(See Concomitant administration of ALTACE with potassium supplements, potassium salt substitutes, or potassium-sparing diuretics can lead to increases of serum potassium. The follow-up time was between 6 and 46 months for this study.Safety data in the HOPE trial were collected as reasons for discontinuation or temporary interruption of treatment. 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. The incidence of cough was similar to that seen in the AIRE trial. 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. Intestinal angioedema should be included in the differential diagnosis of patients on ACE inhibitors presenting with abdominal pain.In a large U.S. postmarketing study, angioedema (defined as reports of angio, face, larynx, tongue, or throat edema) was reported in 3/1523 (0.20%) of black patients and in 8/8680 (0.09%) of white patients. depending upon clinical response and tolerability.ALTACE is available in potencies of 1.25 mg, 2.5 mg, 5 mg, and 10 mg in tablets.ALTACE 1.25 mg tablets are supplied as white tablets in bottles of 100 (ALTACE 2.5 mg tablets are supplied as orange tablets in bottles of 100 (ALTACE 5 mg tablets are supplied as red tablets in bottles of 100 (ALTACE 10 mg tablets are supplied as blue tablets in bottles of 100 (Dispense in well-closed container with safety closure.Store at controlled room temperature, 20° to 25°C (68° to 77°F) with excursions permitted between 15° and 30°C (59° to 86°F).
Downloading FDA Package Insert for Altace capsule. The most likely clinical manifestations would be symptoms attributable to hypotension.Laboratory determinations of serum levels of ramipril and its metabolites are not widely available, and such determinations have, in any event, no established role in the management of ramipril overdose.No data are available to suggest physiological maneuvers (e.g., maneuvers to change the pH of the urine) that might accelerate elimination of ramipril and its metabolites. Increases in blood urea nitrogen levels occurred in 0.5% of patients receiving ALTACE alone and in 3% of patients receiving ALTACE with a diuretic.
Hematological reactions to ACE inhibitors are more likely to occur in patients with collagen vascular disease (e.g. The usual maintenance dosage range is 2.5 to 20 mg per day administered as a single dose or in two equally divided doses. Angiotensin II also stimulates aldosterone secretion by the adrenal cortex. The dose may be increased to 1.25 mg b.i.d. Irreversible kidney damage has been observed in very young rats given a single dose of ramipril.ALTACE has been evaluated for safety in over 4,000 patients with hypertension; of these, 1,230 patients were studied in US controlled trials, and 1,107 were studied in foreign controlled trials. Whether increased levels of bradykinin, a potent vasodepressor peptide, play a role in the therapeutic effects of ALTACE remains to be elucidated.While the mechanism through which ALTACE lowers blood pressure is believed to be primarily suppression of the renin-angiotensin-aldosterone system, ALTACE has an antihypertensive effect even in patients with low-renin hypertension. This study was designed with a prespecified substudy in diabetics with at least one other cardiovascular risk factor. (See In single-dose studies, doses of 5-20 mg of ALTACE lowered blood pressure within 1-2 hours, with peak reductions achieved 3-6 hours after dosing.
The angioedema was diagnosed by procedures including abdominal CT scan or ultrasound, or at surgery, and symptoms resolved after stopping the ACE inhibitor. ALTACE can be used in addition to other needed treatment (such as antihypertensive, antiplatelet or lipid-lowering therapy).ALTACE is indicated for the treatment of hypertension. Email this page. It may be used alone or in combination with thiazide diuretics.In using ALTACE, consideration should be given to the fact that another angiotensin converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen-vascular disease.
and up to a maximum dose of 2.5 mg b.i.d. A patient who becomes hypotensive at this dose may be switched to 1.25 mg twice daily, and after one week at the starting dose, patients should then be titrated (if tolerated) toward a target dose of 5 mg twice daily, with dosage increases being about 3 weeks apart.After the initial dose of ALTACE, the patient should be observed under medical supervision for at least two hours and until blood pressure has stabilized for at least an additional hour.
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