AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

AMLODIPINE BESYLATE (UNII: 864V2Q084H) (AMLODIPINE - UNII:1J444QC288), BENAZEPRIL HYDROCHLORIDE (UNII: N1SN99T69T) (BENAZEPRILAT - UNII:JRM708L703)

Available from:

Physicians Total Care, Inc.

INN (International Name):

AMLODIPINE BESYLATE

Composition:

AMLODIPINE 2.5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Amlodipine besylate and benazepril hydrochloride is indicated for the treatment of hypertension in patients not adequately controlled on monotherapy with either agent. Amlodipine besylate and benazepril hydrochloride 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 inhibitor, or to amlodipine. Pregnancy Category D [see WARNINGS AND PRECAUTIONS (5.4)] The use of ACE inhibitors during the second and third trimesters of pregnancy has been associated with fetal and neonatal injury, including hypotension, neonatal skull hypoplasia, anuria, reversible or irreversible renal failure, and death. Oligohydramnios has also been reported, presumably resulting from decreased fetal renal function; oligohydramnios in this setting has been associated with fetal limb contractures, craniofacial deformation, and hypoplastic lung development. Prematurity, intrauterine growth retardation, and patent duct

Product summary:

Amlodipine besylate and benazepril hydrochloride capsules are available as capsules containing amlodipine besylate equivalent to 2.5 mg, 5 mg or 10 mg of amlodipine, with 10 mg, 20 mg or 40 mg of benazepril hydrochloride providing for the following available combinations: 2.5 mg/10 mg, 5 mg/10 mg, 5 mg/20 mg, 10 mg/20 mg. Amlodipine besylate and benazepril hydrochloride capsules, 2.5 mg/10 mg are size ‘2’ capsules with white opaque cap and white opaque body, imprinted with ‘LU’ (in black ink) on cap and ‘E11’ (in black ink) on body, containing white to off-white powder and white to off-white, circular tablet debossed with ‘1’ on one side and plain on the other side. Amlodipine besylate and benazepril hydrochloride capsules, 5 mg/10 mg are size ‘2’ capsule with light brown opaque cap and light brown opaque body, imprinted with ‘LU’ (in black ink) on cap and ‘E12’ (in black ink) on body, containing white to off-white powder and white to off-white, circular tablet debossed with ‘1’ on one side and plain on the other side. Amlodipine besylate and benazepril hydrochloride capsules, 5 mg/20 mg are size ‘2’ capsule with flesh opaque cap and flesh opaque body, imprinted with ‘LU’ (in black ink) on cap and ‘E13’ (in black ink) on body, containing white to off-white powder and white to off-white, circular tablet debossed with ‘2’ on one side and plain on the other side. Amlodipine besylate and benazepril hydrochloride capsules, 10 mg/20 mg are size ‘2’ capsule with purple cap and purple body, imprinted with ‘LU’ (in black ink) on cap and ‘E14’ (in black ink) on body, containing white to off-white powder and white to off-white, circular tablet debossed with ‘2’ on one side and plain on the other side. Storage: Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature.] Protect from moisture. Dispense in tight container (USP).

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE - AMLODIPINE BESYLATE
AND
BENAZEPRIL HYDROCHLORIDE CAPSULE
PHYSICIANS TOTAL CARE, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
AMLODIPINE BESYLATE AND BENAZEPRIL
HYDROCHLORIDE CAPSULES SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR AMLODIPINE BESYLATE AND
BENAZEPRIL HYDROCHLORIDE CAPSULES.
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULES
INITIAL U.S. APPROVAL: 1995
WARNING: AVOID USE IN PREGNANCY
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_
WHEN PREGNANCY IS DETECTED, DISCONTINUE AMLODIPINE BESYLATE AND
BENAZEPRIL HYDROCHLORIDE CAPSULES AS
SOON AS POSSIBLE.
DRUGS THAT ACT DIRECTLY ON THE RENIN-ANGIOTENSIN SYSTEM CAN CAUSE
INJURY AND DEATH TO THE DEVELOPING
FETUS (5.4)
INDICATIONS AND USAGE
Amlodipine besylate and benazepril hydrochloride capsule is a
combination tablet of amlodipine, a dihydropyridine calcium
channel blocker (DHP CCB) and benazepril, an angiotensin converting
enzyme (ACE) inhibitor. Amlodipine besylate and
benazepril hydrochloride is indicated for the treatment of
hypertension (1) in patients not adequately controlled on
monotherapy with either agent.
DOSAGE AND ADMINISTRATION
Dose once-daily
May be used as add-on therapy for patients not adequately controlled
with either a dihydropyridine calcium channel
blocker or an ACE inhibitor (2.2)
Patients who experience edema with amlodipine may be switched to
amlodipine besylate and benazepril hydrochloride
containing a lower dose of amlodipine (2.2)
Start amlodipine besylate and benazepril hydrochloride at 2.5 mg/10 mg
in patients ≥ 75 years old or in patients with
hepatic impairment (2)
DOSAGE FORMS AND STRENGTHS
Capsules (amlodipine/benazepril mg): 2.5/10, 5/10, 5/20, 5/40, 10/20,
10/40(3)
CONTRAINDICATIONS
Amlodipine besylate and benazepril hydrochloride is contraindicated in
patients with a history of angioedema, with or
without previous ACE inhibitor treatment, or patients who are
hyp