IRBESARTAN AND HYDROCHLOROTHIAZIDE tablet, film coated

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

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

זמין מ:

Hisun Pharmaceuticals USA Inc.

INN (שם בינלאומי):

IRBESARTAN

הרכב:

IRBESARTAN 150 mg

מסלול נתינה (של תרופות):

ORAL

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

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 of achieving

leaflet_short:

Irbesartan and hydrochlorothiazide tablets, USP have markings on both sides and are available in the strengths and packages listed in the following table: Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

מצב אישור:

Abbreviated New Drug Application

מאפייני מוצר

IRBESARTAN AND HYDROCHLOROTHIAZIDE- IRBESARTAN AND HYDROCHLOROTHIAZIDE
TABLET,
FILM COATED
HISUN PHARMACEUTICALS USA INC.
----------
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 USEINITIAL U.S.
APPROVAL: 1997
WARNING: FETAL TOXICITY
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
WHEN PREGNANCY IS DETECTED, DISCONTINUE IBESARTAN AND
HYDROCHLOROTHIAZIDE 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)
INDICATIONS AND USAGE
Irbesartan and hydrochlorothiazide tablets, USP 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, 5.7)
HYPE RTE NSIO N
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
in patients with diabetes ( 4)
WARNINGS AND PRECAUTIONS
Hypotension: Correct volume-depletion prior to administration. ( 5.2)
Impaired re