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Basic Drug Info
Drug Name:Altace
Manufacturer:Monarch Pharmaceuticals, Inc.
Other Info:

In patients with creatinine clearance <40 ml/min/1.73m2 (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.



Clinical Trials:


Indications and Usage

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).
Coronary Artery Disease -- Pathological processes of CORONARY ARTERIES that may derive from a congenital abnormality, atherosclerotic, or non-atherosclerotic cause.

Cerebrovascular accident -- sudden neurologic impairment due to a cerebrovascular disorder, either an arterial occlusion or an intracranial hemorrhage.

Peripheral Vascular Diseases -- Pathological processes involving any one of the BLOOD VESSELS in the vasculature outside the HEART.

Diabetes --

Diabetes Mellitus -- A heterogeneous group of disorders characterized by HYPERGLYCEMIA and GLUCOSE INTOLERANCE.

Diabetes Mellitus, Non-Insulin-Dependent -- subclass of diabetes mellitus that is not insulin responsive or dependent; characterized initially by insulin resistance and hyperinsulinemia and eventually by glucose intolerance, hyperglycemia, and overt diabetes; type II diabetes mellitus is no longer considered a disease exclusively found in adults; patients seldom develop ketosis but often exhibit obesity.

Hypertensive disease -- Persistently high systemic arterial BLOOD PRESSURE. Based on multiple readings (BLOOD PRESSURE DETERMINATION), hypertension is currently defined as when SYSTOLIC PRESSURE is consistently greater than 140 mm Hg or when DIASTOLIC PRESSURE is consistently 90 mm Hg or more.

Microalbuminuria --

Myocardial Infarction -- NECROSIS of the MYOCARDIUM caused by an obstruction of the blood supply to the heart (CORONARY CIRCULATION).

Contraindications
ALTACE is 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).
Hypersensitivity -- Altered reactivity to an antigen, which can result in pathologic reactions upon subsequent exposure to that particular antigen.

Angioedema -- Swelling involving the deep DERMIS, subcutaneous, or submucosal tissues, representing localized EDEMA. Angioedema often occurs in the face, lips, tongue, and larynx.

Warnings
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.

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