Country: United States
Language: English
Source: NLM (National Library of Medicine)
HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH), IRBESARTAN (UNII: J0E2756Z7N) (IRBESARTAN - UNII:J0E2756Z7N)
Lupin Pharmaceuticals, Inc.
HYDROCHLOROTHIAZIDE
HYDROCHLOROTHIAZIDE 12.5 mg
ORAL
PRESCRIPTION DRUG
Irbesartan and hydrochlorothiazide tablets are indicated for the treatment of hypertension. Irbesartan and hydrochlorothiazide tablets may be used in patients whose blood pressure is not adequately controlled on monotherapy. Irbesartan and hydrochlorothiazide tablets may also be used as initial therapy in patients who are likely to need multiple drugs to achieve their blood pressure goals. The choice of irbesartan and hydrochlorothiazide tablets as initial therapy for hypertension should be based on an assessment of potential benefits and risks. Patients with stage 2 (moderate or severe) hypertension are at relatively high risk for cardiovascular events (such as strokes, heart attacks, and heart failure), kidney failure, and vision problems, so prompt treatment is clinically relevant. The decision to use a combination as initial therapy should be individualized and may be shaped by considerations such as the baseline blood pressure, the target goal, and the incremental likelihood of achieving goal with a comb
Irbesartan and hydrochlorothiazide tablets USP are film-coated tablets, have markings on one side and available in the strengths and packages listed in the following table: Store at 25°C (77°F); excursions permitted to 15° to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].
Abbreviated New Drug Application
IRBESARTAN AND HYDROCHLOROTHIAZIDE - IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED LUPIN PHARMACEUTICALS, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLETS. IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLETS, FOR ORAL USE INITIAL U.S. APPROVAL: 1997 WARNING: FETAL TOXICITY _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._ WHEN PREGNANCY IS DETECTED, DISCONTINUE IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLETS AS SOON AS POSSIBLE. (5.1, 8.1) DRUGS THAT ACT DIRECTLY ON THE RENIN-ANGIOTENSIN SYSTEM CAN CAUSE INJURY AND DEATH TO THE DEVELOPING FETUS. (5.1, 8.1) INDICATIONS AND USAGE Irbesartan and hydrochlorothiazide tablet is a combination of irbesartan, an angiotensin II receptor antagonist, and hydrochlorothiazide, a thiazide diuretic, indicated for hypertension: In patients not adequately controlled with monotherapy. (1) As initial therapy in patients likely to need multiple drugs to achieve their blood pressure goals. (1) DOSAGE AND ADMINISTRATION GENERAL CONSIDERATIONS Maximum effects within 2 to 4 weeks after dose change. (2.1) Renal impairment: Not recommended for patients with severe renal impairment (creatinine clearance <30 mL/min). (2.1, 5.8) HYPERTENSION Initiate with 150/12.5 mg. Titrate to 300/12.5 mg then 300/25 mg if needed. (2.2) Replacement therapy: May be substituted for titrated components. (2.3) DOSAGE FORMS AND STRENGTHS 150 mg irbesartan/12.5 mg hydrochlorothiazide tablets (3) 300 mg irbesartan/12.5 mg hydrochlorothiazide tablets (3) CONTRAINDICATIONS Hypersensitivity to any component of this product. (4) Anuria. (4) Hypersensitivity to sulfonamide-derived drugs (4) Do not coadminister aliskiren with irbesartan and hydrochlorothiazide in patients with diabetes (4) WARNINGS AND PRECAUTIONS Hypotension: Correct volume-depletion prior to administration. (5.2) Impaired renal f Read the complete document