CAPTOPRIL

4) and blood pressure response. The recommended maximum daily dose is 150mg. Captopril may be taken before, during and after meals.

Hypertension:

The recommended starting dose is 25-50mg daily in two divided doses. The dose may be increased incrementally, with intervals of at least 2 weeks, to 100-150mg/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.

5mg. 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 50mg per day in one or two doses and if necessary to 100mg per day in one or two doses.

Heart failure:

Treatment with captopril for heart failure should be initiated under close medical supervision. 5mg BID or TID. Titration to the maintenance dose (75 - 150mg per day) should be carried out based on patient's response, clinical status and tolerability, up to a maximum of 150mg 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. 5mg dose being administered 2 hours afterwards and a 25mg dose 12 hours later.

From the following day, captopril should be administered in a 100mg/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 75mg dose is reached. 4), particularly if the patient exhibits normal or low blood pressure at the initiation of therapy. 5mg 3 times daily for 2 days and then 25mg 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 150mg 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 75-100mg 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. 25mg BID) in elderly patients who may have reduced renal function and other organ dysfunctions. 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. 3mg/kg body weight. 15mg 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 administration only. Precautions to be taken before handling or administering the medicinal product. If necessary, captopril solution can be administered via a Polyurethane nasogastric feeding tube. 6.

Frequency is defined using the following convention: common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000) and very rare (< 1/10,000). 4), anaemia (including aplastic and haemolytic), thrombocytopenia, lymphadenopathy, eosinophilia, auto-immune disorder.

4) Psychiatric disorders: Common: insomnia Very rare: confusional state, depression Nervous system disorders: Common: dysgeusia dizziness Uncommon: headache, paraesthesia Rare: somnolence Very rare: cerebrovascular accident, cerebrovascular insufficiencysyncope Eye disorders: Very rare: vision blurred Cardiac disorders: Uncommon: tachycardia, arrhythmia, angina pectoris, palpitations.

4).

Very rare: glossitis, pancreatitis Hepatobiliary disorders:

Very rare: hepatic function abnormal, cholestasis, jaundice, hepatitis, hepatic necrosis, hepatic enzyme increased, blood bilirubin increased, transaminase increased, blood alkaline phosphatase increased. 4) Very rare: urticaria, Stevens Johnson syndrome, erythema multiforme, photosensitivity reaction, pemphigoid, dermatitis exfoliative.

Musculoskeletal, connective tissue disorders:

Very rare: myalgia, arthralgia Renal and urinary disorders: Rare: renal impairment, renal failure, polyuria, oliguria, pollakiuria.

Very rare: nephrotic syndrome Reproductive system and breast disorders:

Very rare: erectile dysfunction, gynaecomastia General disorders and administration site conditions: Uncommon: chest pain, fatigue, malaise, asthenia Very rare: pyrexia Investigations: Very rare: proteinuria, eosinophilia, blood potassium increased, blood sodium decreased, blood urea increased, blood creatinine increased, blood bilirubin increased, haemoglobin decreased, haematocrit decreased, white blood cell count decreased, platelet count decreased, antinuclear antibody positive, red blood cell sedimentation rate increased.

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.

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. Routine monitoring of potassium and creatinine are part of normal medical practice for these patients.

Angioedema:

Angioedema of the extremities, face, lips, mucous membranes, tongue, glottis or larynx may occur in patients treated with ACE inhibitors including captopril. This may occur anytime during treatment. However, in rare cases, severe angioedema may develop after 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. 5 ml) and/or measures to ensure a patent 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). Intestinal angioedema has also been reported 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).

Cough:

Cough has been reported with the use of ACE inhibitors. Characteristically, the cough is non-productive, persistent and resolves after discontinuation of therapy.

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, co-trimoxazole also known as trimethoprim/sulfamethoxazole). 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 […]

1 or any other ACE inhibitor. • History of angioedema associated with previous ACE inhibitor therapy. • Hereditary / idiopathic angioneurotic oedema. 6). 1).