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:

Preferred Pharmaceuticals Inc.

Az alkalmazás módja:

ORAL

Recept típusa:

PRESCRIPTION DRUG

Terápiás javallatok:

Amlodipine and benazepril hydrochloride capsules are indicated for the treatment of hypertension in patients not adequately controlled on monotherapy with either agent. Risk Summary Amlodipine and benazepril hydrochloride can cause fetal harm when administered to a pregnant woman. Use of drugs that act on the RAS during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. Most epidemiologic studies examining fetal abnormalities after exposure to antihypertensive use in the first trimester have not distinguished drugs affecting the RAS from other antihypertensive agents. When pregnancy is detected, discontinue amlodipine and benazepril hydrochloride capsules as soon as possible. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk o

Termék összefoglaló:

Amlodipine and benazepril hydrochloride capsules USP, 10 mg/20 mg contain white to off-white powder and size “4” hard gelatin capsules of flesh color cap and flesh color body, filled in size “1” hard gelatin capsule with light grey color cap and ivory color body, imprinted “RDY” on cap and “341” on body with black ink and are supplied in bottles of 30, 100 and 500.  Bottles of 30                                                               NDC 68788-8168-3 Storage: Store at 20°-25°C (68°-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
PREFERRED PHARMACEUTICALS INC.
----------
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 as soon as
possible ERROR! HYPERLINK REFERENCE NOT VALID..
Drugs that act directly on the renin-angiotensin system (RAS) can
cause injury and death to the
developing fetus ERROR! HYPERLINK REFERENCE NOT VALID..
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
4.
5.
6.
DOSAGE FORMS AND STRENGTHS
Capsules (amlodipine/benazepril mg): 2.5/10, 5/10, 5/20, 5/40, 10/20,
10/40 (3)
CONTRAINDICATIONS
4.
5.
6.
WARNINGS AND PRECAUTIONS
5.
6.
7.
8.
ADVERSE REACTIONS
Discontinuation because of adverse reactions occurred in 4% of
amlodipine and benazepril hydrochloride-
treated patients and 3% of placebo-treated patients. The most common
reasons for discontinuation of
therapy with amlodipine and benazepril hydrochloride were cough and
edema. (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT DR. REDDY’S
LABORATORIES INC. AT 1-888-
375-3784 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH .
Usual starting dose is 2.5/10 mg. (2.1)
May be used as add-on therapy for patients not adequately control