Adult: As adjunctive therapy to conventional treatment including diuretics: Initially, 10 mg once daily. If the initial dose is tolerated, dosage may be increased according to patient response up to Max 40 mg once daily.
Adult: As monotherapy or in combination with other antihypertensive agents: Initially, 10 mg once daily. Dosage is individualised and adjusted according to patient response up to Max 40 mg once daily.
Special Patient Group
Patients taking diuretics: Initially, 10 mg once daily. If possible, discontinue the diuretic for several days (e.g. 2-3 days) before initiating therapy with fosinopril. Dosage recommendations may vary among countries or individual products, refer to specific product guidelines.
Moderate to severe: Initially, 5 mg once daily.
Should be taken on an empty stomach. Best taken 1 hr before meals. May be taken w/ meals to reduce GI discomfort.
History of angioedema related to previous ACE inhibitor treatment, hereditary or idiopathic angioedema, ascites due to cirrhosis or refractory ascites. Concomitant use with aliskiren in patients with diabetes mellitus or renal impairment. Concomitant use and within 36 hours of discontinuation of sacubtril/valsartan. Pregnancy and lactation.
Patient with aortic or mitral valve stenosis, ischaemic heart disease or cerebrovascular disease, left ventricular outflow tract obstruction, hypertrophic cardiomyopathy; collagen vascular disease, diabetes. Patient undergoing desensitisation treatment (e.g. hymenoptera venom); major surgery or during anaesthesia. Black race. Renal and hepatic impairment.
Significant: Hypersensitivity reactions (e.g. anaphylactic reactions), symptomatic hypotension (with or without syncope), hyperkalaemia, cough. Rarely, agranulocytosis and bone marrow suppression. Cardiac disorders: Tachycardia, arrhythmia, palpitation, angina pectoris. Eye disorders: Eye disorder, visual disturbances. Gastrointestinal disorders: Nausea, vomiting, diarrhoea, abdominal pain, dyspepsia, dysgeusia. General disorders and administration site conditions: Chest pain (non-cardiac), fatigue, oedema, asthenia. Infections and infestations: Viral infection. Investigations: Increased alkaline phosphatase, bilirubin, LDH, and transaminases. Musculoskeletal and connective tissue disorders: Musculoskeletal pain, myalgia. Nervous system disorders: Dizziness, headache, paraesthesia. Psychiatric disorders: Mood alteration, sleep disorder. Renal and urinary disorders: Micturition disorder. Reproductive system and breast disorders: Sexual dysfunction. Respiratory, thoracic and mediastinal disorders: Upper respiratory tract infection, pharyngitis, rhinitis, sinus disorder. Skin and subcutaneous tissue disorders: Rash, dermatitis. Potentially Fatal: Angioedema. Rarely, fulminant hepatic necrosis, severe hypotension.
This drug may cause dizziness or vertigo; if affected, do not drive or operate machinery.
Monitor renal function prior to treatment initiation; blood pressure; BUN, serum creatinine, electrolytes (e.g. serum K), and CBC with differential (particularly for patients with renal impairment or collagen vascular disease). Assess the risk for airway obstruction if angioedema is suspected.
Symptoms: dizziness, anxiety, cough, severe hypotension, circulatory shock, electrolyte imbalances, renal failure, hyperventilation, tachycardia, bradycardia, palpitations. Management: Supportive and symptomatic treatment. Administer activated charcoal and Na sulfate, perform gastric lavage if it is within 30 minutes of ingestion. Administer 0.9% NaCl via IV infusion. Monitor electrolytes and creatinine as necessary. For hypotension, place patient in shock position, and administer salt and volume supplementation rapidly. May administer atropine for bradycardia or extensive vagal reactions.
Enhanced antihypertensive effect with other antihypertensive agents, diuretics, or nitrates. May increase serum levels and toxicity of lithium. Concomitant use with NSAIDs including selective COX-2 inhibitors may result in renal function deterioration and decreased antihypertensive effect. May enhance the antihypertensive effect with TCAs and antidepressants. Increased risk of hyperkalaemia with ciclosporin, heparin, trimethoprim, K-sparing diuretics, K-containing salt substitutes, and K supplements. May enhance the glucose-lowering effect of insulin and oral hypoglycaemic agents; may increase the risk of hypoglycaemia. Reduced antihypertensive effect with indomethacin. May impair the absorption with antacids. Increased risk of angioedema with racecadotril, vildagliptin, and mammalian target of rapamycin (mTOR) inhibitors (e.g. sirolimus, everolimus). May increase the risk of leucopenia with immunosuppressants (e.g. azathioprine). Potentially Fatal: Increased risk of hypotension, hyperkalaemia, and decreased renal function with aliskiren. Increased risk of angioedema with sacubitril/valsartan.
Enhanced hypotensive effect with alcohol.
May cause false low serum digoxin levels with assays using the charcoal absorption method for digoxin. May cause a false-negative aldosterone/renin ratio.
Description: Fosinopril is a prodrug of fosinoprilat which competitively inhibits ACE from converting angiotensin I to angiotensin II. Decreased levels of angiotensin II results in increased plasma renin activity, reduced vasoconstriction, and a decrease in aldosterone secretion. Onset: 1 hour. Duration: 24 hours. Pharmacokinetics: Absorption: Absorbed from the gastrointestinal tract. Bioavailability: 36%. Time to peak plasma concentration: Approx 3 hours (fosinoprilat). Distribution: Crosses the placenta and enters breast milk (fosinoprilat). Plasma protein binding: >95% (fosinoprilat). Metabolism: Rapidly and completely hydrolysed to fosinoprilat (active metabolite) in both the gastrointestinal mucosa and liver. Excretion: Via urine and faeces (as fosinoprilat and other metabolites in approx equal portions). Elimination half-life: Approx 11.5 hours (hypertensive patients); approx 14 hours (patients with heart failure).