Product Description.:
Logo, 2875
tablet , film-coated , peach , oval oblong
logo resembles a heartDebossedBiconvex
AVALIDE
(irbesartan-hydrochlorothiazide) tablets
WARNING: USE IN PREGNANCY
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. [See WARNINGS AND PRECAUTIONS.]
DRUG DESCRIPTION
AVALIDE (irbesartan-hydrochlorothiazide) Tablets is a combination of an angiotensin II receptor antagonist (AT1 subtype), irbesartan, and a thiazide diuretic, hydrochlorothiazide (HCTZ).
AVALIDE is available for oral administration in tablets containing either 150 mg or 300 mg of irbesartan combined with 12.5 mg of hydrochlorothiazide or 300 mg of irbesartan combined with 25 mg hydrochlorothiazide. Inactive ingredients include: lactose monohydrate, microcrystalline cellulose, pregelatinized starch, croscarmellose sodium, ferric oxide red, ferric oxide yellow, silicon dioxide, and magnesium stearate. In addition, the 300/25 mg pink film-coated tablet contains ferric oxide black, hypromellose-2910, PEG-3350, titanium dioxide, and carnauba wax.
INDICATIONS
AVALIDE? (irbesartan-hydrochlorothiazide) Tablets is indicated for the treatment of hypertension.
AVALIDE may be used in patients whose blood pressure is not adequately controlled on monotherapy.
AVALIDE 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 AVALIDE 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.
