IRBESARTAN AND HYDROCHLOROTHIAZIDE tablet

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

IRBESARTAN (UNII: J0E2756Z7N) (IRBESARTAN - UNII:J0E2756Z7N), HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH)

متاح من:

West-Ward Pharmaceuticals Corp.

INN (الاسم الدولي):

IRBESARTAN

تركيب:

IRBESARTAN 150 mg

طريقة التعاطي:

ORAL

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الخصائص العلاجية:

Irbesartan and hydrochlorothiazide is indicated for the treatment of hypertension. Irbesartan and hydrochlorothiazide may be used in patients whose blood pressure is not adequately controlled on monotherapy. Irbesartan and hydrochlorothiazide 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 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 combination compared with monotherapy

ملخص المنتج:

Irbesartan and Hydrochlorothiazide Tablets USP The 150 mg/12.5 mg tablets are light red speckled, round biconvex tablets, debossed with product identification “54” over “857” on one side and plain on the other side. NDC 0054-0254-13: Bottle of 30 Tablets NDC 0054-0254-22: Bottle of 90 Tablets NDC 0054-0254-29: Bottle of 500 Tablets The 300 mg/12.5 mg tablets are light yellow speckled, modified oval biconvex tablets, debossed with product identification “54 948” on one side and plain on the other side. NDC 0054-0255-13: Bottle of 30 Tablets NDC 0054-0255-22: Bottle of 90 Tablets NDC 0054-0255-29: Bottle of 500 Tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]

الوضع إذن:

Abbreviated New Drug Application

خصائص المنتج

IRBESARTAN AND HYDROCHLOROTHIAZIDE- IRBESARTAN AND HYDROCHLOROTHIAZIDE
TABLET
WEST-WARD PHARMACEUTICALS CORP.
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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._
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INDICATIONS AND USAGE
Irbesartan and hydrochlorothiazide is a combination of irbesartan, an
angiotensin II receptor antagonist, and
hydrochlorothiazide, a thiazide diuretic, indicated for hypertension:
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DOSAGE AND ADMINISTRATION
GENERAL CONSIDERATIONS
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HYPE RTE NSIO N
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DOSAGE FORMS AND STRENGTHS
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CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
Most common adverse events (≥5% on irbesartan and
hydrochlorothiazide and more often than on placebo) are dizziness,
WHEN PREGNANCY IS DETECTED, DISCONTINUE IRBESARTAN AND
HYDROCHLOROTHIAZIDE 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 coad