Reduction in the Risk of Myocardial Infarction, Stroke, and Death from Cardiovascular Causes

Altace is indicated in patients 55 years or older at high risk of developing a major cardiovascular event because of a history of coronary artery disease, stroke, peripheral vascular disease, or diabetes that is accompanied by at least one other cardiovascular risk factor (hypertension, elevated total cholesterol levels, low HDL levels, cigarette smoking, or documented microalbuminuria), to reduce the risk of myocardial infarction, stroke, or death from cardiovascular causes. Altace can be used in addition to other needed treatment (such as antihypertensive, antiplatelet or lipid-lowering therapy).

Hypertension

Altace is indicated for the treatment of hypertension. 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. Available data are insufficient to show that Altace does not have a similar risk. (See WARNINGS.)

In considering use of Altace, it should be noted that in controlled trials ACE inhibitors have an effect on blood pressure that is less in black patients than in non-blacks. In addition, ACE inhibitors (for which adequate data are available) cause a higher rate of angioedema in black than in non-black patients. (See WARNINGS, Angioedema.)

Heart Failure Post Myocardial Infarction

Altace is indicated in stable patients who have demonstrated clinical signs of congestive heart failure within the first few days after sustaining acute myocardial infarction. Administration of ramipril to such patients has been shown to decrease the risk of death (principally cardiovascular death) and to decrease the risks of failure-related hospitalization and progression to severe/resistant heart failure. (See CLINICAL PHARMACOLOGY, Heart Failure Post Myocardial Infarction for details and limitations of the survival trial.)

Blood pressure decreases associated with any dose of Altace depend, in part, on the presence or absence of volume depletion (e.g., past and current diuretic use) or the presence or absence of renal artery stenosis. If such circumstances are suspected to be present, the initial starting dose should be 1.25 mg once daily.

Reduction in Risk of Myocardial Infarction, Stroke, and Death from Cardiovascular Causes

Altace should be given at an initial dose of 2.5 mg, once a day for 1 week, 5 mg, once a day for the next 3 weeks, and then increased as tolerated, to a maintenance dose of 10 mg, once a day. If the patient is hypertensive or recently post myocardial infarction, it can also be given as a divided dose.

Hypertension

The recommended initial dose for patients to be treated for hypertension, not receiving a diuretic is 2.5 mg once a day. Dosage should be adjusted according to the blood pressure response. The usual maintenance dosage range is 2.5 to 20 mg per day administered as a single dose or in two equally divided doses. In some patients treated once daily, the antihypertensive effect may diminish toward the end of the dosing interval. In such patients, an increase in dosage or twice daily administration should be considered. If blood pressure is not controlled with Altace alone, a diuretic can be added.

Heart Failure Post Myocardial Infarction

For the treatment of post-infarction patients who have shown signs of congestive failure, the recommended starting dose of Altace is 2.5 mg twice daily (5 mg per day). 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. (See WARNINGS and PRECAUTIONS, DRUG INTERACTIONS.) If possible, the dose of any concomitant diuretic should be reduced which may diminish the likelihood of hypotension. The appearance of hypotension after the initial dose of Altace does not preclude subsequent careful dose titration with the drug, following effective management of the hypotension.

The Altace tablet is usually swallowed whole.

Concomitant administration of Altace with potassium supplements, potassium salt substitutes, or potassium-sparing diuretics can lead to increases of serum potassium. (See PRECAUTIONS.)

In patients who are currently being treated with a diuretic, symptomatic hypotension occasionally can occur following the initial dose of Altace. To reduce the likelihood of hypotension, the diuretic should, if possible, be discontinued two to three days prior to beginning therapy with Altace. (See WARNINGS.) Then, if blood pressure is not controlled with Altace alone, diuretic therapy should be resumed.

If the diuretic cannot be discontinued, an initial dose of 1.25 mg Altace should be used to avoid excess hypotension.

Dosage Adjustment in Renal Impairment

In patients with creatinine clearance <40 mL/min/1.73 m² (serum creatinine approximately >2.5 mg/dL) doses only 25% of those normally used should be expected to induce full therapeutic levels of ramiprilat. (See CLINICAL PHARMACOLOGY.)

Hypertension: For patients with hypertension and renal impairment, the recommended initial dose is 1.25 mg Altace once daily. Dosage may be titrated upward until blood pressure is controlled or to a maximum total daily dose of 5 mg.

Heart Failure Post Myocardial Infarction

For patients with heart failure and renal impairment, the recommended initial dose is 1.25 mg Altace once daily. The dose may be increased to 1.25 mg b.i.d. and up to a maximum dose of 2.5 mg b.i.d. 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 (NDC 60793-910-01).

Altace 2.5 mg tablets are supplied as orange tablets in bottles of 100 (NDC 60793-911-01), bottles of 500 (NDC 60793-911-05), and Unit Dose packs of 100 (NDC 60793-911-56).

Altace 5 mg tablets are supplied as red tablets in bottles of 100 (NDC 60793-912-01), bottles of 500 (NDC 60793-912-05), and Unit Dose packs of 100 (NDC 60793-912-56).

Altace 10 mg tablets are supplied as blue tablets in bottles of 100 (NDC 60793-920-01), and bottles of 500 (NDC 60793-920-05).

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). (See USP).

Revised: February 2007
Manufactured by Arrow Pharm (Malta) Ltd., HF 62: Hal Far Industrial Estate, Birzebbugia BBG06, Malta for King Pharmaceuticals, Inc., Bristol, TN 37620.
Distributed by:
King Pharmaceuticals, Inc., Bristol, TN 37620
FDA rev date: 2/27/2007

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