Amlodipine and Olmesartan Medoxomil (Page 7 of 7)

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

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

Amlodipine and Olmesartan Medoxomil tablets are differentiated by tablet color/size and are debossed with an individual product tablet code on one side. Amlodipine and Olmesartan Medoxomil 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 67877-499-30 A22 Off White
Bottle of 90 67877-499-90
10/20 mg Bottle of 30 67877-500-30 A24 Grayish Orange
Bottle of 90 67877-500-90
5/40 mg Bottle of 30 67877-501-30 A23 Light Yellow
Bottle of 90 67877-501-90
10/40 mg Bottle of 30 67877-502-30 A21 Brownish Red
Bottle of 90 67877-502-90

Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

17 PATIENT COUNSELING INFORMATION

Pregnancy: Advise female patients of childbearing age about the consequences of exposure to Amlodipine and Olmesartan Medoxomil Tablets 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 Amlodipine and Olmesartan Medoxomil Tablets [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 by:

Alkem Laboratories Ltd.,

INDIA.

Distributed by:

Ascend Laboratories, LLC

Parsippany, NJ 07054

Revised: August, 2023

PT 2615-03

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 67877-499-30

Amlodipine and Olmesartan Medoxomil Tablets 5mg/20mg

Rx Only 30 Tablets

Amlodipine and Olmesartan 5-20-30
(click image for full-size original)

NDC 67877-501-90

Amlodipine and Olmesartan Medoxomil Tablets 5mg/40mg

Rx Only 90 Tablets

Amlodipine and Olmesartan 5-40-90
(click image for full-size original)

NDC 67877-500-90

Amlodipine and Olmesartan Medoxomil Tablets 10mg/20mg

Rx Only 90 Tablets

Amlodipine and Olmesartan 10-20-90
(click image for full-size original)

NDC 67877-502-30

Amlodipine and Olmesartan Medoxomil Tablets 10mg/40mg

Rx Only 30 Tablets

Amlodipine and Olmesartan 10-40-30
(click image for full-size original)

AMLODIPINE AND OLMESARTAN MEDOXOMIL amlodipine and olmesartan medoxomil tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:67877-499
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
CROSCARMELLOSE SODIUM
STEARIC ACID
STARCH, CORN
MAGNESIUM STEARATE
POLYVINYL ALCOHOL, UNSPECIFIED
POLYETHYLENE GLYCOL 3350
TITANIUM DIOXIDE
TALC
Product Characteristics
Color WHITE (WHITE TO OFF WHITE) Score no score
Shape ROUND Size 6mm
Flavor Imprint Code A22
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:67877-499-30 30 TABLET in 1 BOTTLE None
2 NDC:67877-499-90 90 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA209042 08/14/2017
AMLODIPINE AND OLMESARTAN MEDOXOMIL amlodipine and olmesartan medoxomil tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:67877-500
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
CROSCARMELLOSE SODIUM
STEARIC ACID
STARCH, CORN
MAGNESIUM STEARATE
POLYVINYL ALCOHOL, UNSPECIFIED
POLYETHYLENE GLYCOL 3350
TITANIUM DIOXIDE
TALC
FERRIC OXIDE YELLOW
FERRIC OXIDE RED
FERROSOFERRIC OXIDE
Product Characteristics
Color ORANGE (GRAYISH ORANGE) Score no score
Shape ROUND Size 8mm
Flavor Imprint Code A24
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:67877-500-30 30 TABLET in 1 BOTTLE None
2 NDC:67877-500-90 90 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA209042 08/14/2017
AMLODIPINE AND OLMESARTAN MEDOXOMIL amlodipine and olmesartan medoxomil tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:67877-501
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
CROSCARMELLOSE SODIUM
STEARIC ACID
STARCH, CORN
MAGNESIUM STEARATE
POLYVINYL ALCOHOL, UNSPECIFIED
POLYETHYLENE GLYCOL 3350
TITANIUM DIOXIDE
TALC
FERRIC OXIDE YELLOW
MICROCRYSTALLINE CELLULOSE
Product Characteristics
Color WHITE (Cream to light yellow) Score no score
Shape ROUND Size 8mm
Flavor Imprint Code A23
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:67877-501-30 30 TABLET in 1 BOTTLE None
2 NDC:67877-501-90 90 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA209042 08/14/2017
AMLODIPINE AND OLMESARTAN MEDOXOMIL amlodipine and olmesartan medoxomil tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:67877-502
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
CROSCARMELLOSE SODIUM
STEARIC ACID
STARCH, CORN
MAGNESIUM STEARATE
POLYVINYL ALCOHOL, UNSPECIFIED
POLYETHYLENE GLYCOL 3350
TITANIUM DIOXIDE
TALC
FERRIC OXIDE YELLOW
FERRIC OXIDE RED
Product Characteristics
Color RED (BROWNISH RED) Score no score
Shape ROUND Size 8mm
Flavor Imprint Code A21
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:67877-502-30 30 TABLET in 1 BOTTLE None
2 NDC:67877-502-90 90 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA209042 08/14/2017
Labeler — Ascend Laboratories, LLC (141250469)
Establishment
Name Address ID/FEI Operations
Alkem Laboratories Limited 677605851 ANALYSIS (67877-499), ANALYSIS (67877-500), ANALYSIS (67877-501), ANALYSIS (67877-502), MANUFACTURE (67877-499), MANUFACTURE (67877-500), MANUFACTURE (67877-501), MANUFACTURE (67877-502), PACK (67877-499), PACK (67877-500), PACK (67877-501), PACK (67877-502)

Revised: 08/2023 Ascend Laboratories, LLC

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