Duopress

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

Duopress: instructions for use and reviews

1. Release form and composition
2. Pharmacological properties
3. Indications for use
4. Contraindications
5. Method of application and dosage
6. Side effects
7. Overdose
8. Special instructions
9. Application during pregnancy and lactation
10. Use in childhood
11. In case of impaired renal function
12. For violations of liver function
13. Drug interactions
14. Analogs
15. Terms and conditions of storage
16. Terms of dispensing from pharmacies
17. Reviews
18. Price in pharmacies

Latin name: Duopress

ATX code: C09DA03

Active ingredient: Hydrochlorothiazide (Hydrochlorothiazide), Valsartan (Valsartan)

Producer: ATOLL LLC (Russia)

Description and photo update: 18.10.2018

Duopress is an antihypertensive drug.

Release form and composition

Dosage form Duopress - round biconvex film-coated tablets:

80 mg + 12.5 mg: white or off-white;
160 mg + 12.5 mg: pink to light pink;
160 mg + 25 mg: white or off-white.

On the fracture of the tablet, 2 layers are visible - a white core and a film shell.

Packing of tablets:

80 mg + 12.5 mg and 160 mg + 12.5 mg: 10, 20 and 30 pcs. in blister packs, in a cardboard box 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 or 12 packages; 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 120 and 180 pcs. in polypropylene cans, in a cardboard box 1 can;
160 mg + 25 mg: 10 pcs. in blister packs, in a cardboard box 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 or 12 packages; 20 pcs. in blister packs, in a cardboard box 1, 2, 3 or 4 packages.

Composition of 1 tablet Duopress:

active ingredients: valsartan - 80 mg + hydrochlorothiazide - 12.5 mg, or valsartan - 160 mg + hydrochlorothiazide - 12.5 mg, or valsartan - 160 mg + hydrochlorothiazide - 25 mg;
excipients: croscarmellose sodium, colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, povidone;
the composition of the film shell: macrogol-4000, titanium dioxide, hypromellose, and iron oxide red dye in tablets 160 mg + 12.5 mg.

Pharmacological properties

Pharmacodynamics

Duopress is a combined antihypertensive agent that contains an angiotensin II receptor antagonist and a thiazide diuretic as active substances.

Selective antagonist of angiotensin II receptors of non-protein nature is valsartan. It has a selective antagonistic effect on the AT ₁ subtype receptors, as a result of which the plasma concentration of angiotensin II increases, which stimulates unblocked AT ₂ subtype receptors, thus balancing the effects associated with the stimulation of AT ₁ receptors.

Valsartan has no agonistic activity towards AT ₁ -receptors. Its affinity for the AT ₁ subtype receptors is greater than for the AT ₂ subtype receptors, approximately 20,000 times. The substance does not inhibit ACE (angiotensin-converting enzyme), which destroys bradykinin and converts angiotensin I to angiotensin II, and therefore the effects of bradykinin and substance P are not potentiated, and therefore the likelihood of developing dry cough when taking valsartan is low. The drug does not interact and does not block ion channels and receptors of other hormones involved in the regulation of cardiovascular functions.

In hypertension, valsartan helps to lower blood pressure (BP), but does not affect the heart rate (HR).

After taking a single dose of the drug, the hypotensive effect develops within 2 hours, after 4-6 hours it reaches its maximum effect and lasts for 24 hours. With repeated appointments, the maximum decrease in blood pressure (regardless of the prescribed dose) is achieved after 2-4 weeks and remains at this level throughout therapy.

In the case of a sharp withdrawal of valsartan, the withdrawal syndrome (a sudden rise in blood pressure or the occurrence of other undesirable clinical consequences) does not develop.

A thiazide diuretic is hydrochlorothiazide. Its action is associated with impaired reabsorption of sodium, magnesium, potassium, chlorine and water ions in the distal nephron. The substance delays the excretion of uric acid and calcium ions from the body. It has an antihypertensive effect due to the expansion of arterioles, while practically does not affect the normal values of blood pressure. The diuretic effect develops within 1–2 hours after oral administration of the drug, reaches a maximum after 4 hours and lasts for 6–12 hours. The antihypertensive effect in most cases occurs within 3-4 days, however, to achieve optimal therapeutic effect, it takes up to 3-4 weeks of treatment.

The combination of valsartan with hydrochlorothiazide can achieve a significant decrease in blood pressure.

Pharmacokinetics

Valsartan is rapidly absorbed after oral administration, but the degree of its absorption varies widely. The absolute bioavailability index is about 23%. The maximum concentration is reached after 2 hours. With a single dose per day, the accumulation of the substance is insignificant. Plasma concentrations of the drug are the same in all patients, regardless of gender.

The connection with blood serum proteins (mainly serum albumin) is about 94–97%. The equilibrium volume of distribution is about 17 liters. When compared with hepatic blood flow (about 30 l / h), plasma clearance is relatively low (about 2 l / h).

Metabolized with the participation of the isoenzyme CYP2C9. It does not undergo significant biotransformation, about 20% is excreted in the form of metabolites. The metabolite valeryl-4-hydroxy valsartan is pharmacologically inactive; it is found in blood plasma in low concentrations - less than 10% of the area under the pharmacological concentration-time curve (AUC).

Valsartan is excreted mainly unchanged: about 83% - through the intestines, about 13% - by the kidneys. The half-life from the body is 9 hours. When taking the drug with food, the AUC decreases by 48%, but after 8 hours the plasma concentration of valsartan does not differ from that in patients who took the drug on an empty stomach. Since the decrease in AUC is not accompanied by a clinically significant decrease in the effect of valsartan, the drug can be taken without focusing on meals.

The absorption of hydrochlorothiazide after oral administration is 60–80%. Its maximum concentration in the blood is observed after 2 hours. The connection with blood plasma proteins is from 40 to 70%. Also, the substance accumulates in erythrocytes, while the concentration is approximately 3 times higher than the plasma concentration. Hydrochlorothiazide is not metabolized, more than 95% is rapidly excreted through the kidneys. The half-life is 6-15 hours.

When using a combination of substances valsartan + hydrochlorothiazide, the pharmacokinetics of the former does not change significantly, the bioavailability of the latter decreases by about 30%. In this case, the combination of two drugs does not affect the effectiveness of each of them. According to the data of clinical studies, the antihypertensive effect of this combination exceeds the similar effects of each of the components separately.

The renal clearance of the drug is no more than 30% of the total clearance, therefore, dose adjustment is not required for patients with impaired renal function. However, there are no data on the use of Duopress in patients with severe impairments [creatinine clearance (CC) less than 30 ml / min] and patients on hemodialysis.

Given the high degree of binding of valsartan to proteins, its elimination by hemodialysis is unlikely. But hemodialysis effectively removes hydrochlorothiazide from the body. In patients with impaired renal function, the average peaks in plasma concentration and AUC of hydrochlorothiazide increase, and the rate of excretion decreases. In case of impaired renal function of mild and moderate severity, the half-life increases by almost 2 times.

In patients with mild and moderate hepatic dysfunction (5-6 and 7-9 points on the Child-Pugh scale, respectively), the AUC of valsartan is twice as high as in healthy people. There are no data on the use of Duopress in patients with severe functional disorders of the liver (more than 9 points). In case of impaired liver function, a significant change in the pharmacokinetics of hydrochlorothiazide is not observed, therefore, dose adjustment of the drug is not required. In severe violations, the drug is contraindicated. Caution is required for biliary obstruction.

In elderly people, an increase in the AUC of valsartan is possible, but this change has no clinical significance. In elderly patients (with and without arterial hypertension), the systemic clearance of hydrochlorothiazide is lower than in healthy young volunteers.

Indications for use

Duopress is intended for the treatment of hypertension if combination therapy is recommended for patients.

Contraindications

Absolute:

anuria;
severe renal dysfunction (CC less than 30 ml / min, or 0.5 ml / sec);
severe liver dysfunction (more than 9 points on the Child - Pugh scale);
age up to 18 years;
planning pregnancy, pregnancy and lactation;
simultaneous administration of aliskiren to patients with type 2 diabetes mellitus;
hypersensitivity to any substance of Duopress (active or auxiliary), as well as other sulfonamide derivatives.

Relative:

primary hyperaldosteronism;
moderate liver dysfunction;
condition after kidney transplantation;
bilateral or unilateral renal artery stenosis or stenosis of a solitary kidney artery;
renal failure (CC more than 30 ml / min);
conditions accompanied by a decrease in the volume of circulating blood and / or sodium ions (including diarrhea, vomiting, taking diuretics in high doses);
the simultaneous use of potassium-sparing diuretics, potassium preparations, potassium-containing substitutes for table salt and other agents that can increase the level of potassium in the blood (for example, heparin);
stenosis of the aortic and mitral valves;
chronic heart failure III – IV functional class according to NYHA classification;
hypertrophic obstructive cardiomyopathy;
obstructive diseases of the biliary tract and cholestasis;
Liebman-Sachs disease (systemic lupus erythematosus);
angle-closure glaucoma;
hyperuricemia;
diabetes;
hypertriglyceridemia and hypercholesterolemia;
conditions in which water-electrolyte disturbances occur: in nephropathy, accompanied by loss of salts, prerenal (cardiogenic) renal dysfunction, as well as in patients with hyponatremia, hypomagnesemia, hypercalcemia, hypokalemia.

Instructions for use of Duopress: method and dosage

Before the appointment of Duopress, it is necessary to correct the existing water-electrolyte disturbances and / or replenish the volume of the circulating fluid.

The drug is indicated for oral administration. You need to take the tablets 1 time per day, swallowing whole and drinking plenty of fluids, regardless of meals.

The doctor determines the specific dosage of Duopress individually after evaluating the clinical situation. The effectiveness of therapy is assessed after 2–4 weeks - so much is needed to develop the maximum antihypertensive effect.

Side effects

All the adverse reactions of Duopress described below are divided into groups according to the following gradation of frequency of their development: very often -> 1/10, often - from> 1/100 to 1/1000 to 1/10 000 to <1/1000, very rarely - < 1/10 000, including individual messages, unspecified frequency - there is not enough data to estimate the frequency of reactions.

According to clinical studies, in most cases, side effects were transient, mild.

Possible side effects:

on the part of the cardiovascular system: infrequently - peripheral edema, a marked decrease in blood pressure;
from the respiratory system: infrequently - cough; unspecified frequency - noncardiogenic pulmonary edema;
from the genitourinary system: unspecified frequency - impaired renal function;
from the digestive tract: infrequently - nausea; very rarely - diarrhea;
on the part of the organ of hearing: infrequently - tinnitus;
on the part of the organ of vision: infrequently - decreased visual acuity;
from the side of metabolism: infrequently - dehydration;
on the part of the musculoskeletal system: infrequently - myalgia; very rarely - arthralgia;
from the central and peripheral nervous system: often - headache; infrequently - increased fatigue, paresthesia; very rarely - dizziness; unspecified frequency - syncope;
laboratory parameters: unknown frequency - neutropenia, hyponatremia, hypokalemia, increased concentration of creatinine, bilirubin, uric acid and urea nitrogen in the blood serum.

Side effects, the relationship of which with the use of Duopress has not been reliably established: dryness of the oral mucosa, abdominal pain, dyspepsia, gastroenteritis, nausea, pain in the larynx and pharynx, sinusitis, nasal congestion, nosebleeds, nasopharyngitis, otitis media, shortness of breath, bronchitis (including acute), upper respiratory tract infections, chest pain, palpitations, peripheral edema, postural dizziness, anxiety, headache, insomnia, drowsiness, asthenia, vertigo, arthritis, back pain, muscle hypertonia, muscle spasms, sprain, limb pain, urinary tract infection, neck pain, increased sweating, hyperthermia, flu-like condition, visual impairment, pyrexia, hypoesthesia, pollakiuria, viral infections, erectile dysfunction.

Below are the side effects associated with the use of each Duopress active ingredient separately.

Valsartan

on the part of the organ of hearing: infrequently - vertigo;
from the immune system: unknown frequency - allergic reactions or hypersensitivity phenomena, including serum sickness;
from the blood system: unknown frequency - thrombocytopenia, decreased hemoglobin and hematocrit;
from the side of the skin: an unknown frequency - skin rash, itching, Quincke's edema;
from the kidneys and urinary tract: unknown frequency - renal failure;
from the liver and biliary tract: unspecified frequency - increased activity of hepatic transaminases;
on the part of the cardiovascular system: unknown frequency - vasculitis;
from the side of metabolism: an unknown frequency - an increase in the content of potassium in the blood serum.

Side effects, the relationship of which with the use of valsartan has not been reliably established: rhinitis, pharyngitis, sinusitis, upper respiratory tract infections, back pain, asthenia, arthralgia, insomnia, headache, dizziness, edema, nausea, diarrhea, viral infections, decreased libido.

Hydrochlorothiazide

on the part of the psyche: rarely - sleep disturbances, depression;
from the nervous system: rarely - paresthesia, headache, dizziness;
from the immune system: very rarely - hypersensitivity reactions;
from the digestive system: often - nausea, loss of appetite, vomiting; rarely - diarrhea / constipation, abdominal discomfort; very rarely - pancreatitis;
from the blood system: rarely - thrombocytopenia (in some cases combined with purple); very rarely - hemolytic anemia, inhibition of bone marrow hematopoiesis, agranulocytosis, leukopenia; unspecified frequency - aplastic anemia;
from the respiratory system: very rarely - respiratory distress syndrome, including pneumonitis and pulmonary edema;
from the liver and biliary tract: rarely - jaundice, intrahepatic cholestasis;
on the part of the kidneys and urinary tract: unknown frequency - impaired renal function, acute renal failure;
on the part of the cardiovascular system: often - orthostatic hypotension (can be aggravated by taking analgesics or sedatives, drinking alcohol); rarely - arrhythmias;
from the muscular system: unspecified frequency - muscle spasms;
from the genitals and breast: often - impotence;
from the side of metabolism: very often - an increase in the concentration of lipids in the blood plasma (especially in the case of taking hydrochlorothiazide in high doses); often - hypomagnesemia, hyperuricemia; rarely - glycosuria, hyperglycemia, worsening of the course of diabetes mellitus, hypercalcemia; very rarely - hypochloremic alkalosis;
on the part of the organ of vision: visual impairment (especially in the first few weeks of taking the drug); unknown frequency - acute attack of angle-closure glaucoma;
on the part of the skin: often - skin rashes, including urticaria; rarely - photosensitivity; very rarely - exacerbation of cutaneous manifestations of systemic lupus erythematosus, lupus-like reactions, Lyell's syndrome, necrotizing vasculitis; unknown frequency - erythema multiforme;
others: unknown frequency - asthenic syndrome and fever.

Overdose

Valsartan

In case of an overdose of valsartan, blood pressure is significantly reduced, which can lead to dizziness, collapse and / or shock, including death. Hemodialysis is ineffective. As a therapeutic measure, it is recommended to induce vomiting, rinse the stomach, take activated charcoal, further treatment is symptomatic. With a significant decrease in blood pressure, the patient must take a horizontal position and raise his legs. It also requires corrective therapy for violations of water-electrolyte balance and replenishment of the circulating fluid volume.

Hydrochlorothiazide

Signs of a hydrochlorothiazide overdose are hypochloremia, hypokalemia, hyponatremia, and dehydration; their symptoms are arrhythmia, drowsiness, nausea, muscle spasms. In the case of simultaneous administration of cardiac glycosides due to the development of hypokalemia, the course of arrhythmia may worsen. Therapeutic measures are aimed at eliminating the developed symptoms.

special instructions

According to the instructions, Duopress can be used as an initial therapy to achieve target blood pressure values in patients who need several antihypertensive drugs. However, before prescribing it, the doctor must assess the ratio of the expected benefits and potential risks.

During treatment, it is recommended to monitor blood pressure, plasma electrolytes, creatinine, bilirubin and uric acid concentrations.

In the event of acute hypersensitivity reactions (for example, Quincke's edema), Duopress should be canceled immediately. It is prohibited to resume therapy.

In some cases, hydrochlorothiazide can cause transient myopia and acute development of angle-closure glaucoma. Risk factors for glaucoma may include a history of allergic reactions to penicillin or sulfonamide. The first signs (pain in the eye or a sharp decrease in severity) usually occur in the period from several hours to a week after starting the drug. Such patients should discontinue Duopress therapy. If intraocular pressure does not decrease after discontinuation of the drug, medical or surgical treatment may be required.

Influence on the ability to drive vehicles and complex mechanisms

Duopress can cause dizziness and weakness, so care should be taken when engaging in activities that require quick reactions and increased attention, including driving a car and working with complex mechanisms.

Application during pregnancy and lactation

Drugs that affect the renin-angiotensin-aldosterone system (RAAS), including Duopress, are not prescribed to women during pregnancy and during pregnancy.

The doctor should warn patients of childbearing age about the potential danger of using this drug during pregnancy: when using the drug in the first trimester, the risk of spontaneous abortion, oligohydramnios, the development of jaundice in the fetus or newborn, thrombocytopenia and other undesirable phenomena, the birth of children with impaired renal function and congenital defects; the use of the drug in the II and III trimesters can lead to damage and death of the fetus.

If pregnancy is diagnosed during Duopress therapy, the drug should be discontinued immediately.

Hydrochlorothiazide crosses the placenta and is excreted in breast milk. It is not known whether valsartan penetrates into breast milk, but in experimental studies on animals it was found that it is excreted in breast milk. In this regard, Duopress is contraindicated during breastfeeding.

Pediatric use

Duopress is not prescribed for children and adolescents under 18 years of age, since there is no data on the safety and efficacy of valsartan in patients of this age category.

With impaired renal function

In case of impaired renal function (CC is more than 30 ml / minute), the use of a special dosing regimen is not required, but the drug should be used with caution.

In anuria and severe disorders (CC less than 30 ml / min) Duopress is contraindicated.

For violations of liver function

For mild and moderate liver dysfunctions, provided that there are no concomitant effects of cholestasis, the drug is prescribed at a dose of 80 mg + 12.5 mg.

In severe disorders (more than 9 points on the Child-Pugh scale), the use of Duopress is not recommended.

Drug interactions

Duopress is not recommended to be used in conjunction with lithium preparations, since there is an increase in the concentration of lithium in the blood serum and an increase in its toxic manifestations. If the appointment of such a combination is clinically justified, it is necessary to control the concentration of the substance in the blood serum.

With the simultaneous use of Duopress with the following drugs, caution should be exercised due to the risk of complications:

drugs with an antihypertensive effect (angiotensin II receptor antagonists, slow calcium channel blockers, direct renin inhibitors, beta-blockers, vasodilators, ACE inhibitors, methyldopa, guanethidine): the antihypertensive effect may be enhanced;
pressor amines (norepinephrine, epinephrine): their effectiveness may decrease;
non-steroidal anti-inflammatory drugs (NSAIDs), including selective inhibitors of cyclooxygenase-2: the diuretic and antihypertensive effect of Duopress may decrease, in the presence of concomitant hypovolemia, acute renal failure may develop.

Valsartan

Combinations not recommended:

other drugs that affect the RAAS (for example, aliskiren, ACE inhibitors): the frequency of renal dysfunction, the development of arterial hypotension and hyperkalemia increases (if it is necessary to use such a combination, renal function, blood pressure, plasma electrolytes should be monitored);
NSAIDs: the antihypertensive effect of valsartan may decrease, the development of acute renal failure is possible;
inhibitors of the OATP1B1 transporter protein (rifampicin, cyclosporin), inhibitors of the MRP2 transporter protein (ritonavir): an increase in the systemic exposure of valsartan (AUC and maximum plasma concentration) is possible.

Care should be taken with the concomitant use of dietary supplements containing potassium, potassium-sparing diuretics, potassium-containing substitutes for table salt, or other drugs that increase serum potassium (for example, heparin).

Clinically significant drug interactions were not observed when using valsartan in combination with the following drugs: hydrochlorothiazide, warfarin, glibenclamide, indomethacin, digoxin, cimetidine, amlodipine, atenolol, furosemide.

Hydrochlorothiazide

lithium: it is possible to increase the concentration of lithium in the blood serum and, as a result, increase the toxic effects;
antihypertensive drugs: the antihypertensive effect is enhanced;
curariform muscle relaxants: their action is potentiated;
insulin, hypoglycemic agents: impairment of glucose tolerance is possible, as a result of which a dose adjustment of insulin / hypoglycemic drug may be required;
anion exchange resins (cholestyramine, colestipol): the absorption of hydrochlorothiazide is impaired (at least 4-hour intervals should be observed between doses);
cardiac glycosides: it is possible to develop heart rhythm disturbances against the background of hypokalemia / hypomagnesemia, which developed as a result of taking hydrochlorothiazide;
amphotericin, penicillin, carbenoxolone, glucocorticosteroids, adrenocorticotropic hormone, acetylsalicylic acid and its derivatives, antiarrhythmic drugs and other drugs that affect the potassium content in the blood plasma: the risk of hypokalemia increases;
drugs that affect the sodium content in blood plasma (including antidepressants, anticonvulsants and antipsychotics): it is possible to increase the hyponatremic effect caused by a diuretic;
cyclosporine: the likelihood of developing hyperuricemia and exacerbation of the course of gout increases;
pressor amines: a decrease in the body's response to their administration is possible, however, the clinical significance of this phenomenon is insignificant and does not prevent the simultaneous use of drugs;
methyldopa: there is a risk of developing hemolytic anemia;
n-anticholinergics, m-anticholinergics (including biperiden, atropine): the bioavailability of hydrochlorothiazide may increase;
stimulants of gastrointestinal motility (for example, cisapride): the bioavailability of hydrochlorothiazide may decrease;
NSAIDs: a decrease in the diuretic and antihypertensive effect of hydrochlorothiazide is possible; in the presence of concomitant hypovolemia, there is a risk of acute renal failure;
vitamin D and calcium salts: there is a possibility of developing hypercalcemia;
barbiturates, drugs, ethanol: the risk of orthostatic hypotension increases;
allopurinol: the incidence of hypersensitivity reactions increases;
amantadine: its side effects increase;
drugs with a cytotoxic effect (for example, cyclophosphamide or methotrexate): their excretion by the kidneys decreases, their myelosuppressive effect is potentiated;
diazoxide: its hyperglycemic effect is enhanced.

Analogs

Analogs of Duopress are: Valz N, Valsakor H80, Valsakor H160, Co-Diovan.

Terms and conditions of storage

Store at a temperature not exceeding 25 ° C, out of the reach of children, in a dry, dark place.

The shelf life is 3 years.

Terms of dispensing from pharmacies

Dispensed by prescription.

Reviews about Duopress

There are few reviews about Duopress, which is due to the low popularity of the drug. Patients who took this drug for the treatment of hypertension note its high effectiveness.

Many people independently replaced the drugs prescribed by their doctors with Duopress, citing the fact that they have the same mechanism of action, but the price of Duopress is much lower (for comparison, the cost of the Co-Diovan analogue, depending on the dosage, is 1400-1700 rubles). However, in order to avoid side effects, you should consult with your doctor before taking and strictly adhere to the recommended dosage regimen.

Price for Duopress in pharmacies

Average pharmacy prices for Duopress, depending on the dosage:

80 mg + 12.5 mg - 297 rubles;
160 mg + 12.5 mg - 392 rubles;
160 mg + 25 mg - 397 rubles.

Maria Kulkes Medical journalist About the author

Education: First Moscow State Medical University named after I. M. Sechenov, specialty "General Medicine".

Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!