AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE capsule

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Aktív összetevők:

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

Beszerezhető a:

Par Pharmaceutical Inc.

INN (nemzetközi neve):

AMLODIPINE BESYLATE

Összetétel:

AMLODIPINE 2.5 mg

Az alkalmazás módja:

ORAL

Recept típusa:

PRESCRIPTION DRUG

Terápiás javallatok:

Amlodipine besylate and benazepril hydrochloride capsules is 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, ACE inhibitors, including Amlodipine in patients with diabetes. ● Amlodipine besylate and benazepril hydrochloride 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 inhibitor, to amlodipine, or to any of the excipients of amlodipine besylate and benazepril hydrochloride capsules. Pregnancy Category D Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. Resulting oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations. Potential neonatal adverse effects include skull hypop

Termék összefoglaló:

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, 5 mg/40 mg, 10 mg/20 mg or 10 mg/40 mg. All six strengths are packaged with desiccant in bottles of 100 or 500 capsules. Capsules are imprinted with “Par” and appropriate code. Dose Capsule Color/Code NDC Code Bottle of 100 NDC Code Bottle of 500 2.5 mg/10 mg green/929 NDC 49884-929-01 NDC 49884-929-05 5 mg/10 mg peach/930 NDC 49884-930-01 NDC 49884-930-05 5 mg/20 mg pink/931 NDC 49884-931-01 NDC 49884-931-05 5 mg/40 mg blue/952 NDC 49884-952-01 NDC 49884-952-05 10 mg/20 mg lavender/932 NDC 49884-932-01 NDC 49884-932-05 10 mg/40 mg blue/953 NDC 49884-953-01 NDC 49884-953-05 Storage: Store at 20° to 25°C (68° to 77°F) [See USP controlled room temperature.] Protect from moisture. Dispense in tight container (USP).

Engedélyezési státusz:

Abbreviated New Drug Application

Termékjellemzők

AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE- AMLODIPINE BESYLATE
AND
BENAZEPRIL HYDROCHLORIDE CAPSULE
PAR PHARMACEUTICAL 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
RECENT MAJOR CHANGES
Boxed Warning: Fetal Toxicity 01/2012
Dosage and Administration (2) 10/2012
Contraidications (4) 10/2012
Warnings and Precautions: Fetal Toxicity ( 5.4) 01/2012
INDICATIONS AND USAGE
Amlodipine besylate and benazepril hydrochloride capsules 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 capsules is indicated for the
treatment of hypertension in patients not adequately
controlled on monotherapy with either agent.( 1)
DOSAGE AND ADMINISTRATION
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•
•
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DOSAGE FORMS AND STRENGTHS
Capsules (amlodipine besylate and benazepril hydrochloride): 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 co-administer aliskiren with ARBs or ACEI’s, including
Amlodipine besylate and benazepril hydrochloride capsules
in patients with diabetes. (4)
Amlodipine besylate and benazepril hydrochloride 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 inhibitor,
or to amlodipine. ( 4)
WARNINGS AND PRECAUTIONS
•
•
•
•
•
ADVERSE REACTIONS
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT PAR PHARMACEUTICAL INC.
AT 1-800-828-9393 OR
WWW.PARPHARM.COM OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
Discontinuation because of adverse reactions occurred in 4% of
aml