Irbesartan

Irbesartan tablets are an angiotensin II receptor blocker (ARB) indicated for: Treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. ( 1.1 ) Treatment of diabetic nephropathy in hypertensive patients with type 2 diabetes, an elevated serum creatinine, and proteinuria. ( 1.2 ) 1.1 Hypertension Irbesartan tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular (CV) events, primarily strokes and myocardial infarction. …

• Indication Dose Hypertension 150 to 300 mg once daily Diabetic Nephropathy 300 mg once daily General Considerations Irbesartan tablets may be administered with other antihypertensive agents and with or without food
• Hypertension The recommended initial dose of irbesartan tablets is 150 mg once daily
• The dosage can be increased to a maximum dose of 300 mg once daily as needed to control blood pressure [see Clinical Studies ]
• Nephropathy in Type 2 Diabetic Patients The recommended dose is 300 mg once daily [see Clinical Studies ]
• Dose Adjustment in Volume and Salt-Depleted Patients The recommended initial dose is 75 mg once daily in patients with depletion of intravascular volume or salt (e.g., patients treated vigorously with diuretics or on hemodialysis) [see Warnings and Precautions ]

Irbesartan tablet USP, 150 mg is a white to off-white biconvex oval tablet debossed ‘HH’ on one side and ‘330’ on the other. Tablets: 150 mg ( 3 )

• Pregnancy Advise female patients of childbearing age about the consequences of exposure to irbesartan tablets during pregnancy
• Discuss treatment options with women planning to become pregnant
• Patients should be asked to report pregnancies to their physicians as soon as possible
• Potassium Supplements Advise patients receiving irbesartan tablets not to use potassium supplements or salt substitutes containing potassium without consulting their healthcare provider [see Drug Interactions ]
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• Irbesartan tablets are contraindicated in patients who are hypersensitive to any component of this product
• Do not coadministrate aliskiren with irbesartan tablets in patients with diabetes
• Hypersensitivity to any component of this product
• Coadministration with aliskiren in patients with diabetes

Lithium: Risk of lithium toxicity. ( 7 ) Nonsteroidal Anti-inflammatory Drugs (NSAIDs) and COX-2 inhibitors: Increased risk of renal impairment. Reduced antihypertensive effects. ( 7 ) Dual blockade of the renin-angiotensin system: Increased risk of renal impairment, hypotension, and hyperkalemia. ( 7 ) 7.1 Agents Increasing Serum Potassium Coadministration of irbesartan tablets with other drugs that raise serum potassium levels may result in hyperkalemia, sometimes severe. Monitor serum potassium in such patients. 7.2 Lithium Increases in serum lithium concentrations and lithium toxicity have been reported with concomitant use of irbesartan and lithium. …

Hypotension: Correct volume or salt depletion prior to administration. ( 5.2 ) Monitor renal function and serum potassium. ( 5.3 ) 5.1 Fetal Toxicity Irbesartan tablets can cause fetal harm when administered to a pregnant woman. Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. Resulting oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations. Potential neonatal adverse effects include skull hypoplasia, anuria, hypotension, renal failure, and death. …

The following important adverse reactions are described elsewhere in the labeling: Hypotension in Volume or Salt-Depleted Patients [see Warnings and Precautions (5.2) ] Impaired Renal Function [see Warnings and Precautions (5.3) ] Nephropathy in type 2 diabetic patients: The most common adverse reactions which were more frequent than placebo were hyperkalemia dizziness, orthostatic dizziness, and orthostatic hypotension. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Solco Healthecare US LLC. at 1-866-257-2597 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. …

IN SPECIFIC POPULATIONS Lactation: Potential for adverse effects in infants. ( 8.2 ) 8.1 Pregnancy Risk Summary Irbesartan tablets can cause fetal harm when administered to a pregnant woman. Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death [see Clinical Considerations] . …

No data are available in regard to overdosage in humans. However, daily doses of 900 mg for 8 weeks were well-tolerated. The most likely manifestations of overdosage are expected to be hypotension and tachycardia; bradycardia might also occur from overdose. Irbesartan is not removed by hemodialysis. Acute oral toxicity studies with irbesartan in mice and rats indicated acute lethal doses were in excess of 2000 mg/kg, about 25-fold and 50-fold the MRHD (300 mg) base on body surface area, respectively.

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