Composition, form of production and packaging
The tablets covered with a film membrane of white or almost white color, round, biconcave; On the fracture, two layers are visible: a white or almost white core and a film shell.
1 tab.
valsartan 80 mg
hydrochlorothiazide 12.5 mg
Excipients: microcrystalline cellulose 71.2 mg, croscarmellose sodium 7 mg, povidone 5 mg, silicon dioxide colloid 2.7 mg, magnesium stearate 1.6 mg.
Composition of the film membrane: hypromellose 2.85 mg, macrogol-4000 0.75 mg, titanium dioxide 1.4 mg.
10 pieces. - Cellular outline packaging (aluminum / PVC) (1) - cardboard packs.
10 pieces. - Cellular outline packaging (aluminum / PVC) (2) - cardboard packs.
10 pieces. - Cellular outline packaging (aluminum / PVC) (3) - cardboard packs.
10 pieces. - Cellular outline packaging (aluminum / PVC) (4) - cardboard packs.
10 pieces. - Cellular outline packaging (aluminum / PVC) (5) - cardboard packs.
10 pieces. - Cellular outline packaging (aluminum / PVC) (6) - cardboard packs.
10 pieces. - Cellular outline packaging (aluminum / PVC) (7) - cardboard packs.
10 pieces. - Cellular outline packaging (aluminum / PVC) (8) - cardboard packs.
10 pieces. - Cellular outline packaging (aluminum / PVC) (9) - cardboard packs.
10 pieces. - Cellular outline packaging (aluminum / PVC) (10) - cardboard packs.
10 pieces. - Cellular outline packaging (aluminum / PVC) (12) - cardboard packs.
20 pcs. - Cellular outline packaging (aluminum / PVC) (1) - cardboard packs.
20 pcs. - Cellular outline packaging (aluminum / PVC) (2) - cardboard packs.
20 pcs. - Cellular outline packaging (aluminum / PVC) (3) - cardboard packs.
20 pcs. - Cellular outline packaging (aluminum / PVC) (4) - cardboard packs.
20 pcs. - Cellular outline packaging (aluminum / PVC) (5) - cardboard packs.
20 pcs. - Cellular outline packaging (aluminum / PVC) (6) - cardboard packs.
20 pcs. - Cellular outline packaging (aluminum / PVC) (7) - cardboard packs.
20 pcs. - Cellular outline packaging (aluminum / PVC) (8) - cardboard packs.
20 pcs. - Cellular outline packaging (aluminum / PVC) (9) - cardboard packs.
20 pcs. - Cellular outline packaging (aluminum / PVC) (10) - cardboard packs.
20 pcs. - Cellular outline packaging (aluminum / PVC) (12) - cardboard packs.
30 pcs. - Cellular outline packaging (aluminum / PVC) (1) - cardboard packs.
30 pcs. - Cellular outline packaging (aluminum / PVC) (2) - cardboard packs.
30 pcs. - Cellular outline packaging (aluminum / PVC) (3) - cardboard packs.
30 pcs. - Cellular outline packaging (aluminum / PVC) (4) - cardboard packs.
30 pcs. - Cellular outline packaging (aluminum / PVC) (5) - cardboard packs.
30 pcs. - Cellular outline packaging (aluminum / PVC) (6) - cardboard packs.
30 pcs. - Cellular outline packaging (aluminum / PVC) (7) - cardboard packs.
30 pcs. - Cellular outline packaging (aluminum / PVC) (8) - cardboard packs.
30 pcs. - Cellular outline packaging (aluminum / PVC) (9) - cardboard packs.
30 pcs. - Cellular outline packaging (aluminum / PVC) (10) - cardboard packs.
30 pcs. - Cellular outline packaging (aluminum / PVC) (12) - cardboard packs.
10 pieces. - polypropylene cans (1) - cardboard packs.
20 pcs. - polypropylene cans (1) - cardboard packs.
30 pcs. - polypropylene cans (1) - cardboard packs.
40 pcs. - polypropylene cans (1) - cardboard packs.
50 pcs. - polypropylene cans (1) - cardboard packs.
60 pcs. - polypropylene cans (1) - cardboard packs.
70 pcs. - polypropylene cans (1) - cardboard packs.
80 pcs. - polypropylene cans (1) - cardboard packs.
90 pcs. - polypropylene cans (1) - cardboard packs.
100 pieces. - polypropylene cans (1) - cardboard packs.
120 pcs. - polypropylene cans (1) - cardboard packs.
180 pcs. - polypropylene cans (1) - cardboard packs.
The tablets covered with a film cover from pink to light pink color, round, biconcave; On the fracture, two layers are visible: a white or almost white core and a film shell.
1 tab.
valsartan 160 mg
hydrochlorothiazide 12.5 mg
Excipients: cellulose microcrystalline 154.9 mg, croscarmellose sodium 14 mg, povidone 10 mg, silicon dioxide colloidal 5.4 mg, magnesium stearate 3.2 mg.
Composition of the film membrane: hypromellose 5.7 mg, macrogol-4000 1.5 mg, iron dye red oxide 0.1 mg, titanium dioxide 2.7 mg.
10 pieces. - Cellular outline packaging (aluminum / PVC) (1) - cardboard packs.
10 pieces. - Cellular outline packaging (aluminum / PVC) (2) - cardboard packs.
10 pieces. - Cellular outline packaging (aluminum / PVC) (3) - cardboard packs.
10 pieces. - Cellular outline packaging (aluminum / PVC) (4) - cardboard packs.
10 pieces. - Cellular outline packaging (aluminum / PVC) (5) - cardboard packs.
10 pieces. - Cellular outline packaging (aluminum / PVC) (6) - cardboard packs.
10 pieces. - Cellular outline packaging (aluminum / PVC) (7) - cardboard packs.
10 pieces. - Cellular outline packaging (aluminum / PVC) (8) - cardboard packs.
10 pieces. - Cellular outline packaging (aluminum / PVC) (9) - cardboard packs.
10 pieces. - Cellular outline packaging (aluminum / PVC) (10) - cardboard packs.
10 pieces. - Cellular outline packaging (aluminum / PVC) (12) - cardboard packs.
20 pcs. - Cellular outline packaging (aluminum / PVC) (1) - cardboard packs.
20 pcs. - Cellular outline packaging (aluminum / PVC) (2) - cardboard packs.
20 pcs. - Cellular outline packaging (aluminum / PVC) (3) - cardboard packs.
20 pcs. - Cellular outline packaging (aluminum / PVC) (4) - cardboard packs.
20 pcs. - Cellular outline packaging (aluminum / PVC) (5) - cardboard packs.
20 pcs. - Cellular outline packaging (aluminum / PVC) (6) - cardboard packs.
20 pcs. - Cellular outline packaging (aluminum / PVC) (7) - cardboard packs.
20 pcs. - Cellular outline packaging (aluminum / PVC) (8) - cardboard packs.
20 pcs. - Cellular outline packaging (aluminum / PVC) (9) - cardboard packs.
20 pcs. - Cellular outline packaging (aluminum / PVC) (10) - cardboard packs.
20 pcs. - Cellular outline packaging (aluminum / PVC) (12) - cardboard packs.
30 pcs. - Cellular outline packaging (aluminum / PVC) (1) - cardboard packs.
30 pcs. - Cellular outline packaging (aluminum / PVC) (2) - cardboard packs.
30 pcs. - Cellular outline packaging (aluminum / PVC) (3) - cardboard packs.
30 pcs. - Cellular outline packaging (aluminum / PVC) (4) - cardboard packs.
30 pcs. - Cellular outline packaging (aluminum / PVC) (5) - cardboard packs.
30 pcs. - Cellular outline packaging (aluminum / PVC) (6) - cardboard packs.
30 pcs. - Cellular outline packaging (aluminum / PVC) (7) - cardboard packs.
30 pcs. - Cellular outline packaging (aluminum / PVC) (8) - cardboard packs.
30 pcs. - Cellular outline packaging (aluminum / PVC) (9) - cardboard packs.
30 pcs. - Cellular outline packaging (aluminum / PVC) (10) - cardboard packs.
30 pcs. - Cellular outline packaging (aluminum / PVC) (12) - cardboard packs.
10 pieces. - polypropylene cans (1) - cardboard packs.
20 pcs. - polypropylene cans (1) - cardboard packs.
30 pcs. - polypropylene cans (1) - cardboard packs.
40 pcs. - polypropylene cans (1) - cardboard packs.
50 pcs. - polypropylene cans (1) - cardboard packs.
60 pcs. - polypropylene cans (1) - cardboard packs.
70 pcs. - polypropylene cans (1) - cardboard packs.
80 pcs. - polypropylene cans (1) - cardboard packs.
90 pcs. - polypropylene cans (1) - cardboard packs.
100 pieces. - polypropylene cans (1) - cardboard packs.
120 pcs. - polypropylene cans (1) - cardboard packs.
180 pcs. - polypropylene cans (1) - cardboard packs.
The tablets covered with a film membrane of white or almost white color, round, biconcave; On the fracture, two layers are visible: a white or almost white core and a film shell.
1 tab.
valsartan 160 mg
hydrochlorothiazide 25 mg
Excipients: microcrystalline cellulose 142.4 mg, croscarmellose sodium 14 mg, povidone 10 mg, silicon dioxide colloid 5.4 mg, magnesium stearate 3.2 mg.
Composition of the film membrane: hypromellose 5.7 mg, macrogol-4000 1.5 mg, titanium dioxide 2.8 mg.
10 pieces. - Cellular outline packaging (aluminum / PVC) (1) - cardboard packs.
10 pieces. - Cellular outline packaging (aluminum / PVC) (2) - cardboard packs.
10 pieces. - Cellular outline packaging (aluminum / PVC) (3) - cardboard packs.
10 pieces. - Cellular outline packaging (aluminum / PVC) (4) - cardboard packs.
10 pieces. - Cellular outline packaging (aluminum / PVC) (5) - cardboard packs.
10 pieces. - Cellular outline packaging (aluminum / PVC) (6) - cardboard packs.
10 pieces. - Cellular outline packaging (aluminum / PVC) (7) - cardboard packs.
10 pieces. - Cellular outline packaging (aluminum / PVC) (8) - cardboard packs.
10 pieces. - Cellular outline packaging (aluminum / PVC) (9) - cardboard packs.
10 pieces. - Cellular outline packaging (aluminum / PVC) (10) - cardboard packs.
10 pieces. - Cellular outline packaging (aluminum / PVC) (12) - cardboard packs.
20 pcs. - Cellular outline packaging (aluminum / PVC) (1) - cardboard packs.
20 pcs. - Cellular outline packaging (aluminum / PVC) (2) - cardboard packs.
20 pcs. - Cellular outline packaging (aluminum / PVC) (3) - cardboard packs.
20 pcs. - Cellular outline packaging (aluminum / PVC) (4) - cardboard packs.
20 pcs. - Cellular outline packaging (aluminum / PVC) (5) - cardboard packs.
20 pcs. - Cellular outline packaging (aluminum / PVC) (6) - cardboard packs.
20 pcs. - Cellular outline packaging (aluminum / PVC) (7) - cardboard packs.
20 pcs. - Cellular outline packaging (aluminum / PVC) (8) - cardboard packs.
20 pcs. - Cellular outline packaging (aluminum / PVC) (9) - cardboard packs.
20 pcs. - Cellular outline packaging (aluminum / PVC) (10) - cardboard packs.
20 pcs. - Cellular outline packaging (aluminum / PVC) (12) - cardboard packs.
30 pcs. - Cellular outline packaging (aluminum / PVC) (1) - cardboard packs.
30 pcs. - Cellular outline packaging (aluminum / PVC) (2) - cardboard packs.
30 pcs. - Cellular outline packaging (aluminum / PVC) (3) - cardboard packs.
30 pcs. - Cellular outline packaging (aluminum / PVC) (4) - cardboard packs.
30 pcs. - Cellular outline packaging (aluminum / PVC) (5) - cardboard packs.
30 pcs. - Cellular outline packaging (aluminum / PVC) (6) - cardboard packs.
30 pcs. - Cellular outline packaging (aluminum / PVC) (7) - cardboard packs.
30 pcs. - Cellular outline packaging (aluminum / PVC) (8) - cardboard packs.
30 pcs. - Cellular outline packaging (aluminum / PVC) (9) - cardboard packs.
30 pcs. - Cellular outline packaging (aluminum / PVC) (10) - cardboard packs.
30 pcs. - Cellular outline packaging (aluminum / PVC) (12) - cardboard packs.
10 pieces. - polypropylene cans (1) - cardboard packs.
20 pcs. - polypropylene cans (1) - cardboard packs.
30 pcs. - polypropylene cans (1) - cardboard packs.
40 pcs. - polypropylene cans (1) - cardboard packs.
50 pcs. - polypropylene cans (1) - cardboard packs.
60 pcs. - polypropylene cans (1) - cardboard packs.
70 pcs. - polypropylene cans (1) - cardboard packs.
80 pcs. - polypropylene cans (1) - cardboard packs.
90 pcs. - polypropylene cans (1) - cardboard packs.
100 pieces. - polypropylene cans (1) - cardboard packs.
120 pcs. - polypropylene cans (1) - cardboard packs.
180 pcs. - polypropylene cans (1) - cardboard packs.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2014.
PHARMACHOLOGIC EFFECT
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 1 receptor subtype. The consequence of the blockade of AT 1 - receptors is an increase in the plasma concentration of angiotensin II, which can stimulate the blocked receptors of the AT2 subtype, which balances the effects associated with the stimulation of AT 1 receptors. Valsartan does not have atavistic activity against AT 1 receptors. Its affinity for the receptors of the AT 1 subtype is about 20,000 times greater than in the AT 2 receptor subtype.Valsartan does not inhibit 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. When treating arterial hypertension, valsartan lowers blood pressure (BP), without affecting the heart rate (heart rate). After ingestion of a single dose of valsartan, an antihypertensive the 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 after 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 rise in BP or other undesirable clinical consequences).
Hydrochlorothiazide
The thiazide diuretic, whose diuretic effect is associated with a disruption of the reabsorption of sodium, chlorine, potassium, magnesium, water in the distal part of the peptone; delays the excretion of calcium ions, uric acid. Has hypotensive effect, which is due to the expansion of arterioles. Virtually no effect on normal AD parameters. The diuretic effect develops 1-2 hours after ingestion, 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 max ) is 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 l / h) when compared with hepatic blood flow (approximately 30 l / h).
It is stabilized with the help of the CYP2C9 isoenzyme. Valsartan does not undergo significant biotransformation, only about 20% of the dose is excreted as metabolites. Valeryl-4-hydroxy valsartan is found in plasma at low concentrations (less than 10% of the area under the pharmacological concentration-time curve (AUC)). This metabolite is pharmacologically inactive.
The 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 (AUC) decreases by 48%. Nevertheless, 8 hours after taking plasma concentrations of valsartan taken on an empty stomach or with food are the same. AUC reduction 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 max ) of hydrochlorothiazide in the blood is reached 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 is not metabolized and is rapidly excreted through the kidneys (more than 95%). T 1/2 is 6-15 hours.
Valsartan / hydrochlorothiazide
With simultaneous use with valsartan systemic bioavailability of hydrochlorothiazide decreases by about thirty%. The simultaneous administration of hydrochlorothiazide, for its part, does not have a significant effect on the kinetics of valsartan. The noted interaction does not render effects on the effectiveness of simultaneous use 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 Groups patients
Patients with impaired renal function
Considering, that renal clearance is only 30% of the total clearance value, patients with impaired renal function do not need correction of the doses of the drug.Currently, there are no data on the use of the drug in patients with severe impaired renal function (creatinine clearance less than 30 ml / min) and patients who are 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 allows the effective removal of hydrochlorothiazide from the body. In the presence of violations of kidney function, the average peak concentration in the blood plasma and the AUC values ​​of hydrochlorothiazide increase, and the rate of excretion decreases. In patients with impaired renal function from mild to moderate severity T 1/2 almost doubles.
Patients with impaired hepatic function
AUC valsartan in patients with lungs (5-6 points on the scale Child-Pugh) and moderate (7-9 points on the scale Child-Pugh) violations of liver function b 2 times more than in healthy volunteers. At present, 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, Valsartan AUC 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 (in patients who are shown combined therapy).
DOSING MODE
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)) do not need to change the dose of the drug.
Duopress is not recommended for patients with severe impairment of liver function (more than 9 on the Child-Pugh scale).
In patients with mild or moderate impairment of liver function without concomitant phenomena of cholestasis, the dose of valsartan should not exceed 80 mg.
SIDE EFFECT
Classification of the frequency of development of side effects of the World Health Organization (WHO): very often> 1/10; often from> 1/100 to <1/50; infrequently from> 1/1000 to <1/100; rarely from> 1/10000 to <1/1000; very rarely from <1/10000, including individual messages; frequency unknown (insufficient data to estimate frequency of development)
Undesirable effects were observed in generally weakly expressed and changing character.
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 side of the digestive tract: infrequently - nausea; very rarely diarrhea.
From the side of the opioid-causing apparatus: infrequently - myalgia; very rarely - arthralgia.
On the part of the genitourinary system: the frequency is unknown - a violation of kidney function.
Laboratory indices: frequency unknown - increased serum uric acid concentration, increased serum bilirubin and serum creatinine concentration, hypokalemia, hyponatremia, neutropenia, increased urea nitrogen concentration in the blood serum blood serum.
With spromrons of metabolism: infrequently - dehydration.
From the side of the organs of vision: infrequently - reduced visual acuity.
From the side of the organ of hearing: infrequently - noise in the ears.
The following adverse events were observed in patients with arterial hypertension without apparent connection with the drug: abdominal pain, anxiety, arthritis, asthenia, back pain, bronchitis (including acute), chest pain, postural dizziness, dyspepsia, dyspnea, dryness mucous membrane of the oral cavity, nosebleeds, erectile dysfunction, gastroenteritis, headache, increased sweating, hypoesthesia, flu-like condition, insomnia, sprain, muscle spasms, muscle hypertonia, nasal congestion,nasopharyngitis, nausea, neck pain, peripheral edema, otitis media, pain in the extremities, palpitation, larynx and pharyngeal pain, pyrexia, pollakiuria, hyperthermia, sinusitis, drowsiness, upper respiratory tract infection, urinary tract infection, vertigo, viral infections , impaired vision.
Below are the undesirable phenomena associated with the use of each component separately.
Valsartan
On the part of the blood system: the frequency is unknown - a decrease in hemoglobin, hematocrit, thrombocytopenia.
On the part of the immune system: the frequency is unknown - hypersensitivity phenomena / allergic reactions, including serum sickness.
From the deception of substances: the frequency is unknown - an increase in the potassium content in the blood serum.
From the side of the organ of hearing: infrequently - vertigo.
Cardio-vascular system: the frequency is unknown - vasculitis.
Of the liver and biliary tract: frequency not known - increase in "liver" transaminases.
For the skin: the frequency is unknown - angioneurotic edema, skin rash, itching.
The kidneys and the urinary tract: frequency not known - kidney failure.
The following adverse events were observed during clinical trials of valsartan in hypertensive patients irrespective of their causal relationship with the drug: arthralgia, asthenia, back pain, diarrhea, dizziness, headache, insomnia, decreased libido, nausea, edema, pharyngitis, rhinitis, sinusitis, infections of the upperrespiratory viral infections.
Hydrochlorothiazide
From a metabolism: often - increase in lipid concentration in the blood plasma (especially against the background of high doses of hydrochlorothiazide), often - hypomagnesemia and hyperuricemia, seldom - hypercalcemia, hyperglycemia, glkzhozuriya and worsening of diabetes, it is very rare - gipohloremichesky alkalosis.
Blood system: rarely - thrombocytopenia, sometimes in combination with purpura, rarely - agranulocytosis, inhibition of bone marrow hematopoiesis, hemolytic anemia, leukopenia, the frequency is unknown - aplastic anemia.
Immune system: very rarely - hypersensitivity reactions.
On the part of the psyche: rarely - sleep disorders, depression.
From the nervous system:rarely - headache, paresthesia, dizziness.
Cardio-vascular system: often - orthostatic hypotension (may be aggravated by the use of alcohol, sedatives or anesthetics), rarely - arrhythmias.
The respiratory system: very rare - respiratory distress syndrome, including pulmonary edema and pneumonitis.
From the digestive system: often - decreased appetite, moderately severe nausea, vomiting; rare - abdominal discomfort, constipation, diarrhea; very rarely - pancreatitis.
Of the liver and biliary tract: rarely - intrahepatic cholestasis and jaundice.
For the skin:often - urticaria, and other types of skin rashes; rarely - photosensitivity; very rarely - necrotizing vasculitis and toxic epidermal necrolysis, lupusreaction exacerbation of cutaneous manifestations of systemic lupus erythematosus; the frequency is unknown - erythema multiforme.
On the part of genitals and mammary gland: often - impotence.
From a sight organ: disorders of vision (especially in the first few weeks of therapy); the frequency is unknown - an acute attack of angle-closure glaucoma.
The kidneys and the urinary tract: frequency not known - acute renal failure, renal dysfunction.
On the part of the musculoskeletal system: the frequency is unknown - spasms of the muscles.
Other: the frequency is unknown - fever, asthenia.
CONTRAINDICATIONS
- Hypersensitivity to valsartan, hydrochlorothiazide, and other derivatives of the sulfonamide or other components of the formulation;
- pregnant, planning to become pregnant, during lactation;
- severe hepatic dysfunction (more than 9 points on a scale Child-Pugh);
- anuria, severe renal impairment (creatinine clearance less than 30 mL / min (0.5 mL / sec));
- the age of 18 years (valsartan efficacy and safety in children has not been established);
- simultaneous application of aliskiren in patients with type 2 diabetes.
Carefully
Simultaneous treatment with potassium preparations, potassium-sparing diuretics, potassium-containing substitutes salt and other means capable of increase in blood potassium content (e.g., heparin), chronic heart failure III-IV functional class NYHA classification, renal failure (creatinine clearance of more than 30 ml / min (0.5 ml / sec)), bilateral or unilateral renal artery stenosis or artery stenosis only kidney condition after kidney transplantation;
state, accompanied by decrease in the volume of circulating blood (BCC), and / or sodium ions (including diarrhea, vomiting, high doses of diuretics); moderately expressed human liver, primary hyperaldosteronism, stenosis
Aortic and mitral valve, hypertrophic cardiomyopathy obstruktivpaya (GOKMP), systemic lupus erythematosus (SLE), diabetes mellitus, hyperuricemia, hypercholesterolemia, and hypertriglyceridemia, obstructive diseases of the biliary tract and cholestasis, angle-closure glaucoma; state, accompanied by a water-electrolyte disturbances: nephropathy accompanied by the loss of salt and prerenal (cardiogenic) renal function in patients with hypokalemia, hypomagnesemia, hyponatremia, hypercalcemia.
PREGNANCY AND LACTATION
As with any other drug that affects the RAAS, Duopress should not be used in women planning a pregnancy. In the appointment of any drug acting on the RAAS, the physician should inform women of childbearing age about the potential dangers of these drugs during pregnancy.
Use of the drug Duopress during pregnancy is contraindicated, since, given the mechanism of action of angiotensin receptor antagonists II of, you can not eliminate the risk to the fetus. The action of ACE inhibitors (drugs that affect the RAAS) on the fetus in the case of their destination in the second and third trimesters of pregnancy, resulting in damage and death of the fetus. According to the historical data with the use of ACE inhibitors in the first trimester of pregnancy increases the risk of having children with birth defects. There have been reports of spontaneous abortion, oligohydramnios and renal function in newborns whose mothers during pregnancy inadvertently received valsartan. Introduction of thiazide diuretics, including hydrochlorothiazide, to the uterus led to the development of jaundice or thrombocytopenia in the fetus or in the the neonatal period, as well as to the development of other adverse events have been observed in the following in adults. If pregnancy is diagnosed during treatment with Duopress, the drug should be discontinued as soon as possible.
It is unknown whether penetrates valsartan passes into breast milk. In experimental studies have demonstrated that valsartan is excreted in the milk of lactating animals.
Hydrochlorothiazide crosses the placenta, excreted in breast milk, so it is not recommended to use the drug during lactation.
APPLICATION FOR FUNCTIONS OF THE LIVER
Patients with impaired renal function (creatinine clearance of more than 30 ml / min (0.5 mL / sec)) should be prescribed with caution.
Do not use this drug in anuria, severe renal impairment (creatinine clearance less than 30 mL / min (0.5 mL / sec)).
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
Duopress not recommended for patients with severe hepatic impairment (more than 9 points on the Child-Pugh).
Patients with mild or moderate liver function disorders without concomitant phenomena cholestasis dose of valsartan should not exceed 80 mg.
APPLICATION FOR CHILDREN
Is contraindicated in children under the age of 18 years, as Valsartan efficacy and safety has not been established in children.
SPECIAL INSTRUCTIONS
Duopress can be used as initial therapy for patients who may require more antihypertensive drugs to achieve target blood pressure values. Selection Duopress preparation for initial therapy of hypertension should be based na ratio estimate potential benefits and risks.
Chronic, heart failure III-IV functional class NYHA classification, including post -myocardial infarction
patients, renal function which depends on the RAAS (e.g., patients with chronic heart failure), therapy of ACE inhibitors and receptor antagonists to angiotensin II It may be associated with oliguria and / or progressive azotemia, in rare cases - acute renal failure. Evaluation of patients with circulatory insufficiency and patients with myocardial infarction, should include the study of kidney function.
Patients with hyponatremia 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 is recommended to adjust the content of sodium in the body and / or to fill the bcc, otherwise the therapy should be initiated under close medical supervision.
In arterial development hypotension with clinical manifestations of the patient should be given a horizontal position with raised legs, to fill the bcc and carry out the correction of violations of water-electrolyte balance. Therapy with Duopress can continue only after stabilization of blood pressure indicators.
Changes in serum electrolytes content
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. In the event of hypokalemia clinical manifestations (muscle weakness, paresis, ECG changes) Duopress drug treatment should be discontinued. Before the beginning the drug needs to be adjusted gilokaliemiyu and hypomagnesemia. All patients taking preparations containing thiazide diuretics, requires regular monitoring of a blood plasma electrolytes, especially potassium.
In applying the drug should be considered Duopress ability thiazide diuretics cause hypochloraemic hyponatremia and alkalosis as well as to strengthen the existing hyponatremia. Hyponatremia and these cases are rarely accompanied by neurological symptoms. Requires regular monitoring of sodium in the blood plasma.
Stenosis of the renal artery
In patients with unilateral or bilateral renal artery stenosis or stenosis of the artery to a solitary kidney Duopress receiving the drug may be associated with an increase in the concentration of urea and creatinine in the blood serum, so in these patients Duopress drug should be used with caution.
Renal dysfunction
in patients with impaired renal function (creatinine clearance of more than 30 ml / min (more than 0.5 ml / sec)) is not required
