Država: Združene države Amerike
Jezik: angleščina
Source: NLM (National Library of Medicine)
RAMIPRIL (UNII: L35JN3I7SJ) (RAMIPRILAT - UNII:6N5U4QFC3G)
Aidarex Pharmaceuticals LLC
RAMIPRIL
RAMIPRIL 5 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. 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 w
Ramipril Capsules USP , 5 mg are red/red size ‘4’ hard gelatin capsules imprinted with ‘D’ on red cap and ‘07’ on red body with black edible ink filled with white to almost white powder. Bottles of 30 NDC 33261-0903-30 Bottles of 90 NDC 33261-0903-90 Ramipril Capsules USP , 10 mg are blue/blue size ‘4’ hard gelatin capsules imprinted with ‘D’ on blue cap and ‘08’ on blue body with black edible ink filled with white to almost white powder. Bottles of 30 NDC 33261-0967-30 Bottles of 90 NDC 33261-0967-90 Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in well-closed container with safety closure.
Abbreviated New Drug Application
RAMIPRIL- RAMIPRIL CAPSULE AIDAREX PHARMACEUTICALS LLC ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE RAMIPRIL SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR RAMIPRIL CAPSULES, USP. 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 Indications and Usage: Hypertension (1.1) 11/2013 Contraindications 10/2013 Warnings and Precautions: Anaphylactoid and Possibly Related Reactions (5.1) 9/2013 Warnings and Precautions: Dual Blockade of the Renin-Angiotensin-Aldosterone System (5.7) 10/2013 INDICATIONS AND USAGE Ramipril capsules, USP 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 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 adj Preberite celoten dokument