AMLODIPINE AND OLMESARTAN MEDOXOMIL (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

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 5/20 mg

Amlodipine and Olmesartan medoxomil tablets are white colored, round shaped, biconvex, film-coated tablet debossed with ‘81’ on one side and ‘I’ on other side and contain 5 mg Amlodipine and 20 mg Olmesartan medoxomil. They are supplied in

Bottles of 30 NDC 42571-235-30

Bottles of 90 NDC 42571-235-90

Bottles of 500 NDC 42571-235-05

Bottles of 1000 NDC 42571-235-10

Tablet Strength 10/20 mg

Amlodipine and Olmesartan medoxomil tablets are grayish orange colored, round shaped, biconvex, film-coated tablet debossed with ‘83’ on one side and ‘I’ on other side and contain 10 mg Amlodipine and 20 mg Olmesartan medoxomil. They are supplied in

Bottles of 30 NDC 42571-236-30

Bottles of 90 NDC 42571-236-90

Bottles of 500 NDC 42571-236-05

Bottles of 1000 NDC 42571-236-10

Tablet Strength 5/40 mg

Amlodipine and Olmesartan medoxomil tablets are cream colored, round shaped, biconvex, film-coated tablet debossed with ‘82’ on one side and ‘I’ on other side and contain 5 mg Amlodipine and 40 mg Olmesartan medoxomil. They are supplied in

Bottles of 30 NDC 42571-237-30

Bottles of 90 NDC 42571-237-90

Bottles of 500 NDC 42571-237-05

Bottles of 1000 NDC 42571-237-10

Tablet Strength 10/40 mg

Amlodipine and Olmesartan medoxomil tablets are Brownish red colored, round shaped, biconvex, film-coated tablet debossed with ‘84’ on one side and ‘I’ on other side and contain 10 mg Amlodipine and 40 mg Olmesartan medoxomil. They are supplied in

Bottles of 30 NDC 42571-238-30

Bottles of 90 NDC 42571-238-90

Bottles of 500 NDC 42571-238-05

Bottles of 1000 NDC 42571-238-10

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.

The brands listed are trademarks of their respective owners and are not trademarks of Micro Labs. The makers of these brands are not affiliated with and do not endorse Micro Labs or its products.

Rx Only

Manufactured by:

Micro Labs Limited

Goa- 403 722, INDIA.

Manufactured for:

Micro Labs USA Inc.

Somerset, NJ 08873

Rev.10/2021

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 42571-235-30
Amlodipine and Olmesartan Medoxomil Tablets
5 mg/20 mg
Rx Only
30 Tablets MICRO LABS LIMITED

//medlibrary.org/lib/images-rx/amlodipine-and-olmesartan-medoxomil-10/amlodipineolmesartan-lbl-a-300x112.jpg
(click image for full-size original)

NDC 42571-236-30
Amlodipine and Olmesartan Medoxomil Tablets
10 mg/20 mg
Rx Only
30 Tablets MICRO LABS LIMITED

//medlibrary.org/lib/images-rx/amlodipine-and-olmesartan-medoxomil-10/amlodipineolmesartan-lbl-b-300x111.jpg
(click image for full-size original)

NDC 42571-237-30
Amlodipine and Olmesartan Medoxomil Tablets
5 mg/40 mg
Rx Only
30 Tablets MICRO LABS LIMITED

//medlibrary.org/lib/images-rx/amlodipine-and-olmesartan-medoxomil-10/amlodipineolmesartan-lbl-c-300x112.jpg
(click image for full-size original)

NDC 42571-238-30
Amlodipine and Olmesartan Medoxomil Tablets
10 mg/40 mg
Rx Only
30 Tablets MICRO LABS LIMITED

//medlibrary.org/lib/images-rx/amlodipine-and-olmesartan-medoxomil-10/amlodipineolmesartan-lbl-d-300x111.jpg
(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:42571-235
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
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
STARCH, CORN
CELLULOSE, MICROCRYSTALLINE
POLYVINYL ALCOHOL
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL, UNSPECIFIED
TALC
Product Characteristics
Color white Score no score
Shape ROUND (biconvex) Size 6mm
Flavor Imprint Code 81;I
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42571-235-30 30 TABLET in 1 BOTTLE None
2 NDC:42571-235-90 90 TABLET in 1 BOTTLE None
3 NDC:42571-235-05 500 TABLET in 1 BOTTLE None
4 NDC:42571-235-10 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207435 01/01/2018
AMLODIPINE AND OLMESARTAN MEDOXOMIL amlodipine and olmesartan medoxomil tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42571-236
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
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
STARCH, CORN
CELLULOSE, MICROCRYSTALLINE
POLYVINYL ALCOHOL
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL, UNSPECIFIED
TALC
FERRIC OXIDE YELLOW
FERRIC OXIDE RED
Product Characteristics
Color orange (Grayish orange) Score no score
Shape ROUND (biconvex) Size 8mm
Flavor Imprint Code 83;I
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42571-236-30 30 TABLET in 1 BOTTLE None
2 NDC:42571-236-90 90 TABLET in 1 BOTTLE None
3 NDC:42571-236-05 500 TABLET in 1 BOTTLE None
4 NDC:42571-236-10 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207435 01/01/2018
AMLODIPINE AND OLMESARTAN MEDOXOMIL amlodipine and olmesartan medoxomil tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42571-237
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
MAGNESIUM STEARATE
STARCH, CORN
CELLULOSE, MICROCRYSTALLINE
POLYVINYL ALCOHOL
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL, UNSPECIFIED
TALC
FERRIC OXIDE YELLOW
Product Characteristics
Color yellow (Cream) Score no score
Shape ROUND (biconvex) Size 8mm
Flavor Imprint Code 82;I
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42571-237-30 30 TABLET in 1 BOTTLE None
2 NDC:42571-237-90 90 TABLET in 1 BOTTLE None
3 NDC:42571-237-05 500 TABLET in 1 BOTTLE None
4 NDC:42571-237-10 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207435 01/01/2018
AMLODIPINE AND OLMESARTAN MEDOXOMIL amlodipine and olmesartan medoxomil tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42571-238
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
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
STARCH, CORN
CELLULOSE, MICROCRYSTALLINE
POLYVINYL ALCOHOL
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL, UNSPECIFIED
TALC
FERRIC OXIDE YELLOW
FERRIC OXIDE RED
FERROSOFERRIC OXIDE
Product Characteristics
Color red (Brownish red) Score no score
Shape ROUND (biconvex) Size 8mm
Flavor Imprint Code 84;I
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42571-238-30 30 TABLET in 1 BOTTLE None
2 NDC:42571-238-90 90 TABLET in 1 BOTTLE None
3 NDC:42571-238-05 500 TABLET in 1 BOTTLE None
4 NDC:42571-238-10 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207435 01/01/2018
Labeler — Micro Labs Limited (862174955)
Establishment
Name Address ID/FEI Operations
Micro Labs Limited 915793658 analysis (42571-235), analysis (42571-236), analysis (42571-237), analysis (42571-238), label (42571-235), label (42571-236), label (42571-237), label (42571-238), manufacture (42571-235), manufacture (42571-236), manufacture (42571-237), manufacture (42571-238), pack (42571-235), pack (42571-236), pack (42571-237), pack (42571-238)

Revised: 11/2021 Micro Labs Limited

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