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 65597-114-30 TRIBENZOR (olmesartan medoxomil, amlodipine, hydrochlorothiazide) tablets 20 mg/5 mg* 12.5 mg 30 Tablets Rx Only
(click image for full-size original)

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 65597-115-30 TRIBENZOR (olmesartan medoxomil, amlodipine, hydrochlorothiazide) tablets 40 mg/5 mg* 12.5 mg 30 Tablets Rx Only
(click image for full-size original)

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 65597-116-30 TRIBENZOR (olmesartan medoxomil, amlodipine, hydrochlorothiazide) tablets 40 mg/5 mg* 25 mg 30 Tablets Rx Only
(click image for full-size original)

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 65597-117-30 TRIBENZOR (olmesartan medoxomil, amlodipine, hydrochlorothiazide) tablets 40 mg/10 mg* 12.5 mg 30 Tablets Rx Only
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

NDC 65597-118-90

TRIBENZOR

(olmesartan medoxomil, amlodipine, hydrochlorothiazide) tablets

40 mg/10 mg* 25 mg

90 Tablets

PRINCIPAL DISPLAY PANEL NDC 65597-118-90 TRIBENZOR (olmesartan medoxomil, amlodipine, hydrochlorothiazide) tablets 40 mg/10 mg* 25 mg 90 Tablets Rx Only
(click image for full-size original)

TRIBENZOR olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65597-114
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OLMESARTAN MEDOXOMIL (OLMESARTAN) OLMESARTAN MEDOXOMIL 20 mg
AMLODIPINE BESYLATE (AMLODIPINE) AMLODIPINE 5 mg
HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE 12.5 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
MICROCRYSTALLINE CELLULOSE
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
SILICON DIOXIDE
Product Characteristics
Color ORANGE Score no score
Shape ROUND Size 8mm
Flavor Imprint Code C51
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65597-114-10 10 BLISTER PACK in 1 BOX contains a BLISTER PACK
1 10 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the BOX (65597-114-10)
2 NDC:65597-114-07 7 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:65597-114-30 30 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:65597-114-70 7 TABLET, FILM COATED in 1 BLISTER PACK None
5 NDC:65597-114-90 90 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA200175 07/31/2010
TRIBENZOR olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65597-115
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OLMESARTAN MEDOXOMIL (OLMESARTAN) OLMESARTAN MEDOXOMIL 40 mg
AMLODIPINE BESYLATE (AMLODIPINE) AMLODIPINE 5 mg
HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE 12.5 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
MICROCRYSTALLINE CELLULOSE
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
SILICON DIOXIDE
Product Characteristics
Color YELLOW Score no score
Shape ROUND Size 10mm
Flavor Imprint Code C53
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65597-115-10 10 BLISTER PACK in 1 BOX contains a BLISTER PACK
1 10 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the BOX (65597-115-10)
2 NDC:65597-115-07 7 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:65597-115-30 30 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:65597-115-70 7 TABLET, FILM COATED in 1 BLISTER PACK None
5 NDC:65597-115-90 90 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA200175 07/31/2010
TRIBENZOR olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65597-116
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OLMESARTAN MEDOXOMIL (OLMESARTAN) OLMESARTAN MEDOXOMIL 40 mg
AMLODIPINE BESYLATE (AMLODIPINE) AMLODIPINE 5 mg
HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE 25 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
MICROCRYSTALLINE CELLULOSE
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
SILICON DIOXIDE
Product Characteristics
Color YELLOW Score no score
Shape OVAL Size 15mm
Flavor Imprint Code C54
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65597-116-10 10 BLISTER PACK in 1 BOX contains a BLISTER PACK
1 10 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the BOX (65597-116-10)
2 NDC:65597-116-07 7 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:65597-116-30 30 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:65597-116-70 7 TABLET, FILM COATED in 1 BLISTER PACK None
5 NDC:65597-116-90 90 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA200175 07/31/2010
TRIBENZOR olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65597-117
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OLMESARTAN MEDOXOMIL (OLMESARTAN) OLMESARTAN MEDOXOMIL 40 mg
AMLODIPINE BESYLATE (AMLODIPINE) AMLODIPINE 10 mg
HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE 12.5 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
MICROCRYSTALLINE CELLULOSE
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
SILICON DIOXIDE
Product Characteristics
Color RED Score no score
Shape ROUND Size 10mm
Flavor Imprint Code C55
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65597-117-10 10 BLISTER PACK in 1 BOX contains a BLISTER PACK
1 10 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the BOX (65597-117-10)
2 NDC:65597-117-07 7 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:65597-117-30 30 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:65597-117-70 7 TABLET, FILM COATED in 1 BLISTER PACK None
5 NDC:65597-117-90 90 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA200175 07/31/2010
TRIBENZOR olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65597-118
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OLMESARTAN MEDOXOMIL (OLMESARTAN) OLMESARTAN MEDOXOMIL 40 mg
AMLODIPINE BESYLATE (AMLODIPINE) AMLODIPINE 10 mg
HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE 25 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
MICROCRYSTALLINE CELLULOSE
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
SILICON DIOXIDE
Product Characteristics
Color RED Score no score
Shape OVAL Size 15mm
Flavor Imprint Code C57
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65597-118-10 10 BLISTER PACK in 1 BOX contains a BLISTER PACK
1 10 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the BOX (65597-118-10)
2 NDC:65597-118-07 7 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:65597-118-30 30 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:65597-118-70 7 TABLET, FILM COATED in 1 BLISTER PACK None
5 NDC:65597-118-90 90 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA200175 07/31/2010
Labeler — Daiichi Sankyo, Inc. (068605067)

Revised: 01/2022 Daiichi Sankyo, Inc.

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