Universal reference book for medicines

Active substance: hydrochlorothiazide, irbesartan

Type: Antihypertensive drug

Manufacturer: Pharmaceutical Works POLPHARMA (Poland) manufacturer of the substance INKE (Spain) manufacturer of the substance IPCA LABORATORIES (India) manufacturer of the substance MATRIX Laboratories (India) manufacturer of the substance TEVA API INDIA (India) manufacturer of the substance Pharmaceutical Works POLPHARMA (Poland)
Tablets, film-coated 1 tab.
hydrochlorothiazide 12.5 mg

irbesartan 150 mg

7 pcs.
- blisters (4) - packs of cardboard.
10 pieces.
- blisters (3) - packs of cardboard.
14 pcs.
- blisters (2) - packs of cardboard.
15 pcs.
- blisters (2) - packs of cardboard.
Tablets, film-coated 1 tab.

hydrochlorothiazide 12.5 mg

irbesartan 300 mg

7 pcs.
- blisters (4) - packs of cardboard.
10 pieces.
- blisters (3) - packs of cardboard.
14 pcs.
- blisters (2) - packs of cardboard.
15 pcs.
- blisters (2) - packs of cardboard.
Tablets, film-coated 1 tab.

hydrochlorothiazide 25 mg

irbesartan 300 mg

7 pcs.
- blisters (4) - packs of cardboard.
10 pieces.
- blisters (3) - packs of cardboard.
14 pcs.
- blisters (2) - packs of cardboard.
15 pcs.
- blisters (2) - packs of cardboard.

Description of the drug approved by the manufacturer for the printed edition of 2014.


Combined drug with antihypertensive effect.
The composition includes an angiotensin II receptor antagonist and a thiazide diuretic. The combination of these drugs has an additive antihypertensive effect, reducing blood pressure to a greater extent than each of the drugs individually. Irbesartan is a selective antagonist of angiotensin II receptor (type AT 1 ) for oral administration. Irbesartan blocks all physiologically significant effects of angiotensin II, mediated by AT 1 receptors, regardless of the source or route of synthesis of angiotensin II. Selective antagonism to the receptors of angiotensin II (AT 1 ) leads to an increase in the blood plasma concentrations of renin and angiotensin II and a decrease in the concentration of aldosterone in the blood plasma. Serum potassium content usually does not change significantly when taking irbesartan at recommended doses, Irbesartan does not inhibit kinase II. Irbesartan does not require metabolic activation. Reduces blood pressure with a minimum change in heart rate.
Hydrochlorothiazide is a thiazide diuretic.
Affects the reabsorption of electrolytes in the renal tubules, directly increasing the excretion of sodium and chloride ions in approximately equal amounts. The diuretic effect of hydrochlorothiazide leads to a decrease in the volume of blood plasma, an increase in renin activity in the blood plasma, an increase in the secretion of aldosterone and an increase in the content of potassium ions and bicarbonates in the urine and hypokalemia. Simultaneous administration with irbesartan leads to a decrease in the loss of potassium ions, mainly due to the blockade of the renin-angiotensin-aldosterone system. When taking hydrochlorothiazide, an increase in diuresis occurs after 2 hours and reaches a maximum after 4 hours. The action of hydrochlorothiazide lasts about 6-12 hours.
Reduction of blood pressure in the appointment of irbesartan in combination with hydrochlorothiazide appears even with the first intake of the drug inside and persists for 1-2 weeks, followed by its gradual strengthening and development of maximum effect at 6-8 weeks.


Simultaneous administration of hydrochlorothiazide and irbesartan does not affect the pharmacokinetics of each drug.


After oral administration, absolute bioavailability of irbesartan is 60-80%, hydrochlorothiazide 50-80%.
Admission niches do not affect their bioavailability. C maxirbesartan in blood plasma is achieved 1.5-2 hours after ingestion, hydrochlorothiazide - after 1-2.5 hours.

Irbesartan binds 96% with plasma proteins.
The volume of distribution (V d ) of irbesartan is 53-93 liters. The pharmacokinetic parameters of irbesartan are linear and proportional in the dose range from 10 mg to 600 mg. At doses in excess of 600 mg (a dose twice the recommended maximum dose of the drug), the pharmacokinetics of irbesartan become nonlinear (decrease in absorption).
Hydrochlorothiazide binds to blood plasma proteins by 68%, V d - 0,83-1,14 l / kg.


Irbesartan is metabolized in the liver by conjugation with glucuronic acid and oxidation.
The main metabolite circulating in the blood is irbesartan gutukuronid (about 6%). In vitro studies have shown that irbesartan is oxidized, mainly through the cytochrome P450 isoenzyme CYP2C9. The effect of the CYP3A4 isoenzyme is negligible.
Hydrochlorothiazide is not metabolized.
It penetrates through the placental barrier and is excreted in breast milk. Does not penetrate the blood-brain barrier.

The total clearance and renal clearance are 157-176 and 3.0-3.5 ml / min, respectively.
T 1/2 of irbesartan is 11-15 hours. Irbesartan and its metabolites are excreted through the intestine (80%) and kidneys (20%). and less than 2% of the accepted dose of irbesartan is excreted by the kidneys unchanged.
T 1/2 hydrochlorothiazide - 5-15 hours. It is excreted by the kidneys.
At least 61% of the dose taken internally is excreted unchanged for 24 hours.
Pharmacokinetics in special clinical cases

Several higher concentrations of irbesartan in blood plasma are noted in female patients.
However, differences in the T 1/2 value of cumulation of irbesartan were not revealed. Correction of irbesartan dose in patients with female ileal is not required.
Values ​​for the plaque under the concentration-time curve (AUC) and Cmax of irbesartan in blood plasma were slightly higher in elderly patients (over 65 years) than in younger patients (up to 65 years of age).
T 1/2 irbesartan did not differ significantly. Correction of irbesartan dose in elderly patients is not required.
Disturbance of renal function: in patients with impaired renal function or pa hemodialysis, the pharmacokinetic parameters of irbesartan are changed insignificantly.

Dysfunction of the liver: in patients with impaired liver function of mild or moderate severity, the pharmacokinetic parameters of irbesartan are changed insignificantly.
In patients with severe impairment of liver function, no studies have been performed.

- Arterial hypertension (treatment of patients who are shown combined therapy).


Inside, once a day, regardless of food intake.

The drug Ibertan Plus 12.5 / 150 mg (tablets containing hydrochlorothiazide / irbesartan 12.5 / 150 mg, co-strategically) may be administered to patients who are not adequately controlled by the administration of hydrochlorothiazide (12.5 mg / day) or irbesartan (150 mg / day) in monotherapy.

The drug Ibertan Plus 12.5 / 300 mg (tablets containing hydrochlorothiazide / nebesartan 12.5 / 300 mg, respectively) may be given to patients if the arterial pressure is not adequately controlled by the appointment of irbesartan (300 mg / day) or the drug Ibertan Plus (12.5 / 150 mg).

The drug Ibertan Plus 25-300 mg (tablets containing hydrochlorothiazide / irbesartan 25/300 mg, respectively) can be given to patients if the blood pressure is not adequately controlled by the prescription of the drug Ibertan Plus (12.5 / 300 mg).
Do not administer doses higher than 25 mg hydrochlorothiazide / 300 mg irbesartan 1 time per day.
If necessary, the drug Ibertan Plus can be prescribed together with other antihypertensive drugs.

Impaired renal function: due to the fact that the composition of the drug Ibertan Plus includes hydrochlorothiazide.
the drug is not recommended for patients with impaired renal function of severe severity (creatinine clearance <30 mL / min). In patients in this population, the appointment of "loop" diuretics is more preferable.No dose adjustment is required in patients with impaired renal function with creatinine clearance> 30 mL / min.
Violation of the function of the liver: it is not recommended the appointment of the drug Ibertan Plus in patients with hepatic insufficiency of severe severity.
In patients with hepatic insufficiency of mild and moderate severity, dose adjustment of the Iberto Plus preparation is not required.
Elderly patients: there is no need to adjust the dose of the drug Ibertan Plus in elderly patients.

Reduction of the volume of circulating blood: before the appointment of the drug, Ibertan Plus, it is necessary to adjust the volume of circulating blood and / or the sodium content.


The following side effects are given according to the following gradations of their frequency: very often (> 1/10);
often /> 1/100, <1/10); infrequently (> 1/1 000, <1/100); rarely (> 1/10 000, <1/1 000); very rarely (<1/10 000). Within each frequency of occurrence, adverse reactions are indicated in the sequence according to a decrease in their severity.
The combination of hydrochlorothiazide / irbesartan:

From the side of the central nervous system: often - dizziness;
infrequently orthostatic dizziness.
From the cardiovascular system: infrequently syncope, pronounced lowering of arterial pressure, tachycardia, peripheral edema, "tides" of blood to the skin of the face.

On the part of the digestive system: often - nausea, vomiting;
infrequently diarrhea.
From the urinary system: often - a violation of urination.

From the genitourinary system: infrequently - sexual dysfunction, violation of libido.

Other: often - increased fatigue.

Laboratory indicators: often - increasing the concentration of urea nitrogen, creatinine and plasma creatine phosphokinase;
infrequently - a decrease in the content of potassium and sodium in the blood serum. These changes in laboratory parameters were rarely clinically significant.
Adverse reactions detected with the combination of hydrochlorothiazide / irbesartan, reported in the postmarketing period:

Allergic reactions: rarely - skin rash, hives, angioedema.

From the side of metabolism: very rarely - hyperkalemia.

From the central nervous system: very rarely - a headache.

From the sense organ: very rarely - ringing in the ears.

From the respiratory system : very rarely - cough.

From the digestive system: very rarely - dyspepsia, dysgeusia, dryness of the oral mucosa, hepatitis, violations of the liver.

From the musculoskeletal system: very rarely arthralgia, myalgia.

From the urinary system: very rarely - a violation of kidney function, incl.
individual cases of renal failure in patients at high risk.
Additional information for individual components:

In addition to the already mentioned adverse reactions, other side effects previously reported with respect to each of the components that may be possible side effects in the case of the Iberto Plus drug are listed below.


Other: infrequent - pain in the chest.

Hydrochlorothiazide (without specifying frequency of occurrence)

On the part of the organs of hematopoiesis: aplastic anemia, bone marrow depression, hemolytic anemia, leukopenia, neutropenia / agranulocytosis, thrombocytopenia.

From the central nervous system: depression, sleep disorders, dizziness, paresthesia, anxiety.

On the part of the sense organ: the transient vagueness of vision, xanthopsia.

From the cardiovascular system: arrhythmias, postural hypotension.

On the part of the respiratory system: respiratory distress syndrome (including pneumonitis and pulmonary edema).

From the side of the digestive system: jaundice (intrahepatic cholestatic jaundice).

Allergic reactions: anaphylactic reactions, toxic epidermal necrolysis, lupus-like syndrome, necrotizing angiitis (vasculitis, cutaneous vasculitis), photoconversion reactions, skin rash, exacerbation of systemic lupus erythematosus, urticaria.

From the musculoskeletal system: muscle spasms, weakness.

From the urinary system: interstitial nephritis, kidney dysfunction.

Other: increased body temperature.

Laboratory indicators: violations of the water-electrolyte balance (including hypokalemia and gyonatremia), glucosuria, hyperglycemia, hyperuricemia, increased cholesterol and triglycerides.


- hypersensitivity to any of the components of the drug or to other derivatives of the sulfonamide;

- renal failure of severe severity (creatinine clearance <30 ml / min), anuria;

- hepatic insufficiency of severe severity (class C / more than 9 points / Child-Pugh scale), biliary cirrhosis and cholestasis;

- refractory hypokalemia, hypomagnesemia, hypercalcemia;

- primary hyperaldosteronism;

- hereditary lactose intolerance, lactase insufficiency and glucose-galactose malabsorption syndrome;

- pregnancy and lactation;

- age under 18 years (efficiency and safety not established).


- With stenosis of the aortic or mitral valve;
hypertrophic obstructive cardiomyopathy.
- With dehydration, hyponatremia, diarrhea, vomiting, observance of a diet with restriction of consumption of table salt, treatment with diuretics.

- With bilateral or unilateral stenosis of the renal arteries, chronic heart failure III-IV stage according to the NYHA classification (as with other drugs affecting the renin-angiotensin-aldosterone system, one can not exclude the risk of developing arterial hypotension, oliguria and / or azotemia and progressive acute renal failure).

- With ischemic heart disease and / or atherosclerotic lesions of cerebral vessels.

- With renal insufficiency of mild and moderate severity (QC from 60 to 30 ml / min), hemodialysis;
with recent kidney transplantation (lack of clinical experience).
- With hepatic insufficiency (lack of clinical experience).

- With diabetes mellitus;
increased content of cholesterol and triglycerides in the blood; gout; latent hyperpara ridiculous; sympathectomy.
- With hyperkalemia, simultaneous intake of potassium-sparing drugs and potassium-containing substitutes for table salt, while taking other antihypertensive drugs.

- With systemic lupus erythematosus.


The use of the drug Ibertan Plus is contraindicated in pregnancy, since the effects on the fetus of medicines that affect the renin-angiotensin-aldosterone system can lead to damage and death of the developing fetus.
Thiazide diuretics penetrate the placental barrier and are found in the umbilical cord blood. Usually, the use of diuretics in healthy pregnant women is not recommended and exposes the mother and the fetus to unnecessary risk, including the development of fetal or neonatal jaundice, thrombocytopenia, and possibly other adverse reactions that occur in adults. Especially recommended is the intake of hydrochlorothiazide in the first trimester of pregnancy. The drug is contraindicated in the II and III trimesters of pregnancy. If the pregnancy is diagnosed, then the drug Ibertan Plus should be canceled as soon as possible. If the patient was taking the drug from the second trimester of pregnancy, it is necessary to perform ultrasound examination of the skull and kidney function. The drug Ibertan Plus is contraindicated during the entire lactation period.

Due to the fact that the composition of the drug Ibertan Plus includes hydrochlorothiazide, the drug is not recommended for patients with impaired renal function of severe severity (CK <30 ml / min).
In patients in this population, the appointment of "loop" diuretics is more preferable. There is no need for dose adjustment in patients with impaired renal function with CK> 30 ml / min.

It is not recommended to administer Ibertan Plus in patients with severe hepatic impairment.
In patients with hepatic insufficiency of mild and moderate severity, dose adjustment of the Iberto Plus preparation is not required.

Contraindicated for children under 18 years.


It is not necessary to adjust the dose of the drug Ibertan Plus in elderly patients.


Patients with arterial hypotension and reduced circulating blood volume: in patients with arterial hypertension, the drug Ibertan Plus rarely causes symptomatic arterial hypotension.
Symptomatic arterial hypotension can be observed in patients with a reduced volume of circulating blood or a low sodium content against the background of gerapni diuretics, with a diet with restriction of table salt, with diarrhea or vomiting. Such conditions should be adjusted before the initiation of therapy with the drug Ibertan Plus.
Renovascular hypertension.
In patients with bilateral stenosis of the renal arteries or stenosis of the artery of a single functioning kidney, there is an increased risk of developing severe arterial hypotension and renal failure when taking drugs that affect RAAS. Although against the background of taking the drug Ibertan Plus, no such data were found, this kind of effects can be expected during the application of angiotensin II receptor antagonists.
Renal failure and condition after kidney transplantation.
In the case of the use of the drug Ibertan Plus in patients with impaired renal function, periodic monitoring of potassium, creatinine and uric acid in the serum is indicated. There is no experience with the use of Ibertan Plus in patients after a recent kidney transplantation.
Stenosis of the aortic or mitral valve, hypertrophic obstructive cardiomyopathy.
As with the use of other vasodilators, caution should be exercised in patients with aortic or mitral stenosis or hypertrophic obstructive cardiomyopathy when prescribing the Iberto Plus preparation.
Primary hyperaldosteronism.
Hypotensive drugs acting through the inhibition of the renin-angiotensin-aldosterone system are usually ineffective in patients with primary hyperaldosteroneism. Therefore, the use of the drug Ibertan Plus in such cases is impractical.
Metabolic and endocrine effects.
Thiazide diuretics can reduce glucose tolerance. Patients with diabetes may require a dose adjustment of insulin or hypoglycemic drugs for oral administration. Against the background of taking thiazide diuretics, it is possible to develop latent diabetes mellitus.
In therapy thiazide diuretics in some patients may experience worsening of hyperuricemia or gout.
Disruption of water and electrolyte balance.Thiazide diuretics, including hydrochlorothiazide. may condition the disruption of water-electrolyte balance (hypokalemia, hyponatremia and hypochloraemic alkalosis). Although the use of thiazide diuretics possible development of hypokalemia, simultaneous with the irbesartan may reduce hypokalemia caused by diuretics. It increases the risk of hypokalemia in patients who receive corticosteroids or adrenocorticotropic hormone. On the contrary, due to the irbesartan, a part of the drug Ibertan plus possibly hyperkalemia, especially in the presence of renal insufficiency and / or heart failure, or diabetes. It is recommended to regularly monitor potassium in the blood serum of patients at risk.
Thiazide diuretics may reduce the excretion of calcium ions kidneys and cause a transient in the absence of hypercalcemia confirmed tackle calcium metabolism. Marked hypercalcemia may be evidence of latent hyperparathyroidism. Thiazide diuretics should be discontinued prior to the investigation of parathyroid function.
It is shown that tnazidnye diuretics may increase the renal excretion of magnesium ions, which can lead to the development of hypomagnesemia.
Doping test: hydrochlorothiazide can cause a positive result in doping control.
Others.As with other antihypertensive drugs that affect the renin-angiotensin-aldosterone system, a significant reduction in blood pressure in patients with ischemic heart disease and / or aterosklerozicheskim carotid arteries can lead to heart attack or stroke. Treatment of such patients should be administered iodine strict control of blood pressure.
There are reports of weighting or exacerbation of systemic lupus erythematosus in the appointment of thiazide diuretics.
Impact on the ability to drive vehicles and operate machinery
Plus Ibertan influence of the drug on the ability to drive vehicles and to carry out work that requires increased attention, have not been studied. However, during the period of drug administration must be careful when driving vehicles and operating machinery, because at the time of treatment may cause dizziness and fatigue.

Symptoms (presumed): irbesartan - marked reduction of blood pressure, tachycardia, bradycardia. Hydrochlorothiazide - hypokalemia, hyponatremia, dehydration resulting from excessive diuresis. The most common symptoms of overdose are nausea and somnolence. Hypokalemia can lead to seizures and / or development of cardiac arrhythmias associated with eochetannym use of cardiac glycosides and antiarrhythmics.
Treatment:It depends on the time elapsed since the receiving and the severity of symptoms. Proposed measures include induced vomiting and / or gastric lavage, administration of activated charcoal, careful monitoring the patient's condition holding symptomatic and supportive therapy. It is necessary to monitor the concentration of electrolytes and creatinine in the blood plasma. 13 the case of pronounced reduction in blood pressure of the patient must be laid on its back with elevated lower limb and how to refund salts and liquid quickly. Irbesartan does not appear in hemodialysis.

Other antihypertensive agents: the antihypertensive effect of the drug Ibertan Plus may be enhanced by concomitant administration of other antihypertensive drugs. Irbesartan and hydrochlorothiazide (at doses up to 25 mg of hydrochlorothiazide / 300 mg irbesartan) can be safely used in combination with other antihypertensive drugs, including blockers "slow" calcium channel blockers and beta-blockers. The earlier treatment with high doses of diuretics can lead to Mr excuse it and and and increase the risk of arterial gppotenzii.
Lithium:There are reports of increasing reversible lithium concentrations in serum and toxicity when combined appointment drugs lithium and angiotensin-converting enzyme. With respect to irbesartan, similar effects were hitherto extremely rare. In addition, renal clearance of lithium is reduced in patients receiving thiazide diuretics, so when administering the drug Ibertan Plus there is an increased risk of toxic effects of lithium. If the purpose of this combination is necessary, it is recommended to carry out careful monitoring of lithium in blood serum.
The medicaments affecting the content of potassium in the blood:hypokalemic effect of hydrochlorothiazide is attenuated due to a potassium-sparing effect of irbesartan. However, this effect can be enhanced hydrochlorothiazide other drugs koyuryh assignment is associated with loss of potassium and gnpokalpemiey (e.g., diuretics, laxatives, amphotericin, carbenoxolone sodium salt of penicillin G, salicylic acid derivatives) Conversely, based on experience of using drugs that reduce the activity of renin angiotensin-aldosterone system, concomitant use of kaliysberegayushi.h dpureshkov. oiologicheski active additives, salt substitute containing potassium, go to other drugs, which may lead to an increase in the potassium content in serum (e.g., heparin sodium salt) can cause elevation of serum rolling.Recommended provodsh proper monitoring of potassium in the blood serum of patients with hyperkalemia development risk.
Drugs that are affected by the violation potassium balance in the blood serum: advisable to carefully control the content of potassium in blood serum when assigning Ibertan Plus drug together with the drugs that are affected by the violation potassium balance in the blood serum (e.g., cardiac glikozndy antiarrhythmics.).
Nonsteroidal anti-inflammatory drugs:when assigning angnotenzina II receptor antagonists in combination with non-steroidal anti-inflammatory drugs (e.g., selective inhibitors of cyclooxygenase-2 (COX-2), acetylsalicylic acid (> 3 g / day) and non-selective non-steroidal antiinflammatory drugs) may be expected attenuation antigilertenzivnogo action. As with angiotensin converting enzyme inhibitors and angiotensin II receptor antagonists in combination with NSAIDs, an increased risk of renal impairment, until the development of acute renal failure, improvement in potassium in serum, especially in patients with already compromised renal function. This drug combination should be administered with caution, especially in elderly patients. Patients should not be dehydrated.Monitoring the kidney function must be carried out after the start of combination therapy and periodically thereafter.
Additional information on drug interactions irbesartan: hydrochlorothiazide did not affect the pharmacokinetics of irbesartan. In the appointment of irbesartan in combination with warfarin metabolized with isoenzyme inducers of CYP2C9, there was no significant pharmacokinetic interactions and farmakodinamichesknh. Effect induktrov isoenzyme CYP2C9, e.g. rifampicin, the pharmacokinetics of irbesartan not evaluated. In the appointment of irbesartan in combination with digoxin pharmacokinetics latter did not change.
Additional information about drug interactions hydrochlorothiazide:
The following drugs may interact with thiazide diuretics while appointing:
Ethanol, barbiturates or narcotic drugs:It can be observed amplification of orthostatic hypotension.
Hypoglycemic drugs (means for intake and insulin) may require correction dose hypoglycemic agents.
Cholestyramine and colestipol: in the presence of anion exchange resins have malabsorption hydrochlorothiazide. The interval between administration of these drugs must be at least 4 hours.
Glucocorticosteroids, adrenocorticotropic hormone: a pronounced disruption of water and electrolyte balance, in particular, the strengthening of hypokalemia.
Catecholamines (e.g., norepinephrine) can be reduced efficacy of these drugs.
Non-depolarizing muscle relaxants (e.g., tubocurarine):hydrochlorothiazide can potentiate the effects of non-depolarizing muscle relaxants.
Anti-gout agents: may require correction lots preparations used to treat gout, as hydrochlorothiazide may enhance the uric acid in the blood plasma. You may need to increase the dose or probenenida sulfinpirazona. Co-administration with thiazide diuretics may increase the incidence of hypersensitivity reactions to allopurinol.
Calcium salts:thiazide diuretics may increase the calcium content of the plasma due to the decrease in its clearance. If desired destination calcium supplements or drugs affecting calcium content (e.g., vitamin D), accordingly necessary to adjust the dose of these drugs and to monitor the calcium content in the blood plasma.
Other types of drug interactions:thiazide diuretics may enhance the hyperglycaemic effect of beta-blockers and diazoxide. Anticholinergics (e.g., atropine) may increase the bioavailability of thiazide diuretics by decreasing gastrointestinal motility and gastric emptying rate. Thiazide diuretics may increase the risk of adverse reactions caused by amantadine. Thiazide diuretics may reduce renal excretion of cytotoxic drugs (e.g., cyclophosphamide, methotrexate) and potentiate their myelosuppressive effects.

On prescription.


At temperatures above 25 В° C.
Keep out of the reach of children. Shelf life - 2 years.
The information is provided for your information, do not self-medicate, it is dangerous for your health.

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