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).
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).
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.
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.
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.
Teva Pharmaceuticals USA, Inc.
North Wales, PA 19454
Rev. M 8/2018
DRUG: Irbesartan and Hydrochlorothiazide
GENERIC: Irbesartan and Hydrochlorothiazide
DOSAGE: TABLET, FILM COATED
SCORE: No score
SIZE: 14 mm
PACKAGING: 90 in 1 BOTTLE, PLASTIC
- HYDROCHLOROTHIAZIDE 12.5mg in 1
- IRBESARTAN 300mg in 1
- 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
| IRBESARTAN AND HYDROCHLOROTHIAZIDE |
irbesartan and hydrochlorothiazide tablet, film coated
|Labeler — REMEDYREPACK INC. (829572556)|
Revised: 03/2020 REMEDYREPACK INC.
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