Tribenzor (Page 8 of 8)
16 HOW SUPPLIED/STORAGE AND HANDLING
Tribenzor tablets contain olmesartan medoxomil, amlodipine besylate at a dose equivalent to 5 or 10 mg amlodipine, and hydrochlorothiazide in the strengths described below.
Tribenzor tablets are differentiated by tablet color/size and are debossed with an individual product tablet code on one side. Tribenzor tablets are supplied for oral administration in the following strength and package configurations:
| Tablet Strength(OM/AML equivalent/HCTZ) | Package Configuration | NDC# | Product Code | Tablet Color |
| 20 /5 /12.5 mg | Bottle of 30Bottle of 9010 blisters of 10 | 65597-114-3065597-114-9065597-114-10 | C51 | Orange white |
| 40 /5 /12.5 mg | Bottle of 30Bottle of 9010 blisters of 10 | 65597-115-3065597-115-9065597-115-10 | C53 | Light yellow |
| 40 /5 /25 mg | Bottle of 30Bottle of 9010 blisters of 10 | 65597-116-3065597-116-9065597-116-10 | C54 | Light yellow |
| 40 /10 /12.5 mg | Bottle of 30Bottle of 9010 blisters of 10 | 65597-117-3065597-117-9065597-117-10 | C55 | Grayish red |
| 40 /10 /25 mg | Bottle of 30Bottle of 9010 blisters of 10 | 65597-118-3065597-118-9065597-118-10 | C57 | Grayish red |
Store at 25ºC (77ºF); excursions permitted to 15ºC-30ºC (59ºF-86ºF) [see USP Controlled Room Temperature].
17 PATIENT COUNSELING INFORMATION
Pregnancy: Tell female patients of childbearing age about the consequences of exposure to Tribenzor 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 Tribenzor [see Use in Specific Populations (8.2)].
Symptomatic Hypotension: Advise patients that lightheadedness can occur, especially during the first days of therapy, and that it should be reported to the prescribing physician. Tell patients that if syncope occurs, Tribenzor should be discontinued until the physician has been consulted. Tell patients that inadequate fluid intake, excessive perspiration, diarrhea, or vomiting can lead to an excessive fall in blood pressure, with the same consequences of lightheadedness and possible syncope.
Non-melanoma Skin Cancer: Instruct patients taking hydrochlorothiazide to protect skin from the sun and undergo regular skin cancer screening.
Potassium Supplements: Advise patients not to use potassium supplements or salt substitutes containing potassium without consulting their healthcare provider.
Acute myopia and secondary angle-closure glaucoma: Advise patients to discontinue Tribenzor and seek immediate medical attention if they experience symptoms of acute myopia or secondary angle-closure glaucoma [see Warnings and Precautions (5.9)].
Manufactured for Daiichi Sankyo, Inc., Basking Ridge, NJ 07920Manufactured by Daiichi Sankyo Europe GmbH, Germany
Copyright © Daiichi Sankyo, Inc. 2020. All rights reserved.
USPI-TRI-C9-1020-r101
PRINCIPAL DISPLAY PANEL
NDC 65597-114-30
TRIBENZOR
(olmesartan medoxomil, amlodipine, hydrochlorothiazide) tablets
20 mg/5 mg* 12.5 mg
30 Tablets
PRINCIPAL DISPLAY PANEL
NDC 65597-115-30
TRIBENZOR
(olmesartan medoxomil, amlodipine, hydrochlorothiazide) tablets
40 mg/5 mg* 12.5 mg
30 Tablets
PRINCIPAL DISPLAY PANEL
NDC 65597-116-30
TRIBENZOR
(olmesartan medoxomil, amlodipine, hydrochlorothiazide) tablets
40 mg/5 mg* 25 mg
30 Tablets
PRINCIPAL DISPLAY PANEL
NDC 65597-117-30
TRIBENZOR
(olmesartan medoxomil, amlodipine, hydrochlorothiazide) tablets
40 mg/10 mg* 12.5 mg
30 Tablets
PRINCIPAL DISPLAY PANEL
NDC 65597-118-90
TRIBENZOR
(olmesartan medoxomil, amlodipine, hydrochlorothiazide) tablets
40 mg/10 mg* 25 mg
90 Tablets
| TRIBENZOR olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide tablet, film coated | |||||||||||||||||||||||||||||||||
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| Labeler — Daiichi Sankyo, Inc. (068605067) |
Revised: 06/2022 Daiichi Sankyo, Inc.
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