Azor (Page 7 of 7)

14.2 Amlodipine

The antihypertensive efficacy of amlodipine has been demonstrated in a total of 15 double-blind, placebo-controlled, randomized studies involving 800 patients on amlodipine and 538 on placebo. Once daily administration produced statistically significant placebo-corrected reductions in supine and standing blood pressures at 24 hours post-dose, averaging about 12/6 mmHg in the standing position and 13/7 mmHg in the supine position in patients with mild to moderate hypertension. Maintenance of the blood pressure effect over the 24-hour dosing interval was observed, with little difference in peak and trough effect.

14.3 Olmesartan Medoxomil

The antihypertensive effects of olmesartan medoxomil have been demonstrated in seven placebo-controlled studies at doses ranging from 2.5 mg to 80 mg for 6 to 12 weeks, each showing statistically significant reductions in peak and trough blood pressure. A total of 2693 patients (2145 olmesartan medoxomil; 548 placebo) with essential hypertension were studied. The blood pressure lowering effect was maintained throughout the 24-hour period with olmesartan medoxomil once daily, with trough-to-peak ratios for systolic and diastolic response between 60% and 80%.

16 HOW SUPPLIED/STORAGE AND HANDLING

Azor tablets contain amlodipine besylate at a dose equivalent to 5 or 10 mg amlodipine and olmesartan medoxomil in the strengths described below.

Azor tablets are differentiated by tablet color/size and are debossed with an individual product tablet code on one side. Azor tablets are supplied for oral administration in the following strength and package configurations:

Tablet Strength ( amlodipine equivalent/ olmesartan medoxomil) mg Package Configuration NDC# Product Code Tablet Color
5/20 mg Bottle of 30 Bottle of 90 10 blisters of 10 Bottle of 1000 65597-110-3065597-110-9065597-110-1065597-110-11 C73 White
10/20 mg Bottle of 30 Bottle of 90 10 blisters of 10 Bottle of 1000 65597-111-3065597-111-9065597-111-1065597-111-11 C74 Grayish Orange
5/40 mg Bottle of 30 Bottle of 90 10 blisters of 10Bottle of 1000 65597-112-3065597-112-9065597-112-1065597-112-11 C75 Cream
10/40 mg Bottle of 30Bottle of 90 10 blisters of 10 Bottle of 1000 65597-113-3065597-113-9065597-113-1065597-113-11 C77 Brownish Red

Store at 25ºC (77ºF); excursions permitted to 15ºC-30ºC (59ºF-86ºF) [see USP Controlled Room Temperature].

17 PATIENT COUNSELING INFORMATION

Pregnancy: Advise female patients of childbearing age about the consequences of exposure to Azor during pregnancy. Discuss treatment options with women planning to become pregnant. Tell patients to report pregnancies to their physicians as soon as possible [see Warnings and Precautions (5.1) and Use in Specific Populations (8.1)].

Lactation: Advise nursing women not to breastfeed during treatment with Azor [see Use in Specific Populations (8.2)].

Potassium Supplements: Advise patients not to use potassium supplements or salt substitutes containing potassium without consulting their healthcare provider.

Manufactured for Daiichi Sankyo, Inc., Basking Ridge, NJ 07920

Manufactured by Daiichi Sankyo Europe GmbH, Germany

Copyright © Daiichi Sankyo, Inc. 2020. All rights reserved.

USPI-AZO-C9.1-1020-r100

PRINCIPAL DISPLAY PANEL

NDC 65597-110-30

AZOR

amlodipine and olmesartan medoxomil

5 mg/ 20 mg

30 Tablets

PRINCIPAL DISPLAY PANEL NDC 65597-110-30 AZOR amlodipine and olmesartan medoxomil 5 mg/ 20 mg 30 Tablets Rx Only
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

NDC 65597-111-30

AZOR

amlodipine and olmesartan medoxomil

10 mg/ 20 mg

30 Tablets

PRINCIPAL DISPLAY PANEL NDC 65597-111-30 AZOR amlodipine and olmesartan medoxomil 10 mg/ 20 mg 30 Tablets Rx Only
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

NDC 65597-112-30

AZOR

amlodipine and olmesartan medoxomil

5 mg/ 40 mg

30 Tablets

PRINCIPAL DISPLAY PANEL NDC 65597-112-30 AZOR amlodipine and olmesartan medoxomil 5 mg/ 40 mg 30 Tablets Rx Only
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

NDC 65597-113-30

AZOR

amlodipine and olmesartan medoxomil

10 mg/ 40 mg

30 Tablets

PRINCIPAL DISPLAY PANEL NDC 65597-113-30 AZOR amlodipine and olmesartan medoxomil 10 mg/ 40 mg 30 Tablets Rx Only
(click image for full-size original)

AZOR amlodipine besylate and olmesartan medoxomil tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65597-110
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMLODIPINE BESYLATE (AMLODIPINE) AMLODIPINE 5 mg
OLMESARTAN MEDOXOMIL (OLMESARTAN) OLMESARTAN MEDOXOMIL 20 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE
STARCH, CORN
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
POLYVINYL ALCOHOL, UNSPECIFIED
POLYETHYLENE GLYCOL 3350
TITANIUM DIOXIDE
TALC
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 6mm
Flavor Imprint Code C73
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65597-110-10 10 BLISTER PACK in 1 BOX contains a BLISTER PACK
1 10 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the BOX (65597-110-10)
2 NDC:65597-110-07 7 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
3 NDC:65597-110-11 1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
4 NDC:65597-110-30 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
5 NDC:65597-110-90 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022100 09/26/2007 05/31/2023
AZOR amlodipine besylate and olmesartan medoxomil tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65597-111
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMLODIPINE BESYLATE (AMLODIPINE) AMLODIPINE 10 mg
OLMESARTAN MEDOXOMIL (OLMESARTAN) OLMESARTAN MEDOXOMIL 20 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE
STARCH, CORN
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
POLYVINYL ALCOHOL, UNSPECIFIED
POLYETHYLENE GLYCOL 3350
TITANIUM DIOXIDE
TALC
FERRIC OXIDE YELLOW
FERRIC OXIDE RED
FERROSOFERRIC OXIDE
Product Characteristics
Color ORANGE (Grayish) Score no score
Shape ROUND Size 8mm
Flavor Imprint Code C74
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65597-111-10 10 BLISTER PACK in 1 BOX contains a BLISTER PACK
1 10 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the BOX (65597-111-10)
2 NDC:65597-111-07 7 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
3 NDC:65597-111-11 1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
4 NDC:65597-111-30 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
5 NDC:65597-111-90 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022100 09/26/2007 08/31/2024
AZOR amlodipine besylate and olmesartan medoxomil tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65597-112
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMLODIPINE BESYLATE (AMLODIPINE) AMLODIPINE 5 mg
OLMESARTAN MEDOXOMIL (OLMESARTAN) OLMESARTAN MEDOXOMIL 40 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE
STARCH, CORN
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
POLYVINYL ALCOHOL, UNSPECIFIED
POLYETHYLENE GLYCOL 3350
TITANIUM DIOXIDE
TALC
FERRIC OXIDE YELLOW
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 8mm
Flavor Imprint Code C75
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65597-112-10 10 BLISTER PACK in 1 BOX contains a BLISTER PACK
1 10 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the BOX (65597-112-10)
2 NDC:65597-112-07 7 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
3 NDC:65597-112-11 1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
4 NDC:65597-112-30 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
5 NDC:65597-112-90 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022100 09/26/2007 10/31/2023
AZOR amlodipine besylate and olmesartan medoxomil tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65597-113
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMLODIPINE BESYLATE (AMLODIPINE) AMLODIPINE 10 mg
OLMESARTAN MEDOXOMIL (OLMESARTAN) OLMESARTAN MEDOXOMIL 40 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE
STARCH, CORN
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
POLYVINYL ALCOHOL, UNSPECIFIED
POLYETHYLENE GLYCOL 3350
TITANIUM DIOXIDE
TALC
FERRIC OXIDE YELLOW
FERRIC OXIDE RED
Product Characteristics
Color RED Score no score
Shape ROUND Size 8mm
Flavor Imprint Code C77
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65597-113-10 10 BLISTER PACK in 1 BOX contains a BLISTER PACK
1 10 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the BOX (65597-113-10)
2 NDC:65597-113-07 7 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
3 NDC:65597-113-11 1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
4 NDC:65597-113-30 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
5 NDC:65597-113-90 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022100 09/26/2007 02/28/2025
Labeler — Daiichi Sankyo Inc. (068605067)

Revised: 06/2022 Daiichi Sankyo Inc.

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