RAMIPRIL capsule

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

ramipril (UNII: L35JN3I7SJ) (ramipril - UNII:L35JN3I7SJ)

Διαθέσιμο από:

Rebel Distributors Corp

INN (Διεθνής Όνομα):

ramipril

Σύνθεση:

ramipril 2.5 mg

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

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

Περίληψη προϊόντος:

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

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Αρχείο Π.Χ.Π.

RAMIPRIL- RAMIPRIL CAPSULE
REBEL DISTRIBUTORS CORP
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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