Universal reference book for medicines
Product name: VALSARTAN-HYDROCHLOROTHYAZID-ACRYCHIN (VALSARTAN-HYDROCHLOROTHIAZIDE-AKRIKHIN)

Active substance: hydrochlorothiazide, valsartan

Type: Antihypertensive drug

Manufacturer: POLPHARMA PHARMACEUTICAL WORKS (Poland)
Composition, form of production and packaging
The tablets covered with a film membrane of
pink color, oblong, biconcave;
On a break of white color with a pink edge.
1 tab.

valsartan 80 mg

hydrochlorothiazide 12.5 mg

Excipients: lactose monohydrate - 44 mg, croscarmellose sodium - 10.5 mg, silicon dioxide colloidal anhydrous - 1.125 mg, magnesium stearate - 1.875 mg.

The composition of the membrane: hypromellose-6 cP - 2.344 mg, macrogol 400 - 0.469 mg, titanium dioxide (E171) - 0.907 mg, iron oxide red (E172) - 0.03 mg.

14 pcs.
- blisters (1) - packs of cardboard.
14 pcs.
- blisters (2) - packs of cardboard.
Tablets covered with a film membrane of orange-brown color, oblong, biconcave;
On a break of white color with an orange-brown edge.
1 tab.

valsartan 160 mg

hydrochlorothiazide 12.5 mg

Excipients: lactose monohydrate - 100.5 mg, croscarmellose sodium - 21 mg, silicon dioxide colloidal anhydrous - 2.25 mg, magnesium stearate - 3.75 mg.

The composition of the membrane: hypromellose-6 cP - 4.6875 mg, macrogol 400 - 0.9375 mg, titanium dioxide (E171) - 0.075 mg, iron oxide red (E172) 1.68 mg, iron oxide yellow (E172) 0.1125 mg, iron oxide black E172) 0.0075 mg.

14 pcs.
- blisters (1) - packs of cardboard.
14 pcs.
- blisters (2) - packs of cardboard.
The tablets covered with a film membrane of light brown color, oblong, biconcave;
On a break of white color with a light brown edge.
1 tab.

valsartan 160 mg

hydrochlorothiazide 25 mg

Excipients: lactose monohydrate - 88 mg, croscarmellose sodium - 21 mg, silicon dioxide colloidal anhydrous - 2.25 mg, magnesium stearate - 3.75 mg.

The composition of the membrane: hypromellose-6 cP - 4.6875 mg, macrogol-400 - 0.9375 mg, titanium dioxide (E171) - 1.47 mg, iron oxide red (E172) - 0.12 mg, iron oxide yellow (E172) - 0.2625 mg, iron oxide black (E172) 0.0225 mg.

14 pcs.
- blisters (1) - packs of cardboard.
14 pcs.
- blisters (2) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2015.

PHARMACHOLOGIC EFFECT

Combined antihypertensive drug, which includes an angiotensin II receptor antagonist (ARAII) and a thiazide diuretic.

Angiotensin II is an active hormone of the renin-angiotensin-aldosterone system (RAAS) and 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 primarily both direct and indirect participation in the regulation of blood pressure. Being a potent vasoconstrictor, angiotensin II causes a direct pressor response. In addition, it stimulates the secretion of aldosterone and promotes the retention of sodium ions.
Valsartan is a selective angiotensin II receptor antagonist.
Has a selective antagonistic effect on the receptors of the AT 1 subtype, responsible for the vasopressor effect of angiotensin II. An increase in serum angiotensin II concentration due to valsartan blockade of AT 1 -receptors can stimulate free receptors of the AT 2subtype, which balances the effects associated with the stimulation of AT 1 -receptors. Has no agonistic activity against AT 1 -receptors. Does not inhibit ACE.Valsartan does not interact and does not block the receptors of other hormones or ion channels involved in the regulation of the functions of the cardiovascular system.
Hydrochlorothiazide is a thiazide diuretic.
The point of application of the action of thiazide diuretics is the distal convoluted renal tubules. When thiazide diuretics are applied to highly sensitive receptors in the distal tubules of the cortical layer of the kidneys, reabsorption of sodium and chlorine ions occurs. The suppression of the co-transport system of sodium and chlorine is apparently due to competition for the binding sites of chlorine ions, as a result of which the excretion of sodium and chlorine ions increases approximately to the same extent. As a result of diuretic action, a decrease in the volume of circulating blood (BCC) is observed, which increases the activity of renin, the secretion of aldosterone, the excretion of potassium by the kidneys and, consequently, the decrease in the potassium content in the serum.
PHARMACOKINETICS

Valsartan

Suction

After oral administration, the maximum concentration (C max ) of valsartan in the blood plasma is reached after 2-4 hours. The average bioavailability is 23%.
When taking valsartan concomitantly with food, the area under the concentration-time curve (AUC) is reduced by 48%, although approximately 8 hours after taking the drug, the concentration of valsartan in the blood plasma, either in the case of fasting or in the case of food intake are aligned. The decrease in AUC is not accompanied by a clinically significant decrease in the therapeutic effect, so valsartan can be administered regardless of the time of ingestion.
Distribution

Valsartan largely binds to blood serum proteins (94-97%), mainly with albumin.
After intravenous administration of valsartan, the volume of distribution during the equilibrium period is about 17 liters, which indicates that valsartan is not distributed in tissues to a large extent.
When taking valsartan 1 time / day, the cumulation is insignificant.
The concentrations of valsartan in blood plasma in women and men are the same.
Metabolism

Valsartan does not undergo a pronounced metabolism (about 20% of the dose is determined in the form of metabolites).
Hydroxy-metabolite is determined in blood plasma at low concentrations (less than 10% of Valsartan AUC). This metabolite is pharmacologically inactive.
Excretion

The pharmacological curve of vatsartan has a downward multiexponential character (half-life T 1/2? <1 h and T 1/2? About 9 h).
Valsartan is excreted through the intestine (about 83% of the dose) and kidneys (about 13% of the dose), mostly unchanged. After intravenous administration, the plasma clearance of valsartan is about 2 l / h, its renal clearance is 0.62 l / h (about 30% of the total clearance). T 1/2 of valsartan is 6 hours.
In the range of doses studied, the kinetics of valsartan is linear.
With repeated use of valsartan, no changes in the kinetic parameters were noted.
Hydrochlorothiazide

Suction

After oral intake of hydrochlorothiazide occurs quickly, the time to reach the maximum concentration (C max ) - about 2 hours. In the therapeutic range of doses, the average value of AUC increases in direct proportion to the increase in dose.
Simultaneous intake of hydrochlorothiazide with a beggar can lead to both an increase and a decrease in systemic bioavailability compared with fasting, but the magnitude of these effects is small and clinically insignificant. When administered, the absolute bioavailability of hydrochlorothiazide is 70%.
Distribution

The pharmacokinetics of hydrochlorothiazide in the phases of distribution and elimination are generally described by the bi-exponential descending curve.
The apparent volume of distribution is 4-8 l / kg. Binding to blood plasma proteins (mainly with albumins) is 40-70%. Hydrochlorothiazide also accumulates in erythrocytes in a concentration three times that of plasma.
Metabolism

Hydrochlorothiazide is eliminated in almost unchanged form.

Excretion

The half-life (T 1/2 ) of the final phase is 6-15 hours. When the drug is used again the kinetics of hydrochlorothiazide does not change, with the prescription of the drug 1 time / day, the accumulation of the drug is minimal.
More than 95% of the absorbed dose is excreted by the kidneys unchanged.
Valsartan / hydrochlorothiazide

When combined with valsartan, the systemic bioavailability of hydrochlorothiazide is reduced by about 30%.
The concomitant administration of hydrochlorothiazide does not significantly affect the kinetics of valsartan. This interaction does not affect the effectiveness of combined use of valsartan and hydrochlorothiazide.
The distinct anti-hypertensive effect of this combination exceeds the effect of each of the components separately.

Pharmacokinetics in selected patient groups

Patients of advanced age (over 65 years)

In some elderly patients, Valsartan AUC was slightly larger than in young patients, but this was not clinically significant.
Limited data suggest that in elderly patients (both healthy and patients with hypertension) the systemic clearance of I hydrochlorothiazide is lower than in healthy young volunteers.
Patients with impaired renal function

In patients with creatinine clearance (CK) 30-70 ml / min, dose adjustment is not required.

Currently, there is no data on the use of the drug in patients with severe renal dysfunction (CK <30 ml / min) and in patients receiving hemodialysis.
Valsartan is not excreted by hemodialysis due to significant binding to blood proteins. At the same time, hemodialysis allows the effective removal of hydrochlorothiazide from the body.
In the presence of renal insufficiency, the average plasma concentration peaks and 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 is almost doubled.
Patients with impaired hepatic function

In patients with impaired hepatic function (5-6 points on the Child-Pugh scale) and moderate (7-9 on the Child-Pugh scale), the severity of ATS valsartan is 2 times more on average compared to healthy volunteers (of the corresponding age, sex and body weight).

Pharmacokinetic studies in patients with severe impairment of liver function (more than 9 points on the Child-Pugh scale) were not performed.

Since the violation of liver function does not have a clinically significant effect on the kinetics of hydrochlorothiazide, dose adjustment in patients with impaired liver function is not required.

Contraindicated the use of the drug Valsartan-Hydrochlorothiazide-Akrihin patients with severe (more than 9 points on the scale Child-Pugh) violations of liver function.
In patients with bile duct obstruction, the drug Valsartan-Hydrochlorothiazide-Acrichin should be used with caution.
INDICATIONS

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

DOSING MODE

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

The drug Valsartan-Hydrochlorothiazide-Akrihin is taken orally, regardless of the meal, 1 tab.
1 time / day, washing down with a liquid.
Depending on the clinical situation, the recommended daily dose is 1 tab.
of the drug Valsartan-Hydrochlorothiazide-Akrihin, containing valsartan / hydrochlorothiazide at a dose of 80 mg + 12.5 mg, 160 mg + 12.5 mg.
If necessary, assign 1 tab.
preparation Valsartan-hydrochlorothiazide-Akrihin, containing valsartan / hydrochlorothiazide 160 mg + 25 mg / day - the maximum daily dose for hydrochlorothiazide.
The maximum decrease in blood pressure is usually achieved in 2-4 weeks of therapy.

In elderly patients (over 65 years), dose adjustment is not required.

In patients with impaired renal function of mild or moderate severity (CK> 30 ml / min), dose adjustment is not required.

In patients with lungs (5-6 points on the Child-Pugh scale) and moderate (7-9 points on the Child-Pugh scale), violations of liver function without concomitant phenomena of cholestasis, the dose of valsartan should not exceed 80 mg.

SIDE EFFECT

The following side effects are given in accordance with the following grades of their frequency in accordance with the classification of the World Health Organization: very often (? 1/10);
often (? 1/100, <1/10); infrequently (? 1/1000, <1/100); rarely (? 1/10 000, <1/1000) and very rarely (<1/10 000), the frequency is unknown (insufficient data to estimate the frequency of development).
Adverse events were generally mild and transitory in nature.

The combination of valsartan / hydrochlorothiazide

From the side of metabolism and nutrition: infrequently - dehydration.

From the nervous system: often - headache;
infrequently paresthesia; very rarely - dizziness; frequency unknown - faint.
From the side of the organ of vision: infrequently - reduced visual acuity.

From the side of the organ of hearing and labyrinthine disturbances: rarely - noise in the ears.

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

From the respiratory system, chest and mediastinum: infrequently - cough;
frequency unknown - noncardiogenic pulmonary edema.
From the digestive tract: infrequently - nausea;
very rarely, diarrhea.
From the osteomuscular and connective tissue: infrequently - myalgia;
very rarely - arthralgia.
From the side of the kidneys and urinary tract: the frequency is unknown - a violation of kidney function.

Laboratory and instrumental data: frequency unknown - increased serum uric acid concentration, increased serum bilirubin concentration, increased serum creatinine, hypokalemia, hyponatremia, neutropenia, increased urea blood levels.

Allergic reactions: rarely - angioedema.

General disorders and disorders at the injection site: infrequently - fatigue;
very rarely - epistaxis, viral infection, fever.
In the clinical practice of the combination valsartan / hydrochlorothiazide, the following side effects were also observed (frequency unknown): abdominal pain, upper abdominal pain, anxiety, arthritis, asthenia, back pain, bronchitis (including acute), pain in the breast, postural dizziness, dyspepsia, dyspnea, dryness of the oral mucosa, nosebleeds, erectile dysfunction, gastroenteritis, headache, increased sweating, hypoesthesia, flu-like condition, insomnia, sprain, muscle spasms, musclehypertension, nasal congestion, nasopharyngitis, nausea, neck pain, peripheral edema, otitis media, pain in the extremities, palpitations, pain in the larynx and pharynx, pyrexia, hyperthermia, sinusitis, drowsiness, upper respiratory tract infections, urinary tract infections, vertigo, viral infections, impaired vision.

The following are side reactions associated with the use of each component separately.

Valsartan

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

On the part of the immune system: the frequency is unknown - hypersensitivity reactions / allergic reactions, including serum sickness.

From the side of metabolism and nutrition: the frequency is unknown - an increase in potassium in the blood serum, hyponatremia.

From the side of the organ of hearing and labyrinthine disturbances: infrequently - vertigo.

From the cardiovascular system: the frequency is unknown - vasculitis.

From the digestive tract: infrequently - pain in the abdomen.

From the side of the liver and bile ducts: the frequency is unknown - an increase in the activity of liver enzymes.

From the skin and subcutaneous tissues: the frequency is unknown - Quincke's edema, skin rash, skin itch.

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

In the clinical practice of valsartan, the following side effects were also observed (frequency unknown) 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

On the part of the blood and lymphatic 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 side of the immune system: very rarely - reactions of increased sensitivity.

From the side of metabolism and nutrition: 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.
Disorders of the psyche: rarely - depression, sleep disturbances.

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

From the side of the organ of vision: rarely - visual impairment (especially in the first few weeks of treatment);
frequency unknown - acute attack of angle-closure glaucoma.
From the cardiovascular system: rarely - arrhythmia;
often - orthostatic hypotension (may worsen with alcohol, sedatives or pain medications).
On the part of the respiratory system, chest and mediastinal organs: very rarely - respiratory distress syndrome, including pulmonary edema and pneumonitis.

From the digestive tract: 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 or jaundice.

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

From the skin and subcutaneous tissues: often - hives or other forms of skin rash;
rarely - photosensitivity; very rarely - necrotizing vasculitis, toxic epidermal necrolysis, lupus-like reactions, exacerbation of cutaneous manifestations of systemic lupus erythematosus; frequency is unknown - erythema multiforme.
From the osteomuscular and connective tissue: the frequency is unknown - muscle spasms.

From the genitals and the breast: often - impotence.

General disorders and disorders at the injection site: the frequency is unknown - hyperthermia, asthenia.

CONTRAINDICATIONS

- lactose intolerance, lactase deficiency, glucose-galactose malabsorption;

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

- Anuria, severe renal dysfunction (CK <30 ml / min);

pregnancy, pregnancy planning;

- the period of breastfeeding;

- the age of 18 years (safety and efficacy not established);
- simultaneous application of aliskiren in patients with type 2 diabetes mellitus;
- Hypersensitivity to valsartan, hydrochlorothiazide, and other sulfonamide derivatives, or any other component of the formulation.
Carefully

Caution must be exercised when using the drug in patients with hereditary angioedema or angioedema amid prior therapy of angiotensin II receptor antagonists (ARA II) or ACE inhibitors.
Caution must be exercised while the use of potassium preparations, potassium-sparing diuretics, kaliysoderzhashih edible salt substitutes and other drugs which may cause increase of potassium in the blood (e.g., heparin).
The drug should be used with caution in patients with unilateral or bilateral renal artery stenosis or stenosis of the artery only kidneys, with states accompanied aqueous electrolyte disturbances: nephropathy accompanied salts loss and prerenal (cardiogenic) renal function in patients with hypokalemia, hypomagnesemia, hyponatremia, hypocalcemia.
Caution must be exercised when using the drug in patients with significant deficits in sodium body and / or with reduced BCC (e.g., receiving high doses of diuretics), with moderate hepatic impairment, chronic heart failure (III-IV functional class NYNA classification) mitral or aortic stenosis, hypertrophic obstructive cardiomyopathy, systemic lupus erythematosus, primary hyperaldosteronism, diabetes mellitus, hyperuricemia, hypercholesterolemia and triglyceryl demiey with obstructive biliary tract disease and cholestasis in patients with narrow-angle glaucoma and in patients after kidney transplantation.
PREGNANCY AND LACTATION

As with any other drug that affects the RAAS drug Valsartan-hydrochlorothiazide-Akrikhin 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 valsartan-hydrochlorothiazide-Akrikhin during pregnancy is contraindicated, since, given the mechanism of action of angiotensin II receptor antagonists, 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 II and III trimester of pregnancy leads to damage or destruction of the developing fetus. According to the historical data with the use of ACE inhibitors in the I 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 were inadvertently received valsartan.
Introduction of thiazide diuretics, including hydrochlorothiazide, to the uterus led to the development of jaundice and thrombocytopenia in the fetus or in 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 valsartan-hydrochlorothiazide-Akrikhin, the drug should be discontinued as soon as possible.
It is not known whether valsartan passes into breast milk. In experimental studies have demonstrated that valsartan is excreted in the milk of lactating animals. Hydrochlorothiazide crosses the placental barrier and is excreted in breast milk. If necessary, use during lactation, breast-feeding should be discontinued.
APPLICATION FOR FUNCTIONS OF THE LIVER

Patients with impaired renal function, mild or moderate severity (QA> 30 ml / min) a dose adjustment is required.
Do not use this drug in anuria, severe renal impairment (creatinine clearance <30 mL / min).
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS

Patients with mild (5-6 points on the Child-Pugh) and mild (7-9 points on the Child-Pugh) liver dysfunction without concomitant phenomena cholestasis dose of valsartan should not exceed 80 mg.
Not use this drug in severe hepatic dysfunction (more than 9 points on the Child-Pugh).
APPLICATION FOR CHILDREN

Do not use this drug before the age of 18 years (the safety and efficacy has not been established).
APPLICATION IN ELDERLY PATIENTS

In elderly patients (over 65 years) correction dose is not required.
SPECIAL INSTRUCTIONS

The drug-Valsartan hydrochlorothiazide-Akrikhin can be used as primary therapy for patients who, most likely, may require multiple drugs to achieve target blood pressure values. The choice of drug-Valsartan hydrochlorothiazide-Akrikhin for initial therapy of hypotension should be based on an assessment of the ratio of the potential benefits and risks.
Liver dysfunction
drug Valsartan-hydrochlorothiazide-Akrikhin not applicable in patients with severe (more than 9 points on the Child-Pugh) liver dysfunction, the presence of biliary tract obstruction and cholestasis should be used with caution.
The change 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) violation nochek function. In the event of hypokalemia clinical manifestations (muscle weakness, paresis, ECG changes) treatment with Valsartan-hydrochlorothiazide-Akrikhin should cease. Before the start of the drug necessary to correct hypokalemia and hypomagnesemia. All patients receiving thiazide diuretics, preparations containing, requires regular monitoring of serum electrolytes, particularly potassium.
In applying the drug valsartan-hydrochlorothiazide-Akrikhin should take into account the ability of thiazide diuretics cause hyponatremia and alkalosis gipohloremicheeky and exacerbate existing hyponatremia. Hyponatremia in these cases is rarely accompanied by neurological symptoms. Requires regular monitoring of sodium in the blood serum.
The deficit in the body of sodium and / or bcc
Patients with a marked deficiency in the body of sodium and / or under reduced bcc (e.g., in patients receiving high doses of diuretics), in rare cases, early treatment with Valsartan-hydrochlorothiazide-Akrikhin may occur marked reduction of blood pressure with clinical manifestations. Before treatment should carry out the correction contents in the body of sodium and / or fill BCC, otherwise, treatment should start under strict medical control.
In the case of pronounced reduction in blood pressure of the patient to be put, the legs lift and, if necessary, to carry out on / in infusion of 0.9% sodium chloride solution. After stabilization of blood pressure, treatment with Valsartan hydrochlorothiazide-Akrikhin can be continued.
Renal artery stenosis
In patients with unilateral or bilateral renal artery stenosis or stenosis of the artery to a solitary kidney, the drug Valsartan Hydrochlorothiazide-Akrikhin may be accompanied by an increase in the concentration of urea and creatinine in serum, therefore in these patients the drug valsartan-hydrochlorothiazide-Akrikhin should be used with caution.
Chronic heart failure III-IV functional class (NYHA classification on), including after myocardial infarction
For patients whose kidney function is dependent on RAAS state (e.g., patients with chronic heart failure III-IV functional class), therapy of ACE inhibitors and ARA II may be accompanied by oliguria and / or progressive azotemia, in rare cases - acute renal failure. Evaluation of patients with chronic heart failure and patients who have had myocardial infarction, should include the study of kidney function.
Systemic lupus erythematosus
has been reported on the development of acute and worsening of diseases of the connective tissue (eg systemic lupus erythematosus) for use of thiazide diuretics, including hydrochlorothiazide.
Other metabolic disorders
Thiazide diuretics, including hydrochlorothiazide, can cause changes in glucose tolerance, as well as increase the concentration of cholesterol and triglycerides in the serum. Reducing uric acid clearance can lead to the development of hyperuricemia and gout in predisposed patients. Thiazide diuretics reduce calcium excretion by the kidneys and may cause a slight increase of calcium in plasma in the absence of concomitant disorders of calcium metabolism. Marked hypercalcemia during therapy with a thiazide diuretic (> 12 mg / dl) or not responding to the abolition of the drug may indicate the presence of concomitant disorders of calcium metabolism. In a few patients with hypercalcemia and hypophosphatemia against the backdrop of the prolonged use of thiazide diuretics determined by pathological changes in the parathyroid glands.
Hypersensitivity reactions
The occurrence of hypersensitivity reactions during treatment with hydrochlorothiazide is most commonly observed in patients with allergic reactions and asthma history.
Angioedema, including angioedema
angioedema, including edema of the larynx and the vocal cords, leading to airway obstruction, and / or facial edema, lips, pharynx and / or tongue edema encountered in patients treated with valsartan, in some of these patients previously arisen angioneurotic edema in patients receiving other medications in including ACE inhibitors. The drug valsartan-hydrochlorothiazide-Akrikhin in the case of angioedema should be immediately canceled the renewal of the drug valsartan-hydrochlorothiazide-Akrikhin prohibited.
Acute attack of angle-closure glaucoma
Against the background of hydrochlorothiazide have been cases of transient myopia and acute angle-closure glaucoma development. A risk factor for developing acute angle-closure glaucoma may be a medical history of allergic reactions to penicillin and sulfanilamide.
Symptoms: sudden onset, sudden decrease in vision or pain in the eye, usually resulting in a period of a few hours up to a week after initiation of therapy. Untreated closure glaucoma can lead to permanent vision loss. The first step is to stop taking hydrochlorothiazide. Additional medical or surgical treatment may be necessary if the intraocular pressure after the drug is not reduced.
Hydrochlorothiazide may produce positive results in doping control.
Impact on the ability to drive vehicles and manage mechanisms

Be careful when driving vehicles and operating machinery that require attention, as during treatment may develop dizziness or weakness in the arterial hypotension.
OVERDOSE

Symptoms: an overdose with valsartan is observed marked reduction LD up to the oppression of consciousness, circulatory collapse and / or shock with a fatal outcome. With an overdose of hydrochlorothiazide may experience the following symptoms: nausea, somnolence, hypovolemia, cardiac arrhythmias and muscle spasms caused by violation of water-electrolyte balance.
Treatment:symptomatic, the nature of which depends on the time elapsed since administration of the drug, and the degree of severity of symptoms. In the case of early detection of drug overdose it is recommended to call the patient vomiting. In the case of pronounced reduction in blood pressure of the patient must be laid on its back, raising his legs, and as quickly as possible to carry out / in a 0.9% sodium chloride solution. It should regularly monitor the activity of the heart and respiratory system, bcc, and urine output.
Valsartan does not rely on hemodialysis due to a significant binding to plasma proteins. At the same time, hemodialysis can effectively excrete the hydrochlorothiazide.
DRUG INTERACTION

Common drug interactions for valsartan and hydrochlorothiazide
Medicaments joint application with which should be avoided
lithium Formulations
With simultaneous use of drugs lithium with ACE inhibitors or ARA II thiazide diuretics mentioned reversible increases lithium in blood serum and related amplification toxic manifestations. The risk of toxic effects associated with the use of lithium preparations can be further increased while the use of drug-Valsartan hydrochlorothiazide-Akrikhin because renal clearance is reduced lithium preparations under the influence of thiazide diuretics. In this regard, we recommend careful monitoring of lithium in blood serum.
Drugs, the combined use of which requires caution
Antihypertensive drugs
Perhaps increased antihypertensive effect when used together with other drugs. lowering blood pressure (ACE inhibitors, beta-blockers, calcium channel blockers slow, guanethidine, methyldopa, vasodilators, direct renin inhibitors, ARA II).
Pressor amines
may weaken the effect of pressor amines (norepinephrine, epinephrine) that does not require the termination of the joint application.
Nonsteroidal anti-inflammatory drugs (NSAIDs), including selective inhibitors of cyclooxygenase-2 (COX-2)
May decrease diuretic and antihypertensive effect of the drug, hydrochlorothiazide, Valsartan Akrikhin while the use of NSAIDs, such as salicylic acid derivative, indomethacin. Related hypovolemia can lead to acute renal failure.
Drug interactions for valsartan
Medicaments joint application to Avoid
The simultaneous use of the angiotensin II receptor antagonists with other drugs affecting RAAS leads to an increase in the incidence of cases of hypotension, hyperkalaemia, renal dysfunction. It is necessary to control blood pressure parameters, renal function, as well as the content of blood plasma electrolytes in the appointment of the drug valsartan-hydrochlorothiazide-Akrikhin with other drugs that affect the RAAS. The simultaneous use of potassium-sparing diuretics, dietary supplements containing potassium; potassium-containing substitutions
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