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Indications:

Hypertension: this medicine is indicated for the treatment of hypertension. Heart Failure: this medicine is indicated for the treatment of chronic heart failure with reduction of systolic ventricular function, in combination with diuretics and when appropriate, digitalis and beta-blockers. Myocardial Infarction: -Short -term (4 weeks) treatment: this medicine is indicated in any clinically stable patients within the first 24 hours of an infarction. -Long term prevention of symptomatic heart failure: this medicine is indicated in clinically stable patients with asymptomatic left ventricular dysfunction (ejection fraction <40%). Type I Diabetic Nephropathy: this medicine is indicated for the treatment of macroproteinuric diabetic nephropathy in patients with type I diabetes. (See section 5.1, Pharmacodynamic properties).

Contraindications:

A history of previous hypersensitivity to any ingredients of the product. Use in patients with aortic stenosis or outflow tract obstruction. Use in patients with bilateral renal artery stenosis in a single functioning kidney. Use in patients with a history of anfioneurotic oedema relating to previous treatment with an ACE inhibitor. Pregnancy: Capoten has been shown to be lethal to rabbit and sheep foetuses. There were no foetotoxic effects to hamster or rat foetuses. Capoten is contraindicatied in pregnancy and should not be used in women of child bearing potential unless protected by effective contraception. Exposure of the mother in the second and third trimester of pregnancy has been associated with oligohydramnios and neonatal hypertension and/or anuria.

Adverse reactions:

Undesirable effects reported for captopril and/or ACE inhibitor include: Blood and lymphatic disorders: Very Rare: neutropenia/agranulocytosis (see section 4.4, Special warnings and precautions for use), pancytopenia particularly in patients with renal dysfunction (see section 4.4, Special warnings and precautions for use), anaemia (including aplastic and haemolytic), thrombocytopenia, lymphadenopathy, eosinophilia, auto-immune diseases and/or positive ANA-titres. Metabolism and nutrition disorders: Rare: Anorexia Very Rare: Hyperkalaemia, hypoglycaemia (see section 4.4, Special warnings and precautions for use) Psychiatric disorders: Common: Sleep disorders. Very Rare: Confusion, depression. Nervous system disorders: Common: Taste impairment, dizziness. Rare: Drowsiness, headache and paraesthesia. Very Rare: Cerebrovascular incidents, including stroke, and syncope. Eye disorders: Very Rare: Blurred vision. Cardiac disorders: Uncommon: Tachycardia or tachyarrhythmia, angina pectoris, palpitations. Very Rare: Cardiac arrest, cardiogenic shock. Vascular disorders Uncommon: Hypotension (see section 4.4, Special warnings and precautions for use), Raynaud syndrome, flush, pallor. Respiratory, thoracic and mediastinal disorders: Common: Dry, irritating (non productive) cough (see section 4.4, Special warnings and precautions for use) and dyspnoea. Very Rare: Bronchospasm, rhinitis, allergic alveolitis / eosinophilic pneumonia. Gastrointestinal disorders: Common: Nausea, vomiting, gastric irritations, abdominal pain, diarrhoea, constipation, dry mouth. Rare: Stomatitis/aphthous ulcerations. Very Rare: Glossitis, peptic ulcer, pancreatitis. Hepato-biliary disorders: Very Rare: Impaired hepatic function and cholestasis. (including jaundice), hepatitis including necrosis, elevated liver enzymes and bilirubin. Skin and subcutaneous tissue disorders: Common: Pruritus with or without a rash, rash and alopecia. Uncommon: Angioedema (see section 4.4, Special warnings and precautions for use) Very Rare: Urticaria, Stevens Johnson syndrome, erythema multiforme, photosensitivity, erythroderma, pemphigoid reactions and exfoliative dermatitis. Musculoskeletal, connective tissue and bone disorders: Very rare: Myalgia, arthralgia. Renal and urinary disorders: Rare: Renal function disorders including renal failure, polyuria, oliguria, increased urine frequency. Very Rare: Nephrotic syndrome. Reproductive system and breast disorders: Very Rare: Impotence, gynaecomastia. General disorders: Uncommon: Chest pain, fatigue, malaise. Very Rare: Fever Investigations: Very Rare: 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 ANAtitre, elevated ESR. Intestinal angioedema has also been reported very rarely in patients with ACE inhibitors and should be included in the differential diagnosis of patients on ACE inhibitors presenting with abdominal pain.

Interactions:

Potassium sparing diuretics or potassium supplements: ACE inhibitors attenuate diuretic induced potassium loss. Potassium sparing diuretics (e.g. spironolactone, triamterene or amiloride), potassium supplements, or potassium-containing salt substitutes may lead to significant increases in serum potassium. If concomitant use is indicated because of demonstrated hypokalaemia they should be used with caution and with frequent monitoring of serum potassium (see section 4.4, Special warnings and precautions for use). Diuretics (Thiazide or loop Diuretics) Prior treatment with high dose diuretics may result in volume depletion and a risk of hypotension when initiating therapy with captopril (see section 4.4, Special warnings and precautions for use) The hypotensive effects can be reduced by discontinuation of the diuretic, by increasing volume or salt intake or by initiating therapy with a low dose of captopril. However, no clinically significant drug interactions have been found in specific studies with hydrochlorothiazide or furosemide. Other antihypertensive agents: Captopril has been safely co-administered with other commonly used anti-hypertensive agents (e.g. beta-blockers and long-acting calcium channel blockers). Concomitant use of these agents may increase the hypotensive effects of captopril. Treatment with nitroglycerine and other nitrates, or other vasodilators, should be used with caution. Treatments of acute myocardial infarction: Captopril may be used concomitantly with acetylsalicylic acid (at cardiologic doses), thrombolytics, beta-blockers and/or nitrates in patients with myocardial infarction. Lithium: Reversible increases in serum lithium concentrations and toxicity have been reported during concomitant administration of lithium with ACE inhibitors. Concomitant use of thiazide diuretics may increase the risk of lithium toxicity and enhance the already increased risk of lithium toxicity with ACE inhibitors. Use of captopril with lithium is not recommended, but if the combination proves necessary, careful monitoring of serum lithium levels should be performed (see section 4.4, Special warnings and precautions for use). Tricyclic antidepressants / Antipsychotics: ACE inhibitors may enhance the hypotensive effects of certain tricyclic antidepressants and antipsyschotics (see section 4.4, Special warnings and precautions for use) Postural hypotension may occur. Allopurinol, procainamide, cytostatic or immuno-suppressive agents: Concomitant administration with ACE inhibitors may lead to an increased risk for leucopenia especially when the latter are used at a higher than currently recommended doses. Non-steroidal anti-inflammatory medicinal products: It has been described that non-steroidal anti-inflammatory medicinal products (NSAIDs) and ACE inhibitors exert an additive effect on the increase in serum potassium whereas renal function may decrease. These effects are in principle, reversible. Rarely, acute renal failure may occur, particularly in patients with compromised renal function such as the elderly or dehydrated. Chronic administration of NSAIDs may reduce the antihypertensive effect of an ACE inhibitor. Sympathomimetics: May reduce the antihypertensive effects of ACE inhibitors; patients should be carefully monitored. Antidiabetics: Pharmacological studies have shown that ACE inhibitors, including captopril, can potentiate the blood glucose reducing effects of insulin and oral antidiabetics such as sulphonylurea in diabetics. Should this very rare interaction occur, it may be necessary to reduce the dose of antidiabetic during simultaneous treatment with ACE inhibitors. Clinical Chemistry: Captopril may cause a false-positive urine test for acetone.

Warnings:

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 a high 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. Renal impairment: In cases of renal impairment (creatinine clearance < 40ml/min), the initial dosage of captopril must be adjusted according to the patient’s creatinine clearance (see section 4.2, Posology and method of administration), 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 particularly during the first weeks of treatment. However, in rare cases, severe angioedema may develop after 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. 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. Patients at risk for the development of hyperkalaemia include those with renal insufficiency, diabetes mellitus, or those using concomitant potassium-sparing diuretics, potassium supplements or potassium-containing salt substitutes; or those patients taking other drugs associated with increases in serum potassium (e.g. heparin). If concomitant use of the above mentioned agents is deemed appropriate, regular monitoring of serum potassium is recommended. Lithium: The combination of lithium and captopril is not recommended (see section 4.5, Interaction with other medicinal products and other forms of interaction). Aortic and mitral valve stenos/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 significant obstruction. Neutropenia/Agranulocytosis: Neutropenia/agranulocytosis, thrombocytopenia and anaemia have been reported in patients receiving ACE inhibitors, including captopril. In patients with normal renal function and no other complicating factors, neutropenia occurs rarely. Captopril should be used with extreme caution in patients with collagen vascular disease, immunosuppressant therapy, treatment with allopurinol or procainamide, or a combination of these complicating factors, especially if there is a pre-existing impaired renal function. Some of these patients developed serious infections which in a few instances did not respond to intensive antibiotic therapy. If captopril is used in such patients, it is advised that white blood cell count and differential counts should be performed prior to therapy, every 2 weeks during the first 3 months of captopril therapy, and periodically thereafter. During treatment all patients should be instructed to report any sign of infection (e.g. sore throat, fever) when a differential white blood cell count should be performed. Captopril and other concomitant medication (see section 4.5, Interaction with other medicinal products and other forms of interaction) should be withdrawn if neutropenia (neutrophils less than 1000/mm3) is detected or suspected. In most patients neutrophil counts rapidly return to normal upon discontinuing captopril. Proteinuria: Proteinuria may occur particularly in patients with existing renal function impairment or on relatively high doses of ACE inhibitors. Total urinary proteins greater than 1 g per day were seen in about 0.7% of patients receiving captopril. The majority of patients had evidence of prior renal disease or had received relatively high doses of captopril (in excess of 150 mg/day), or both. Nephrotic syndrome occurred in about one-fifth of proteinuric patients. In most cases, proteinuria subsided or cleared within six months whether or not captopril was continued. Parameters of renal function, such as BUN and creatinine, were seldom altered in the patients with proteinuria. Patients with prior renal disease should have urinary protein estimations (dip-stick on first morning urine) prior to treatment, and periodically thereafter. Anaphylactoid reactions during desensitisation: Sustained life-threatening anaphylactoid reactions have been rarely reported for patients undergoing desensitising treatment with hymenoptera venom while receiving another ACE inhibitor. In the same patients, these reactions were avoided when the ACE inhibitor was temporarily withheld, but they reappeared upon inadvertent rechallenge. Therefore, caution should be used in patients treated with ACE inhibitors undergoing such desensitisation procedures. Anaphylactoid reactions during high-flux dialysis/lipoprotein apheresis membrane exposure: Anaphylactoid reactions have been reported in patients haemodialysed with high-flux dialysis membranes or undergoing low-density lipoprotein apheresis with dextran sulphate absorption. In these patients, consideration should be given to using a different type of dialysis; membrane or a different class of medication. Surgery/Anesthesia: Hypotension may occur in patients undergoing major surgery or during treatment with anaesthetic agents that are known to lower blood pressure. If hypotension occurs, it may be corrected by volume expansion. Diabetic patients: The glycaemia levels should be closely monitored in diabetic patients previously treated with oral antidiabetic drugs or insulin, namely during the first month of treatment with an ACE inhibitor. Lactose: this medicine contains lactose, therefore it should not be used in cases of congenital galactosaemia, glucose and galactose malabsorption or lactase deficiency syndromes (rare metabolic diseases). Ethnic differences: As with other angiotensin converting enzyme inhibitors, captopril is apparently less effective in lowering blood pressure in black people than in non-blacks, possibly because of a higher prevalence of low-renin states in the black hypertensive population.

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Consultants Corner

Dr . Dirar Abboud

Dr . Dirar Abboud Hepatologist – Gastroenterologist

Dr. Samer Al-Jneidy

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Samir Moussa M.D.

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