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
NDC 67877-501-90
Amlodipine and Olmesartan Medoxomil Tablets 5mg/40mg
Rx Only 90 Tablets
NDC 67877-500-90
Amlodipine and Olmesartan Medoxomil Tablets 10mg/20mg
Rx Only 90 Tablets
NDC 67877-502-30
Amlodipine and Olmesartan Medoxomil Tablets 10mg/40mg
Rx Only 30 Tablets
AMLODIPINE AND OLMESARTAN MEDOXOMIL amlodipine and olmesartan medoxomil tablet | ||||||||||||||||||||||
| ||||||||||||||||||||||
| ||||||||||||||||||||||
| ||||||||||||||||||||||
| ||||||||||||||||||||||
| ||||||||||||||||||||||
|
AMLODIPINE AND OLMESARTAN MEDOXOMIL amlodipine and olmesartan medoxomil tablet | ||||||||||||||||||||||||||||
| ||||||||||||||||||||||||||||
| ||||||||||||||||||||||||||||
| ||||||||||||||||||||||||||||
| ||||||||||||||||||||||||||||
| ||||||||||||||||||||||||||||
|
AMLODIPINE AND OLMESARTAN MEDOXOMIL amlodipine and olmesartan medoxomil tablet | ||||||||||||||||||||||||
| ||||||||||||||||||||||||
| ||||||||||||||||||||||||
| ||||||||||||||||||||||||
| ||||||||||||||||||||||||
| ||||||||||||||||||||||||
|
AMLODIPINE AND OLMESARTAN MEDOXOMIL amlodipine and olmesartan medoxomil tablet | ||||||||||||||||||||||||||
| ||||||||||||||||||||||||||
| ||||||||||||||||||||||||||
| ||||||||||||||||||||||||||
| ||||||||||||||||||||||||||
| ||||||||||||||||||||||||||
|
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
All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.
https://medlibrary.org/lib/rx/meds/amlodipine-and-olmesartan-medoxomil-12/page/7/