IRBESARTAN AND HYDROCHLOROTHIAZIDE tablet, film coated

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

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

Beschikbaar vanaf:

Aurobindo Pharma Limited

INN (Algemene Internationale Benaming):

IRBESARTAN

Samenstelling:

IRBESARTAN 150 mg

Toedieningsweg:

ORAL

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

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

Product samenvatting:

Irbesartan and Hydrochlorothiazide Tablets USP, 150 mg/12.5 mg are peach colored, film-coated biconvex oval shaped tablets, debossed with “H 35” on one side and plain on the other side.                         Bottles of 30               NDC 65862-629-30                         Bottles of 90               NDC 65862-629-90                         Bottles of 500             NDC 65862-629-05                         Bottles of 1,000          NDC 65862-629-99 Irbesartan and Hydrochlorothiazide Tablets USP, 300 mg/12.5 mg are peach colored, film-coated biconvex oval shaped tablets, debossed with “H 36” on one side and plain on the other side.                         Bottles of 30               NDC 65862-630-30                         Bottles of 90               NDC 65862-630-90                         Bottles of 500             NDC 65862-630-05                         Bottles of 1,000          NDC 65862-630-99 Irbesartan and Hydrochlorothiazide Tablets USP, 300 mg/25 mg are pink colored, film-coated biconvex oval shaped tablets, debossed with “H 37” on one side and plain on the other side.                         Bottles of 30               NDC 65862-631-30                         Bottles of 90               NDC 65862-631-90                         Bottles of 500             NDC 65862-631-05                         Bottles of 1,000          NDC 65862-631-99 Store at 20ºC to 25ºC (68ºF to 77ºF). [See USP Controlled Room Temperature.]

Autorisatie-status:

Abbreviated New Drug Application

Productkenmerken

IRBESARTAN AND HYDROCHLOROTHIAZIDE - IRBESARTAN AND
HYDROCHLOROTHIAZIDE TABLET, FILM COATED
AUROBINDO PHARMA LIMITED
----------
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 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)
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:
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 mg/12.5 mg. Titrate to 300 mg/12.5 mg then 300 mg/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)
300 mg irbesartan/25 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
tablets in patients with