Irbesartan and Hydrochlorothiazide (Page 7 of 7)

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied

Irbesartan and Hydrochlorothiazide Tablets USP are available as follows:

150 mg/12.5 mg: Light pink to pink, film-coated, capsule-shaped, unscored tablets, debossed with “TEVA” on one side of the tablet and “7238” on the other side and are available in bottles of 30 (NDC 0093-8238-56) and 90 (NDC 0093-8238-98).

300 mg/12.5 mg: Light pink to pink, film-coated, capsule-shaped, unscored tablets, debossed with “TEVA” on one side of the tablet and “7239” on the other side and are available in bottles of 30 (NDC 0093-8232-56) and 90 (NDC 0093-8232-98).

16.2 Storage

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).

17 PATIENT COUNSELING INFORMATION

Pregnancy

Tell female patients of childbearing age about the consequences of exposure to irbesartan and hydrochlorothiazide tablets 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 tablets 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 tablets and contact the prescribing doctor.

Tell patients using irbesartan and hydrochlorothiazide tablets 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 Myopia and Secondary Angle-Closure Glaucoma

Advise patients to discontinue irbesartan and hydrochlorothiazide tablets and seek immediate medical attention if they experience symptoms of Acute Myopia or Secondary Angle-Closure Glaucoma [ see Warnings and Precautions ( 5.8) ].

Manufactured In Croatia By:
Pliva Hrvatska d.o.o.
Zagreb, Croatia

Manufactured For:
Teva Pharmaceuticals USA, Inc.
North Wales, PA 19454

Rev. M 8/2018

PRINCIPAL DISPLAY PANEL

DRUG: Irbesartan and Hydrochlorothiazide

GENERIC: Irbesartan and Hydrochlorothiazide

DOSAGE: TABLET, FILM COATED

ADMINSTRATION: ORAL

NDC: 70518-2619-0

COLOR: pink

SHAPE: OVAL

SCORE: No score

SIZE: 14 mm

IMPRINT: TEVA;7239

PACKAGING: 90 in 1 BOTTLE, PLASTIC

ACTIVE INGREDIENT(S):

  • HYDROCHLOROTHIAZIDE 12.5mg in 1
  • IRBESARTAN 300mg in 1

INACTIVE INGREDIENT(S):

  • MAGNESIUM STEARATE
  • POLOXAMER 188
  • POLYETHYLENE GLYCOL 6000
  • MICROCRYSTALLINE CELLULOSE
  • POLYETHYLENE GLYCOL 400
  • POVIDONE K30
  • STARCH, CORN
  • CROSCARMELLOSE SODIUM
  • FERROSOFERRIC OXIDE
  • HYPROMELLOSE 2910 (5 MPA.S)
  • SILICON DIOXIDE
  • FERRIC OXIDE RED
  • FERRIC OXIDE YELLOW
  • TITANIUM DIOXIDE
Remedy_Label
(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:70518-2619(NDC:0093-8232)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
IRBESARTAN (IRBESARTAN) IRBESARTAN 300 mg
HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE 12.5 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
HYPROMELLOSE 2910 (5 MPA.S)
FERROSOFERRIC OXIDE
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POLOXAMER 188
POLYETHYLENE GLYCOL 6000
POLYETHYLENE GLYCOL 400
POVIDONE K30
STARCH, CORN
TITANIUM DIOXIDE
Product Characteristics
Color pink (light pink to pink) Score no score
Shape OVAL (capsule-shaped) Size 14mm
Flavor Imprint Code TEVA;7239
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70518-2619-0 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077369 03/09/2020
Labeler — REMEDYREPACK INC. (829572556)

Revised: 03/2020 REMEDYREPACK INC.

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