Страна: США
мова: англійська
Джерело: NLM (National Library of Medicine)
RAMIPRIL (UNII: L35JN3I7SJ) (RAMIPRILAT - UNII:6N5U4QFC3G)
Zydus Pharmaceuticals USA Inc.
RAMIPRIL
RAMIPRIL 1.25 mg
ORAL
PRESCRIPTION DRUG
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
Ramipril Capsules USP, 1.25 mg are white to off-white granular powder filled in size '4' hard gelatin capsules with white opaque cap printed with "ZA-43" in black ink and yellow opaque body printed with "1.25 mg" in black ink and are supplied as follows: NDC 68382-144-06 in bottle of 30 capsules with child-resistant closure NDC 68382-144-16 in bottle of 90 capsules with child-resistant closure NDC 68382-144-01 in bottle of 100 capsules NDC 68382-144-05 in bottle of 500 capsules NDC 68382-144-77 in unit-dose blister cartons of 100 (10 x 10) unit-dose capsules Ramipril Capsules USP, 2.5 mg are white to off-white granular powder filled in size '4' hard gelatin capsules with white opaque cap printed with "ZA-44" in black ink and orange opaque body printed with "2.5 mg" in black ink and are supplied as follows: NDC 68382-145-06 in bottle of 30 capsules with child-resistant closure NDC 68382-145-16 in bottle of 90 capsules with child-resistant closure NDC 68382-145-01 in bottle of 100 capsules NDC 68382-145-05 in bottle of 500 capsules NDC 68382-145-77 in unit-dose blister cartons of 100 (10 x 10) unit-dose capsules Ramipril Capsules USP, 5 mg are white to off-white granular powder filled in size '4' hard gelatin capsules with white opaque cap printed with "ZA-45" in black ink and red opaque body printed with "5 mg" in black ink and are supplied as follows: NDC 68382-146-06 in bottle of 30 capsules with child-resistant closure NDC 68382-146-16 in bottle of 90 capsules with child-resistant closure NDC 68382-146-01 in bottle of 100 capsules NDC 68382-146-05 in bottle of 500 capsules NDC 68382-146-77 in unit-dose blister cartons of 100 (10 x 10) unit-dose capsules Ramipril Capsules USP, 10 mg are white to off-white granular powder filled in size '4' hard gelatin capsules with white opaque cap printed with "ZA-46" in black ink and blue opaque body printed with "10 mg" in black ink and are supplied as follows: NDC 68382-147-06 in bottle of 30 capsules with child-resistant closure NDC 68382-147-16 in bottle of 90 capsules with child-resistant closure NDC 68382-147-01 in bottle of 100 capsules NDC 68382-147-05 in bottle of 500 capsules NDC 68382-147-77 in unit-dose blister cartons of 100 (10 x 10) unit-dose capsules Storage: Store at 20o C to 25o C (68o F to 77o F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container with child-resistant closure.
Abbreviated New Drug Application
RAMIPRIL- RAMIPRIL CAPSULE ZYDUS PHARMACEUTICALS USA INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE RAMIPRIL CAPSULES SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR RAMIPRIL CAPSULES. RAMIPRIL CAPSULES, FOR ORAL USE INITIAL U.S. APPROVAL: 1991 WARNING: FETAL TOXICITY _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_ WHEN PREGNANCY IS DETECTED, DISCONTINUE RAMIPRIL AS SOON AS POSSIBLE (5.6). DRUGS THAT ACT DIRECTLY ON THE RENIN-ANGIOTENSIN SYSTEM CAN CAUSE INJURY AND DEATH TO THE DEVELOPING FETUS (5.6). INDICATIONS AND USAGE Ramipril capsules are 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). In patients 55 years or older at high risk of developing a major cardiovascular event, ramipril capsules are indicated to reduce the risk of myocardial infarction, stroke, or death from cardiovascular causes (1.2). Ramipril capsules are indicated in stable patients who have demonstrated clinical signs of congestive heart failure post-myocardial infarction (1.3). DOSAGE AND ADMINISTRATION Hypertension: Initial dose is 2.5 mg to 20 mg once daily. Adjust dosage according to blood pressure response after 2 to 4 weeks of treatment. The usual maintenance dose following titration is 2.5 mg to 20 mg daily as a single dose or equally divided doses (2.1). Reduction in the risk of myocardial infarction, stroke, or death from cardiovascular causes: 2.5 mg once daily for 1 week, 5 mg once daily for 3 weeks, and increased as tolerated to a maintenance dose of 10 mg once daily (2.2). Heart failure post-myocardial infarction: Starting dose of 2.5 mg twice daily. If patient becomes hypotensive at this dose, decrease dosage to 1.25 mg twice daily. Increase dose as tolerated tow Прочитайте повний документ