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AVAPRO
Diabetes
Hypertension
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Drug Name:

AVAPRO Rx

Generic Name and Formulations:
Irbesartan 75mg, 150mg, 300mg; tabs.

Company:
Sanofi Aventis

Therapeutic Use:

Indications for AVAPRO:

Treatment of diabetic nephropathy in patients with type 2 diabetes and hypertension.

Adult:

300mg once daily.

Children:

Not recommended.

Contraindications:

Concomitant aliskiren in patients with diabetes.

Warnings/Precautions:

Fetal toxicity may develop; discontinue if pregnancy is detected. Correct salt/volume depletion before beginning therapy, or reduce initial dose. Renal impairment. Severe CHF. Renal artery stenosis. Elderly. Neonates. Pregnancy (Cat.D); monitor. Nursing mothers: not recommended.

Interactions:

Hyperkalemia with K+ supplements, K+ sparing diuretics, K+-containing salt substitutes. May increase lithium levels; monitor. May be antagonized by, and renal toxicity potentiated by, NSAIDs, including selective COX-2 inhibitors (monitor renal function periodically in elderly and/or volume depleted). 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.

Pharmacological Class:

Angiotensin II receptor blocker (ARB).

Adverse Reactions:

Diarrhea, dyspepsia, fatigue, orthostatic hypotension; increased BUN, hyperkalemia; rhabdomyolysis (rare).

Metabolism:

Hepatic (CYP2C9); 90% protein bound.

Elimination:

Biliary, renal.

Generic Availability:

YES

How Supplied:

Tabs—30, 90

Indications for AVAPRO:

Hypertension.

Adult:

≥16yrs: 150mg once daily; may increase to 300mg once daily. Or, may add a low dose of diuretic. Salt/volume depletion: initially 75mg once daily.

Children:

Not recommended.

Contraindications:

Concomitant aliskiren in patients with diabetes.

Warnings/Precautions:

Fetal toxicity may develop; discontinue if pregnancy is detected. Correct salt/volume depletion before beginning therapy, or reduce initial dose. Renal impairment. Severe CHF. Renal artery stenosis. Elderly. Neonates. Pregnancy (Cat.D); monitor. Nursing mothers: not recommended.

Interactions:

Hyperkalemia with K+ supplements, K+ sparing diuretics, K+-containing salt substitutes. May increase lithium levels; monitor. May be antagonized by, and renal toxicity potentiated by, NSAIDs, including selective COX-2 inhibitors (monitor renal function periodically in elderly and/or volume depleted). 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.

Pharmacological Class:

Angiotensin II receptor blocker (ARB).

Adverse Reactions:

Diarrhea, dyspepsia, fatigue; increased BUN, hyperkalemia; rhabdomyolysis (rare).

Metabolism:

Hepatic (CYP2C9); 90% protein bound.

Elimination:

Biliary, renal.

Generic Availability:

YES

How Supplied:

Tabs—30, 90

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