IRBESARTAN AND HYDROCHLOROTHIAZIDE- irbesartan and hydrochlorothiazide tablet

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:

REMEDYREPACK INC.

Uygulama yolu:

ORAL

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

Irbesartan and hydrochlorothiazide is indicated for the treatment of hypertension. Irbesartan and hydrochlorothiazide may be used in patients whose blood pressure is not adequately controlled on monotherapy. Irbesartan and hydrochlorothiazide 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 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 with a combination compared with monotherapy

Ürün özeti:

Irbesartan and Hydrochlorothiazide Tablets USP The 150 mg/12.5 mg tablets are light red speckled, round biconvex tablets, debossed with product identification “54” over “857” on one side and plain on the other side. NDC 0054-0254-13: Bottle of 30 Tablets NDC 0054-0254-22: Bottle of 90 Tablets NDC 0054-0254-29: Bottle of 500 Tablets The 300 mg/12.5 mg tablets are light yellow speckled, modified oval biconvex tablets, debossed with product identification “54 948” on one side and plain on the other side. NDC 0054-0255-13: Bottle of 30 Tablets NDC 0054-0255-22: Bottle of 90 Tablets NDC 0054-0255-29: Bottle of 500 Tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]

Yetkilendirme durumu:

Abbreviated New Drug Application

Ürün özellikleri

IRBESARTAN AND HYDROCHLOROTHIAZIDE- IRBESARTAN AND HYDROCHLOROTHIAZIDE
TABLET
REMEDYREPACK 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 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 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 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)
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 renal function. (5.8)
Thiazide diuretics