altace fda label


The initial rapid decline, which represents distribution of the drug into a large peripheral compartment and subsequent binding to both plasma and tissue ACE, has a half-life of 2-4 hours. There were insufficient data to determine whether or not ramipril was equally effective in ethnic subgroups. In isolated cases, agranulocytosis, pancytopenia, and bone marrow depression may occur. Inhibition of ACE results in decreased plasma angiotensin II, which leads to decreased vasopressor activity and to decreased aldosterone secretion. ALTACE treatment usually can be continued following restoration of blood pressure and volume.Rarely, ACE inhibitors, including ALTACE, have been associated with a syndrome that starts with cholestatic jaundice and progresses to fulminant hepatic necrosis and (sometimes) death. Cerebrovascular disease was defined as stroke or transient ischemic attacks. In these rare cases, the mothers should be apprised of the potential hazards to their fetuses, and serial ultrasound examinations should be performed to assess the intraamniotic environment.If oligohydramnios is observed, ALTACE should be discontinued unless it is considered life-saving for the mother. Ramipril is converted to ramiprilat by hepatic cleavage of the ester group.Altace Tablets (ramipril) are supplied as tablets for oral administration containing 1.25 mg, 2.5 mg, 5 mg and 10 mg of ramipril. ALTACE — ramipril capsule Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC. This was a multinational (mainly European) 161-center, 2006-patient, double-blind, randomized, parallel-group study comparing ALTACE to placebo in stable patients, 2–9 days after an acute myocardial infarction (MI), who had shown clinical signs of congestive heart failure (CHF) at any time after the MI. Ramipril’s chemical name is (2Ramiprilat, the diacid metabolite of ramipril, is a non-sulfhydryl angiotensin converting enzyme inhibitor. Angiotensin II also stimulates aldosterone secretion by the adrenal cortex. The latter decrease may result in a small increase of serum potassium. Multiple oral doses of ramipril of 2.0 mg or more cause plasma ACE activity to fall by more than 90% 4 hours after dosing, with over 80% inhibition of ACE activity remaining 24 hours after dosing. In dogs, oral doses as high as 1 g/kg induced only mild gastrointestinal distress. Less than 2% of the administered dose is recovered in urine as unchanged ramipril.Blood concentrations of ramipril and ramiprilat increase with increased dose, but are not strictly dose-proportional. Ramipril is a 2-aza-bicyclo [3.3.0]-octane-3-carboxylic acid derivative. As these studies were carried out before the relationship of cough to ACE inhibitors was recognized, some of these events may represent ramipril-induced cough. (See ALTACE Tablets are contraindicated in patients who are hypersensitive to this product or any other angiotensin converting enzyme inhibitor (e.g., a patient who has experienced angioedema during therapy with any other ACE inhibitor).Presumably because angiotensin-converting enzyme inhibitors affect the metabolism of eicosanoids and polypeptides, including endogenous bradykinin, patients receiving ACE inhibitors (including ALTACE) may be subject to a variety of adverse reactions, some of them serious.Patients with a history of angioedema unrelated to ACE inhibitor therapy may be at increased risk of angioedema while receiving an ACE inhibitor. Dosage should be adjusted according to the blood pressure response. ALTACE 5 mg tablets are supplied as red tablets in bottles of 100 (NDC 60793-502-01), bottles of 500 (NDC 60793-502-05), and Unit Dose packs of 100 (NDC 60793-502-56). Patients in severe (NYHA class IV) heart failure, patients with unstable angina, patients with heart failure of congenital or valvular etiology, and patients with contraindications to ACE inhibitors were all excluded. and up to a maximum dose of 2.5 mg b.i.d. After multiple daily doses of ramipril 5-10 mg, the half-life of ramiprilat concentrations within the therapeutic range was 13-17 hours.After once-daily dosing, steady-state plasma concentrations of ramiprilat are reached by the fourth dose. In such patients renal function should be monitored during the first few weeks of therapy. Available for Android and iOS devices. Some hypertensive patients with no apparent pre-existing renal vascular disease have developed increases in blood urea nitrogen and serum creatinine, usually minor and transient, especially when ALTACE has been given concomitantly with a diuretic. A study in rats with dosages as great as 500 mg/kg/day did not produce adverse effects on fertility.Pregnancy Categories C (first trimester) and D (second and third trimesters). Ramipril has been only rarely associated with hypotension in uncomplicated hypertensive patients. Compared to normal subjects, patients with creatinine clearance less than 40 mL/min/1.73 mIn patients with impaired liver function, the metabolism of ramipril to ramiprilat appears to be slowed, possibly because of diminished activity of hepatic esterases, and plasma ramipril levels in these patients are increased about 3-fold. Easy to read FDA package insert, drug facts, dosage and administration, and adverse effects for Altace (ramipril) Skip to: full site navigation. None of these increases required discontinuation of treatment. The size of each symbol is proportional to the number of patients in each group.

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