देश: संयुक्त राज्य
भाषा: अंग्रेज़ी
स्रोत: NLM (National Library of Medicine)
RAMIPRIL (UNII: L35JN3I7SJ) (RAMIPRILAT - UNII:6N5U4QFC3G)
Exelan Pharmaceuticals, Inc.
RAMIPRIL
RAMIPRIL 1.25 mg
ORAL
PRESCRIPTION DRUG
Ramipril Capsules, USP are indicated for the treatment of hypertension. They may be used alone or in combination with thiazide diuretics. Ramipril capsules are contraindicated in patients who are hypersensitive to this product or any other ACE inhibitor (e.g., a patient who has experienced angioedema during therapy with any other ACE inhibitor). Do not co-administer ramipril capsules with aliskiren: - in patients with diabetes Pregnancy Category D third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. Resulting oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations. Potential neonatal adverse effects include skull hypoplasia, anuria, hypotension, renal failure, and death. When pregnancy is detected, discontinue ramipril as soon as possible. These adverse outcomes are usually associated with use of these drugs in the second and third trimester of pregnancy. Most epidemiologic studies examining fetal abnormalities after e
Ramipril Capsules, USP 1.25 mg are hard gelatin capsules size “4”, yellow opaque body with yellow opaque cap imprinted with IG271 on cap and 1.25 mg on body in black ink, filled with white to off-white powder and supplied in bottles of 100 (NDC 76282-271-01), 500 (76282-271-05) and 1000 (NDC 76282-271-10). Ramipril Capsules, USP 2.5 mg are hard gelatin capsules size “4”, orange opaque body with orange opaque cap imprinted with IG272 on cap and 2.5 mg on body in black ink, filled with white to off-white powder and supplied in bottles of 100 (NDC 76282-272-01), 500 (NDC 76282-272-05) and 1000 (NDC 76282-272-10). Ramipril Capsules, USP 5 mg capsules are hard gelatin capsules size “4”, red opaque body with red opaque cap imprinted with IG273 on cap and 5 mg on body in black ink, filled with white to off-white powder and supplied in bottles of 100 (NDC 76282-273-01), 500 (NDC 76282-273-05) and 1000 (NDC 76282-273-10). Ramipril Capsules, USP 10 mg are hard gelatin capsules size “4”, blue opaque body with blue opaque cap imprinted with IG274 on cap and 10 mg on body in black ink, filled with white to off-white powder and supplied in bottles of 100 (NDC 76282-274-01), 500 (NDC 76282-274-05) and 1000 (NDC 76282-274-10). Dispense in well-closed container with safety closure. Store at controlled room temperature between 20° and 25°C (68°F to 77°F) [see USP Controlled Room Temperature].
Abbreviated New Drug Application
RAMIPRIL- RAMIPRIL CAPSULE EXELAN PHARMACEUTICALS, 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 CAPSULES 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 Warnings and Precautions, Hyperkalemia (5.8) 9/2015 INDICATIONS AND USAGE Ramipril capsules, USP is an angiotensin converting enzyme (ACE) inhibitor indicated for the treatment of hypertension, to lower blood pressure. They may be used alone or in combination with thiazide diuretics (1.1). 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). Dosage adjustment: See respective sections pertaining to dosage adjustment in special situations (2.5). DOSAGE FORMS AND STRENGTHS Capsule: 1.25 mg, 2.5 mg, 5 mg, 10 mg (3) CONTRAINDICATIONS Angioedema related to previous treatment with an ACE inhibitor, or a history of hereditary or idiopathic angioedema. (4). Do not co-administer aliskiren with ramipril in patients with diabetes. (4) WARNINGS AND PRECAUTIONS Angioedema, increased risk in patients with a prior history (5.1) Hypotension and hyperkalemia (5.5, 5.8) Renal impairment: monitor renal function during therapy (5.3) Avoid concomitant use of an ACE inhibitor and angiotensin blocker (5.7) Rare cholestatic jaundice and hepatic failure (5.2) Rare neutropenia and agranulocytosis (5.4) ADVERSE REACTIONS The most common adverse reactions in patients with hypertension in पूरा दस्तावेज़ पढ़ें