AMLODIPINE 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:

AvKARE

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Amlodipine and benazepril hydrochloride capsules are indicated for the treatment of hypertension in patients not adequately controlled on monotherapy with either agent. - Do not coadminister aliskiren with angiotensin receptor blockers (ARBs), angiotensin-converting enzyme (ACE) inhibitors, including amlodipine and benazepril hydrochloride capsules in patients with diabetes. - Amlodipine and benazepril hydrochloride capsules  are 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, to amlodipine, or to any of the excipients of amlodipine and benazepril hydrochloride capsules. - Amlodipine and benazepril hydrochloride capsules are contraindicated in combination with a neprilysin inhibitor (e.g., sacubitril). Do not administer amlodipine and benazepril hydrochloride capsules within 36 hours of switching to or from a neprilysin inhibitor, e.g., sacubitril/valsartan [see Warni

Product summary:

Amlodipine and benazepril hydrochloride is available as capsules containing amlodipine besylate USP (3.5 mg, 6.9 mg or 13.9 mg, equivalent to 2.5 mg, 5 mg or 10 mg of amlodipine respectively), with 10 mg, 20 mg, or 40 mg of benazepril hydrochloride USP providing for the following available combinations: 2.5 mg/10 mg, 5 mg/10 mg, 5 mg/20 mg, 5 mg/40 mg, 10 mg/20 mg, and 10 mg/40 mg. They are available as follows: Amlodipine and Benazepril Hydrochloride Capsules USP, 2.5 mg/10 mg are white to pale yellow colored powder filled in empty hard gelatin capsule shells, size “0” of white cap and white body imprinted with ‘I’ on white cap and ‘96’ on white body with black edible ink. Amlodipine and Benazepril Hydrochloride Capsules USP, 5 mg/10 mg are white to pale yellow colored powder filled in empty hard gelatin capsule shells, size “0” of light brown cap and light brown body imprinted with ‘I’ on light brown cap and ‘97’ on light brown body with black edible ink. Bottles of 100 NDC 42291-011-01 Amlodipine and Benazepril Hydrochloride Capsules USP, 5 mg/20 mg are white to pale yellow colored powder filled in empty hard gelatin capsule shells, size “0” of pink cap and pink body imprinted with ‘I’ on pink cap and ‘98’ on pink body with black edible ink. Bottles of 100 NDC 42291-012-01 Amlodipine and Benazepril Hydrochloride Capsules USP, 5 mg/40 mg are white to pale yellow colored powder filled in empty hard gelatin capsule shells, size “0” of light blue cap and light blue body imprinted with ‘J’ on light blue cap and ‘01’ on light blue body with black edible ink. Bottles of 100 NDC 42291-013-01 Amlodipine and Benazepril Hydrochloride Capsules USP, 10 mg/20 mg are white to pale yellow colored powder filled in empty hard gelatin capsule shells, size “0” of purple cap and purple body imprinted with ‘J’ on purple cap and ‘02’ on purple body with black edible ink. Bottles of 100 NDC 42291-014-01 Amlodipine and Benazepril Hydrochloride Capsules USP, 10 mg/40 mg are white to pale yellow colored powder filled in empty hard gelatin capsule shells, size “0” of dark blue cap and dark blue body imprinted with ‘J’ on dark blue cap and ‘03’ on dark blue body with black edible ink. Bottles of 100 NDC 42291-015-01 Storage: Store at 20° to 25°C (68° to 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 AND BENAZEPRIL HYDROCHLORIDE- AMLODIPINE AND BENAZEPRIL
HYDROCHLORIDE CAPSULE
AVKARE
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE CAPSULES USP
RX ONLY
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
AMLODIPINE AND
BENAZEPRIL HYDROCHLORIDE CAPSULES SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING
INFORMATION FOR AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE CAPSULES.
INITIAL U.S. APPROVAL: 1995
WARNING: FETAL TOXICITY
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
WHEN PREGNANCY IS DETECTED, DISCONTINUE AMLODIPINE AND BENAZEPRIL
HYDROCHLORIDE AS
SOON AS POSSIBLE ( 5.1).
DRUGS THAT ACT DIRECTLY ON THE RENIN-ANGIOTENSIN SYSTEM (RAS) CAN
CAUSE INJURY AND
DEATH TO THE DEVELOPING FETUS ( 5.1).
INDICATIONS AND USAGE
Amlodipine and benazepril hydrochloride capsules are a combination
capsule of amlodipine, a
dihydropyridine calcium channel blocker (DHP CCB) and benazepril, an
angiotensin-converting enzyme
(ACE) inhibitor. Amlodipine and benazepril hydrochloride capsules are
indicated for the treatment of
hypertension in patients not adequately controlled on monotherapy with
either agent. (1)
DOSAGE AND ADMINISTRATION
Usual starting dose is 2.5 mg/10 mg. ( 2.1)
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 and benazepril
hydrochloride capsules containing a lower dose of amlodipine. ( 2.1)
DOSAGE FORMS AND STRENGTHS
Capsules (amlodipine and benazepril hydrochloride): 2.5 mg/10 mg, 5
mg/10 mg, 5 mg/20 mg, 5 mg/40
mg, 10 mg/20 mg, and 10 mg/40 mg. (3)
CONTRAINDICATIONS
Do not coadminister aliskiren with ACE inhibitors, including
amlodipine and benazepril hydrochloride
capsules, in patients with diabetes. (4)
Amlodipine and benazepril hydrochloride capsules are contraindicated
in patients with a history of
angioedema or patients who are hypersensitive to benazepril or to
a