IRBESARTAN AND HYDROCHLOROTHIAZIDE tablet, film coated

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

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

Mevcut itibaren:

Proficient Rx LP

INN (International Adı):

IRBESARTAN

Kompozisyon:

IRBESARTAN 150 mg

Uygulama yolu:

ORAL

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

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

Ürün özeti:

Irbesartan and hydrochlorothiazide film-coated tablets have markings on one side and are available in the strengths and packages listed in the following table:    150 mg/12.5 mg     peach, oval-shaped  ML; 34 debossed on one side and plain on the reverse Bottles of 30 Bottles of 60 Bottles of 90 63187-653-30 63187-653-60 63187-653-90    Store at 25°C (77°F); excursions permitted to 15°C-30°C (59°F-86°F) [see USP Controlled Room Temperature].

Yetkilendirme durumu:

Abbreviated New Drug Application

Ürün özellikleri

IRBESARTAN AND HYDROCHLOROTHIAZIDE- IRBESARTAN AND HYDROCHLOROTHIAZIDE
TABLET,
FILM COATED
PROFICIENT RX LP
----------
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
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:
•
•
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
•
•
•
•
ADVERSE REACTIONS
MOST COMMON ADVERSE EVENTS (≥5% ON IRBESARTAN AND
HYDROCHLOROTHIAZIDE TABLETS AND MORE OFTEN THAN ON
PLACEBO) ARE DIZZINESS, FATIGUE, AND MUSCULOSKELETAL PAIN (6.1).TO
REPORT SUSPECTED ADVERSE REACTIONS,
CONTACT MACLEODS PHARMA USA, INC. AT 1-888-943-3210OR FDA AT
1-800-FDA-1088 OR www.fda.gov/medwatch
DRUG INTERACTIONS
• NSAIDS and selective COX-2 inhibitors: May lead to increased risks
of renal impairment and loss of antihypertensive
effect. Monitor renal function periodically.