CAPTOPRIL

Captopril Oral Solution is available in two strengths 5mg/5ml and 25mg/5ml; For lower doses that include fractions of a mg, the 5mg/5ml product should be used. For higher doses the 25mg/5ml product is recommended. The following table provides a guide for using Captopril 5mg/5ml or Captopril 25mg/5ml for most common dose.

2mg captopril). 2mL (= 1mg captopril). • 30 mL measuring cup graduated in numbered increments of 5 mL (= 25mg captopril) and intermediate increments of 1mL (= 5mg captopril). 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.

1). A once-daily dosing regimen may be appropriate when concomitant antihypertensive medication such as thiazide diuretics is added. 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 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. 5 Elderly patients: as with other […]

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 Anorexia Hyperkalaemia, hypoglycemia Psychiatric disorders Sleep disorders Confusion, depression Nervous system disorders Taste impairment, dizziness Drowsiness, headache and paraesthesia Cerebrovascular incidents, including stroke, and syncope Eye disorders Blurred vision Cardiac disorders Tachycardia or tachyarrhythmia, angina pectoris, Cardiac arrest, cardiogenic shock palpitations Vascular Disorders Hypotension, Raynaud syndrome, flush, pallor 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 Intestinal angioedema, Stomatitis/ aphthous ulcerations glossitis, peptic ulcer, pancreatitis Hepatobiliary disorders Impaired hepatic function and cholestasis (including jaundice), hepatitis including necrosis, elevated liver enzymes and bilirubin Skin and subcutaneous tissue disorders Pruritus with or without a rash, rash, and alopecia Angioedema Urticaria, Stevens Johnson syndrome, erythema multiforme, photosensitivity, erythroderma, pemphigoid reactions and exfoliative dermatitis Musculoskeletal and connective tissue disorders Myalgia, arthralgia Renal and urinary disorders Renal function disorders including renal failure, polyuria, oliguria, increased urine frequency Nephrotic syndrome Reproductive system and breast disorders Impotence, gynaecomastia Immune system disorders Insulin autoimmune syndrome General disorders and administration site conditions Chest pain, fatigue, malaise 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, positive ANA- titre, elevated ESR 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.

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.

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.

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. 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.

Routine monitoring of potassium and creatinine are part of normal medical practice for these patients. Hypersensitivity/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. 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. Black patients receiving ACE inhibitors have been reported to have a higher incidence of angioedema compared to non-blacks.

3 contraindications) 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). 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 risk of hypotension, hyperkalemia and decreased renal function (including acute renal failure). 1). If dual blockade therapy is considered absolutely necessary, this should only occur under specialist supervision and subject to frequent close monitoring of renal function, electrolytes and blood pressure.

” Hepatic failure: rarely, ACE inhibitors have been associated with a syndrome that starts with cholestatic jaundice and progresses to fulminant hepatic necrosis and (sometimes) death. The mechanism of this syndrome is not understood.

Patients receiving ACE inhibitors who develop jaundice or marked elevations of hepatic enzymes should discontinue the ACE inhibitor and receive appropriate medical follow-up. Hyperkalaemia: elevations in serum potassium have been observed in some patients treated with ACE inhibitors, including captopril.

g. heparin). If concomitant use of the above mentioned agents is deemed appropriate, regular monitoring of serum potassium is recommended. 5) Aortic and mitral valve stenosis / Obstructive hypertropic cardiomyopathy: ACE inhibitors should be used with caution in patients with left ventricular valvular and outflow tract obstruction and avoided in cases of cardiogenic shock and haemodynamically […]

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