п»їIrbesartan and Hydrochlorothiazide tablet
What is this medicine?
IRBESARTAN; HYDROCHLOROTHIAZIDE is a combination of a drug that relaxes blood vessels and a diuretic. It is used to treat high blood pressure.
What should my health care professional know before I take this medicine?
They need to know if you have any of these conditions:
decreased urine
if you are on a special diet, like a low salt diet
immune system problems, like lupus
kidney disease
liver disease
an unusual or allergic reaction to irbesartan, hydrochlorothiazide, sulfa drugs, other medicines, foods, dyes, or preservatives
pregnant or trying to get pregnant
breast-feeding
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п»їAvalide
Generic Name: irbesartan and hydrochlorothiazide
Dosage Form: tabletsHIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use Avalide safely and effectively. See full prescribing information for Avalide.
Avalide (irbesartan and hydrochlorothiazide) tablet for oral use
Avalide (irbesartan and hydrochlorothiazide) tablet, film coated for oral use
Initial U.S. Approval: 1997
WARNING: USE IN PREGNANCY
See full prescribing information for complete boxed warning.
When pregnancy is detected, discontinue Avalide as soon as possible. When used in pregnancy during the second and third trimesters, drugs that act directly on the renin-angiotensin system can cause injury and even death to the developing fetus. (5.1)
RECENT MAJOR CHANGES
Indications and Usage (1) 11/2007
Dosage and Administration, Add-On Therapy (2.2) 11/2007
Dosage and Administration, Initial Therapy (2.4) 11/2007
INDICATIONS AND USAGE
Avalide is a combination of irebesartan, 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 <30mL/min) (2.1, 5.8)
Hypertension
Not controlled on monotherapy: Initiate with 150/12.5 mg. Titrate to 300/12.5 mg then 300/25 mg if needed. One tablet daily (2.2)
Replacement therapy: May be substituted for titrated components (2.3)
Initial therapy: Initiate with 150/12.5 mg once daily for 1 to 2 weeks and titrate as needed up to maximum of 300/25 mg once daily. (2.4)
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