ramipril- Ramipril capsule

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

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

Tillgänglig från:

InvaGen Pharmaceuticals, Inc

INN (International namn):

Ramipril

Läkemedelsform:

CAPSULE

Sammansättning:

1.25 mg

Administreringssätt:

ORAL

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

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.

Produktsammanfattning:

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.

Produktens egenskaper

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