Dioxor 160 mg tablets №90

Author Ольга Кияница

2017-05-11

Amount in a package 90
Product form Pills
Manufacturer Pharma Start LLC (Ukraine, Kiev)
Registration certificate UA/8318/01/01
The main medicament Diocor
morion code 325921

Diocor (DIOCOR) user's manual

Composition:

active ingredients: valsartan, hydrochlorothiazide; 1 film-coated tablet contains: 80 mg of valsartan and 12.5 mg of hydrochlorothiazide (Dyocor 80) or 160 mg of valsartan and 12.5 mg of hydrochlorothiazide (Dyokor 160);
auxiliary substances: microcrystalline cellulose, potato starch, corn starch, sodium lauryl sulfate, talc, croscarmellose sodium, silicon dioxide, colloidal anhydrous, magnesium stearate, coating for applying the shell. Diocor 80 - Opadry II White (polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide 171)); Diokor 160 - Opadry II Orange (talc, polyvinyl alcohol, quinoline yellow (E 104), polyethylene glycol, iron oxide red (E 172), iron oxide yellow (E 172), titanium dioxide (E 171)).

Dosage form.

Film-coated tablets.

Basic physical and chemical properties.

Dyocor 80 - round tablets with biconvex surface, covered with a film shell of white color.
Diorcor 160 - round tablets with biconvex surface, covered with a film coating of brown-orange color.

Pharmacotherapeutic group.

Combined preparations of angiotensin II inhibitors. Valsartan and diuretics. ATC code C09D A03.

Pharmacological properties.

Pharmacodynamics.

Diocorus is an antihypertensive drug that contains an angiotensin II receptor antagonist and a thiazide diuretic.

The active hormone of the renin-angiotensin-aldosterone system is angiotensin II, which is formed from angiotensin I with the participation of an angiotensin-converting enzyme (ACE). Angiotensin II binds to specific receptors located on cell membranes in various tissues. It has a wide range of physiological effects, including both direct and indirect participation in the regulation of blood pressure. As a powerful vasoconstrictor, angiotensin II causes a direct vasopressor effect. In addition, it promotes sodium retention and stimulates the secretion of aldosterone.

Valsartan - an active and specific antagonist of angiotensin II receptors, intended for oral administration. It acts selectively on the AT1 receptor subtype, which is responsible for the effects of angiotensin II. Valsartan does not have any partial agonist activity with respect to AT 1 receptors and has a much greater (approximately 20,000-fold) affinity with AT1 receptors than with AT2 receptors.

Valsartan does not inhibit ACE (kininase II), which converts angiotensin I into angiotensin II and destroys bradykinin.There are no side effects due to bradykinin. In clinical studies comparing valsartan with an ACE inhibitor, the incidence of dry cough was significantly lower in patients treated with valcartan than in patients using an ACE inhibitor. Valsartan does not interact and does not block the receptors of other hormones or ion channels, which play an important role in regulating the function of the cardiovascular system.

In patients with hypertension, the drug causes a decrease in blood pressure, without affecting the pulse rate.

In most patients after a single dose of the drug, the onset of antihypertensive activity is observed within 2 hours, and the maximum reduction in blood pressure is achieved within 4-6 hours. The antihypertensive effect persists for more than 24 hours after taking a single dose. Subject to regular use of the drug, the maximum therapeutic effect is usually achieved within 2-4 weeks and maintained at the achieved level during prolonged therapy. When taking a combination with hydrochlorothiazide, a more effective reduction in blood pressure is observed.

The point of action of thiazide diuretics is the cortical part of the distal convoluted renal tubules, where receptors are located, which have a high sensitivity to the action of diuretics, where the transport of sodium and chlorine ions occurs.The mechanism of action of thiazides is associated with the suppression of the pump Na + Cl-, which is due to competition for transport sites Cl-. As a result, the excretion of sodium and chlorine ions increases approximately equally. As a result of diuretic action, a decrease in the volume of circulating blood is observed, which increases the activity of renin, the secretion of aldosterone, the excretion of potassium in the urine and, consequently, a decrease in the potassium concentration in the blood serum. The relationship between renin and aldosterone is mediated by angiotensin II, so the use of an angiotensin II receptor antagonist will reduce potassium loss associated with the use of a thiazide diuretic.

Pharmacokinetics.

After internal administration of the drug, absorption of valsartan and hydrochlorothiazide occurs rapidly, however, the degree of absorption varies widely. The average absolute bioavailability of Dicor is 23%.

In the range of doses studied, the kinetics of valsartan is linear. With repeated use of the drug, no changes in the kinetic parameters were noted. When taking the drug once a day, cumulation is negligible.

Valsartan is largely (94-97%) bound to blood plasma proteins, mainly with albumins. The equilibrium volume of distribution is low (about 17 liters).

The excretion of valsartan with feces is 70% (of the amount taken internally in the dose). With urine output is about 30%, mostly in unchanged form.

When valsartan is used with food, the area under the concentration-time curve (AUC) decreases by 48%, although starting from about 8 hours after taking the drug, the concentration of the drug in the plasma, either in the case of fasting or in the case of food intake are the same. The decrease in the area under the "concentration-time" curve is not accompanied by a significant decrease in the therapeutic effect.

Hydrochlorothiazide. After oral administration, hydrochlorothiazide absorption is very rapid (tmax approximately 2 hours). Pharmacokinetics of the drug in the phases of distribution and excretion is described as a whole by a bi-exponential descending curve; the half-life of the final phase is 6-15 hours.

In the therapeutic range of doses, the average AUC increases in direct proportion to the increase in dose. With repeated appointments, the pharmacokinetics of hydrochlorothiazide does not change; when used once a day, the cumulation is negligible.

When administered, the bioavailability of hydrochlorothiazide is 60-80%. It is excreted in urine: more than 95% of the dose in unchanged form and about 4% in the form of hydrolyzate of 2-amino-4-chloro-m-benzene disulfonamide.

With the simultaneous administration of hydrochlorothiazide with food, both the increase and decrease in its systemic bioavailability were noted compared with the corresponding index when administered on an empty stomach. The range of these changes is small and clinically insignificant.

Valsartan / hydrochlorothiazide. With simultaneous administration with valsartan, the systemic bioavailability of hydrochlorothiazide is reduced by about 30%. The simultaneous use of hydrochlorothiazide does not significantly affect the kinetics of valsartan. The noted interaction does not affect the effectiveness of the combined use of valsartan and hydrochlorothiazide. In controlled clinical trials, a distinct antihypertensive effect of this combination was found, which exceeded the effect of each of the components alone, as well as the placebo effect.

Clinical characteristics.

Indications.

Arterial hypertension in patients for whom monotherapy is ineffective.

Contraindications.

Hypersensitivity to any of the components of the drug and to other drugs that are derivatives of the sulfonamide.

Severe violations of the liver, biliary cirrhosis and cholestasis.

Severe renal impairment (creatinine clearance <30 mL / min), anuria.

Refractory hypokalemia, hyponatremia, hypercalcemia, symptomatic hyperuricemia.

Pregnant women and women planning pregnancy (see section "Use during pregnancy or lactation").

Simultaneous use of angiotensin receptor antagonists, including valsartan, or angiotensin-converting enzyme inhibitors with aliskiren in patients with diabetes mellitus or renal dysfunction (glomerular filtration rate (GFR) <60 mL / min / 1.73 m2).

Interaction with other drugs and other types of interactions.

Interactions associated with the combination of valsartan / hydrochlorothiazide.

Do not use concurrently.

Lithium.

With simultaneous use of lithium preparations with angiotensin-converting enzyme (ACE) inhibitors or thiazide diuretics, including hydrochlorothiazide, a reversible increase in serum lithium concentration and the appearance of toxicity were noted. The experience of simultaneous application of valsartan and lithium preparations is not available, therefore this combination is not recommended. If the use of the drug is still necessary, then it is recommended to monitor the concentration of lithium in the serum during their simultaneous application.

A simultaneous application requiring special care.

Other antihypertensive drugs.

It is possible to enhance the antihypertensive effect of other antihypertensive drugs when used together with Dioxor (eg, ACE inhibitors, beta-blockers, calcium channel blockers).

Pressor amines (for example, noradrenaline, adrenaline).

There may be a decrease in the response to pressor amines, but not to the extent that it is necessary to exclude their use.

Non-steroidal anti-inflammatory drugs (NSAIDs), including selective inhibitors of COX-2, acetylsalicylic acid> 3 g / day and nonselective NSAIDs.

It is possible to reduce the antihypertensive effect of both an angiotensin II antagonist and a thiazide component, while using non-steroidal anti-inflammatory drugs. The concomitant use of these drugs may lead to impaired renal function and an increase in potassium in the blood serum. Therefore, monitoring of kidney function during treatment is recommended, as well as monitoring of adequate hydration of the patient.

Interactions associated with valsartan.

Double blockade of the renin-angiotensin system (RAS) with drugs of the APA groups, ACE inhibitors or aliskiren.

Caution should be exercised with the simultaneous use of ARA drugs, including valsartan, with other agents blocking RAAS, such as drugs from the ACEI group or aliskiren.

The simultaneous use of angiotensin receptor antagonists, including valsartan, or angiotensin-converting enzyme inhibitors with aliskiren in patients with diabetes mellitus or patients with impaired renal function (glomerular filtration rate (GFR) <60 mL / min / 1.73 m2) is contraindicated.

Do not use concurrently.

Potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium, or other medications that can raise the level of potassium in the blood serum.

You should be careful and often check the potassium content in the blood serum, if necessary, the use of drugs that affect the level of potassium in combination with valsartan.

Conveyors.

According to the results of in vitro studies, valsartan is a substrate for the hepatic transporter of the capture of OATP1B1 / OATP1B3 and the hepatic MRP2 excretory transporter. The clinical significance of this data is not known.Simultaneous use of inhibitors of the capture transporter (eg, rifampicin, cyclosporine) or excretion transporter (eg ritonavir) can increase the systemic exposure of valsartan. Appropriate measures should be taken at the beginning and at the end of the concomitant use of these medicines.

There are no interactions.

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

Digoxin and indomethacin can interact with hydrochlorothiazide in a combination of valsartan / hydrochlorothiazide.

Interactions associated with hydrochlorothiazide.

A simultaneous application requiring special care.

The risk of hypokalemia increases with the simultaneous use of saluretics, laxatives, corticosteroids, ACTH, amphotericin, carbenoxolone, penicillin G and salicylic acid derivatives. These drugs can potentiate the action of hydrochlorothiazide on the level of potassium in the blood, so it is necessary to measure the potassium content in the blood.

Medicines that can cause ventricular tachycardia such as "pirouette".

  • Antiarrhythmic drugs of Class I (for example, quinidine, disopyramide).
  • Antiarrhythmic drugs of the third class (for example, amiodarone, sotalol, dofetilide, ibutilide).
  • Some antipsychotics (for example, thioridazine, chlorpromazine, levomepromazine, trifluoperazine, cyamemazine, sulpiride, sultopride, amisulpride, tiaprid, pimozide, haloperidol, droperidol).
  • Others (eg, bepridil, cisapride, difemanyl, erythromycin for intravenous administration, halofantrine, ketanserin, misolastine, pentamidine, sparfloxacin, terfenadine, vincamine for intravenous administration).

Because of the risk of hypokalemia, hydrochlorothiazide should be used with caution with these drugs.

Cardiac glycosides.

Thiazide diuretics can cause such undesirable effects as hypokalemia or hypomagnesemia, which, in turn, increase the risk of arrhythmia with glycosidic intoxication.

Salts of calcium and vitamin D.

When combined with vitamin D or calcium salts, potentiation of increased serum calcium levels is possible.

Antidiabetic drugs (oral preparations, insulin).

Thiazide diuretics can cause a change in glucose tolerance. There may be a need to adjust the dose of insulin or oral hypoglycemic agents in patients with diabetes mellitus. Joint use of metformin and hydrochlorothiazide with functional kidney failure can lead to the development of metabolic acidosis.

Beta-blockers and diazoxide.

The simultaneous use of thiazide diuretics, including hydrochlorothiazide, with beta-blockers can increase the risk of hyperglycemia. Thiazide diuretics, including hydrochlorothiazide, can increase the hyperglycemic effect of diazoxide.

Drugs used to treat gout (probenecid, sulfinpyrazone and allopurinol).

It may be necessary to adjust the dose of uricosuric agents that stimulate the excretion of uric acid, since hydrochlorothiazide can increase the level of uric acid in the blood serum. It may be necessary to increase the dose of probenecid or sulfinpyrazone.

The simultaneous use of thiazide diuretics can increase the frequency of hypersensitivity reactions to allopurinol.

Anticholinergics (for example, atropine, biperiden).

Increased bioavailability of the thiazide diuretic is observed with the simultaneous administration of cholinergic receptor blockers (eg, atropine, biperidene), possibly associated with a decrease in motor activity in the digestive tract and a slowdown in gastric emptying.

Amantadine.

Thiazides, including hydrochlorothiazide, may increase the risk of side effects of amantadine.

Cholesterol and cholesterol.

The absorption of hydrochlorothiazide is disturbed in the presence of anion-exchange resins.

Cholestyramine slows the absorption of thiazide diuretics.

Cytotoxic drugs (eg cyclophosphamide, methotrexate).

Reducing the excretion of cytotoxic drugs by the kidneys (eg, cyclophosphamide, methotrexate) can lead to potentiation of their myelosuppressive effects.

Nondepolarizing muscle relaxants (eg tubocurarine).

Thiazides potentiate the action of curare-like muscle relaxants.

Cyclosporine.

Simultaneous use of cyclosporine may increase the risk of hyperuricemia and the appearance of symptoms resembling an exacerbation of gout.

Alcohol, anesthetics and sedatives.

Can potentiate orthostatic hypotension.

Methyldopa. There have been reports of cases of hemolytic anemia with simultaneous use of a thiazide diuretic and methyldopa.

Carbamazepine. The risk of hyponatremia may increase. Clinical monitoring of the patient's condition and laboratory blood testing are necessary.

Contrast substances containing iodine.

With dehydration caused by diuretics, the risk of acute renal failure may increase, especially when large doses of contrast medium are administered. Before the introduction of iodine, it is necessary to restore the water balance.

Features of application.

Changes in the balance of electrolytes. Caution must be exercised while the use DioCore with potassium-sparing diuretics, potassium supplements, potassium-salt food substitutes as well as pharmaceuticals that may cause an increase in potassium level in the blood (e.g., heparin).

During treatment with thiazide diuretics reported cases of hypokalemia.

It is recommended to carry out regular monitoring of the level of potassium in serum.

As with all patients receiving treatment with diuretics, at appropriate intervals should periodically determine serum levels of electrolytes.

Patients deficient in the body of sodium and / or blood volume (CBV). Patients with a marked deficiency in the body of sodium and / or BCC, such as those receiving high doses of diuretics, and occasionally at the beginning of treatment with hypotension may occur with clinical manifestations. Therefore, before the initiation of treatment is recommended to DioCore correction contents in the body of sodium and / or blood volume.

In case of hypotension the patient should be transferred to a horizontal position and hold an intravenous infusion of saline solution, if necessary. Following stabilization of arterial pressure DioCore treatment may be continued.

Patients with severe heart failure or other cases of activation of the renin-angiotensin-aldosterone system. In patients whose renal function depends on the activity of the renin-angiotensin-aldosterone system (eg patients with severe coronary heart failure), treatment with ACE inhibitors can cause oliguria and / or progressive azotemia, and in some cases - lead to the development of acute renal nedostatochnosti.Primenenie drug to patients with severe chronic heart failure is not justified because it can not be ruled out that due to the suppression of the renin-angiotensin-aldosterone system application valsarta on it can also be associated with renal dysfunction.

Primary aldosteronism. You should not use the drug in patients with primary hyperaldosteronism, as their renin-angiotensin system is not activated. Aortic and mitral stenosis, obstructive hypertrophic cardiomyopathy. As with other vasodilators, should be particularly careful in the application of the drug to patients with aortic and mitral stenosis, obstructive or hypertrophic cardiomyopathy.

Renal artery stenosis. In patients with unilateral or bilateral renal artery stenosis or stenosis of the artery to a solitary kidney valsartan it may result in increased plasma levels of creatinine or blood urea, so it should not be used in these patients.

Impaired renal function. In applying the drug to patients with mild or moderate renal impairment (creatinine clearance ≥ 30 ml / min) a dose adjustment is not necessary, but it is recommended potassium periodic monitoring of serum creatinine and uric acid.

Thiazide diuretics may induce azotemia in patients with chronic renal impairment. They are not effective as monotherapy in severe renal failure (creatinine clearance <30 mL / min), but can be used with appropriate caution in combination with loop diuretics even in patients with a creatinine clearance <30 mL / min.

The simultaneous use of angiotensin receptor antagonists, including valsartan, or angiotensin converting enzyme inhibitors with aliskiren patients with impaired renal function (glomerular filtration rate (GFS) <60 ml / min / 1.73 m2) is contraindicated.

Kidney transplantation. No Information about the safety of valsartan in patients with recent kidney transplantation.

Systemic lupus erythematosus. There are reports that thiazide diuretics may exacerbate systemic lupus erythematosus.

Other metabolic disorders. Thiazide diuretics may cause a change in glucose tolerance, as well as increase the concentration of cholesterol, triglycerides and uric acid in serum. Diabetic patients may need a dose adjustment of insulin or oral hypoglycemic agents.

Thiazides may decrease the urinary excretion of calcium and lead to intermittent and slight increase in serum calcium in the absence of metabolic disorders known kaltsiya.Znachitelnaya hypercalcemia may indicate hyperparathyroidism hidden. The use of thiazides should be discontinued before testing parathyroid function.

Abnormal liver function. In patients with mild and moderate hepatic impairment without cholestasis the dose adjustment is not necessary. However, the drug should be taken with caution. liver diseases did not significantly alter the pharmacokinetic parameters of hydrochlorothiazide.

Photosensitivity. There were reports of photosensitivity when taking thiazide diuretics. If during the treatment of photosensitivity reaction occurs, discontinue treatment with the drug. If there is a need for repeated administration of a diuretic, it is recommended to protect vulnerable areas from the sun or artificial ultraviolet radiation.

Are common. It should be especially careful in the application of the drug to patients who have had a marked hypersensitivity to other angiotensin II receptor antagonists. Allergic reactions to hydrochlorothiazide are likely to occur in patients with allergy and asthma.

Angioedema.

On the occurrence of angioedema (including swelling of the larynx and glottis, resulting in airway obstruction and / or swelling of the face, lips, throat and / or tongue) have been reported in patients treated with valsartan, some of these patients had a history of swelling Quincke the use of other medications, including other angiotensin II receptor antagonists. With the development of angioedema treatment with the drug should be discontinued immediately. Contraindicated re-use of the preparation.

The acute angle-closure glaucoma.

Application hydrochlorothiazide, sulfonamide been associated with the occurrence of idiosyncratic reactions that can cause acute transient myopia and acute angle-closure glaucoma. It has been a sharp decrease in visual acuity and eye pain. This symptoms usually lasts for several hours a week when using the drug. Untreated glaucoma can lead to irreversible vision loss. Should immediately stop using the product. Factor in the risk of developing acute angle-closure glaucoma is an allergic response to the use of a sulfonamide or penicillin.

Hydrochlorothiazide may reduce the level of protein-bound iodine in the blood plasma.

Hydrochlorothiazide is capable of increasing the serum concentration of free bilirubin.

Use during pregnancy or lactation.

Pregnancy.

Valsartan. Use of an angiotensin II receptor antagonist is contraindicated and pregnant women planning pregnancy. Women planning a pregnancy should be prescribed an alternative antihypertensive treatment with the established safety profile regarding the use during pregnancy. If pregnancy is detected during treatment DioCore, the drug should be lifted immediately, and if necessary, replace it with another drug approved for use for pregnant women.

Considering the mechanism of action receptor antagonists of angiotensin II, one can not exclude the risk for the fetus when used in the I DioCore trimester. It is known that the use of angiotensin II receptor antagonists for trimesters II and III may induce fetotoxicity (decreased renal function, oligohydramnios, delayed ossification of bones of the skull) and neonatal toxicity (renal failure, hypotension, hyperkalaemia).

If the use of angiotensin II receptor antagonists has occurred, starting with II trimester recommended to perform ultrasonic inspection of the kidneys and the skull.

Infants whose mothers have taken Angiotensin II receptor antagonists, require careful observation on hypotensive.

Hydrochlorothiazide. Hydrochlorothiazide crosses the placenta. Based on the pharmacological mechanisms of action of hydrochlorothiazide its use for II and III trimester of gestation may lead to disruption foetoplacental circulation and cause fetal and neonatal effects, such as jaundice, disorders of electrolyte balance and thrombocytopenia.

Lactation.

It is not known whether valsartan passes into breast milk. Hydrochlorothiazide passes into breast milk in small amounts. Thiazides in high doses cause diuresis, which can lead to a decrease in the production of breast milk. During the period of lactation should be given to alternative methods of treatment with the more well-known manifestations of the security on the application during the period of lactation.

If use of the drug is essential, breast-feeding should be discontinued.

The ability to influence the reaction rate when driving vehicles or other mechanisms.

At the beginning of drug therapy (1-2 days) should refrain from car driving or working with other mechanisms. Further it is necessary to consider that the reaction rate can be reduced in the presence of symptoms such as dizziness, headache, fatigue and nausea.

Dosing and dose.

The recommended dose - 1 tablet of 80 mg / 12.5 mg (80 DioCore) 1 time per day. With insufficient reduction in blood pressure after 3-4 weeks of treatment is recommended to consider the possibility of continuing the treatment with 1 tablet dosing 160 mg / 12.5 mg (DioCore 160) 1 time per day. The maximum daily dose is 320 mg / 25 mg. The maximum antihypertensive effect is reached during 2-4 weeks of application.

The drug can be administered independently from the meal with a little water.

If the kidney function.

For patients with mild and moderate renal impairment (creatinine clearance of> 30 ml / min) to adjust the dose is not necessary.

If abnormal liver function.

For patients with mild to moderate hepatic impairment nebiliarnogo origin and without cholestasis the dose of valsartan should not exceed 80 mg, and the drug should be used with caution.

Patients of advanced age.

For elderly patients, a dose adjustment is required.

Duration of use is established by the doctor individually.

Children.

Safety and effectiveness of DioCore children have not been established, so the drug should not be used in pediatric practice.

Overdose.

Cases DioCore information is not overdose.

The main manifestation of an overdose can be severe hypotension, which in turn can lead to a decrease in the level of consciousness, heart failure, and / or shock.

With an overdose of hydrochlorothiazide may experience such signs and symptoms: nausea, somnolence, hypovolaemia, electrolyte disturbances associated with arrhythmias and muscle spasms. Characteristic features are also overdose: tachycardia, weakness, confusion, dizziness, paresthesia, depletion, vomiting, thirst, polyuria, oliguria, anuria, alkalosis, elevated blood urea nitrogen (primarily renal failure).

If the drug was recently adopted, should induce vomiting or to gastric lavage. The first priority is to stabilize the circulation. If hypotension occurs, the patient should be given the supine position and the fill as quickly as possible and the salt content in the body fluid. Valsartan can not be derived from the body by dialysis due to its significant binding to plasma proteins, although for removal from the body of hydrochlorothiazide hemodialysis effective.

Adverse reactions.

Side reactions are generally bland, transient in nature and are presented below.

Cardio-vascular system: tachycardia, arterialnayagipotenziya, vasculitis.

Blood system: neutropenia, thrombocytopenia.

From the nervous system: headache, dizziness, hypoesthesia, paresthesia, syncope, insomnia, somnolence.

From the side of Hearing: noise / ringing in the ears, vertigo, otitis media.

On the part of the organs of vision: visual disturbances.

The respiratory system: nasopharyngitis, cough, nasal congestion, bronchitis, acute bronchitis, chest pain, shortness of breath, faringolaringealnaya pain, sinusitis; very rarely - pulmonary edema with granulocytic infiltration and deposition of IgG in the alveolar membranes associated with hydrochlorothiazide. Non-cardiogenic pulmonary edema may be immunologically mediated idiosyncratic reaction to hydrochlorothiazide that is rare.

On the part of the digestive tract: diarrhea, abdominal pain, dyspepsia, dry mouth, gastroenteritis, nausea, isolated cases of increased liver function.

From the side of metabolism: hyperkalemia, dehydration.

From the genitourinary system: pollakiuria; very rarely - impaired renal function, acute renal failure, urinary tract infection, decreased libido.

From the skin and subcutaneous tissue: increased sweating, rash, itching.

From the immune system: hypersensitivity reaction / allergies, including serum sickness.

From the musculoskeletal system: back pain, arthralgia, muscle cramps, muscle strain, neck pain, pain in the extremities, sprain, myalgia, arthritis.

Common disorders: fatigue, nervousness, asthenia, fever, viral infections, edema, peripheral edema, angioedema.

Laboratory indicators: hypokalemia, hyponatremia, increased levels of bilirubin, creatinine and urea nitrogen, decreased hemoglobin and hematocrit.

Other adverse reactions inherent in hydrochlorothiazide and which may also be potential for Diocoras, even if they have not been observed with a combination drug (valsartan / hydrochlorothiazide).

Hydrochlorothiazide is widely used for many years, with doses more often than those that are part of Diocoras. When carrying out monotherapy with thiazide diuretics, including hydrochlorothiazide, some side reactions may occur.

Changes in electrolytes and metabolism. The development of hypokalemia in the treatment of thiazide diuretics was reported. With the use of thiazide diuretics, hypercalcemia, hyponatremia and hypochloraemic alkalosis can develop, which can induce hepatic encephalopathy or hepatic coma. Thiazides cause an increase in urinary excretion of magnesium, which can lead to hypomagnesemia. Thiazide diuretics can cause an increase in the concentration of cholesterol, triglycerides and uric acid in the blood serum, which can provoke gout attacks in patients with asymptomatic course of the disease. It is possible to reduce glucose tolerance, which can cause the manifestation of latent diabetes mellitus.

Other possible adverse reactions.

From the cardiovascular system: cardiac arrhythmia, heart failure, postural hypotension, the severity of which increases with the use of alcohol, the use of funds for anesthesia or sedatives; nasal bleeding.

On the part of the blood system: thrombocytopenia, sometimes with purpura; very rarely - leukopenia, agranulocytosis, bone marrow depression, hemolytic anemia, aplastic anemia.

From the side of the psyche: sleep disorders, depression, confusion, disorientation, mood change.

From the side of the organs of vision: xanthopsia, acute closed angle glaucoma.

On the part of the respiratory system: respiratory failure, respiratory distress, pneumonitis.

From the digestive tract: loss of appetite, mild nausea and vomiting, gastrointestinal upset, constipation; sensation of thirst, inflammation of the salivary glands, very rarely - pancreatitis.

From the hepatobiliary system: cholestasis or jaundice, cholecystitis.

From the skin and subcutaneous tissue: urticaria and other types of rash, eczema, purpura, photosensitization; very rarely - necrotizing vasculitis and toxic epidermal necrolysis, skin reactions resembling systemic lupus erythematosus, exacerbation of cutaneous manifestations of systemic lupus erythematosus, erythema multiforme.

From the side of the urinary system: interstitial nephritis.

On the part of the reproductive system: impotence.

Common disorders: anaphylactic reaction, shock.

Shelf life

3 years.

Storage conditions.

Keep in original packaging out of the reach of children at a temperature of no higher than 25 ° C.

Packaging.

10 tablets in a blister; 1, 3, 4 or 9 blisters in a pack of cardboard.

Category of vacation.

On prescription.


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