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:

Bryant Ranch Prepack

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 goal

Product samenvatting:

150 mg and 12.5 mg; peach, oval-shaped. "ML 34" debossed on one side and plain on the reverse. NDC: 63629-7468-1: 30 Tablets in a BOTTLE NDC: 63629-7468-2: 90 Tablets in a BOTTLE NDC: 63629-7468-3: 28 Tablets in a BOTTLE

Autorisatie-status:

Abbreviated New Drug Application

Productkenmerken

IRBESARTAN AND HYDROCHLOROTHIAZIDE- IRBESARTAN AND
HYDROCHLOROTHIAZIDE TABLET, FILM COATED
BRYANT RANCH PREPACK
----------
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 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)
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 150/12.5 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)
DOSAGE FORMS AND STRENGTHS
• 150 mg irbesartan/12.5 mg hydrochlorothiazide tablets (3)
• 300 mg irbesartan/12.5 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 diabetes.
(4)