AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE - amlodipine besylate and benazepril hydrochloride capsule

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

AMLODIPINE BESYLATE (UNII: 864V2Q084H) (AMLODIPINE - UNII:1J444QC288), BENAZEPRIL HYDROCHLORIDE (UNII: N1SN99T69T) (BENAZEPRIL - UNII:UDM7Q7QWP8)

Disponible desde:

PD-Rx Pharmaceuticals, Inc.

Designación común internacional (DCI):

AMLODIPINE BESYLATE

Composición:

AMLODIPINE BESYLATE 5 mg

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Amlodipine besylate and benazepril hydrochloride combination capsules is indicated for the treatment of hypertension.       This fixed combination drug is not indicated for the initial therapy of hypertension (see DOSAGE AND ADMINISTRATION).       In using amlodipine besylate and benazepril hydrochloride combination capsules, consideration should be given to the fact that an ACE inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen-vascular disease. Available data are insufficient to show that benazepril does not have a similar risk (see WARNINGS, Neutropenia/Agranulocytosis).       Black patients receiving ACE inhibitors have been reported to have a higher incidence of angioedema compared to nonblacks. Amlodipine besylate and benazepril hydrochloride combination capsules is contraindicated in patients with a history of angioedema, with or without previous ACE inhibitor treatment, or patients who are hypersensitive to benazepril, to any other ACE inhibito

Resumen del producto:

Amlodipine besylate and benazepril hydrochloride combination capsules are available as capsules containing amlodipine besylate equivalent to 2.5 mg, 5 mg or 10 mg of amlodipine, with 10 mg or 20 mg of benazepril hydrochloride providing for the following available combinations: 2.5/10 mg, 5/10 mg, 5/20 mg, and 10/20 mg . All capsules are imprinted with “S” in a triangle, SANDOZ and appropriate code. The capsule color and code is as follows: 2.5/10 mg is white with 2 gold bands/571, 5/10 mg is light brown with 2 white bands/572, 5/20 mg is pink with 2 white bands/573 and 10/20 mg is purple with 2 white bands/574. All four strengths are packaged in bottles or blisters as follows: Storage: Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F). [See USP controlled room temperature.] Protect from moisture. Dispense in tight container (USP). ** Trademark of Thomson Healthcare, Inc. T2009-86      

Estado de Autorización:

New Drug Application

Ficha técnica

AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE - AMLODIPINE BESYLATE
AND
BENAZEPRIL HYDROCHLORIDE CAPSULE
PD-RX PHARMACEUTICALS, INC.
----------
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE
COMBINATION CAPSULES
2.5 MG/10 MG
5 MG/10 MG
5 MG/20 MG
10 MG/20 MG
RX ONLY
PRESCRIBING INFORMATION
USE IN PREGNANCY
WHEN USED IN PREGNANCY, ACE INHIBITORS CAN CAUSE INJURY AND EVEN DEATH
TO THE DEVELOPING
FETUS. When pregnancy is detected, amlodipine besylate and benazepril
hydrochloride
combination capsules should be discontinued as soon as possible. See
WARNINGS,
FETAL/NEONATAL MORBIDITY AND MORTALITY.
DESCRIPTION
Benazepril hydrochloride is a white to off-white crystalline powder,
soluble (>100 mg/mL) in water, in
ethanol, and in methanol. Benazepril hydrochloride’s chemical name
is 3-[[1-(ethoxycarbonyl)-3-
phenyl-(1S)-propyl]amino]-2,3,4,5-tetrahydro-2-oxo-1_H_-1-(3S)-benzazepine-1-acetic
acid
monohydrochloride; its structural formula is
Its empirical formula is C
H N O •HCl, and its molecular weight is 460.96.
Benazeprilat, the active metabolite of benazepril, is a nonsulfhydryl
angiotensin-converting enzyme
(ACE) inhibitor. Benazepril is converted to benazeprilat by hepatic
cleavage of the ester group.
Amlodipine besylate is a white to pale yellow crystalline powder,
slightly soluble in water and
sparingly soluble in ethanol. Its chemical name is
(R,S)3-ethyl-5-methyl-2-(2-aminoethoxymethyl)-4-(2-
chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate
benzenesulfonate; its structural formula
is
24
28
2
5
Its empirical formula is C
H ClN O •C H O S, and its molecular weight is 567.1.
Amlodipine besylate is the besylate salt of amlodipine, a
dihydropyridine calcium channel blocker.
This product is a combination of amlodipine besylate and benazepril
hydrochloride. The capsules
are formulated in four different strengths for oral administration
with a combination of amlodipine
besylate equivalent to 2.5 mg, 5 mg or 10 mg of amlodipine, with 10 mg
or 20 mg of