AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE- 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:

PD-Rx Pharmaceuticals, Inc.

INN (International Name):

AMLODIPINE BESYLATE

Composition:

AMLODIPINE 5 mg

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), ACE inhibitors, including amlodipine besylate and benazepril hydrochloride 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 Warnings and Precautions ( 5.1) ]. Pregnan

Product summary:

Amlodipine and benazepril hydrochloride capsules, USP are available as capsules containing amlodipine besylate, USP equivalent to 2.5 mg, 5 mg, or 10 mg of amlodipine, 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. All 6 strengths are packaged with a desiccant in bottles. They are available as follows: 2.5 mg/10 mg capsules: a hard gelatin capsule with a white opaque cap and body, filled with white to off-white powder, imprinted “TEVA” on the cap and “7370” on the body in bottles of 100 (NDC 0093-7370-01). 5 mg/10 mg capsules: a hard gelatin capsule with an orange opaque cap and white opaque body, filled with white to off-white powder, imprinted “TEVA” on the cap and “7371” on the body in bottles of 100 (NDC 0093-7371-01). 5 mg/20 mg capsules: a hard gelatin capsule with a pink opaque cap and white opaque body, filled with white to off-white powder, imprinted “TEVA” on the cap and “7372” on the body in bottles of 100 (NDC 0093-7372-01). 5 mg/40 mg capsules: a hard gelatin capsule with a light turquoise blue cap and light turquoise blue body, filled with white to off-white powder, imprinted “TEVA” on the cap and “7670” on the body in bottles of 100 (NDC 0093-7670-01). 10 mg/20 mg capsules: a hard gelatin capsule with a blue violet opaque cap and body, filled with white to off-white powder, imprinted “TEVA” on the cap and “7373” on the body in bottles of 100 (NDC 0093-7373-01). 10 mg/40 mg capsules: a hard gelatin capsule with a light blue cap and light blue body, filled with white to off-white powder, imprinted “TEVA” on the cap and “7671” on the body in bottles of 100 (NDC 0093-7671-01). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from moisture. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE- AMLODIPINE AND BENAZEPRIL
HYDROCHLORIDE CAPSULE
PD-RX PHARMACEUTICALS, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
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.
AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE CAPSULES, FOR ORAL USE
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 CAPSULES AS SOON AS
POSSIBLE ( 5.5). DRUGS THAT ACT DIRECTLY ON THE RENIN-ANGIOTENSIN
SYSTEM (RAS) CAN CAUSE INJURY AND DEATH
TO THE DEVELOPING FETUS ( 5.5).
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 2.5/10 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/benazepril mg): 2.5 mg/10 mg, 5 mg/10 mg, 5 mg/20
mg, 5 mg/40 mg, 10 mg/20 mg, 10 mg/40 mg (
3)
CONTRAINDICATIONS
Do not coadminister aliskiren with ACE inhibitors, including
amlodipine and benazepril hydrochloride, 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 t