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 2,693 patients (2,145 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, USP at a dose equivalent to 5 or 10 mg amlodipine and olmesartan medoxomil, USP in the strengths described below.

Amlodipine and olmesartan medoxomil tablets are differentiated by tablet color/size. Amlodipine and olmesartan medoxomil tablets are supplied for oral administration in the following strength and package configurations:

Amlodipine and olmesartan medoxomil tablets 5/20 mg are white to off white, round, film coated tablets debossed with “24” on one side and plain on the other side.

Bottles of 30 NDC 13668-324-30

Bottles of 90 NDC 13668-324-90

Bottles of 500 NDC 13668-324-05

Bottles of 1,000 NDC 13668-324-10

100 Unit Dose Tablets NDC 13668-324-74

Amlodipine and olmesartan medoxomil tablets 10/20 mg are pale orange to light brown, round, film coated tablets debossed with “72” on one side and plain on the other side.

Bottles of 30 NDC 13668-312-30

Bottles of 90 NDC 13668-312-90

Bottles of 500 NDC 13668-312-05

Bottles of 1,000 NDC 13668-312-10

100 Unit Dose Tablets NDC 13668-312-74

Amlodipine and olmesartan medoxomil tablets 5/40 mg are cream to yellow, round, film coated tablets debossed with “1313” on one side and plain on the other side.

Bottles of 30 NDC 13668-313-30

Bottles of 90 NDC 13668-313-90

Bottles of 500 NDC 13668-313-05

Bottles of 1,000 NDC 13668-313-10

100 Unit Dose Tablets NDC 13668-313-74

Amlodipine and olmesartan medoxomil tablets 10/40 mg are brownish red, round, film coated tablets debossed with “1311” on one side and plain on the other side.

Bottles of 30 NDC 13668-311-30

Bottles of 90 NDC 13668-311-90

Bottles of 500 NDC 13668-311-05

Bottles of 1,000 NDC 13668-311-10

100 Unit Dose Tablets NDC 13668-311-74

Store at 20° to 25°C (68° to 77°F); excursions permitted between 15°C and 30°C (59°F and 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.

Trade marks are property of the respective owner.

logo

Manufactured by:

TORRENT PHARMACEUTICALS LTD., INDIA.

Manufactured for:

TORRENT PHARMA INC., Basking Ridge, NJ 07920.

8081085 Revised: 12/2020

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Amlodipine and olmesartan medoxomil tablets 5/20 mg

Amlo Olme 5-20
(click image for full-size original)

Amlodipine and olmesartan medoxomil tablets 10/20 mg

Amlo Olme 10-20
(click image for full-size original)

Amlodipine and olmesartan medoxomil tablets 5/40 mg

Amlo Olme 5-40
(click image for full-size original)

Amlodipine and olmesartan medoxomil tablets 10/40 mg

Amlo Olme 10-40
(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:13668-324
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMLODIPINE (AMLODIPINE) AMLODIPINE 5 mg
OLMESARTAN MEDOXOMIL (OLMESARTAN) OLMESARTAN MEDOXOMIL 20 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
LACTOSE MONOHYDRATE
TALC
POLYVINYL ALCOHOL, UNSPECIFIED
TITANIUM DIOXIDE
MAGNESIUM STEARATE
STARCH, CORN
SUCCINIMIDYL-4-(N-MALEIMIDOMETHYL)CYCLOHEXANE-1-CARBOXYLATE
POLYETHYLENE GLYCOL 400
Product Characteristics
Color white (white to off white, round, film coated tablets) Score no score
Shape ROUND (white to off white, round, film coated tablets) Size 3mm
Flavor Imprint Code debossedwith24ononeside
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:13668-324-05 500 TABLET in 1 BOTTLE None
2 NDC:13668-324-10 1000 TABLET in 1 BOTTLE None
3 NDC:13668-324-74 100 TABLET in 1 BOTTLE None
4 NDC:13668-324-30 30 TABLET in 1 BOTTLE None
5 NDC:13668-324-90 90 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202933 11/25/2016
AMLODIPINE AND OLMESARTAN MEDOXOMIL amlodipine and olmesartan medoxomil tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:13668-312
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMLODIPINE (AMLODIPINE) AMLODIPINE 10 mg
OLMESARTAN MEDOXOMIL (OLMESARTAN) OLMESARTAN MEDOXOMIL 20 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
LACTOSE MONOHYDRATE
TALC
POLYVINYL ALCOHOL, UNSPECIFIED
TITANIUM DIOXIDE
FERRIC OXIDE YELLOW
FERRIC OXIDE RED
MAGNESIUM STEARATE
STARCH, CORN
SUCCINIMIDYL-4-(N-MALEIMIDOMETHYL)CYCLOHEXANE-1-CARBOXYLATE
POLYETHYLENE GLYCOL 400
Product Characteristics
Color orange (pale orange to light brown film coated tablets) Score no score
Shape ROUND (pale orange to light brown film coated tablets) Size 3mm
Flavor Imprint Code debossdwith72ononeside
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:13668-312-30 30 TABLET in 1 BOTTLE None
2 NDC:13668-312-90 90 TABLET in 1 BOTTLE None
3 NDC:13668-312-05 500 TABLET in 1 BOTTLE None
4 NDC:13668-312-10 1000 TABLET in 1 BOTTLE None
5 NDC:13668-312-74 100 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202933 11/25/2016
AMLODIPINE AND OLMESARTAN MEDOXOMIL amlodipine and olmesartan medoxomil tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:13668-313
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMLODIPINE (AMLODIPINE) AMLODIPINE 5 mg
OLMESARTAN MEDOXOMIL (OLMESARTAN) OLMESARTAN MEDOXOMIL 40 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
LACTOSE MONOHYDRATE
TALC
POLYVINYL ALCOHOL, UNSPECIFIED
TITANIUM DIOXIDE
FERRIC OXIDE YELLOW
MAGNESIUM STEARATE
STARCH, CORN
SUCCINIMIDYL-4-(N-MALEIMIDOMETHYL)CYCLOHEXANE-1-CARBOXYLATE
POLYETHYLENE GLYCOL 400
Product Characteristics
Color yellow (cream to yellow, round, film coated tablets) Score no score
Shape ROUND (cream to yellow, round, film coated tablets) Size 4mm
Flavor Imprint Code debossedwith1313ononeside
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:13668-313-30 30 TABLET in 1 BOTTLE None
2 NDC:13668-313-90 90 TABLET in 1 BOTTLE None
3 NDC:13668-313-05 500 TABLET in 1 BOTTLE None
4 NDC:13668-313-10 1000 TABLET in 1 BOTTLE None
5 NDC:13668-313-74 100 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202933 11/25/2016
AMLODIPINE AND OLMESARTAN MEDOXOMIL amlodipine and olmesartan medoxomil tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:13668-311
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMLODIPINE (AMLODIPINE) AMLODIPINE 10 mg
OLMESARTAN MEDOXOMIL (OLMESARTAN) OLMESARTAN MEDOXOMIL 40 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
LACTOSE MONOHYDRATE
TALC
POLYVINYL ALCOHOL, UNSPECIFIED
TITANIUM DIOXIDE
FERRIC OXIDE YELLOW
FERRIC OXIDE RED
MAGNESIUM STEARATE
STARCH, CORN
SUCCINIMIDYL-4-(N-MALEIMIDOMETHYL)CYCLOHEXANE-1-CARBOXYLATE
POLYETHYLENE GLYCOL 400
Product Characteristics
Color red (brownish red,round, film coated tablets) Score no score
Shape ROUND (Brownish red,round, film coated tablets) Size 4mm
Flavor Imprint Code debossedwith1311ononeside
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:13668-311-30 30 TABLET in 1 BOTTLE None
2 NDC:13668-311-90 90 TABLET in 1 BOTTLE None
3 NDC:13668-311-05 500 TABLET in 1 BOTTLE None
4 NDC:13668-311-10 1000 TABLET in 1 BOTTLE None
5 NDC:13668-311-74 100 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202933 11/25/2016
Labeler — Torrent Pharmaceuticals Limited (916488547)

Revised: 01/2021 Torrent Pharmaceuticals Limited

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