Ibertan (Tablets) Instructions for Use

Instructions
Dosage forms

ATC Code

C09CA04 (Irbesartan)

Active Substance

Irbesartan (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Angiotensin II receptor antagonist

Pharmacotherapeutic Group

Angiotensin II receptor antagonist

Pharmacological Action

Antihypertensive agent, angiotensin II receptor antagonist. It blocks AT₁ receptors, which leads to a decrease in the biological effects of angiotensin II, including its vasoconstrictive action, stimulating effect on aldosterone release, and activation of the sympathetic nervous system. As a result, blood pressure decreases.

It reduces total peripheral vascular resistance and decreases afterload. It lowers blood pressure (with minimal change in heart rate) and pressure in the pulmonary circulation, and the reduction in blood pressure is dose-dependent.

It does not affect the concentration of triglycerides, cholesterol, glucose, uric acid in blood plasma or the excretion of uric acid in urine.

Pharmacokinetics

After oral administration, it is well absorbed from the gastrointestinal tract. The C_max of irbesartan in blood plasma is reached 1.5-2 hours after oral administration. Bioavailability is 60-80%. Concurrent food intake does not affect the bioavailability of irbesartan.

Plasma protein binding is about 96%. V_d is 53-93 L. C_ss is reached within 3 days after starting irbesartan once daily. With repeated once-daily administration, limited accumulation of irbesartan in plasma is observed (less than 20%).

After oral administration of ¹⁴C-irbesartan, 80-85% of the radioactivity in the circulating blood is due to unchanged Irbesartan.

Irbesartan is metabolized in the liver by conjugation to form a glucuronide and by oxidation. The main metabolite is Irbesartan glucuronide (about 6%).

Within the therapeutic dose range, Irbesartan exhibits linear pharmacokinetics, with a T_1/2 in the terminal phase of 11-15 hours. Total clearance and renal clearance are 157-176 ml/min and 3-3.5 ml/min, respectively. Irbesartan and its metabolites are excreted in bile and urine.

In patients with impaired renal function and moderate liver cirrhosis, the pharmacokinetic parameters of irbesartan do not change significantly.

Indications

Arterial hypertension.

Nephropathy in patients with arterial hypertension and type 2 diabetes mellitus (as part of combined antihypertensive therapy).

ICD codes

Open the list of ICD codes

ICD-10 code	Indication
I10	Essential [primary] hypertension
N08.3	Glomerular disorders in diabetes mellitus

ICD-11 code	Indication
BA00.Z	Essential hypertension, unspecified
MF83	Diabetic glomerular changes

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

Administer the initial dose of 150 mg orally once daily.

Take the tablet at the same time each day, with or without food.

If adequate blood pressure control is not achieved, increase the dose to the maximum recommended dose of 300 mg once daily.

For patients with volume depletion, initiate therapy at a lower initial dose.

This includes patients on a low-chloride diet, receiving high-dose diuretic therapy, or with a history of vomiting or diarrhea.

In patients with type 2 diabetes mellitus and hypertension for nephropathy, the recommended maintenance dose is 300 mg once daily.

For patients with mild to severe hepatic impairment, no dosage adjustment is necessary.

For patients with renal impairment, including those on hemodialysis, no initial dosage adjustment is required.

Adverse Reactions

From the central nervous system headache, dizziness.

From the digestive system nausea, vomiting.

Other malaise, weakness.

Contraindications

Pregnancy, childhood, hypersensitivity to irbesartan.

Use in Pregnancy and Lactation

Contraindicated for use during pregnancy.

If use during lactation is necessary, the issue of discontinuing breastfeeding should be considered.

Use in Renal Impairment

Use with caution in patients with impaired renal function.

Pediatric Use

Contraindicated in childhood.

Special Precautions

Use with caution in patients with impaired renal function, after severe vomiting or diarrhea, and during concurrent therapy with potassium-sparing diuretics or potassium supplements.

In experimental studies on laboratory animals, no mutagenic, clastogenic, or carcinogenic effects of irbesartan were established.

Effect on the ability to drive vehicles and operate machinery

There are no reports on the effect of irbesartan on the ability to drive vehicles and operate machinery.

Drug Interactions

Concomitant use with potassium-sparing diuretics or potassium supplements may increase plasma potassium levels.

Concomitant use with hydrochlorothiazide demonstrates an additive nature of the hypotensive effect.

Concomitant use with lithium carbonate may increase plasma lithium concentrations.

Concomitant use of fluconazole may inhibit the metabolism of irbesartan.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.

Medical Disclaimer