País: Estados Unidos
Língua: inglês
Origem: NLM (National Library of Medicine)
IRBESARTAN (UNII: J0E2756Z7N) (IRBESARTAN - UNII:J0E2756Z7N), HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH)
Proficient Rx LP
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 com
Irbesartan and hydrochlorothiazide tablets USP are available as follows: 150 mg/12.5 mg: Light pink to pink, film-coated, capsule-shaped 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). 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).
Abbreviated New Drug Application
IRBESARTAN AND HYDROCHLOROTHIAZIDE- IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED PROFICIENT RX LP ---------- 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_. 3. 4. INDICATIONS AND USAGE Irbesartan and hydrochlorothiazide tablets are a combination of irbesartan, an angiotensin II receptor antagonist, and hydrochlorothiazide, a thiazide diuretic, indicated for hypertension: 3. 4. DOSAGE AND ADMINISTRATION GENERAL CONSIDERATIONS 3. 4. HYPE RTE NSIO N 3. 4. DOSAGE FORMS AND STRENGTHS 3. 4. CONTRAINDICATIONS 5. 6. 7. 8. WARNINGS AND PRECAUTIONS 5. 6. 7. 8. WHEN PREGNANCY IS DETECTED, DISCONTINUE IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLETS AS SOON AS POSSIBLE. (5.1) DRUGS THAT ACT DIRECTLY ON THE RENIN-ANGIOTENSIN SYSTEM CAN CAUSE INJURY AND DEATH TO THE DEVELOPING FETUS. (5.1) 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) 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) 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) 150 mg irbesartan/12.5 mg hydrochlorothiazide tablets (3) 300 mg irbesartan/12.5 mg hydrochlorothiazide tablets (3) Hypersensitivity to any component of this product (4) Anuria (4) Hypersensitivity to sulfonamide-derived drugs (4) Do not coadminister aliskiren with irbesartan and hydrochlorothiazide tablets in patients with diabetes. (4) Hypotension: Correct volume-depletion pr Leia o documento completo