer, dyspepsia Intestinal angioedema, Stomatitis/ aphthous stomatitis glossitis, pancreatitis Hepatobiliary disorders Hepatic function abnormal, cholestasis, jaundice, hepatitis, hepatic necrosis, elevated liver enzymes and blood bilirubin, transaminase increase, blood alkaline phosphatase increase Skin and subcutaneous tissue disorders Pruritus with or without a rash, rash, and alopecia Angioedema Urticaria, Stevens Johnson syndrome, erythema multiforme, photosensitivity reaction, erythroderma multiforme, pemphigoid reactions and exfoliative dermatitis Frequency System organ class Common Uncommon Rare Very rare Not Known Musculoskeletal and connective tissue disorders Myalgia, arthralgia Renal and urinary disorders Renal impairment, renal failure, polyuria, oliguria, increased urine frequency (pollakiuria) Nephrotic syndrome Reproductive system and breast disorders Impotence, gynaecomastia General disorders and administration site conditions Chest pain, fatigue, malaise, asthenia Fever Investigations Proteinuria, eosinophilia, increase of serum potassium, decrease of serum sodium, elevation of BUN, serum creatinine and serum bilirubin, decreases in haemoglobin, haematocrit, leucocytes, thrombocytes and platelet count, positive ANA- titre, elevated ESR Immune System Disorders Insulin autoimmune syndrome Paediatric Population The major adverse events seen in the paediatric population were persistent dry cough, hyperkalemia, angioedema, decreased GFR, hypotension, neutropenia, impaired hepatic function and renal disorders.
Hypotension Rarely, hypotension is observed in uncomplicated hypertensive patients. Symptomatic hypotension is more 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. Patients with heart failure are at higher risk of hypotension and a lower starting dose is recommended when initiating therapy with an ACE inhibitor.
The magnitude of the decrease is greatest early in the course of treatment; this effect stabilises within a week or two, and generally returns to pre-treatment levels, without a decrease in therapeutic efficacy, within two months. Caution should be used whenever the dose of captopril or diuretic is increased in patients with heart failure.
As with any antihypertensive agent, excessive blood pressure lowering in patients with ischaemic cardiovascular or cerebrovascular disease may increase the risk of myocardial infarction or stroke. If hypotension develops, the patient should be placed in a supine position.
Volume repletion with intravenous normal saline may be required. Infants, especially new-borns, may be more susceptible to the adverse haemodynamic effects of captopril. Excessive, prolonged and unpredictable decreases in blood pressure and associated complications, including oliguria and seizures have been reported.
Renovascular hypertension 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.
Loss of renal function may occur with only mild changes in serum creatinine. In these patients, therapy should be initiated under close medical supervision with low doses, careful titration and monitoring of renal function. 2), and then as a function of the patient's response to treatment.
6). - Use in patients with aortic stenosis or outflow tract obstruction. - Use in patients with bilateral renal artery stenosis in a single functioning kidney. 1). - Concomitant use with sacubitril/valsartan therapy. 5).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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The recommended dose for effective cardioprotection during long-term treatment is 75 to 150 mg daily in two or three doses. In cases of symptomatic hypotension, as in heart failure, the dosage of diuretics and/or other concomitant vasodilators may be reduced in order to attain the steady state dose of captopril.
Where necessary, the dose of captopril should be adjusted in accordance with the patient's clinical reactions. Captopril may be used in combination with other treatments for myocardial infarction such as thrombolytic agents, beta-blockers and acetylsalicylic acid.
Type I Diabetic nephropathy: in patients with type I diabetic nephropathy, the recommended daily dose of captopril is 75-100 mg in divided doses. If additional lowering of blood pressure is desired, additional antihypertensive medications may be added.
Renal impairment: since captopril is excreted primarily via the kidneys, dosage should be reduced or the dosage interval should be increased in patients with impaired renal function. g. furosemide), rather than a thiazide diuretic, is preferred in patients with severe renal impairment.
In patients with impaired renal function, the following daily dose may be recommended to avoid accumulation of captopril. 4). Dosage should be titrated against the blood pressure response and kept as low as possible to achieve adequate control.
Paediatric Population The efficacy and safety of captopril have not been fully established. The use of captopril in children and adolescents should be initiated under close medical supervision. 3 mg/kg body weight to be divided in 3 equal doses daily.
15 mg captopril/kg weight. Generally, captopril is administered to children 3 times a day, but dose and interval of dose should be adapted individually according to patient's response. Method of administration For oral use only
The reactions most frequently observed during captopril therapy were headache, tachycardia, vomiting, postural symptoms, anaemia, rash and anorexia. 4 Special Warnings and Precautions for use, Paediatric Population). 4 Special Warnings and Precautions for use, Paediatric Population).
Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
Routine monitoring of potassium and creatinine are part of normal medical practice for these patients. Angioedema Angioneurotic oedema of the extremities, face, lips, mucous membranes, tongue, glottis and/or larynx may occur in patients treated with ACE inhibitors particularly during the first week of treatment.
However, in rare cases, severe angioedema may develop after months or years of long-term treatment with an ACE inhibitor. In such cases, Captopril should be discontinued promptly and appropriate monitoring should be instituted to ensure complete resolution of symptoms prior to dismissing the patient.
In those instances where swelling has been confined to the face and lips the condition generally resolved without treatment, although antihistamines have been useful in relieving symptoms. Angioedema involving the tongue, glottis or larynx may be fatal.
Emergency therapy should be instituted. 5 ml) and/or measures to ensure a patient airway, should be administered promptly. 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.
Black patients receiving ACE inhibitors have been reported to have a higher incidence of angioedema compared to non-blacks. 3 contraindications) Intestinal angioedema: Intestinal angioedema has also been reported very rarely in patients treated with ACE inhibitors.
These patients presented with abdominal pain (with or without nausea or vomiting); in some cases there was no prior facial angioedema and C-1 esterase levels were normal. The angioedema was diagnosed by procedures including abdominal CT scan, or ultrasound or at surgery and symptoms resolved after stopping the ACE inhibitor.
8 undesirable effects).
Hypersensitivity/angioedema:
Concomitant use of ACE inhibitors with sacubitril/valsartan is contraindicated due to the increased risk of angioedema. Treatment with sacubitril/valsartan must not be initiated earlier than 36 hours after the last dose of captopril.
5). g. g. 5). g. sirolimus, everolimus, temsirolimus) and vildagliptin in a patient already taking an ACE inhibitor. 8). If IAS is suspected, captopril should be discontinued, and appropriate treatment should be initiated. Cough Cough has been reported with the use of ACE inhibitors.
Characteristically, the cough is non-productive, persistent and resolves after discontinuation of therapy. Dual blockade of the renin-angiotensin-aldosterone system (RAAS) There is evidence that the concomitant use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren increases the […]