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Ramipril

1 INDICATIONS AND USAGE Ramipril is an angiotensin converting enzyme (ACE) inhibitor indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. It may be used alone or in combination with thiazide diuretics ( 1.1 ). Ramipril is indicated in stable patients who have demonstrated clinical signs of congestive heart failure postmyocardial infarction (1.3) Structure 1.1 hypertension Ramipril capsules are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including this drug. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Ramipril capsules may be used alone or in combination with thiazide diuretics. 1.3 Heart Failure Post-Myocardial Infarction Ramipril capsules are 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 capsules 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 ( 14.3 )].

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4 years ago CAPSULE RED APO 5 Ramipril

CAPSULE RED APO 5

16 HOW SUPPLIED/ STORAGE AND HANDLING Ramipril capsules, USP are available for oral administration in potencies of 1.25 mg, 2.5 mg, 5 mg, and 10 mg in hard gelatin capsules. Ramipril capsules, USP 1.25 mg are supplied as hard gelatin capsules with a white opaque body and a yellow opaque cap, imprinted with “APO 1.25” in black ink. They are supplied as follows: Bottles of 30 (NDC 60505-2875-3) Bottles of 100 (NDC 60505-2875-1) Bottles of 500 (NDC 60505-2875-5) Bottles of 1,000 (NDC 60505-2875-8) Ramipril capsules, USP 2.5 mg are supplied as hard gelatin capsules with a white opaque body and an orange opaque cap, imprinted with “APO 2.5” in black ink. They are supplied as follows: Bottles of 30 (NDC 60505-2876-3) Bottles of 100 (NDC 60505-2876-1) Bottles of 500 (NDC 60505-2876-5) Bottles of 1,000 (NDC 60505-2876-8) Unit Dose Blisters of 100 (NDC 60505-2876-0) Ramipril capsules, USP 5 mg are supplied as hard gelatin capsules with a white opaque body and a red opaque cap, imprinted with “APO 5” in black ink. They are supplied as follows: Bottles of 30 (NDC 60505-2877-3) Bottles of 100 (NDC 60505-2877-1) Bottles of 500 (NDC 60505-2877-5) Bottles of 1,000 (NDC 60505-2877-8) Unit Dose Blisters of 100 (NDC 60505-2877-0) Ramipril capsules, USP 10 mg are supplied as hard gelatin capsules with a white opaque body and a blue opaque cap, imprinted with “APO 10” in black ink. They are supplied as follows: Bottles of 30 (NDC 60505-2878-3) Bottles of 100 (NDC 60505-2878-1) Bottles of 500 (NDC 60505-2878-5) Bottles of 1,000 (NDC 60505-2878-8) Unit Dose Blisters of 100 (NDC 60505-2878-0) Store at 20°C to 25°C (68°F to 77°F); excursions permitted from 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Dispense in a tight container [see USP].


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