Generic Name and Formulations:
Irbesartan, hydrochlorothiazide; 150mg/12.5mg, 300mg/12.5mg; tabs.
Company:
Sanofi Aventis
 
Select therapeutic use: Hypertension
Indications for AVALIDE :
Hypertension.

Adult:
Take once daily. Not controlled on monotherapy: initially 150/12.5mg, titrate to 300/12.5mg then 300/25mg if needed. Replacement therapy: may be substituted for titrated components. Initial therapy: start at 150/12.5mg for 1–2 weeks, then titrate as needed up to max 300mg/25mg. Severe renal impairment (CrCl ≤30mL/min): not recommended.

Children:
Not established.

Contraindications:
Anuria. Sulfonamide allergy. Concomitant aliskiren in patients with diabetes.

Warnings/Precautions:
Fetal toxicity may develop; discontinue if pregnancy is detected. Intravascular volume- or sodium-depletion. Correct hypovolemia before starting therapy. Hepatic impairment. Severe CHF. Severe renal disease. Renal artery stenosis. Asthma. Postsympathectomy. SLE. Gout. Acute myopia. Secondary angle-closure glaucoma. Monitor renal function and electrolytes periodically. Elderly. Neonates. Pregnancy (Cat.D); monitor. Nursing mothers: not recommended.

Interactions:
See Contraindications. Dual inhibition of the renin-angiotensin system with ARBs, ACEIs, or aliskiren may increase risk of hypotension, hyperkalemia, renal function changes; monitor closely. Concomitant aliskiren in renal impairment (CrCl <60mL/min): not recommended. Hyperkalemia with K+ supplements, K+ sparing diuretics, K+ containing salt substitutes. Orthostatic hypotension with alcohol, other CNS depressants. Hypokalemia with corticosteroids, ACTH. Potentiates other antihypertensives, tubocurarine. May be antagonized by, and renal toxicity potentiated by NSAIDs, including COX-2 inhibitors; monitor. Antagonizes norepinephrine. Adjust antihyperglycemics. Separate dosing by ≥4hrs before or 4–6hrs after cholestyramine or colestipol resins. May increase lithium toxicity. Risk of hyponatremia with carbamazepine (monitor). May interfere with parathyroid tests.

Pharmacological Class:
Angiotensin II receptor blocker (ARB) + thiazide diuretic.

Adverse Reactions:
Dizziness, fatigue, musculoskeletal pain, GI upset; renal dysfunction, electrolyte and metabolic disturbances.

How Supplied:
Tabs—30, 90