AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE capsule

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

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

Prieinama:

Dr.Reddy's Laboratories Limited

INN (Tarptautinis Pavadinimas):

AMLODIPINE BESYLATE

Sudėtis:

AMLODIPINE 2.5 mg

Vartojimo būdas:

ORAL

Recepto tipas:

PRESCRIPTION DRUG

Terapinės indikacijos:

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 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. - Amlodipine and benazepril hydrochloride is contraindicated in combination with a neprilysin inhibitor (e.g., sacubitril). Do not administer amlodipine and benazepril hydrochloride within 36 hours of switching to or from a neprilysin inhibitor, e.g., sacubitril/valsartan [see Warnings and Precautions (5.1)]. Risk Summary Amlodipine and benazepril hydrochloride c

Produkto santrauka:

Amlodipine and benazepril hydrochloride is 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. All six strengths are packaged with 1 desiccant in bottles of 30 capsules, 2 desiccants in bottles of 100 capsules and 3 desiccants in bottles of 500 capsules.  Amlodipine and benazepril hydrochloride capsules USP, 2.5 mg/10 mg contain white to off-white powder and size “4” hard gelatin capsules of ivory color cap and ivory color body, filled in size “1” hard gelatin capsule with bluish green color cap and ivory color body, imprinted “RDY”on cap and “338”on body with black ink and are supplied in bottles of 30, 100 and 500.  Bottles of 30                                                               NDC 55111-338-30 Bottles of 100                                                              NDC 55111-338-01 Bottles of 500                                                              NDC 55111-338-05  Amlodipine and benazepril hydrochloride capsules USP, 5 mg/10 mg contain white to off-white powder and size “4” hard gelatin capsules of ivory color cap and ivory color body, filled in size “1” hard gelatin capsule with yellow color cap and ivory color body, imprinted “RDY”on cap and “339” on body with black ink and are supplied in bottles of 30, 100 and 500.  Bottles of 30                                                               NDC 55111-339-30 Bottles of 100                                                             NDC 55111-339-01 Bottles of 500                                                             NDC 55111-339-05  Amlodipine and benazepril hydrochloride capsules USP, 5 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 medium orange color cap and ivory color body, imprinted “RDY” on cap and “340” on body with black ink and are supplied in bottles of 30, 100 and 500.    Bottles of 30                                                               NDC 55111-340-30 Bottles of 100                                                             NDC 55111-340-01 Bottles of 500                                                             NDC 55111-340-05  Amlodipine and benazepril hydrochloride capsules USP, 5 mg/40 mg contain white to off-white powder and size “4” hard gelatin capsules of white opaque color cap and white opaque color body, filled in size “1” hard gelatin capsule with dark brown opaque color cap and ivory opaque color body, imprinted “RDY” on cap and “587” on body with black ink and are supplied in bottles of 30, 100 and 500.  Bottles of 30                                                               NDC 55111-587-30 Bottles of 100                                                             NDC 55111-587-01 Bottles of 500                                                             NDC 55111-587-05  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 55111-341-30 Bottles of 100                                                             NDC 55111-341-01 Bottles of 500                                                             NDC 55111-341-05  Amlodipine and benazepril hydrochloride capsules USP, 10 mg/40 mg contain white to off-white powder and size “4” hard gelatin capsules of white opaque color cap and white opaque color body, filled in size “1” hard gelatin capsule with purple opaque color cap and ivory opaque color body, imprinted “RDY” on cap and “586” on body with black ink and are supplied in bottles of 30, 100 and 500.  Bottles of 30                                                               NDC 55111-586-30 Bottles of 100                                                             NDC 55111-586-01 Bottles of 500                                                             NDC 55111-586-05 Storage: Store at 20°-25°C (68°-77°F); [See USP Controlled Room Temperature.] Protect from moisture. Dispense in tight container (USP). 

Autorizacija statusas:

Abbreviated New Drug Application

Prekės savybės

AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE- AMLODIPINE
BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE
DR.REDDY'S LABORATORIES LIMITED
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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 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): 2.5/10, 5/10, 5/20, 5/40, 10/20,
10/40 (3)
CONTRAINDICATIONS
Do not coadminister 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 benazepr