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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: Hypertension: The management of mild to moderate hypertension. In severe hypertension it should be used where standard therapy is ineffective or inappropriate. Congestive heart failure: Captopril is indicated for the treatment of congestive heart failure. The drug should be used together with diuretics and, when…
Verbatim from this product's MHRA label. Tap a section to expand.
4) and blood pressure response. The recommended maximum daily dose is 150mg.
Adults:
Hypertension: Treatment with captopril should be at the lowest effective dose which should be titrated according to the needs of the patient. 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 50mg per day in one or two doses and if necessary to 100mg per day in one or two doses.
Congestive heart failure:
Treatment with captopril for congestive 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).
Frequency is defined using the following convention: common (≥1/100, < 1/10), uncommon (≥ 1/1,000, < 1/100), rare (≥ 1/10,000, < 1/1,000) and very rare (< 1/10,000). 4), anaemia (including aplastic and haemolytic), thrombocytopenia, lymphadenopathy, eosinophilia, auto-immune disease and/or positive ANA- titres.
4) Psychiatric disorders: Common: insomnia Very rare: confusional state, depression.
Nervous system disorders:
Common: Dysguesia, reversible and self limiting taste impairment and dizziness Uncommon: headache, paraesthesia Rare: Somnolence Very rare: cerebrovascular accident, including stroke cerebrovascular insufficiency, syncope.
Eye disorder:
Very rare: blurred vision Cardiac disorders: Uncommon: tachycardia or tachyarrhythmia, arrhythmia, angina pectoris, palpitations. 4) and dyspnoea Very rare: bronchospasm, rhinitis, allergic alveolitis allergic/eosinophilic pneumonia Gastrointestinal disorders: Common: nausea, vomiting, epigastric discomfort, peptic ulcer, dyspepsia, loss of taste (usually reversible on stopping treatment), gastric irritations, abdominal pain, diarrhoea, constipation, dry mouth.
Rare:
Weight loss and loss of appetite, stomatitis, resembling aphthous ulcers, intestinal angioedema, mouth ulcers Very rare: glossitis, pancreatitis.
Hepato-biliary disorders:
Very rare: hepatic function abnormal, cholestasis (including jaundice) hepatitis including necrosis, hepatic enzyme increased, blood bilirubin increased, transaminase increased, blood alkaline phosphatase increased.
Skin and subcutaneous tissue disorders:
Pregnancy:
ACE inhibitors should not be initiated during pregnancy. Unless continued ACE inhibitor therapy is considered essential, patients planning pregnancy should be changed to alternative antihypertensive treatments which have an established safety profile for use in pregnancy.
6). 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.
1. 1. 2. History of angioedema associated with previous ACE inhibitor therapy. 3. Hereditary/idiopathic angioneurotic oedema. 4. 6) 5. 1) 6. 6). 7. Concomitant use with sacubitril/valsartan therapy. 5).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Captopril in United Kingdom.
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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 is 75-100mg in divided doses. e. diuretics, beta blockers, centrally acting agents or vasodilators if the reduction in blood pressure is inadequate with captopril alone.
Patients with 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. 3mg/kg body weight. 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 Captopril tablets may be taken before, during and after […]
Common: pruritus with or without a rash, rash, and alopecia. 4) Very rare: urticaria, Steven Johnson syndrome, erythema multiforme, photosensitivity reaction, erythroderma, pemphigoid and exfoliative dermatitis, psoriasis and psoriasiform dermatitis.
Musculoskeletal, connective tissue and bone 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: impotence, erectile dysfunction, gynaecomastia.
General disorders and administration site conditions:
Uncommon: chest pain, fatigue, malaise, asthenia Very rare: fever Investigations: Very rare: proteinuria, eosinophilia, increase of serum potassium, decrease of serum sodium, elevation of BUN, serum creatinine and serum bilirubin, decrease in haemoglobin, haematocrit, leucocytes, thrombocytes, positive antinuclear antibody (ANA) titre, elevated ESR.
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
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.
Renal impairment:
The incidence of adverse reactions to captopril is principally associated with renal function since the drug is excreted primarily by the kidney. 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.
The dose should not exceed that necessary for adequate control and should be reduced in patients with impaired renal function. Evaluation of the patient should include assessment of renal function (monitoring of potassium and creatinine) prior to initiation of therapy and at appropriate intervals thereafter.
Patients with renal impairment should not normally be treated with captopril. Hypersensitivity / 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. 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). 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). 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. swelling of the […]