Irbesartan and Hydrochlorothiazide (Page 7 of 7)

16.2 Storage

Store at 25°C (77°F); excursions permitted to 15° to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

17 PATIENT COUNSELING INFORMATION

Pregnancy

Tell female patients of childbearing age about the consequences of exposure to irbesartan and hydrochlorothiazide during pregnancy. Discuss treatment options with women planning to become pregnant. Ask patients to report pregnancies to their physician as soon as possible.

Symptomatic Hypotension

Tell patients using irbesartan and hydrochlorothiazide that they may feel lightheaded, especially during the first days of use. Tell patients to inform their physician if they feel lightheaded or faint. Tell the patient, if fainting occurs, stop using irbesartan and hydrochlorothiazide and contact the prescribing doctor.

Tell patients using irbesartan and hydrochlorothiazide that getting dehydrated can lower their blood pressure too much and lead to lightheadedness and possible fainting. Dehydration may occur with excessive sweating, diarrhea, or vomiting and with not drinking enough liquids.

Potassium Supplements

Advise patients not to use potassium supplements or salt substitutes containing potassium without consulting their healthcare provider [see DRUG INTERACTIONS (7.3)].

Acute Angle-Closure Glaucoma Acute Myopia, and Choroidal Effusion

Advise patients to discontinue irbesartan and hydrochlorothiazide tablets and seek immediate medical attention if they experience symptoms of acute angle-closure glaucoma, acute myopia, and choroidal effusion [see WARNINGS AND PRECAUTIONS (5.8)].

Non-melanoma Skin Cancer

Instruct patients taking hydrochlorothiazide to protect skin from the sun and undergo regular skin

cancer screening.

Manufactured for:

Lupin Pharmaceuticals, Inc.

Baltimore, Maryland 21202

United States.

Manufactured by:

Lupin Limited

Pithampur (M.P.) — 454775

INDIA.

Revised: August 2021 ID #: 268243

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Irbesartan and Hydrochlorothiazide Tablets USP

Rx Only

150 mg/12.5 mg

NDC 68180-413-06

30’s Tablets

150-12.5mg
(click image for full-size original)

Irbesartan and Hydrochlorothiazide Tablets USP

Rx Only

300 mg/12.5 mg

NDC 68180-414-06

30’s Tablets

300mg-12.5
(click image for full-size original)
IRBESARTAN AND HYDROCHLOROTHIAZIDE irbesartan and hydrochlorothiazide tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68180-413
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE 12.5 mg
IRBESARTAN (IRBESARTAN) IRBESARTAN 150 mg
Inactive Ingredients
Ingredient Name Strength
CROSPOVIDONE
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
FERROSOFERRIC OXIDE
HYPROMELLOSE 2910 (15 MPA.S)
MAGNESIUM STEARATE
MANNITOL
POLOXAMER 188
POLYETHYLENE GLYCOL 3350
POVIDONE
PROPYLENE GLYCOL
SHELLAC
SILICON DIOXIDE
TITANIUM DIOXIDE
Product Characteristics
Color PINK (Light Peach) Score no score
Shape OVAL (oval shaped biconvex) Size 14mm
Flavor Imprint Code L058
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68180-413-06 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:68180-413-09 90 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA201524 04/04/2013
IRBESARTAN AND HYDROCHLOROTHIAZIDE irbesartan and hydrochlorothiazide tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68180-414
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE 12.5 mg
IRBESARTAN (IRBESARTAN) IRBESARTAN 300 mg
Inactive Ingredients
Ingredient Name Strength
CROSPOVIDONE
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
FERROSOFERRIC OXIDE
HYPROMELLOSE 2910 (15 MPA.S)
MAGNESIUM STEARATE
MANNITOL
POLOXAMER 188
POLYETHYLENE GLYCOL 3350
POVIDONE
PROPYLENE GLYCOL
SHELLAC
SILICON DIOXIDE
TITANIUM DIOXIDE
Product Characteristics
Color PINK (Light Peach) Score no score
Shape OVAL (oval shaped biconvex) Size 19mm
Flavor Imprint Code L059
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68180-414-06 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:68180-414-09 90 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA201524 04/04/2013
Labeler — Lupin Pharmaceuticals, Inc. (089153071)
Registrant — LUPIN LIMITED (675923163)
Establishment
Name Address ID/FEI Operations
LUPIN LIMITED 863645527 MANUFACTURE (68180-413), MANUFACTURE (68180-414), PACK (68180-413), PACK (68180-414)

Revised: 08/2021 Lupin Pharmaceuticals, Inc.

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