Captopril + hydrochlorothiazide

Concise Prescribing Info
Dosage/Direction for Use
Adult: PO Each tab contains captopril (mg)/hydrochlorothiazide (mg): 25/12.5, 25/15, 25/25, 50/15, or 20/25: As initial treatment or substituted for previously titrated doses of the individual components: Initial: 25 mg/15 mg once daily. Subsequent titrations may be with additional doses of individual components or as fixed combinations, if necessary. Dosage is individualised and adjusted according to patient response. Max: 150 mg captopril and 50 mg hydrochlorothiazide daily.
Should be taken on an empty stomach. Take on an empty stomach 1 hr before meals.
Hypersensitivity. History of angioedema related to previous ACE inhibitor treatment, hereditary or idiopathic angioneurotic oedema, anuria. Severe renal and hepatic impairment. Pregnancy. Concomitant use with aliskiren in patients with diabetes mellitus or renal impairment (GFR <60 mL/min/1.73 m2). Concomitant use with or within 36 hours of switching to or from sacubitril.
Special Precautions
Patient with volume and Na depletion, unstented unilateral/bilateral renal artery stenosis, aortic and mitral valve stenosis, hypertrophic cardiomyopathy with outflow obstruction, cardiogenic shock, CV disease (e.g. ischaemic heart disease, heart failure), cerebrovascular disease, collagen vascular disease, pre-diabetes or diabetes mellitus, parathyroid disease, hypercalcaemia, hypercholesterolaemia, SLE, liver cirrhosis, bronchial asthma. Patient undergoing major surgery or during anaesthesia, LDL apheresis with dextran sulfate cellulose, and desensitisation with hymenoptera venom. Black race. Elderly. Renal and hepatic impairment. Lactation. Patient Counselling This drug may cause dizziness, if affected, do not drive or operate machinery. Avoid or limit exposure to direct sunlight and UV light. Monitoring Parameters Monitor blood pressure, BUN, serum creatinine, serum electrolyte levels (e.g. Na, K); CBC with differential for the 1st 3 months of treatment and periodically thereafter. Assess skin for photosensitivity and skin cancer; signs and symptoms of angioedema; pregnancy status.
Adverse Reactions
Significant: Symptomatic hypotension with or without syncope, intestinal angioedema, electrolyte disturbances (e.g. hyperkalaemia, hypokalaemia, hypochloraemic alkalosis, hypomagnesaemia, hyponatraemia), cough, gout, haematologic effects (e.g. neutropenia, agranulocytosis, anaemia, thrombocytopenia), photosensitivity, ocular effects (e.g. acute transient myopia, acute angle-closure glaucoma), non-melanoma skin cancer (prolonged use), SLE exacerbation or activation, proteinuria, progressive azotaemia, decreased renal Ca excretion, increased cholesterol and triglycerides, impaired glucose tolerance. Blood and lymphatic system disorders: Lymphadenopathy, pancytopenia, eosinophilia. Cardiac disorders: Tachycardia, angina pectoris, palpitations. Ear and labyrinth disorders: Vertigo. Eye disorders: Blurred vision. Gastrointestinal disorders: Nausea, vomiting, dysgeusia, abdominal pain, diarrhoea, constipation, dry mouth, peptic ulcer. General disorders and administration site conditions: Fatigue, asthenia. Investigations: Increased BUN, serum creatinine, and liver transaminases. Metabolism and nutrition disorders: Anorexia. Musculoskeletal and connective tissue disorders: Rarely, myalgia, arthralgia. Nervous system disorders: Dizziness, headache, paraesthesia. Psychiatric disorders: Sleep disorders, depression. Reproductive system and breast disorders: Rarely, impotence, gynaecomastia. Respiratory, thoracic and mediastinal disorders: Dyspnoea, bronchospasm, rhinitis. Skin and subcutaneous tissue disorders: Pruritus, rash, alopecia. Rarely, erythema multiforme, pemphigoid reactions, and exfoliative dermatitis. Vascular disorders: Orthostatic hypotension.
Potentially Fatal: Angioneurotic oedema associated with laryngeal oedema. Rarely, cholestatic jaundice that may progress to fulminant hepatic necrosis; anaphylactoid reactions.
C D in 2nd & 3rd trimesters.
Drug Interactions
May increase antihypertensive effects with other diuretics, vasodilators, and nitrates. Increased risk of lithium toxicity. May reduce antihypertensive effects with NSAIDs. Captopril: Increased risk of hyperkalaemia with heparin, K-sparing diuretics, K supplements, or K-containing salt substitutes. May increase serum levels of digoxin. May decrease gastrointestinal absorption with antacids. May elevate serum concentrations with probenecid. May increase the hypoglycaemic effect of insulin and oral anti-diabetics. Increased risk of leucopenia with allopurinol, procainamide, and immunosuppressant agents. Hydrochlorothiazide: Increased risk of hypokalaemia with amphotericin B, carbenoxolone, corticosteroids, corticotropin, stimulant laxatives, and agents that induce torsades de pointes (e.g. digoxin, antiarrhythmics, antipsychotics). May cause hypercalcaemia with Ca salts. May decrease absorption with colestyramine and colestipol. May increase the effects of non-depolarising muscle relaxants (e.g. tubocurarine). May increase the risk of symptomatic hyponatremia with carbamazepine. Orthostatic hypotensive effects may be potentiated by barbiturates and narcotics.
ATC Classification
C09AA01 - captopril ; Belongs to the class of ACE inhibitors. Used in the treatment of cardiovascular disease.
C03AA03 - hydrochlorothiazide ; Belongs to the class of low-ceiling thiazide diuretics.
Disclaimer: This information is independently developed by CIMS based on captopril + hydrochlorothiazide from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to CIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, CIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2020 CIMS. All rights reserved. Powered by
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