HIGHLIGHTS 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)
INDICATIONS AND USAGE
AVALIDE 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).
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).
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)
CONTRAINDICATIONS
Hypersensitivity to any component of this product (4)
Anuria (4)
Hypersensitivity to sulfonamide-derived drugs (4)
WARNINGS AND PRECAUTIONS
Symptomatic hypotension with intravascular volume- or sodium-depletion. Correct volume-depletion prior to administration. Not recommended as initial therapy in volume-depleted patients (2.4, 5.2).
Impaired hepatic function: Thiazides should be used with caution as minor fluid and electrolyte imbalances may precipitate hepatic coma (5.7).
Impaired renal function: Use with caution. Oliguria or azotemia with acute renal failure and/or death has been reported in medications affecting the renin-angiotensin-aldosterone system (5.8).
Thiazide diuretics may cause an exacerbation or activation of systemic lupus erythematosus (5.4).
ADVERSE REACTIONS
Most common adverse events (≥5% on AVALIDE and more often than on placebo) are dizziness, fatigue, and musculoskeletal pain (6.1).
To report SUSPECTED ADVERSE REACTIONS, contact Bristol-Myers Squibb at 1-800-721-5072 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
DRUG INTERACTIONS
Hydrochlorothiazide (7):
Alcohol, Barbiturates, Narcotics: Potentiation of orthostatic hypotension
Antidiabetic Drugs: Dosage adjustment of antidiabetic may be required
Cholestyramine and colestipol: Reduced absorption of thiazides
Corticosteroids, ACTH: Hypokalemia, electrolyte depletion
Lithium: Reduced renal clearance and high risk of lithium toxicity when used with diuretics. Should not be given with