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

Irbesartan and Hydrochlorothiazide Tablets USP

Rx Only

300 mg/12.5 mg

NDC 68180-414-06

30’s Tablets

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.