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:

BluePoint Laboratories

INN (International Name):

AMLODIPINE BESYLATE

Composition:

AMLODIPINE 2.5 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 co-administer aliskiren with angiotensin receptor blockers (ARBs), ACE inhibitors, including amlodipine and benazepril hydrochloride in patients with diabetes. - Amlodipine 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, to amlodipine, or to any of the excipients of amlodipine and benazepril hydrochloride capsules. - Amlodipine and benazepril hydrochloride is 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). Risk Summary Aml

Product summary:

Amlodipine and benazepril hydrochloride capsules USP 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, 5 mg/40 mg, 10 mg/20 mg and 10 mg/40 mg. Amlodipine and benazepril hydrochloride capsules USP, 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. NDC 68001-132-00    Bottles of 100 capsules Amlodipine and benazepril hydrochloride capsules USP, 5 mg/10 mg are size '2' capsules with yellow opaque cap and yellow 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 and benazepril hydrochloride capsules USP, 5 mg/20 mg are size '2' capsules 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, plain on both sides. NDC 68001-134-00    Bottles of 100 capsules Amlodipine and benazepril hydrochloride capsules USP, 5 mg/40 mg are size '2' capsules with dark green cap and white body, imprinted with 'LU' (in black ink) on cap and 'E15' (in black ink) on body, containing white to off-white powder and two white to off-white, circular tablet, plain on both sides. NDC 68001-135-00    Bottles of 100 capsules Amlodipine and benazepril hydrochloride capsules USP, 10 mg/20 mg are size '2' capsules with brown cap and brown 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, plain on both sides. NDC 68001-130-00    Bottles of 100 capsules Amlodipine and benazepril hydrochloride capsules USP, 10 mg/40 mg are size '2' capsules with dark blue cap and white body, imprinted with 'LU' (in black ink) on cap and 'E16' (in black ink) on body, containing white to off-white powder and two white to off-white, circular tablet, plain on both sides. NDC 68001-131-00    Bottles of 100 capsules 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

Patient Information leaflet

HYDROCHLORIDE CAPSULE
BluePoint Laboratories
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Patient Information
AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE
(am loe′ di peen and ben az′ e pril hye′′ droe klor′ ide)
CAPSULES
Read this Patient Information leaflet before you start taking
amlodipine and benazepril hydrochloride
capsules and each time you get a refill. There may be new information.
This leaflet does not replace
talking with your doctor. If you have any questions, ask your doctor
or pharmacist.
What is the most important information I should know about amlodipine
and benazepril hydrochloride
capsules?
•
Amlodipine and benazepril hydrochloride capsules can cause harm or
death to an unborn baby.
•
Talk to your doctor about other ways to lower your blood pressure if
you plan to become pregnant.
•
If you get pregnant while taking amlodipine and benazepril
hydrochloride capsules, tell your
doctor right away.
What is amlodipine and benazepril hydrochloride capsule?
Amlodipine and benazepril hydrochloride capsule contains 2
prescription medicines that work together to
lower blood pressure: amlodipine besylate, a calcium channel blocker,
and benazepril hydrochloride, an
ACE inhibitor. Your doctor will prescribe amlodipine and benazepril
hydrochloride capsules only after
other medicines haven't worked.
High Blood Pressure (hypertension).Blood pressure is the force of
blood in your blood vessels. You have
high blood pressure when the force is too much. Amlodipine and
benazepril hydrochloride capsules can
help your blood vessels relax so your blood pressure is lower.
Amlodipine and benazepril hydrochloride capsules have not been studied
in children.
Who should not take amlodipine and benazepril hydrochloride capsules?
Don't take amlodipine and benazepril hydrochloride capsules if you are
allergic to any of the ingredients.
There is a complete list at the end of this leaflet.
What should I tell my Doctor before taking amlodipine and benazepril
hydrochloride capsules?
Tell your doctor about all your medical conditions, including if:
•
yo

Summary of Product characteristics

AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE- AMLODIPINE
BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE
BLUEPOINT LABORATORIES
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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 capsule, is a combination
capsule of amlodipine, a
dihydropyridine calcium channel blocker (DHP CCB) and benazepril, an
angiotensin converting-enzyme
(ACE) inhibitor. Amlodipine and benazepril hydrochloride capsule, is
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): 2.5/10, 5/10, 5/20, 5/40, 10/20,
10/40 ( 3)
CONTRAINDICATIONS
Do not co-administer aliskiren with ACE inhibitors, including
amlodipine and benazepril hydrochloride in
patients with diabetes. ( 4)
Amlodipine and benazepril hydrochloride is contraindicated in patients
with a history of angioedema, or
patients who are hypersensitive to benazepril or to amlodipine. ( 4)
Amlodipine and b