IRBESARTAN AND HYDROCHLOROTHIAZIDE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Solco Healthcare US, LLC

INN (International Name):

IRBESARTAN

Composition:

IRBESARTAN 150 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

Irbesartan and Hydrochlorothiazide film-coated tablets have markings on both sides and are available in the strengths 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 and 12.5 mg Pink, oval-shaped Bottles of 30 43547-330-03 Bottles of 90 43547-330-09 Bottles of 500 43547-330-50 300 mg and 12.5 mg Pink, capsule-shaped Debossed '327' on one side and 'HH' on the other side Bottles of 30 43547-331-03 Bottles of 90 43547-331-09 Bottles of 500 43547-331-50 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].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

IRBESARTAN AND HYDROCHLOROTHIAZIDE- IRBESARTAN AND
HYDROCHLOROTHIAZIDE TABLET
SOLCO HEALTHCARE US, LLC
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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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RECENT MAJOR CHANGES
Warnings and Precautions (5.8) 5/2021
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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HYPERTENSION
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DOSAGE FORMS AND STRENGTHS
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CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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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)
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