Valz N - instructions for use, dose, side effects, contraindications

Excipients: cellulose microcrystalline 36.00 mg, lactose monohydrate 29.72 mg, croscarmellose sodium 10.80 mg, povidone K29-32 7.20 mg, talc 1.80 mg, magnesium stearate 1.26 mg, silicon dioxide colloid 0.72 mg;

film sheath: Opapray II 85G34642 pink about 7.20 mg (polyvinyl alcohol 3.17 mg, talc 1.44 mg, titanium dioxide 1.39 mg, macrogol-3350 0.89 mg, lecithin 0.25 mg, ferric oxide red oxide 0.03 mg , iron oxide dye yellow oxide 0.03 mg, iron oxide dye black 0.0006 mg).

1 tablet, film-coated, 160 mg + 12.5 mg contains:

active substance: valsartan 160 mg + hydrochlorothiazide 12.5 mg;

Excipients: cellulose microcrystalline 72.00 mg, lactose monohydrate 71.94 mg, croscarmellose sodium 21.60 mg, povidone K29-32 14.40 mg, talc 3.60 mg, magnesium stearate 2.52 mg, silicon dioxide colloid 1.44 mg;

film sheath: Opapray II 85G25455 red about 14.40 mg (polyvinyl alcohol 6.34 mg, talc 2.88 mg, macrogol-3350 1.78 mg, titanium dioxide 1.57 mg, iron dye oxide red 0.78 mg, dye solar yellow aluminum varnish 0.56 mg, lecithin 0.50 mg).

1 tablet, film-coated, 160 mg + 25 mg contains:

active substance: valsartan 160 mg + hydrochlorothiazide 25 mg;

Excipients: cellulose microcrystalline 72.00 mg, lactose monohydrate 59.44 mg, croscarmellose sodium 21.60 mg, povidone K29-32 14.40 mg, talc 3.60 mg, magnesium stearate 2.52 mg, silicon dioxide colloid 1.44 mg ;

film sheath: Opapray II 85G23675 orange about 14.40 mg (polyvinyl alcohol 6.34 mg, talc 2.88 mg, titanium dioxide 1.81 mg, macrogol-3350 1.78 mg, iron dye oxide yellow 0.88 mg, lecithin 0.50 mg, iron dye oxide red 0.18 mg, ferric oxide black oxide 0.03 mg).

Description:

For tablets 80 mg + 12.5 mg: oval biconvex tablets covered with a pink film cover, marked "V" on one side and "H" on the other.

For tablets 160 mg + 12.5 mg: oval biconvex tablets covered with a film cover of red-brown color, labeled "V" on one side and "H" on the other side.

For tablets 160 mg + 25 mg: oval biconvex tablets, covered with a film shell of orange color, labeled "V" on one side and "H" on the other side.

Pharmacotherapeutic group:A combined hypotensive drug (angiotensin II receptor antagonist + diuretic)

ATX: & nbsp

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

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

Pharmacodynamics:

Combination drug with hypotensive effect, consisting of an angiotensin II receptor blocker and a thiazide diuretic.

Valsartan - peripheral vasodilator, has an antihypertensive and diuretic effect. Specific receptor blocker AT₁ angiotensin II, does not inhibit ACE; does not affect the content of total cholesterol, triglycerides,glucose and uric acid, does not interact and does not block the receptors of other hormones or ion channels that are important for regulating the functions of the cardiovascular system. There is a decrease in blood pressure (BP), not accompanied by a change in heart rate.

Hydrochlorothiazide - Thiazide diuretic of medium strength. Reduces the reabsorption of sodium ions at the level of the cortical segment of the Henle loop, without affecting its area passing through the medulla of the kidney, which determines a weaker diuretic effect compared to furosemide. It blocks carbonic anhydrase in the proximal part of convoluted tubules, increases the excretion of potassium ions by the kidneys (in the distal tubules sodium ions are exchanged for potassium ions), hydrocarbonates and phosphates. Virtually does not affect the acid-base state (sodium ions are withdrawn either together with chlorine ions or with hydrocarbonate, so with alkalosis, the excretion of bicarbonate is enhanced, with acidosis, chlorine ions). Increases the excretion of magnesium; ions of calcium and urates in the body. Diuretic effect develops in 1-2 hours, reaches a maximum after 4 hours, lasts 10-12 hours.The effect decreases with a decrease in the glomerular filtration rate and stops when its value is less than 30 ml / min. Reduces blood pressure (BP) by decreasing the volume of circulating blood (BCC), changes in the reactivity of the vascular wall, reducing the pressor effect of endogenous catecholamines (epinephrine and norepinephrine) and increasing the depressor effect on the ganglion.

The maximum hypotensive effect is observed in the first 2-4 weeks of treatment.

Pharmacokinetics:

Valsartan

After ingestion absorption - fast, the degree of absorption is variable. Bioavailability - 23%. Time to reach the maximum concentration (TC_mOh) - 2 hours When taken with food the area under the curve "concentration-time" (AUC) decreases by 48%, which is not accompanied by a clinically significant decrease in the therapeutic effect. The connection with blood plasma proteins is 94-97%. When the equilibrium state is reached, the volume of distribution is 17 liters. The drug is metabolized by the enzyme system CYP2C9. The half-life (T_1/2) - 9 hours. It is excreted through the intestine - 70%, kidneys - 30%, mainly in unchanged form.

Hydrochlorothiazide

After oral administration hydrochlorothiazide quickly absorbed.Bioavailability is 60-80%. TS_mOh - 2-5 hours. Communication with blood plasma proteins - 60-80%. Penetrates through the hematoplacental barrier and into breast milk. T_1/2- 6-15 hours. It is not metabolized by the liver. It is excreted by the kidneys: more than 95% of the dose in unchanged form and about 4% in the form of hydrolyzate-2-amino-4-chloro-mbenzene disulfonamide.

Valsartan / hydrochlorothiazide

When combined with valsartan, the systemic bioavailability of hydrochlorothiazide is reduced by about 30%, hydrochlorothiazide has no significant effect on the kinetics of valsartan. The noted interaction does not affect the efficiency of the combined application.

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

Contraindications:

- Hypersensitivity to the active ingredients or excipients of the drug;

- Mr.liver function disorders associated with the obstruction of the biliary tract (including biliary cirrhosis, cholestasis);

- anuria;

- xrenal failure (creatinine clearance (CC) less than 30 ml / min), incl. patients on hemodialysis;

- ghypnotraemia, hypokalemia, hypercalcemia, hyperuricemia with clinical manifestations, refractory to adequate therapy;

- fromSystemic lupus erythematosus (SLE);

- atozrast to 18 years (safety and efficacy not established);

- bVariability, lactation period.

Carefully:Stenosis of the renal artery (unilateral or bilateral), kidney transplantation (there is no safety data for valsartan in patients who have recently undergone kidney transplantation); conditions, accompanied by a decrease in BCC (including diarrhea, vomiting); simultaneous reception with preparations of potassium salts, potassium-sparing diuretics, as well as with drugs that can cause an increase in the concentration of potassium in the blood (for example, heparin); with simultaneous admission with thiazide diuretics; with mild or moderately expressed violations of the liver in the absence of phenomena of cholestasis.

Dosing and Administration:

Inside, regardless of the time of eating, squeezed with enough liquid.

The following doses of Valz H are indicated in the ratio valsartan / hydrochlorothiazide.

The recommended dose is 1 tablet of Vals H once a day with a dosage of 80 / 12.5 mg. In patients for whom the daily dose of 80 / 12.5 mg does not give the desired effect, it is recommended to increase the daily dose of Vals H to 160 / 12.5 mg, for those patients who show a further decrease in blood pressure, the daily dose of Valz H is 160/25 mg, respectively.

Patients with impaired renal function, when the QC is more than 30 ml / min, as well as in patients with weak or moderately expressed violations of liver function in the absence of the phenomena of cholestasis, no adjustment of the dose of the drug Valz N.

Side effects:

Dizziness, fatigue, diarrhea, abdominal pain, nausea, cough, rhinitis, pharyngitis, viral infections, decreased hematocrit, hyperkalaemia, hypercreatinemia, arthralgia, chest pain, allergic reactions, angioedema, itching, serum sickness, vasculitis, skin rash, impaired renal function.

Potentially possible: valsartan - edema, insomnia, asthenia, decreased libido (less than 1%); hydrochlorothiazide - disturbance of water-electrolyte balance; often: urticaria, decreased appetite, nausea, vomiting, orthostatic hypotension, decreased potency; rarely: photosensitivity, constipation or diarrhea, discomfort in the abdomen, intrahepatic cholestasis, jaundice, arrhythmias, headache, depression, paresthesia, visual impairment, thrombocytopenia, sometimes with purpura; very rarely: necrotizing vasculitis, toxic epidermal necrolysis (Lyell's syndrome), skin reactions,reminiscent of SLE, exacerbation of cutaneous manifestations of SLE, pancreatitis, leukopenia, agranulocytosis, bone marrow depression, hemolytic anemia, pneumonitis, pulmonary edema.

Overdose:

Symptoms: decrease in blood pressure, which can lead to loss of consciousness and collapse.

Treatment: gastric lavage, intake of a sufficient amount of activated carbon, intravenously 0.9% sodium chloride solution.

Valsartan is not excreted during dialysis due to active binding to plasma proteins.

Hemodialysis is effective against hydrochlorothiazide.

Interaction:

It is possible to enhance the antihypertensive effect when combined with other antihypertensive agents (such as vasodilators, beta-adrenoblockers, etc.).

Strengthens the neurotoxicity of salicylates, side effects of cardiac glycosides, cardiotoxic and neurotoxic effects of lithium preparations, the effectiveness of curare-like muscle relaxants.

Reduces the excretion of quinidine, weakens the effect of hypoglycemic agents for oral administration, norepinephrine, epinephrine and antidotal drugs.

Increases the frequency of allergic reactions to allopurinol; reduces the excretion of kidney cytotoxic agents (cyclophosphamide, methotrexate) and leads to an increase in their mielosupressivnogo action.

Medicines that bind intensively to blood proteins (indirect anticoagulants, clofibrate, non-steroidal anti-inflammatory drugs (NSAIDs)) increase the diuretic effect.

The hypotensive effect is enhanced by barbiturates, phenothiazines, tricyclic antidepressants, ethanol.

With the simultaneous administration of methyldopa, the development of hemolysis is possible; colestramine reduces absorption.

The risk of hypokalemia increases with the simultaneous appointment of saluretics, corticosteroids, adrenocorticotropic hormone (ACTH), amphotericin B, carbenoxolone, penicillin G and derivatives of salicylic acid.

An increase in the bioavailability of the thiazide diuretic is observed with simultaneous administration of cholinergic blockers (for example, atropine, biperidene), which is apparently associated with a decrease in the motor activity of the gastrointestinal tract and a slowdown in the emptying of the stomach.

With the joint use of thiazide diuretics with vitamin D or calcium salts, an increase in the serum calcium concentration is possible.

Simultaneous administration of cyclosporine may lead to an increase in the concentration of uric acid in the blood, which increases the risk of developing hyperuricemia and can also provoke a gout attack.

Special instructions:

Before treatment, the correction of the content of sodium ions in the blood and / or BCC is performed.

It is necessary to regularly monitor the content of potassium ions, glucose, uric acid, lipid profile and creatinine in the blood plasma, as thiazide diuretics can cause a change in glucose tolerance, as well as an increase in the concentration of cholesterol, triglycerides and uric acid in the blood serum.

Simultaneous use of potassium salts, potassium-sparing diuretics, potassium-containing substitutes for edible salt or any other medicines that can cause an increase in the potassium concentration in the blood (for example, heparin), requires precaution and, in particular, frequent determination of the potassium concentration in the blood.

You may need to adjust the dose of insulin or an oral hypoglycemic drug.

There are reports that thiazide diuretics can cause exacerbation of systemic lupus erythematosus.

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

If the pregnancy occurs during treatment, the drug should be discontinued.

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

During the treatment period, care must be taken when driving vehicles and engaging in other potentially dangerous activities that require an increased concentration of attention and speed of psychomotor reactions.

Form release / dosage:

The film-coated tablets are 80 mg + 12.5 mg, 160 mg + 12.5 mg and 160 mg + 25 mg.

Packaging:

For 7, 10 or 14 tablets in a blister of PVC / PE / PVDC / Aluminum foil or strips Aluminum foil / Aluminum foil.

For a dosage of 80 mg+12.5 mg: 1, 2, 4 blisters or a strip of 7 tablets; 1, 2, 3, 10 blisters or strips of 10 tablets; for 4 or 7 blisters or strips of 14 tablets together with instructions for use in the pack.

For dosages of 160 mg+12.5 mg and 160 mg+25 mg: 1, 2, 4 blisters or a strip of 7 tablets; 1, 2, 3, 9 blisters or strips of 10 tablets; on 4 or 7 blisters or from trips to 14 tablets together with the instruction on application in a pack.

Storage conditions:

At a temperature of no higher than 30 ° C.

Keep out of the reach of children!

Shelf life:

3 years.

Do not use after the expiration date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:LSR-002882/09

Date of registration:13.04.2009 / 11.09.2014

Expiration Date:Unlimited

The owner of the registration certificate:AKTAVIS GROUP, AO AKTAVIS GROUP, AO Iceland

Manufacturer: & nbsp

ACTAVIS, Ltd. Iceland

BALKANPHARMA-DUPNITSA, AD Bulgaria

Representation: & nbspAktavis, Open Company Aktavis, Open Company

Information update date: & nbsp18.01.2017

Illustrated instructions

Instructions

WALZ H (Valz H)