P : Contraindicated in pregnancy
L : Contraindicated in lactation
|| See TERMINOLOGY & ABBREVIATIONS ||
|Indication(s) & Dosage||HYPERTENSION
Adult: Initially, 10 mg orally once daily at bedtime. Maintenance: 10-40 mg once daily. In patients on diuretic therapy, diuretic should be withdrawn, if possible, a few days before starting fosinopril and restarted later if needed.
Adult: Initially, 10 mg orally once daily. May increase gradually. Max: 40 mg once daily. For patients at high risk of hypotension, 5 mg once daily may be given as an initial dose.
Special Populations: For patients with moderate to severe renal failure, 5 mg once daily.
|Administration||Should be taken on an empty stomach. Best taken 1 hr before meals. May be taken w/ meals to reduce GI discomfort.
|Contraindications||Hypersensitivity, idiopathic or hereditary angioedema, history of angioedema related to previous treatment with an ACE inhibitor. Bilateral renal artery stenosis. Pregnancy (2nd and 3rd trimesters), lactation.|
|Special Precautions||Severely impaired renal function; hyperkalaemia, hypovolaemia, collagen vascular diseases, valvular stenosis; before, during or immediately after anaesthesia, unilateral renal artery stenosis.|
|Adverse Drug Reaction(s)||Dizziness, orthostatic hypotension, palpitation, headache, weakness, fatigue, hyperkalaemia, chest pain, musculoskeletal pain, dry cough, nausea, vomiting, dyspepsia, diarrhoea.
Potentially Fatal: Cerebrovascular accident, rhythm disturbances, palpitations, hypotension, syncope, rashes, oedema, hypersensitivity reactions, angioedema.
|Drug Interactions||Co-admin with diuretics may cause an excessive reduction of BP. Antacids may impair absorption of fosinopril.
Potentially Fatal: Potassium loss caused by potassium-sparing diuretics or potassium supplements can increase the risk of hyperkalaemia. Increased serum lithium levels and toxicity.
|Lab Interference||False-positive Coombs' test and urine-acetone determination. False low measurement of serum digoxin levels with some laboratory kits.|
|Pregnancy Category (FDA)||
Category C: Either studies in animals have revealed adverse effects on the foetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the foetus.
Category D: There is positive evidence of human foetal risk, but the benefits from use in pregnant women may be acceptable despite the risk (e.g., if the drug is needed in a life-threatening situation or for a serious disease for which safer drugs cannot be used or are ineffective).
|Storage||Oral: Store at 20-25Â°C.|
|Pharmacology||Fosinopril competitively inhibits ACE from converting angiotensin I to angiotensin II resulting in decreased levels of angiotensin II which causes increased plasma renin activity and reduced aldosterone secretion. It also reduces sodium and water retention. By these mechanisms, fosinopril produces hypotensive effect.
Absorption: 36% is absorbed from the GI tract (oral); peak plasma concentrations after 3 hr (fosinoprilat).
Distribution: Protein-binding: >95% (fosinoprilat).
Metabolism: Rapidly and completely hydrolysed to fosinoprilat (active metabolite) in GI mucosa and liver.
Excretion: Urine and faeces. Elimination half-life: 11.5 hr (hypertensive patients), 14 hr (patients with heart failure).
|ATC Classification||C09AA09 - fosinopril; Belongs to the class of ACE inhibitors. Used in the treatment of cardiovascular disease.|
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