IDE is not recommended as initial therapy in patients with intravascular volume depletion [see Warnings and Precautions (5.2)].
3 DOSAGE FORMS AND STRENGTHS
AVALIDE® (irbesartan-hydrochlorothiazide) 150/12.5 mg and 300/12.5 mg tablets are peach, biconvex, and oval with a heart debossed on one side and "2775" or "2776" on the reverse side. The 300/25 mg film-coated tablet is pink, biconvex, and oval with a heart debossed on one side and "2788" on the reverse side.
4 CONTRAINDICATIONS
AVALIDE is contraindicated in patients who are hypersensitive to any component of this product.
Because of the hydrochlorothiazide component, this product is contraindicated in patients with anuria or hypersensitivity to other sulfonamide-derived drugs.
5 WARNINGS AND PRECAUTIONS
5.1 Fetal/Neonatal Morbidity and Mortality
AVALIDE can cause fetal harm when administered to a pregnant woman. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus [see Use in Specific Populations (8.1)]. In several dozen published cases, angiotensin converting enzyme (ACE) inhibitor use during the second and third trimesters of pregnancy was associated with fetal and neonatal injury, including hypotension, neonatal skull hypoplasia, anuria, reversible or irreversible renal failure, and death. Similar renal findings occur in reproductive toxicology studies in rats. Thiazides cross the placenta, and use of thiazides during pregnancy is associated with a risk of fetal or neonatal jaundice, thrombocytopenia, and possibly other adverse reactions that have occurred in adults.
5.2 Hypotension in Volume- or Salt-Depleted Patients
Excessive reduction of blood pressure was rarely seen in patients with uncomplicated hypertension treated with irbesartan alone (<0.1%) or with irbesartan-hydrochlorothiazide (approximately 1%). Initiation of antihypertensive therapy may cause symptomatic hypotension in patients with intravascular volume- or sodium-depletion, eg, in patients treated vigorously with diuretics or in patients on dialysis. Such volume depletion should be corrected prior to administration of antihypertensive therapy.
If hypotension occurs, the patient should be placed in the supine position and, if necessary, given an intravenous infusion of normal saline. A transient hypotensive response is not a contraindication to further treatment, which usually can be continued without difficulty once the blood pressure has stabilized.
5.3 Hypersensitivity Reaction
Hydrochlorothiazide
Hypersensitivity reactions to hydrochlorothiazide may occur in patients with or without a history of allergy or bronchial asthma, but are more likely in patients with such a history.
5.4 Systemic Lupus Erythematosus
Hydrochlorothiazide
Thiazide diuretics have been reported to cause exacerbation or activation of systemic lupus erythematosus.
5.5 Lithium Interaction
Hydrochlorothiazide
Lithium generally should not be given with thiazides. [See Drug Interactions (7).]
5.6 Electrolyte and Metabolic Imbalances
Irbesartan-Hydrochlorothiazide
In double-blind clinical trials of various doses of irbesartan and hydrochlorothiazide, the incidence of hypertensive patients who developed hypokalemia (serum potassium <3.5 mEq/L) was 7.5% versus 6.0% for placebo; the incidence o |
