IRBESARTAN AND HYDROCHLOROTHIAZIDE tablet, film coated

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

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

Dostępny od:

Physicians Total Care, Inc.

INN (International Nazwa):

IRBESARTAN

Skład:

IRBESARTAN 150 mg

Droga podania:

ORAL

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

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

Podsumowanie produktu:

Irbesartan and hydrochlorothiazide film-coated tablets have markings on one side and are available in the strengths and packages listed in the following table:  Store at 25°C (77°F); excursions permitted to 15°C-30°C (59°F-86°F) [see USP Controlled Room Temperature].

Status autoryzacji:

Abbreviated New Drug Application

Charakterystyka produktu

IRBESARTAN AND HYDROCHLOROTHIAZIDE- IRBESARTAN AND HYDROCHLOROTHIAZIDE
TABLET,
FILM COATED
PHYSICIANS TOTAL CARE, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLETS
USP SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLETS
USP.
IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLETS, USP
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).
• DRUGS THAT ACT DIRECTLY ON THE RENIN-ANGIOTENSIN SYSTEM CAN CAUSE
INJURY AND EVEN DEATH TO THE
DEVELOPING FETUS. (5.1)
INDICATIONS AND USAGE
Irbesartan and hydrochlorothiazide tablet USP is 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 co-administer aliskiren with irbesartan and
hydrochlorothiazide tablets in patients with diabetes (4)
WARNINGS AND PRECAUTIONS
Hypotension: Correct volume-depleti