Irbesartan is in a class of drugs called angiotensin II receptor antagonists. Irbesartan prevents the constriction (narrowing) of blood vessels (veins and arteries) also termed as vasodilator agents.
Indications: For the treatment of hypertension (high blood pressure) and diabetic and hypertensive nephropathy (kidney disease caused by type 2 diabetes mellitus and high blood pressure).
Special precautions: Pregnancy and lactation (US FDA category D). Do not take irbesartan if you are pregnant or could become pregnant during treatment. When used during the second and third trimesters of pregnancy, irbesartan can cause injury and even death to the developing fetus. Do not take irbesartan without first talking to our doctor if you are nursing a baby. Use caution when driving, operating machinery, or performing other hazardous activities. Irbesartan may cause dizziness or drowsiness. Also use caution when rising from a sitting or lying position. Avoid alcohol, it may further lower blood pressure and increase drowsiness and dizziness while taking irbesartan.
Before taking irbesartan, tell your doctor if you have any of the following:
• kidney disease;
• liver disease;
• on a salt-restricted diet or have high levels of potassium in your blood.
You may not be able to take irbesartan, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.
Take the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and take only the next regularly scheduled dose. Do not take a double dose of this medication.
Symptoms of an irbesartan overdose are not well known, but might include dizziness, weakness, fainting, fatigue, and chest pain. Seek emergency medical attention if you have these symptoms.
Serious side effects: an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives); or little or no urine.
Less serious side effects: diarrhea or upset stomach; swelling; muscle pain, cramps, or backache; dizziness; headache; insomnia; or congestion or cough (very unlikely).
Drug interactions: potassium supplements such as K-Dur, Klor-Con, and others;
potassium-sparing diuretic (water pill) such as amiloride (Midamor), spironolactone (Aldactone), or triamterene (Dyrenium, Dyazide, Maxzide); or a salt substitute; other heart medications or other drugs for high blood pressure (it may cause very low blood pressure). Inform your doctor if you are taking drugs other than those listed here.
Irbesartan is a white to off-white crystalline powder with a molecular weight of 428.5. It is a nonpolar compound with a partition coefficient (octanol/water) of 10.1 at pH of 7.4. Irbesartan is slightly soluble in alcohol and methylene chloride and practically insoluble in water. Irbesartan is a non-peptide compound, chemically described as a 2-butyl-3-[p-(o-1H-tetrazol-5-ylphenyl)benzyl] -1,3-diazaspiro[4.4]non-1-en-4-one. AVAPRO is available for oral administration in unscored tablets containing 75 mg, 150 mg, or 300 mg of irbesartan. Inactive ingredients include: lactose, microcrystalline cellulose, pregelatinized starch, croscarmellose sodium, poloxamer 188, silicon dioxide and magnesium stearate.
Irbesartan has the following structural formula: