Duopress - instructions for use, doses, side effects, contraindications

auxiliary substances (core): cellulose microcrystalline 71.2 mg, croscarmellose sodium 7.0 mg, povidone-K25 5.0 mg, silicon dioxide colloid 2.7 mg, magnesium stearate 1.6 mg;

auxiliary substances (shell): hypromellose 2.85 mg, macrogol-4000 0.75 mg, titanium dioxide 1.4 mg.

Each tablet of 160.0 mg + 12.5 mg contains:

active substances: valsartan 160.0 mg and hydrochlorothiazide 12.5 mg;

auxiliary substances (core): cellulose microcrystalline 154.9 mg, croscarmellose sodium 14.0 mg, povidone-K25 10.0 mg, silicon dioxide colloid 5.4 mg, magnesium stearate 3.2 mg;

auxiliary substances (shell): hypromellose 5.7 mg, macrogol-4000 1.5 mg, iron dye red oxide 0.1 mg, titanium dioxide 2.7 mg.

Each tablet of 160.0 mg + 25.0 mg contains:

active substances: valsartan 160.0 mg and hydrochlorothiazide 25.0 mg;

auxiliary substances (core): cellulose microcrystalline 142.4 mg, croscarmellose sodium 14.0 mg, povidone-K25 10.0 mg, silicon dioxide colloidal 5.4 mg, magnesium stearate 3.2 mg;

auxiliary substances (shell): hypromellose 5.7 mg, macrogol-4000 1.5 mg, titanium dioxide 2.8 mg.

Description:

Tablets with a dosage of 80 mg + 12.5 mg. Round biconvex tablets covered with a film coat of white or almost white color. On the fracture, two layers are visible: a white or almost white core and a film shell.

Tablets with a dosage of 160 mg + 12.5 mg. Round biconvex tablets, covered with a film coat from pink to light pink. On the fracture, two layers are visible: a white or almost white core and a film shell.

Tablets with a dosage of 160 mg + 25 mg. Round biconvex tablets covered with a film coat of white or almost white color. On the fracture, two layers are visible: a white or almost white core and a film shell.

Pharmacotherapeutic group:antihypertensive agent combined (angiotensin II receptor antagonist + diuretic)

ATX: & nbsp

C.09.D.A.03 Valsartan in combination with diuretics

C.09.D.A Angiotensin II antagonists in combination with diuretics

Pharmacodynamics:

Duopress is an antihypertensive combination that includes an angiotensin II receptor antagonist and a thiazide diuretic.

Valsartan

Valsartan is a selective angiotensin II receptor antagonist for ingestion, non-protein nature.

Has a selective antagonistic effect on the AT subtype receptors₁. The consequence of the blockade AT₁-receptors is an increase in the plasma concentration of angiotensin II, which can stimulate the unblocked receptors of the subtype AT₂, which balances the effects associated with AT stimulation₁receptors. Valsartan has no agonistic activity in relation to AT₁receptors. Its affinity for AT subtype receptors₁approximately 20,000 times greater than to the AT subtype receptors₂. Valsartan does not inhibit angiotensin-converting enzyme (ACE), also known as kininase II, which converts angiotensin I into angiotensin II and breaks down bradykinin.Due to the lack of influence on the ACE, the effects of bradykinin and P substance are not potentiated, so when taking angiotensin II receptor antagonists, the development of a dry cough is unlikely. Valsartan does not interact and does not block the receptors of other hormones or ion channels involved in the regulation of cardiovascular function. In the treatment of hypertension valsartan lowers blood pressure (BP), without affecting the heart rate (heart rate). After ingestion of a single dose of valsartan, the antihypertensive effect develops within 2 hours, and the maximum decrease in blood pressure is achieved within 4-6 hours. The antihypertensive effect of valsartan is maintained for 24 hours. With repeated appointments of valsartan, the maximum decrease in blood pressure, regardless of the dose, is achieved in 2-4 weeks and remains at the reached level during prolonged therapy. Combination with hydrochlorothiazide allows to achieve a significant additional reduction in blood pressure. The sudden discontinuation of valsartan is not accompanied by a withdrawal syndrome (sudden increase in BP or other undesirable clinical consequences).

Hydrochlorothiazide

A thiazide diuretic whose diuretic effect is associated with a disruption of the reabsorption of sodium, chlorine, potassium, magnesium, water in the distal nephron; delays the excretion of calcium ions, uric acid. Has hypotensive effect, which is due to the expansion of arterioles. Virtually no effect on normal BP. Diuretic effect develops 1-2 hours after taking the drug inside, reaches a maximum after 4 hours and persists for 6-12 hours. Antihypertensive effect occurs in 3-4 days, but it may take 3-4 weeks to achieve the optimal therapeutic effect.

Pharmacokinetics:

Valsartan

Valsartan is rapidly absorbed after ingestion, but the degree of absorption varies widely. The average absolute bioavailability of valsartan is 23%. The time required to reach the maximum concentration (TC_mOh) - 2 hours. When taking the drug inside, once a day, its accumulation is negligible. Plasma concentrations of valsartan are the same for men and women. Valsartan actively binds to blood serum proteins (94-97%), mainly with serum albumin. The equilibrium volume of distribution of the preparation is small, about 17 liters. Plasma clearance is relatively low (approximately 2 liters / hour) when compared with hepatic blood flow (approximately 30 liters / hour).

Metabolized by isoenzyme CYP2C9. Valsartan does not undergo significant biotransformation, only about 20% of the dose is excreted as metabolites. Valeryl-4-hydroxy valsartan is detected in blood plasma at low concentrations (less than 10% of the area under the pharmacological concentration-time curve (AUC)). This metabolite is pharmacologically inactive.

Half-life (T_1/2) is 9 hours. It is excreted mainly unchanged through the intestine (about 83%) and kidneys (about 13%). When taking valsartan with food, the area under the concentration-time curve decreases (AUC) by 48%. Nevertheless, 8 hours after taking plasma concentrations of valsartan taken on an empty stomach or with food are the same. Decrease AUC is not accompanied by a clinically significant decrease in the therapeutic effect of valsartan, so the drug can be used regardless of food intake.

Hydrochlorothiazide

After oral intake of hydrochlorothiazide is 60-80%.The maximum concentration (C_mOh) hydrochlorothiazide in the blood is achieved 2 hours after ingestion. Connection with blood plasma proteins - 40-70%. Hydrochlorothiazide also accumulates in erythrocytes in a concentration approximately 3 times that of plasma. Hydrochlorothiazide It is not metabolized and is quickly excreted through the kidneys (more than 95%). T_1/2is 6-15 hours.

Valsartan / hydrochlorothiazide

With simultaneous use with valsartan, the systemic bioavailability of hydrochlorothiazide is reduced by about 30%. The simultaneous administration of hydrochlorothiazide, for its part, does not have a significant effect on the kinetics of valsartan. The noted interaction does not affect the effectiveness of simultaneous application of valsartan and hydrochlorothiazide. In clinical studies, a clear antihypertensive effect of this combination was shown, which exceeded the effect of each of the components separately.

Special patient groups

Patients with impaired renal function

Given that the renal clearance is only 30% of the total clearance, patients with impaired renal function do not require correction of the doses of the drug.Currently, there are no data on the use of the drug in patients with severe renal dysfunction (creatinine clearance less than 30 ml / min) and in patients on hemodialysis.

Because the degree of binding of valsartan to plasma proteins is high, its excretion in hemodialysis is unlikely. At the same time, hemodialysis can be effectively removed from the body hydrochlorothiazide. In the presence of violations of kidney function, the average peak concentration in plasma and the value AUC hydrochlorothiazide increases, and the rate of excretion decreases. In patients with impaired renal function from mild to moderate T_1/2almost doubles.

Patients with impaired hepatic function

AUC valsartan in patients with lungs (5-6 on the Child-Pugh scale) and moderate (7-9 on the Child-Pugh scale), liver function impairment is 2 times greater than in healthy volunteers. Currently, there are no data on the use of the drug in patients with severe impairment of liver function (more than 9 on the Child-Pugh scale). Since violations of the liver do not have a clinically significant effect on the pharmacokinetics of hydrochlorothiazide, correction of its dose in patients with impaired liver function is not required.Contraindicated use of the drug in patients with severe impairment of liver function. In patients with bile duct obstruction, the drug should be used with caution.

Elderly patients

In some elderly patients AUC Valsartan was slightly higher than in young patients, but this is clinically insignificant. In elderly patients (both without arterial hypertension and in patients with hypertension) systemic clearance of hydrochlorothiazide is lower than in healthy young volunteers.

Indications:Arterial hypertension (patients who are shown combined therapy).

Contraindications:

- Hypersensitivity to valsartan, hydrochlorothiazide and other sulfonamide derivatives or to other components of the drug;

- Pregnancy, pregnancy planning, lactation period;

- severe violations of the liver (more than 9 points on the scale Child-Pugh);

- anuria, severe renal dysfunction (creatinine clearance (CK) less than 30 ml / min (0.5 ml / s));

- age under 18 years (effectiveness and safety of valsartan in children is not established);

- simultaneous use with aliskiren in patients with type 2 diabetes mellitus.

Carefully:

Simultaneous intake of potassium preparations, potassium-sparing diuretics, potassium-containing substitutes for edible salt and other agents that can increase the potassium content in the blood (eg, heparin), chronic heart failure III-IV functional class by classification NYHA, renal failure (QC more than 30 ml / min (0.5 ml / s)), bilateral or unilateral stenosis of the renal arteries or stenosis of the single kidney artery, condition after kidney transplantation; conditions, accompanied by a decrease in the volume of circulating blood (BCC) and / or sodium ions (including diarrhea, vomiting, high doses of diuretics); moderately severe violations of liver function, primary hyperaldosteronism, aortic and mitral valve stenosis, hypertrophic obstructive cardiomyopathy, systemic lupus erythematosus, diabetes mellitus, hyperuricemia, hypercholesterolemia and hypertriglyceridemia, obstructive bile duct disease and cholestasis, angle-closure glaucoma; state,accompanied aqueous electrolyte disturbances: nephropathy accompanied by the loss of salt and prerenal (cardiogenic) renal function in patients with hypokalemia, hypomagnesemia, hyponatremia, hypercalcemia.

Pregnancy and lactation:

Like any other drug that affects RAAS, Duopress should not be used in women planning a pregnancy. When appointing any drug that affects RAAS, the doctor should inform women of childbearing age of the potential danger of using these drugs during pregnancy.

The use of Duopress during pregnancy is contraindicated, since, given the mechanism of action of receptor antagonists for angiotensin II, the risk to the fetus can not be ruled out. The effect of ACE inhibitors (drugs that affect RAAS) on the fetus, if prescribed in the second and third trimesters of pregnancy, leads to damage and death of the fetus. According to the retrospective data, when using ACE inhibitors in the first trimester of pregnancy, the risk of having children with congenital defects increases.There are reports of spontaneous abortions, malnutrition and renal dysfunction in newborns whose mothers during pregnancy were unintentionally receiving valsartan. Introduction of thiazide diuretics, including hydrochlorothiazide, into the uterus cavity led to the development of jaundice or thrombocytopenia in the fetus or in the neonatal period, as well as to the development of other undesirable phenomena that are subsequently observed in adults.

If pregnancy is diagnosed during treatment with Duopress, the drug should be discontinued as soon as possible.

It is not known whether the valsartan in breast milk. In experimental studies it was shown that valsartan is excreted with the milk of lactating animals.

Hydrochlorothiazide penetrates the placenta, excreted in breast milk, so it is not recommended to use the drug during breastfeeding.

Dosing and Administration:

Before starting therapy with Duopress, it is necessary to correct water electrolyte disturbances (see the sections "With caution" and "Special instructions").

Inside, regardless of the time of ingestion, the frequency of intake is 1 time per day.The tablet should be swallowed whole, washed down with liquid.

Depending on the clinical situation, the recommended daily dose of the drug is 1 tablet of Duopress, containing valsartan / hydrochlorothiazide at a dose of 80 mg + 12.5 mg, 160 mg + 12.5 mg or maximum 160 mg + 25 mg.

The maximum antihypertensive effect of Duopress is developed during 2-4 weeks of therapy.

Patients with impaired renal function (QC more than 30 ml / min (0.5 ml / s)) there is no need to change the doses of the drug.

Duopress is not recommended patients with severe impairment of liver function (more than 9 on the Child-Pugh scale). In patients with mild or moderate hepatic impairment Without concomitant phenomena of cholestasis, the dose of valsartan should not exceed 80 mg.

Side effects:

Classification of the frequency of development of side effects of the World Health Organization (WHO):

very often -> 1/10

often from> 1/100 to <1/10

infrequently - from> 1/1000 to <1/100

rarely from> 1/10000 to <1/1000

very rarely - from <1/10000, including a separate message.

frequency unknown (insufficient data to estimate frequency of development)

The adverse effects were generally mild and transitory in nature.

From the central and peripheral nervous system: often - headache; infrequently - paresthesia, increased fatigue; very rarely - dizziness; the frequency is unknown - syncope.

From the respiratory system: infrequently - cough; frequency unknown - noncardiogenic pulmonary edema.

From the side of the cardiovascular system: infrequent - marked decrease in blood pressure, peripheral edema.

From the digestive tract: infrequently - nausea; very rarely diarrhea.

From the side of the musculoskeletal system: infrequently - myalgia; very rarely - arthralgia.

From the genitourinary system: frequency unknown - impaired renal function.

Laboratory indicators: frequency unknown - increased serum uric acid concentration, increased serum bilirubin and serum creatinine concentration, hypokalemia, hyponatremia, neutropenia, increased urea nitrogen concentration in blood serum.

From the side of metabolism: infrequently - dehydration.

From the side of the organ of vision: infrequent - reduced visual acuity.

From the side of the hearing organ: infrequently, noise in the ears.

The following adverse events were observed in patients with arterial hypertension without an obvious connection with taking the drug: abdominal pain, anxiety, arthritis, asthenia, back pain,bronchitis (including acute), chest pain, postural dizziness, dyspepsia, shortness of breath, dryness of the oral mucosa, nosebleeds, erectile dysfunction, gastroenteritis, headache, increased sweating, hypoesthesia, flu-like condition, insomnia, sprains, muscle spasms, muscle hypertonus, nasal congestion, nasopharyngitis, nausea, neck pain, peripheral edema, otitis media, pain in the extremities, palpitation, pain in the larynx and pharynx, pyrexia, pollakiuria, hyperthermia, sinusitis, s nlivost, upper respiratory tract infection, urinary tract infection, vertigo, viral infections, blurred vision.

Below are the undesirable phenomena associated with the use of each component separately.

Valsartan

On the part of the blood system: frequency unknown - decrease in hemoglobin, hematocrit, thrombocytopenia.

From the immune system: frequency unknown - hypersensitivity phenomena / allergic reactions, including serum sickness.

From the side of metabolism: the frequency is unknown - an increase in the potassium content in the serum.

From the side of the hearing organ: infrequently - vertigo.

From the cardiovascular system: frequency is unknown - vasculitis.

From the liver and bile ducts: frequency unknown - increased activity of "liver" transaminases.

From the skin: frequency unknown - Quincke's edema, skin rash, itching.

From the side of the kidneys and urinary tract: frequency unknown - renal failure.

The following adverse events were observed during clinical trials of valsartan in patients with arterial hypertension regardless of their causal relationship with the drug: arthralgia, asthenia, back pain, diarrhea, dizziness, headache, insomnia, decreased libido, nausea, swelling, pharyngitis, rhinitis, sinusitis, upper respiratory tract infections, viral infections.

Hydrochlorothiazide

From the side of metabolism: very often - an increase in the concentration of lipids in the blood plasma (especially against a background of high doses of hydrochlorothiazide); often hypomagnesemia and hyperuricemia; rarely - hypercalcemia, hyperglycemia, glucosuria and worsening of the course of diabetes mellitus; very rarely - hypochloraemic alkalosis.

On the part of the blood system: rarely - thrombocytopenia, sometimes in combination with purpura; very rarely - agranulocytosis, oppression of bone marrow hematopoiesis, hemolytic anemia, leukopenia; frequency unknown - aplastic anemia.

From the immune system: very rarely - hypersensitivity reactions.

From the side of the psyche: rarely - sleep disorders, depression.

From the nervous system: rarely - headache, paresthesia, dizziness.

From the cardiovascular system: often - orthostatic hypotension (may worsen with alcohol, sedatives or pain medication); rarely - arrhythmia.

From the respiratory system: very rarely - respiratory distress syndrome, including pulmonary edema and pneumonitis.

From the digestive system: often - decreased appetite, mild nausea, vomiting; rarely - discomfort in the abdomen, constipation, diarrhea; very rarely - pancreatitis.

From the liver and bile ducts: rarely intrahepatic cholestasis and jaundice.

From the skin: often - hives and other skin rashes; rarely - photosensitivity; very rarely - necrotizing vasculitis and toxic epidermal necrolysis, lupus-like reactions,exacerbation of cutaneous manifestations of systemic lupus erythematosus; frequency is unknown - erythema multiforme.

From the genitals and breast: often - impotence.

From the side of the organ of vision: visual impairment (especially in the first few weeks of therapy); frequency unknown - acute attack of angle-closure glaucoma.

From the side of the kidneys and urinary tract: frequency unknown - acute renal failure, impaired renal function.

From the muscular system: frequency unknown - muscle spasms.

Other: frequency unknown - fever, asthenia.

Overdose:

Valsartan

Symptoms: a marked decrease in blood pressure, which can lead to dizziness, collapse and / or shock with a fatal outcome.

Treatment: symptomatic, it is recommended to induce vomiting and rinse the stomach, the appointment of activated charcoal. At the expressed decrease in arterial pressure it is necessary: to give the patient a horizontal position with raised legs, to fill the volume of the circulating fluid (BCC) and to correct the violations of the water-electrolyte balance. Hemodialysis is ineffective.

Hydrochlorothiazide

Symptoms: the most frequent symptoms are a consequence of deficiency of electrolytes (hypokalemia, hypochloraemia, hyponatremia) and dehydration due to excessive diuresis: nausea, drowsiness, arrhythmia, muscle spasms. With the simultaneous administration of cardiac glycosides, hypokalemia can aggravate the course of arrhythmias.

Treatment: symptomatic.

Interaction:

Interactions for valsartan and hydrochlorothiazide

Medicines that should be avoided at the same time:

Lithium preparations

With concomitant use of lithium drugs with ACE inhibitors or thiazide diuretics, a reversible increase in the concentration of lithium in serum and associated increased toxic effects were noted. Experience with the simultaneous use of valsartan and lithium preparations is not yet available, so in this case it is recommended to control the concentration of lithium in the blood serum.

Medicines, simultaneous use with which requires caution:

Hypotensive drugs

It is possible to intensify antihypertensive action with simultaneous use with other means that reduce blood pressure (ACE inhibitors, beta-adrenoblockers, slow calcium channel blockers, guanethidine, methyldopa, vasodilators, direct renin inhibitors, angiotensin II receptor antagonists).

Pressor amines

Possible weakening of the action of pressor amines (norepinephrine, epinephrine), which do not require the termination of simultaneous use.

Non-steroidal anti-inflammatory drugs (NSAIDs), including selective inhibitors of cyclooxygenase-2 (COX-2)

It is possible to reduce the diuretic and antihypertensive effect of Duopress when used simultaneously with NSAIDs, for example, with derivatives of salicylic acid, indomethacin. Concomitant hypovolemia can lead to acute renal failure.

Interactions for valsartan

Medicines that should be avoided at the same time:

Simultaneous use of receptor antagonists for angiotensin II with other drugs that affect RAAS (ACE inhibitors, aliskiren), leads to an increased incidence of arterial hypotension, hyperkalemia, impaired renal function. It is necessary to monitor blood pressure, kidney function, and the electrolyte content in blood plasma when Duopress is prescribed with other drugs that affect RAAS.Simultaneous use of potassium-sparing diuretics, biologically active additives containing potassium; potassium-containing substitutes for edible salt; other drugs that increase the potassium content in the blood serum (for example, heparin) requires the observance of precautionary measures (including the regular determination of the potassium content in the blood).

Non-steroidal anti-inflammatory drugs (NSAIDs)

When valsartan is used simultaneously with NSAIDs (selective inhibitors of COX-2), it is possible to reduce its antihypertensive effect. Simultaneous use of angiotensin II receptor antagonists and NSAIDs, especially in patients with impaired renal function and / or hypovolemia (including with diuretic therapy), can lead to the development of acute renal failure. If it is necessary to simultaneously use valsartan with an NSAID before starting therapy, it is necessary to evaluate the function of the kidneys and correct the water-electrolyte disturbances.

Protein-carriers

By the results of the study in vitro on liver cultures valsartan is a substrate for the OATP1B1 carrier proteins and MRP2.Simultaneous administration of valsartan with inhibitors of the carrier protein OATP1B1 (rifampicin, ciclosporin) and with inhibitors of the carrier protein MRP2 (ritonavir) can increase the systemic exposure of valsartan (maximum concentration in the blood plasma and AUC).

Lack of drug interaction

There have been no clinically significant interactions with monotherapy with valsartan against the background of the following drugs: cimetidine, warfarin, furosemide, digoxin, atenolol, indomethacin, hydrochlorothiazide, amlodipine, glibenclamide.

Interactions for hydrochlorothiazide

Lithium

With simultaneous use with ACE inhibitors and diuretics, cases of a reversible increase in the plasma concentration of lithium and its toxic effect were reported. Studies of simultaneous use of hydrochlorothiazide with valsartan and lithium preparations have not been conducted. Therefore, with the simultaneous use of hydrochlorothiazide and preparations containing lithium, it is recommended to monitor the concentration of lithium in the blood.

Other antihypertensives

Thiazide diuretics increase the antihypertensive effect of other antihypertensive drugs (including,guanethidine, methyldopa, beta adrenoblockers, vasodilators, slow calcium channel blockers, ACE inhibitors, angiotensin II receptor antagonists, renin inhibitors).

Curare like muscle relaxants

Thiazide diuretics, including hydrochlorothiazide, potentiate the action of nondepolarizing muscle relaxants.

Drugs affecting the content of potassium in blood plasma

The risk of hypokalemia caused by diuretics can be exacerbated by the simultaneous use of glucocorticosteroids (GCS), adrenocorticotropic hormone (ACTH), amphotericin, carbenoxolone, penicillin, acetylsalicylic acid or its derivatives and antiarrhythmic drugs.

Drugs affecting the sodium content in blood plasma

Hyponatremic effect caused by diuretics can be intensified with simultaneous use with antidepressants, antipsychotic, anticonvulsants, etc. Caution should be exercised in the long-term simultaneous use of hydrochlorothiazide with the above drugs.

Hypoglycemic agents

Thiazide diuretics can interfere with glucose tolerance, which may require correction of insulin doses and hypoglycemic agents for oral administration.

Cardiac glycosides

Hypokalemia and hypomagnesemia (undesirable effects of thiazide diuretics) can contribute to the development of cardiac rhythm disturbances in patients receiving cardiac glycosides.

NSAIDs

The simultaneous use of NSAIDs and hydrochlorothiazide can lead to a decrease in the diuretic and antihypertensive effects of the latter. Concomitant hypovolemia can provoke the development of acute renal failure.

H- and m-holinoblokatory

N- and m-holinoblokatory (including atropine, biperidene) can increase the bioavailability of hydrochlorothiazide, which is associated with a decrease in the peristalsis of the gastrointestinal tract (GIT) and the rate of gastric emptying. Accordingly, GI motility stimulants (cisapride) can reduce the bioavailability of hydrochlorothiazide.

Anion exchange resins

The absorption of hydrochlorothiazide is disturbed in the presence of colestyramine and colestipol. Hydrochlorothiazide should be taken either 4 hours before or 4-6 hours after taking these compounds.

Vitamin D and calcium salts

Simultaneous intake of hydrochlorothiazide with vitamin D or calcium preparations can lead to hypercalcemia, due to increased reabsorption of calcium.

Cyclosporin

With the simultaneous use of hydrochlorothiazide and cyclosporine, the risk of hyperuricemia and exacerbation of the gout current increases.

Methyldopa

There have been reports of cases of hemolytic anemia with simultaneous administration of hydrochlorothiazide and methyldopa.

Pressor amines

Hydrochlorothiazide can reduce the body's response to the introduction of pressor amines (norepinephrine). The clinical significance of this interaction is insignificant and can not prevent their joint application.

Other types of interaction

Simultaneous administration of thiazide diuretics, including hydrochlorothiazide, may lead to an increase in the frequency of hypersensitivity reactions to allopurinol; increased risk of side effects of amantadine; increase the hyperglycemic effect of diazoxide, reduce the excretion of drugs that have a cytotoxic effect (for example, cyclophosphamide, methotrexate), and potentiate their mielosuppressive effects.

Ethanol, barbiturates and narcotic drugs

Simultaneous use with hydrochlorothiazide can potentiate the development of orthostatic hypotension.

Special instructions:

Duopress can be used as an initial therapy in patients who may need several antihypertensive drugs to achieve target blood pressure values. The choice of Duopress for initial treatment of hypertension should be based on an assessment of the relationship between potential benefits and risks.

Chronic heart failure III-IV functional class by classification NYHA, including after a previous myocardial infarction

In patients whose renal function depends on the state of RAAS (eg, patients with chronic heart failure), therapy with ACE inhibitors and angiotensin II receptor antagonists may be accompanied by oliguria and / or progressive azotemia, in rare cases with acute renal failure. The examination of patients with circulatory failure and patients who underwent myocardial infarction should include a study of kidney function.

Patients with hyponatraemia and / or reduced BCC

In patients with severe hyponatremia and / or reduced BCC (eg, due to taking high doses of diuretics), in rare cases at the beginning of therapy with Duopress may develop severe hypotension. Before treatment, it is recommended to adjust the sodium content and / or replenish the BCC, otherwise the therapy should be started under strict medical supervision.

With the development of arterial hypotension with clinical manifestations, it is necessary to give the patient a horizontal position with raised legs, fill the BCC and correct the disturbances of the water-electrolyte balance. Therapy with Duopress can be continued only after the blood pressure has stabilized.

Changes in the content of serum electrolytes

Thiazide diuretics due to the ability to reduce the content of potassium and magnesium in serum should be used with caution in patients with states accompanied aqueous electrolyte disturbances: nephropathy accompanied by the loss of salt and prerenal (cardiogenic) renal dysfunction. If there are clinical manifestations of hypokalemia (muscle weakness, paresis, changes in ECG parameters) treatment with Duopress should be discontinued.Before starting the use of the drug, it is necessary to correct hypokalemia and hypomagnesemia. All patients taking medications containing thiazide diuretics need regular monitoring of the content of plasma electrolytes, especially potassium.

When using Duopress, the ability of thiazide diuretics to cause hyponatremia and hypochloraemic alkalosis should be considered, and the existing hyponatremia should be strengthened. Hyponatremia in these cases is rarely accompanied by neurologic symptoms. It is necessary to regularly monitor the sodium content in the blood plasma.

Stenosis of the renal artery

In patients with unilateral or bilateral stenosis of the renal artery or stenosis of the artery of a single kidney, taking Duopress may be accompanied by an increase in the concentration of urea and creatinine in the serum, so Duopress should be used with caution in such patients.

Impaired renal function

In patients with impaired renal function (QC more than 30 ml / min (more than 0.5 ml / sec)) there is no need to change the doses of the drug. It is recommended to periodically monitor the potassium content,the concentration of creatinine and uric acid in the blood serum.

The experience of using Duopress in patients with recent kidney transplantation is absent.

Impaired liver function

The drug Duopress should not be used in patients with severe (more than 9 points on the Child-Pugh scale) violations of liver function; In the presence of bile duct obstruction and cholestasis, Duopress should be used with caution.

Primary hyperaldosteronism

Duopress is not recommended for patients with primary hyperaldosteronism.

Systemic lupus erythematosus (SLE)

There have been reports of an exacerbation of connective tissue disease (eg, SLE) with thiazide diuretics, including hydrochlorothiazide.

Other metabolic disorders

Thiazide diuretics, including hydrochlorothiazide, can impair glucose tolerance and increase serum cholesterol, triglyceride and uric acid concentrations in serum.

Decreased uric acid clearance may lead to hyperuricemia and the development of gout in predisposed patients, with concomitant calcium metabolism disorders.Thiazide diuretics reduce the excretion of calcium by the kidneys and can cause a slight increase in calcium in the blood plasma in the absence of concomitant disorders of calcium metabolism. Expressed hypercalcemia with thiazide diuretic therapy (more than 12 mg / dl) or not responding to withdrawal may indicate a concomitant metabolic disorder of calcium. In several patients with hypercalcemia and hypophosphatemia, long-term use of thiazide diuretics was determined by pathological changes in parathyroid glands.

Hypersensitivity reactions

The emergence of hypersensitivity reactions against the background of hydrochlorothiazide was most often observed in patients with allergic reactions and bronchial asthma in the anamnesis. Quincke's edema, including swelling of the larynx and vocal cords, leading to airway obstruction, and / or swelling of the face, lips, pharynx and / or edema of the tongue, was seen in patients who received valsartan, some of these patients previously developed Quincke's edema on the background of the use of other drugs, including ACE inhibitors.Taking Duopress in case of the development of Quincke's edema should be immediately canceled, the resumption of the use of Duopress is prohibited.

Acute attack of angle-closure glaucoma.

Against the background of the use of hydrochlorothiazide there have been cases of transient myopia and acute development of closed-angle glaucoma. The risk factors for acute development of an angle-closure glaucoma may be anamnestic data on allergic reactions to sulfanilamide and penicillin.

Symptoms: a sudden onset, a sharp decrease in visual acuity or pain in the eye, usually occurring in the period from a few hours to a week after the start of therapy.

An untreated, closed-angle glaucoma can lead to persistent loss of vision. The first step is to stop taking hydrochlorothiazide. Additional medication or surgical treatment may be required if intraocular pressure after drug withdrawal is not reduced.

Effect on the ability to drive transp. cf. and fur:

Patients should be careful when driving vehicles and working with mechanisms that require increased attention and reaction speed, may develop dizziness or weakness.

Form release / dosage:The film-coated tablets are 80 mg + 12.5 mg, 160 mg + 12.5 mg and 160 mg + 25 mg.

Packaging:

For 10, 20, 30 tablets in a contour mesh box made of polyvinylchloride film and aluminum foil printed lacquered.

10, 20, 30, 40, 50, 60, 90, 100, 120 or 180 tablets in cans of polypropylene for medicines.

One jar or 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 or 12 contour mesh packages together with the instruction for use are placed in a cardboard package.

Storage conditions:

In the dark place at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

3 years.

Do not use after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:LP-002445

Date of registration:30.04.2014

Date of cancellation:2019-04-30

The owner of the registration certificate:ATOLL, LLC ATOLL, LLC Russia

Manufacturer: & nbsp

OZONE, LLC Russia

Representation: & nbspOZONE LLC OZONE LLC Russia

Information update date: & nbsp08.12.2015

Illustrated instructions

Instructions

Duopress (Duopress)