Irbesartan Tablets

Irbesartan belongs to the group of medicines known as angiotensin-II receptor antagonists. Angiotensin-II is a substance produced in the body that binds to receptors by constricting blood vessels. This causes an increase in blood pressure. Irbesartan prevents the binding of angiotensin-II to these receptors, relaxing blood vessels and reducing blood pressure. Irbesartan slows the deterioration of kidney function in patients with high blood pressure and type 2 diabetes.

The benefits of Irbesartan happen due to it being a potent, orally active, selective angiotensin-II receptor antagonist (type AT1). It appears to block all actions of angiotensin-II mediated by the AT1 receptor, regardless of the origin or pathway of angiotensin-II synthesis. Selective antagonism of angiotensin-II (AT1) receptors produces increases in plasma renin and angiotensin-II levels and decreases in plasma aldosterone concentration. Serum potassium levels do not change significantly at the recommended doses of irbesartan monotherapy. Irbesartan does not inhibit ACE (quininease-II), an enzyme that generates angiotensin-II and that also breaks down bradykinin to inactive metabolites. Irbesartan does not require metabolic activation to be active.

Irbesartan Tablets uses include being indicated in adult patients:

• to treat high blood pressure (essential hypertension)
• to protect the kidney in patients with high blood pressure, type 2 diabetes and with clinical evidence of impaired kidney function

Always use this medicine exactly as your doctor has told you. If in doubt, consult your doctor or pharmacist again.

Administration method

Irbesartan is administered orally. The tablets should be swallowed with a sufficient amount of liquid (e.g. a glass of water). Irbesartan can be taken with or without food. You should try to take your daily dose at the same time every day. It is important that you continue taking this medicine until your doctor advises you otherwise. The tablet can be divided into equal doses. 

Patients with high blood pressure

The normal dose is 150 mg once a day. Subsequently, and depending on the blood pressure response, this dose can be increased to 300 mg once a day (two tablets a day).

Patients with high blood pressure and type 2 diabetes with impaired kidney

In patients with high blood pressure and type 2 diabetes, the recommended maintenance dose for the treatment of associated renal impairment is 300 mg once a day (two tablets a day).

The doctor may advise a lower dose, especially at the start of treatment, in certain patients, such as those on hemodialysis or those over 75 years of age.

The maximum reducing effect of blood pressure should be reached 4-6 weeks after the start of treatment.

Use in children and adolescents

Irbesartan should not be used in children under the age of 18. If a child swallows multiple tablets, contact your doctor immediately.

If you take more Irbesartan tablets than you should

If you accidentally take too many tablets, contact your doctor immediately.

Like all medicines, this medicine can cause side effects, although not everybody gets them. However, some effects can be serious and may need medical attention.

As with similar medications, cases of allergic skin reactions (rash, hives), as well as localized inflammation of the face, lips and/or tongue have been reported rarely in patients treated with irbesartan. If you think you may have such a reaction or have shortness of breath, stop taking irbesartan and go to a medical center immediately.

Adverse effects reported in clinical trials in patients treated with irbesartan were:

Very common (may affect more than 1 in 10 patients): If you have high blood pressure and type 2 diabetes with kidney failure, blood tests may show an increase in potassium levels.

Common (may affect up to 1 in 10 people): dizziness, nausea/vomiting, fatigue, and blood tests may show elevated levels of an enzyme that measures muscle and heart function (creatine kinase enzyme). In patients with high blood pressure and type 2 diabetes with impaired kidney function, dizziness (especially when standing up), low blood pressure (especially when standing up), muscle or joint pain, and decreased levels of a protein present in red blood cells (hemoglobin).

Uncommon (may affect up to 1 in 100 patients): tachycardia, redness of the skin, cough, diarrhea, indigestion/heartburn, sexual dysfunction (disturbances of sexual function), and chest pain.

Some adverse effects have been reported since the marketing of irbesartan. Side effects observed with unknown frequency (cannot be estimated from the available data) are: spinning sensation, headache, altered taste, ringing in the ears, muscle cramps, muscle and joint pain, reduction in platelet count, abnormal liver function, increased blood potassium levels, impaired kidney function, and inflammation of small blood vessels, mainly in the skin area (a condition known as leukocytoclastic vasculitis).

Infrequent cases of jaundice (yellowing of the skin and/or whites of the eyes) have also been observed.

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