IRBESARTAN AND HYDROCHLOROTHIAZIDE tablet IRBESARTAN AND HYDROCHLOROTHIAZIDE tablet, film coated

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

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

Dostupné z:

Alembic Pharmaceuticals Inc.

INN (Medzinárodný Name):

IRBESARTAN

Zloženie:

IRBESARTAN 150 mg

Spôsob podávania:

ORAL

Typ predpisu:

PRESCRIPTION DRUG

Terapeutické indikácie:

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 w

Prehľad produktov:

Irbesartan and Hydrochlorothiazide Tablets USP are supplied as follows: Irbesartan and Hydrochlorothiazide Tablets USP 150 mg/12.5 mg: Peach coloured mottled, oval shaped, biconvex, uncoated tablets debossed with “L180” on one side and plain on other side. NDC 62332-051-30   bottle of 30 tablets. NDC 62332-051-90   bottle of 90 tablets. NDC 62332-051-91   bottle of 1000 tablets. NDC 62332-051-10    carton of 10 blisters of 10 tablets. Irbesartan and Hydrochlorothiazide Tablets USP 300 mg/12.5 mg: Peach coloured mottled, oval shaped, biconvex, uncoated tablets debossed with “L181” on one side and plain on other side. NDC 62332-052-30   bottle of 30 tablets. NDC 62332-052-90   bottle of 90 tablets. NDC 62332-052-91   bottle of 1000 tablets. NDC 62332-052-10   carton of 10 blisters of 10 tablets. Irbesartan and Hydrochlorothiazide Tablets USP 300 mg/25 mg: Pinkish brown, oval shaped, biconvex, film coated tablets, debossed with “L182” on one side and plain on other side. NDC 62332-053-30   bottle of 30 tablets. NDC 62332-053-90   bottle of 90 tablets. NDC 62332-053-91   bottle of 1000 tablets. NDC 62332-053-10   carton of 10 blisters of 10 tablets. Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

Stav Autorizácia:

Abbreviated New Drug Application

Súhrn charakteristických

IRBESARTAN AND HYDROCHLOROTHIAZIDE - IRBESARTAN AND
HYDROCHLOROTHIAZIDE TABLET
IRBESARTAN AND HYDROCHLOROTHIAZIDE - IRBESARTAN AND
HYDROCHLOROTHIAZIDE TABLET, FILM COATED
ALEMBIC PHARMACEUTICALS INC.
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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._
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 USP is a combination of
irbesartan, an angiotensin II receptor
antagonist, and hydrochlorothiazide, a thiazide diuretic, indicated
for hypertension: (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)
DOSAGE AND ADMINISTRATION
GENERAL CONSIDERATIONS (2)
Maximum effects within 2 to 4 weeks after dose change. (2.1)
Renal impairment: Not recommended for patients with severe renal
impairment (creatinine clearance
<30mL/min). (2.1, 5.8)
HYPERTENSION (2)
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)
• 300 mg irbesartan/25 mg hydrochlorothiazide tablets (3) (3)
CONTRAINDICATIONS
Hypersensitivity to any component of this product. (4)
Anuria. (4)
Hypersensitivity to sulfonamide-d