Kraj: Stany Zjednoczone
Język: angielski
Źródło: NLM (National Library of Medicine)
RAMIPRIL (UNII: L35JN3I7SJ) (RAMIPRILAT - UNII:6N5U4QFC3G)
BluePoint Laboratories
RAMIPRIL
RAMIPRIL 1.25 mg
ORAL
PRESCRIPTION DRUG
Ramipril capsules, USP 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.Ramipril capsules, USP 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 dr
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 68001-140-04 in bottle of 30 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 68001-142-00 in bottle of 100 capsules NDC 68001-142-03 in bottle of 500 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 68001-143-00 in bottle of 100 capsules NDC 68001-143-03 in bottle of 500 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 68001-141-00 in bottle of 100 capsules NDC 68001-141-03 in bottle of 500 capsules Storage: Store at 20 o to 25 o C (68 o to 77 o F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container with child-resistant closure.
Abbreviated New Drug Application
RAMIPRIL- RAMIPRIL CAPSULE BLUEPOINT LABORATORIES ---------- 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 USP, 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). RECENT MAJOR CHANGES 1. Contraindications (4) 04/2017 Warnings and Precautions, Anaphylactoid and 1. Possibly Related Reactions (5.1). 04/2017 INDICATIONS AND USAGE Ramipril capsules, USP 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). Ramipril capsules, USP 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). 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 toward a target dose of 5 mg twice daily, with dosage increases about 3 weeks apart ( 2.3). Dosage adjustment: See respective sections pertaining to dosage adjustment in special situations ( 2.5). DOSAGE FORMS AND STRENGTHS Capsules: 1.25 mg, 2.5 mg, 5 mg, 10 mg ( 3) CONTRAINDICATIONS Angioe Przeczytaj cały dokument