Land: USA
Språk: engelsk
Kilde: NLM (National Library of Medicine)
ramipril (UNII: L35JN3I7SJ) (ramipril - UNII:L35JN3I7SJ)
Rebel Distributors Corp
ramipril
ramipril 2.5 mg
ORAL
PRESCRIPTION DRUG
Ramipril capsules are indicated in patients 55 years or older at high risk of developing a major cardiovascular event because of a history of coronary artery disease, stroke, peripheral vascular disease, or diabetes that is accompanied by at least one other cardiovascular risk factor (hypertension, elevated total cholesterol levels, low HDL levels, cigarette smoking, or documented microalbuminuria), to reduce the risk of myocardial infarction, stroke, or death from cardiovascular causes. Ramipril capsules can be used in addition to other needed treatment (such as antihypertensive, antiplatelet or lipid-lowering therapy). Ramipril capsules are indicated for the treatment of hypertension. It may be used alone or in combination with thiazide diuretics. In using ramipril capsules, 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 insuf
Ramipril is available in potencies of 1.25 mg, 2.5 mg, 5 mg, and 10 mg in hard gelatin capsules. Ramipril 2.5 mg capsules are supplied as hard gelatin capsules with white opaque body and orange opaque cap. The body has “RP 2.5" and the cap has “>” both printed in black: bottles of 30 (NDC 21695-821-30). Ramipril 5 mg capsules are supplied as hard gelatin capsules with white opaque body and red opaque cap. The body has “RP 5" and the cap has “>” both printed in black: bottles of 30 (NDC 21695-822-30). Ramipril 10 mg capsules are supplied hard gelatin capsules with white opaque body and blue opaque cap. The body has “RP 10" and the cap has “>” both printed in black: bottles of 30 (NDC 21695-823-30). Dispense in well-closed container with safety closure. Store at controlled room temperature, 20 to 25o C (68 to 77o F) with excursions permitted between 15 to 30o C (59 to 86o F). (See USP). Manufactured for: Cobalt Laboratories, Bonita Springs, Florida, U.S.A., 34134 Item Number: LFT0129AB Date: May 2009 Repackaged by: Rebel Distributors Corp, Thousand Oaks, CA 91320
Abbreviated New Drug Application
RAMIPRIL- RAMIPRIL CAPSULE REBEL DISTRIBUTORS CORP ---------- RAMIPRIL CAPSULES 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. The CAS Registry Number is 87333-19-5. Ramipril's chemical name is (2_S,3aS,6aS_)-1[(_S_)-N-[(_S_)-1- Carboxy-3-phenylpropyl] alanyl] octahydrocyclopenta [_b_]pyrrole-2-carboxylic acid, 1-ethyl ester; its structural formula is: Its molecular 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 yellow iron oxide, the 2.5 mg capsule shell contains D&C yellow #10, D&C red #28, FD&C red #40 and yellow iron oxide, the 5 mg capsule shell contains D&C red #28, D&C yellow #10, FD&C blue #1 and FD&C red #40, and the 10 mg capsule shell contains D&C red #28, FD&C blue #1, FD&C red #40 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 Les hele dokumentet