Hypertension

ALTACE® is indicated for the treatment of hypertension. It may be used alone or in combination with thiazide diuretics.

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) [see Clinical Studies].

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 A LTACE 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 Studies].

Hypertension

The recommended initial dose for patients not receiving a diuretic is 2.5 mg once a day. Adjust dose according to blood pressure response. The usual maintenance dosage range is 2.5 mg 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, consider an increase in dosage or twice daily administration. If blood pressure is not controlled with ALTACE alone, a diuretic can be added.

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

Initiate dosing at 2.5 mg once daily for 1 week, 5 mg once daily for the next 3 weeks, and then increase as tolerated, to a maintenance dose of 10 mg once daily. If the patient is hypertensive or recently post-myocardial infarction, ALTACE can also be given as a divided dose.

Heart Failure Post-Myocardial Infarction

For the treatment of post-myocardial infarction patients who have shown signs of congestive heart failure, the recommended starting dose of ALTACE is 2.5 mg twice daily (5 mg per day). A patient who becomes hypotensive at t his dose may be switched to 1.25 mg twice daily. After one week at the starting dose, increase dose (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, observe the patient under medical supervision for at least two hours and until blood pressure has stabilized for at least an additional hour. If possible, reduce the dose of any concomitant diuretic as this 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 [see WARNINGS AND PRECAUTIONS, DRUG INTERACTIONS].

General Dosing Information

Generally, swallow ALTACE capsules whole. The ALTACE capsule can also be opened and the contents sprinkled on a small amount (about 4 oz.) of applesauce or mixed in 4 oz. (120 mL) of water or apple juice. To be sure that ramipril is not lost when such a mixture is used, consume the mixture in its entirety. The described mixtures can be pre-prepared and stored for up to 24 hours at room temperature or up to 48 hours under refrigeration.

Concomitant administration of ALTACE with potassium supplements, potassium salt substitutes, or potassium-sparing diuretics can lead to increases of serum potassium [see WARNINGS AND PRECAUTIONS].

Dosage Adjustment

Renal Impairment

Establish baseline renal function in patients initiating ALTACE. Usual regimens of therapy with ALTACE may be followed in patients with estimated creatinine clearance >40 mL/min. However, in patients with worse impairment, 25 % of the usual dose of ramipril is expected to produce full therapeutic levels of ramiprilat [see Use In Specific Populations].

Hypertension

For patients with hypertension and renal impairment, the recommended initial dose is 1.25 mg ALTACE once daily. Dosage may be titrated up ward 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 twice daily, and up to a maximum dose of 2.5 mg twice daily depending on clinical response and tolerability.

Volume Depletion or Renal Artery Stenosis

Blood pressure decreases associated with any dos e 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 circumstance s are suspected to be present, initiate dosing at 1.25 mg once daily. Adjust dosage according to blood pressure response.

Dosage Forms And St Rengths

ALTACE (ramipril) is supplied as hard gelatin capsules containing 1.25 mg, 2.5 mg, 5 mg, and 10 mg of ramipril.

Storage And Handling

ALTACE is available in 1.25 mg, 2.5 mg, 5 mg, and 10 mg hard gelatin capsules. Descriptions of ALTACE capsules are summarized below.

Dispense in well-closed container with safety closure. Store at controlled room temperature (59°–86°F).

Distributed by: Monarch Pharmaceuticals, Inc. Bristol, TN 37620 (A wholly owned subsidiary of King Pharmaceuticals, Inc.). Manufactured by: King Pharmaceuticals, Inc. Bristol, TN 37620. Revised: 04/2012

Last reviewed on RxList: 4/26/2012
This monograph has been modified to include the generic and brand name in many instances.