AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE capsule

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

Clinical Solutions Wholesale

INN (Διεθνής Όνομα):

AMLODIPINE BESYLATE

Σύνθεση:

AMLODIPINE 2.5 mg

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

Amlodipine Besylate and Benazepril Hydrochloride Capsules are indicated for the treatment of hypertension in patients not adequately controlled on monotherapy with either agent.   Amlodipine Besylate 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, or to amlodipine. 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 hypoplasia, anuria, hypotension, renal failure, and death. When pregnancy is detected, discontinue Amlodipine Besylate and Benazepril Hydrochloride Capsules as soon as possible. These adverse outcomes are usually associat

Περίληψη προϊόντος:

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: Storage: Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F). [See USP controlled room temperature.] Protect from moisture. Dispense in tight container (USP).

Καθεστώς αδειοδότησης:

New Drug Application Authorized Generic

Αρχείο Π.Χ.Π.

AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE- AMLODIPINE BESYLATE
AND
BENAZEPRIL HYDROCHLORIDE CAPSULE
CLINICAL SOLUTIONS WHOLESALE
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO
USEAMLODIPINEBESYLATE AND BENAZEPRIL
HYDROCHLORIDE CAPSULES SAFELY AND EFFECTIVELY.SEE FULL PRESCRIBING
INFORMATION FORAMLODIPINEBESYLATE AND
BENAZEPRIL HYDROCHLORIDE CAPSULES.
AMLODIPINEBESYLATE AND BENAZEPRILHYDROCHLORIDE CAPSULES
INITIAL U.S. APPROVAL:1995
WARNING:FETAL TOXICITY
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_
WHEN PREGNANCY IS DETECTED, DISCONTINUE AMLODIPINEBESYLATE AND
BENAZEPRIL HYDROCHLORIDE CAPSULES AS
SOON AS POSSIBLE (5.4). DRUGS THAT ACT DIRECTLY ON THE
RENIN-ANGIOTENSIN SYSTEM CAN CAUSE INJURY AND DEATH
TO THE DEVELOPING FETUS (5.4).
RECENT MAJOR CHANGES
Boxed Warning: Fetal Toxicity 01/2012
Warnings and Precautions: Fetal Toxicity (5.4) 01/2012
INDICATIONS AND USAGE
Amlodipine Besylate 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 Besylate 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
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
capsules containing a lower dose of amlodipine
(2.2)
Start Amlodipine Besylate and Benazepril Hydrochloride Capsules at
2.5/10 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 Capsules are
contraindicated in patients with a hist