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언어: 영어
출처: NLM (National Library of Medicine)
Ramipril (UNII: L35JN3I7SJ) (ramipril - UNII:L35JN3I7SJ)
InvaGen Pharmaceuticals, Inc
Ramipril
CAPSULE
1.25 mg
ORAL
PRESCRIPTION DRUG
Ramipril is indicated for the treatment of hypertension. It may be used alone or in combination with thiazide diuretics. In using ramipril, consideration should be given to the fact that another angiotensin converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen-vascular disease. Available data are insufficient to show that ramipril does not have a similar risk. (See WARNINGS. ) In considering use of ramipril, it should be noted that in controlled trials ACE inhibitors have an effect on blood pressure that is less in black patients than in non-blacks. In addition, ACE inhibitors (for which adequate data are available) cause a higher rate of angioedema in black than in non-black patients. (see WARNINGS, Angioedema. ) Ramipril is contraindicated in patients who are hypersensitive to this product or any other angiotensin converting enzyme inhibitor (e.g., a patient who has experienced angioedema during therapy with any other ACE inhibitor.
Ramipril Capsules 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 and supplied in bottles of 100 (NDC 67787-271-01) and 1000 (NDC 67787-271-10). 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 and supplied in bottles of 100 (NDC 67787-272-01) and 1000 (NDC 67787-272-10). 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 67787-273-01) and 1000 (NDC 67787-273-10). 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 and supplied in bottles of 100 (NDC 67787-274-01) and 1000 (NDC 67787-274-10). Dispense in well-closed container with safety closure. Store at controlled room temperature between 20° and 25°C (68° and 77°F) (See USP). Manufactured by: InvaGen Pharmaceuticals, Inc Hauppauge NY 11788.
RAMIPRIL- RAMIPRIL CAPSULE INVAGEN PHARMACEUTICALS, INC ---------- USE IN PREGNANCY WHEN USED IN PREGNANCY DURING THE SECOND AND THIRD TRIMESTERS, ACE INHIBITORS CAN CAUSE INJURY AND EVEN DEATH TO THE DEVELOPING FETUS. When pregnancy is detected, ramipril should be discontinued as soon as possible. See WARNINGS: FETAL/NEONATAL MORBIDITY AND MORTALITY. DESCRIPTION Ramipril is a 2-aza-bicyclo [3.3.0]-octane-3-carboxylic acid derivative. It is a white, crystalline substance soluble in polar organic solvents and buffered aqueous solutions. Ramipril melts between 105°C and 112°C. Ramipril's chemical name is (2_S_,3_aS_,6_aS_)-1[(_S_)-N-[(_S_) -1-Carboxy-3-phenylpropyl] alanyl] octahydrocyclopenta [_b_] pyrrole-2-carboxylic acid, 1-ethyl ester; its structural formula is: Its empiric formula is C H N O , and its molecular weight is 416.5. Ramiprilat, the diacid metabolite of ramipril, is a non-sulfhydryl angiotensin converting enzyme inhibitor. Ramipril is converted to ramiprilat by hepatic cleavage of the ester group. Ramipril is supplied as hard shell capsules for oral administration containing 1.25 mg, 2.5 mg, 5 mg, and 10 mg of ramipril. The inactive ingredients present are pregelatinized starch NF, gelatin, and titanium dioxide. The 1.25 mg capsule shell contains D&C Yellow # 10 and FD&C Yellow # 6 the 2.5 mg capsule shell contains D&C Red # 28, D&C Yellow # 10 and FD&C Red #40, the 5 mg capsule shell contains D&C Red # 28, D&C Red # 33, D&C Yellow # 10 and FD&C Blue #1, and the 10 mg capsule shell contains D&C Red # 28, and FD&C Blue #1. Capsule shells are imprinted with ink containing Shellac and Black iron oxide. CLINICAL PHARMACOLOGY MECHANISM OF ACTION Ramipril and ramiprilat inhibit angiotensin-converting enzyme (ACE) in human subjects and animals. ACE is a peptidyl dipeptidase that catalyzes the conversion of angiotensin I to the vasoconstrictor substance, angiotensin II. Angiotensin II also stimulates aldosterone secretion by the adrenal cortex. Inhibition of ACE results in decreased plasma angiotensin II 전체 문서 읽기