IRBESARTAN AND HYDROCHLOROTHIAZIDE tablet

देश: संयुक्त राज्य

भाषा: अंग्रेज़ी

स्रोत: NLM (National Library of Medicine)

सक्रिय संघटक:

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

थमां उपलब्ध:

Proficient Rx LP

प्रशासन का मार्ग:

ORAL

प्रिस्क्रिप्शन प्रकार:

PRESCRIPTION DRUG

चिकित्सीय संकेत:

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. 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. Data from Studies V and VI [see Clinical Studies (14.2) ] provide estimates of the probability of reaching a blood pressure

उत्पाद समीक्षा:

Irbesartan and Hydrochlorothiazide film-coated tablets have markings on both sides and packages listed in the following table: Tablet Strength (irbesartan and hydrochlorothiazide) Film-Coated Tablet Color/Shape Tablet Markings Package Size NDC Code 150 mg/12.5 mg Pink, capsule-shaped Bottles of 30 71205-063-30 Bottles of 60 71205-063-60 Bottles of 90 71205-063-90 Store at 20°C-25°C (68°F-77°F); excursions permitted to 15°C-30°C (59°F-86°F) [see USP Controlled Room Temperature].

प्राधिकरण का दर्जा:

Abbreviated New Drug Application

उत्पाद विशेषताएं

IRBESARTAN AND HYDROCHLOROTHIAZIDE- IRBESARTAN AND HYDROCHLOROTHIAZIDE
TABLET
PROFICIENT RX LP
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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, USP, 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 Tablets are 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 Tablets and more often than on placebo) are
dizziness, fatigue, and musculoskeletal pain. (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT SOLCO HEALTHCARE US,
LLC AT 1-866-257-2597 OR FDA AT
1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH
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