Pays: États-Unis
Langue: anglais
Source: NLM (National Library of Medicine)
RAMIPRIL (UNII: L35JN3I7SJ) (RAMIPRILAT - UNII:6N5U4QFC3G)
AvKARE, Inc.
RAMIPRIL
RAMIPRIL 5 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). Pregnancy Categories C (first trimester) and D (second and third trimesters) [ see Warnings and Precautions ( 5.6 ) ]. Ingestion of a single 10 mg oral dose of ramipril resulted in undetectable amounts of ramipril and its metabolites in breast milk. However, because multiple doses may produce low milk concentrations that are not predictable from a single dose, do not use ramipril in nursing mothers. Safety and effectiveness in pediatric patients have not been established. Irreversible kidney damage has been observed in very young rats given a single dose of ramipril. Of the total number of patients who received ramipril in U.S. clinical
Ramipril capsules, USP are available as 1.25 mg, 2.5 mg, 5 mg, and 10 mg in hard gelatin capsules. Ramipril 1.25 mg capsules 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. Ramipril 2.5 mg capsules 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. Ramipril 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 42291-692-01) Ramipril 10 mg capsules 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. Dispense in well-closed container with safety closure. Store at controlled room temperature between 20° and 25°C (68° and 77°F) (See USP).
Abbreviated New Drug Application
RAMIPRIL- RAMIPRIL CAPSULE AVKARE, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION RAMIPRIL CAPSULES, USP 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, ORAL INITIAL U.S. APPROVAL: 1991 WARNING: AVOID USE IN PREGNANCY _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_ WHEN USED IN PREGNANCY, ACE INHIBITORS CAN CAUSE INJURY AND DEATH TO THE DEVELOPING FETUS. WHEN PREGNANCY IS DETECTED, DISCONTINUE RAMIPRIL AS SOON AS POSSIBLE (5.6). RECENT MAJOR CHANGES WARNINGS AND PRECAUTIONS Dual Blockade of the Renin-Angiotensin- Aldosterone System: Telmisartan ( 5.7) 10/2010 INDICATIONS AND USAGE Ramipril capsules, USP are indicated for the treatment of hypertension. It 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). WARNINGS AND PRECAUTIONS ACE inhibitor use has been associated with the following: Angioedema, with 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) Increased risk of renal impairment when combined with another blocker of the renin-angiotensin-aldosterone system (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 i Lire le document complet