Walz N
Latin name: Valz H
ATX code: C09DA03
Active ingredient: Valsartan + Hydrochlorothiazide (Valsartan + Hydrochlorothiazide)
Manufacturer: Actavis Group hf. (Iceland)
Description and photo updated: 12.12.2018
Valz N is a combined antihypertensive drug.
Release form and composition
Dosage form Valza N - film-coated tablets: oval biconvex shape, engraving "V" on one side, "H" on the other, at a dose of 80 mg + 12.5 mg - pink, 160 mg + 12.5 mg - red-brown color, 160 mg + 25 mg - orange; pink (320 mg + 12.5 mg) and yellow (320 mg + 25 mg) - with a dividing line on the side with the letter "V" and two side marks (in a strip or blister: for tablets at a dose of 80 mg + 12.5 mg, 160 mg + 12.5 mg, 160 mg + 25 mg - 7 pcs., In a cardboard box 1, 2 or 4 strips or blisters, in a cardboard box for hospitals 50 or 100 strips or blisters; 10 each pcs., in a cardboard box for hospitals 50 or 100 strips or blisters; 14 pcs., in a cardboard box 4 or 7 strips or blisters,in a cardboard box for hospitals 50 or 100 strips or blisters; for tablets at a dose of 80 mg + 12.5 mg - 10 pcs., in a cardboard box 1, 2, 3 or 10 strips or blisters; for tablets at a dose of 160 mg + 12.5 mg, 160 mg + 25 mg - 10 pcs., in a cardboard box 1, 2, 3, 9 or 10 strips or blisters; for tablets at a dose of 80 mg + 12.5 mg - 10 pcs., in a cardboard box 1, 2, 3 or 10 strips or blisters; for tablets in a dose of 320 mg + 12.5 mg and 320 mg + 25 mg - 7 pcs. in a blister, in a cardboard box 1, 2 or 4 blisters; 10 pcs. in a blister, in a cardboard box 1, 2, 3, 9 or 10 blisters; 14 pcs. in a blister, in a carton box of 4 or 7 blisters).9 or 10 strips or blisters; for tablets at a dose of 80 mg + 12.5 mg - 10 pcs., in a cardboard box 1, 2, 3 or 10 strips or blisters; for tablets in a dose of 320 mg + 12.5 mg and 320 mg + 25 mg - 7 pcs. in a blister, in a cardboard box 1, 2 or 4 blisters; 10 pcs. in a blister, in a cardboard box 1, 2, 3, 9 or 10 blisters; 14 pcs. in a blister, in a carton box of 4 or 7 blisters).9 or 10 strips or blisters; for tablets at a dose of 80 mg + 12.5 mg - 10 pcs., in a cardboard box 1, 2, 3 or 10 strips or blisters; for tablets in a dose of 320 mg + 12.5 mg and 320 mg + 25 mg - 7 pcs. in a blister, in a cardboard box 1, 2 or 4 blisters; 10 pcs. in a blister, in a cardboard box 1, 2, 3, 9 or 10 blisters; 14 pcs. in a blister, in a carton box of 4 or 7 blisters).
1 tablet contains:
- active ingredients: valsartan and hydrochlorothiazide (respectively) - 80 mg and 12.5 mg, 160 mg and 12.5 mg, 160 mg and 25 mg, 320 mg and 12.5 mg, 320 mg and 25 mg;
- auxiliary components: croscarmellose sodium, lactose monohydrate, povidone K29-32, magnesium stearate, microcrystalline cellulose, colloidal silicon dioxide, talc;
- composition of the film shell: titanium dioxide, polyvinyl alcohol, macrogol 3350, talc, lecithin.
Film casing composition:
- tablets at a dose of 80 mg + 12.5 mg: opadray II 85G34642 pink - iron dye red oxide, iron dye black oxide, iron dye yellow oxide;
- tablets at a dose of 160 mg + 12.5 mg: opadry II 85G25455 red - iron dye red oxide, dye sunny yellow aluminum varnish;
- tablets at a dose of 160 mg + 25 mg: opadry II 85G23675 orange - iron dye yellow oxide, iron dye black oxide, iron dye red oxide;
- tablets at a dose of 320 mg + 12.5 mg: opadry II 85G34643 pink - iron dye red oxide, iron dye yellow oxide;
- tablets at a dose of 320 mg + 25 mg: opadry II 85G32408 yellow - iron dye yellow oxide, iron dye red oxide.
Pharmacological properties
Pharmacodynamics
Valz N consists of the angiotensin II receptor blocker valsartan and the thiazide diuretic hydrochlorothiazide.
Valsartan is a specific blocker of AT 1 receptors of angiotensin II, a peripheral vasodilator with hypotensive and diuretic activity. Does not inhibit angiotensin-converting enzymes, does not interact and does not block ion channels or receptors of other hormones, does not affect the content of thyroglobulin, total cholesterol, uric acid and glucose, which affect the regulation of the functions of the cardiovascular system. Lowering blood pressure (BP) does not affect the change in heart rate.
Hydrochlorothiazide is a medium-strength thiazide diuretic. Unlike furosemide, it has a weaker diuretic effect, since a decrease in sodium reabsorption occurs at the level of the cortical segment of Henle's loop (without affecting its section passing in the medulla of the kidney). In the proximal section of the convoluted tubules, it blocks carbonic anhydrase, enhances the excretion of phosphates, bicarbonates and potassium with urine (exchanging sodium in the distal tubules for potassium). It practically does not affect the acid-base state, since the excretion of sodium ions occurs together with chlorine ions or with bicarbonate, therefore, the excretion of bicarbonate is enhanced with alkalosis, chlorine - with acidosis. Promotes increased excretion of magnesium, retains urates and calcium ions in the body.
Diuretic activity develops within 1–2 hours, the maximum effect occurs after 4 hours and lasts for 10–12 hours. With a decrease in the glomerular filtration rate, the effect is weakened and completely stops at its value less than 30 ml / min. Blood pressure decreases due to a decrease in the volume of circulating blood, changes in the reactivity of the vascular walls, a decrease in the pressor effect of adrenaline and norepinephrine (endogenous catecholamines) and an increase in the depressor effect on the ganglia.
The maximum hypotensive effect of Valza N is observed during the first 2–4 weeks of treatment.
Pharmacokinetics
Valsartan is rapidly absorbed after oral administration, the degree of absorption is variable. Its bioavailability is 23%, the maximum concentration in the blood is reached 2 hours after ingestion. The total concentration in blood plasma when taken with meals is reduced by 48%, this has a clinically significant effect on reducing the therapeutic effect.
The binding of valsartan to blood plasma proteins is up to 97%.
After reaching equilibrium, the volume of distribution is 17 liters.
Valsartan metabolism occurs with the participation of the isoenzyme CYP2C9. The half-life is 9 hours. Mainly unchanged, up to 70% is excreted through the intestines, and 30% through the kidneys.
Absorption of hydrochlorothiazide occurs quickly, its bioavailability is 60-80%. The maximum concentration in the blood occurs in 2–5 hours. The thiazide diuretic binds to blood plasma proteins by 60-80%, crosses the hematoplacental barrier and enters breast milk.
It is not metabolized by the liver, the elimination half-life is from 6 to 15 hours. More than 95% of the dose is excreted through the kidneys unchanged, and only about 4% is excreted in the form of 2-amino-4-chloro-m-benzenedisulfonamide hydrolyzate.
The interaction of the two active components of the drug leads to a decrease (about 30%) in the systemic bioavailability of hydrochlorothiazide. This does not have a clinically significant effect on the effectiveness of Walz N.
Indications for use
The use of Valza N is indicated for the treatment of arterial hypertension in patients who need combination therapy.
Contraindications
- chronic renal failure with creatinine clearance (CC) less than 30 ml / min, including patients on hemodialysis;
- anuria;
- cholestasis, biliary cirrhosis and other liver dysfunction caused by obstruction of the biliary tract;
- systemic lupus erythematosus;
- hypercalcemia, hyponatremia, hypokalemia, hyperuricemia - with clinical manifestations refractory to adequate therapy;
- age up to 18 years;
- period of pregnancy;
- breast-feeding;
- hypersensitivity to the components of the drug.
According to the instructions, Valz N should be prescribed with caution to patients with unilateral or bilateral renal artery stenosis, kidney transplantation, reduced circulating blood volume (including conditions with diarrhea, vomiting), liver dysfunction in a weak or moderate degree (without cholestasis), concomitant therapy with thiazide diuretics, combined with potassium-sparing diuretics, potassium salt preparations, heparin and other drugs that increase the concentration of potassium in the blood.
Instructions for use Valza N: method and dosage
Valz N tablets are taken orally, regardless of food intake and washed down with a sufficient amount of liquid.
The dose that provides the required therapeutic effect should be selected individually.
Recommended dose: initial - 1 tablet (80 mg + 12.5 mg) once a day. In the absence of a sufficient decrease in blood pressure, it is recommended to increase the daily dose of valsartan to 160 mg and take Valz N tablets 160 mg + 12.5 mg. If the indicated dose does not provide the required efficacy, the patient is transferred to Valz N 160 mg + 25 mg tablets.
In case of impaired renal function (CC more than 30 ml / min), mild or moderate liver dysfunction (without cholestasis), dose adjustment is not required.
Side effects
- from the digestive system: abdominal pain, diarrhea, nausea;
- from the nervous system: feeling tired, dizziness;
- from the respiratory system: rhinitis, cough, pharyngitis;
- from the side of metabolism: hyperkalemia;
- from the urinary system: functional impairment of the kidneys, hypercreatininemia;
- allergic reactions: itchy skin, rash, serum sickness, vasculitis, angioedema;
- others: chest pain, viral infections, arthralgia, decreased hematocrit.
Given the combined composition of Valza N, side effects are potentially possible that are characteristic of each of the active substances:
- valsartan: insomnia, edema, asthenia, decreased libido;
- hydrochlorothiazide: violation of water and electrolyte balance; often - orthostatic hypotension, nausea, vomiting, decreased appetite, urticaria, decreased potency; rarely - headache, constipation, diarrhea, abdominal discomfort, photosensitivity, jaundice, intrahepatic cholestasis, arrhythmias, depression, paresthesia, thrombocytopenia (possibly with purpura), visual impairment; very rarely - Lyell's syndrome (toxic epidermal necrolysis), necrotizing vasculitis, dermatological reactions (similar to systemic lupus erythematosus), skin exacerbations of systemic lupus erythematosus, bone marrow suppression, leukopenia, pancreatitis, agranulocytosis, hemolytic anemia, pulmonary edema, pneumonitis.
Overdose
Symptoms: lowering blood pressure, which can cause the patient to lose consciousness and lead to collapse.
Treatment: immediate gastric lavage, administration of a sufficient dose of activated charcoal, intravenous administration of 0.9% sodium chloride solution.
Since valsartan actively binds to blood plasma proteins, the use of hemodialysis is effective only for hydrochlorothiazide.
special instructions
The content of sodium ions in the blood and / or the volume of circulating blood should be normalized before taking Valza N.
Treatment should be accompanied by regular monitoring of the level of potassium ions, uric acid, glucose, lipid profile and creatinine in the blood plasma, since during treatment with thiazide diuretics, it is possible to change glucose tolerance, increase the concentration of thyroglobulin, uric acid, and serum cholesterol.
When combined with insulin or an oral hypoglycemic agent, dose adjustment should be considered.
There is a risk of exacerbation of systemic lupus erythematosus, the development of undesirable effects in the form of hypokalemia or hypomagnesemia.
Influence on the ability to drive vehicles and complex mechanisms
During the period of taking Valza N, care must be taken when driving vehicles and performing other potentially dangerous types of work.
Application during pregnancy and lactation
The use of Valza N is contraindicated during pregnancy and breastfeeding, therefore, pills should be discontinued when pregnancy occurs.
Pediatric use
Since the safety and efficacy of using Valza N in children and adolescents under 18 years of age have not been established, the appointment of the drug in this category of patients is contraindicated.
With impaired renal function
Do not take pills to patients with chronic renal failure (CC less than 30 ml / min), including patients on hemodialysis.
Correction of the dose of the drug is not required in case of impaired renal function with CC more than 30 ml / min.
If liver function is impaired
Valz N should not be prescribed to patients with impaired liver function associated with obstruction of the biliary tract, including cholestasis and biliary cirrhosis.
With a weak or moderately expressed degree of liver functional impairment (without cholestasis), dose adjustment is not required.
Drug interactions
With the simultaneous use of Valza N:
- vasodilators, beta-blockers, other antihypertensive drugs - can enhance the antihypertensive effect;
- salicylates - increase neurotoxicity;
- cardiac glycosides - increase the risk of developing their own side effects;
- lithium preparations - increase neurotoxic and cardiotoxic effects;
- curariform muscle relaxants - increase their effectiveness;
- quinidine - lowers its excretion;
- cyclosporine - can cause an increase in the level of uric acid in the blood and the risk of developing hyperuricemia or a gout attack;
- anti-gout agents, norepinephrine, hypoglycemic agents for oral administration, epinephrine - weaken their effect;
- cholestyramine - helps to reduce the absorption of the drug;
- methyldopa - can cause the development of hemolysis;
- barbiturates, tricyclic antidepressants, phenothiazines, ethanol - enhance the hypotensive effect of the drug;
- vitamin D, calcium salts - can increase serum calcium levels;
- atropine, biperiden and other m-anticholinergics - increase the bioavailability of a thiazide diuretic;
- derivatives of salicylic acid, corticosteroids, saluretics, adrenocorticotropic hormone preparations, amphotericin B, carbenoxolone, penicillin G - increase the risk of hypokalemia;
- non-steroidal anti-inflammatory drugs, clofibrate, indirect anticoagulants - increase the diuretic activity of the drug;
- allopurinol - increases the incidence of allergic reactions;
- cyclophosphamide, methotrexate - reduce their excretion by the kidneys and increase the risk of increased myelosuppression.
Analogs
Analogues of Valza N are: Atakand Plus, Valsakor N, Vasotenz N, Kandekor N, Losartan N, Lorista N, Lakea N, Prezartan N.
Terms and conditions of storage
Keep out of the reach of children.
Store at temperatures up to 30 ° C.
The shelf life is 3 years.
Terms of dispensing from pharmacies
Dispensed by prescription.
Reviews about Walza N
Reviews about Walza N are mostly positive. Patients note that regular use of the drug helps to effectively lower blood pressure and allows you to consolidate the achieved result. Side effects when taking the drug are mentioned, but extremely rarely.
Price for Valz N in pharmacies
The price of Walz N for a pack containing 28 tablets is:
- 80 mg + 12.5 mg - 388 rubles;
- 160 mg + 12.5 mg - 446 rubles;
- 160 mg + 25 mg - 452 rubles;
- 320 mg + 25 mg - 565 rubles.
The price of Walz N per pack containing 98 tablets is:
- 80 mg + 12.5 mg - 892 rubles;
- 160 mg + 12.5 mg - 1066 rubles.
Maria Kulkes Medical journalist About the author
Education: First Moscow State Medical University named after I. M. Sechenov, specialty "General Medicine".
Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!
