Irbesartan

1 General Considerations Irbesartan tablets may be administered with other antihypertensive agents and with or without food. 2 Hypertension The recommended initial dose of irbesartan tablets is 150 mg once daily. 1) ]. 2) ]. 2) ].

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. 1 ) To report SUSPECTED ADVERSE REACTIONS, contact Solco Healthecare US LLC.

gov/medwatch. 1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse events that appear to be related to drug use and for approximating rates. Hypertension Irbesartan tablets have been evaluated for safety in more than 4300 patients with hypertension and about 5000 subjects overall.

This experience includes 1303 patients treated for over 6 months and 407 patients for 1 year or more. In placebo-controlled clinical trials, the following adverse reactions were reported in at least 1% of patients treated with irbesartan tablets (n=1965) and at a higher incidence versus placebo (n=641), excluding those too general to be informative and those not reasonably associated with the use of drug because they were associated with the condition being treated or are very common in the treated population, include: diarrhea (3% vs 2%), dyspepsia/heartburn (2% vs 1%), and fatigue (4% vs 3%).

Irbesartan use was not associated with an increased incidence of dry cough, as is typically associated with ACE inhibitor use. 7% in patients receiving placebo. 0% in the placebo group. 4% in the placebo group. 2%). 2 Postmarketing Experience The following adverse reactions have been identified during postapproval use of irbesartan tablets.

5 WARNINGS AND PRECAUTIONS Hypotension: Correct volume or salt depletion prior to administration. 2 ) Monitor renal function and serum potassium. 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. 1) ]. , those being treated with high doses of diuretics), symptomatic hypotension may occur after initialization of treatment with irbesartan tablets.

4) ]. 3 Impaired Renal Function Changes in renal function including acute renal failure can be caused by drugs that inhibit the renin-angiotensin system. , patients with renal artery stenosis, chronic kidney disease, severe heart failure, or volume depletion) may be at particular risk of developing acute renal failure or death on irbesartan tablets.

Monitor renal function periodically in these patients. 3) ].

4 CONTRAINDICATIONS 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.

( 4 ) Coadministration with aliskiren in patients with diabetes. ( 4 )