Universal reference book for medicines
Name of the preparation: VALZ H (VALZ H)

Active substance: hydrochlorothiazide, valsartan

Type: Antihypertensive drug

Manufacturer: ACTAVIS GROUP hf.
(Iceland) manufactured by ACTAVIS (Malta)
Composition, form of production and packaging
The tablets covered with a film covering of
pink color, oval, biconcave, with marking "V" on one side and "H" - on another.

1 tab.

valsartan 80 mg

hydrochlorothiazide 12.5 mg

Excipients: microcrystalline cellulose - 36 mg, lactose monohydrate - 29.72 mg, croscarmellose sodium - 10.8 mg, povidone K29-32 - 7.2 mg, talc - 1.8 mg, magnesium stearate - 1.26 mg, silicon dioxide colloid - 0.72 mg.

The composition of the film shell: opedrai II 85G34642 pink about 7.2 mg (polyvinyl alcohol 3.17 mg, talc 1.44 mg, titanium dioxide 1.39 mg macrogol 3350 0.89 mg, lecithin 0.25 mg, iron dye oxide red 0.03 mg, iron dye oxide yellow - 0.03 mg, ferric oxide black oxide - 0.0006 mg).

7 pcs.
- blisters (1) - packs of cardboard.
7 pcs.
- blisters (2) - packs of cardboard.
7 pcs.
- blisters (4) - packs of cardboard.
10 pieces.
- blisters (1) - packs of cardboard.
10 pieces.
- blisters (2) - packs of cardboard.
10 pieces.
- blisters (3) - packs of cardboard.
10 pieces.
- blisters (10) - packs of cardboard.
14 pcs.
- blisters (4) - packs of cardboard.
14 pcs.
- blisters (7) - packs of cardboard.
Tablets covered with a film membrane of red-brown color, oval, biconcave, labeled "V" on one side and "H" on the other.

1 tab.

valsartan 160 mg

hydrochlorothiazide 12.5 mg

Excipients: microcrystalline cellulose - 72 mg, lactose monohydrate - 71.94 mg, croscarmellose sodium - 21.6 mg, povidone K29-32 - 14.4 mg, talc - 3.6 mg, magnesium stearate - 2.52 mg, silicon dioxide colloid - 1.44 mg.

The composition of the film shell: opedrai II 85G25455 red about 14.4 mg (polyvinyl alcohol - 6.34 mg, talc - 2.88 mg, macrogol 3350 - 1.78 mg, titanium dioxide - 1.57 mg, iron dye red oxide - 0.78 mg, dye solar yellow aluminum varnish - 0.56 mg, lecithin - 0.5 mg).

7 pcs.
- blisters (1) - packs of cardboard.
7 pcs.
- blisters (2) - packs of cardboard.
7 pcs.
- blisters (4) - packs of cardboard.
10 pieces.
- blisters (1) - packs of cardboard.
10 pieces.
- blisters (2) - packs of cardboard.
10 pieces.
- blisters (3) - packs of cardboard.
10 pieces.
- blisters (9) - packs of cardboard.
10 pieces.
- blisters (10) - packs of cardboard.
14 pcs.
- blisters (4) - packs of cardboard.
14 pcs.
- blisters (7) - packs of cardboard.
The tablets covered with a film cover of orange color, oval, biconcave, with marking "V" on one side and "H" - on another.

1 tab.

valsartan 160 mg

hydrochlorothiazide 25 mg

Excipients: cellulose microcrystalline - 72 mg, lactose monohydrate - 59.44 mg, croscarmellose sodium - 21.6 mg, povidone K29-32 - 14.4 mg, talc - 3.6 mg, magnesium stearate - 2.52 mg, silicon dioxide colloid - 1.44 mg.

The composition of the film shell: opedrai II 85G23675 orange is about 14.4 mg (polyvinyl alcohol is 6.34 mg, talc is 2.88 mg, titanium dioxide is 1.81 mg, macrogol is 3350-1.78 mg, iron oxide is yellow oxide - 0.88 mg, lecithin 0.5 mg, iron dye oxide red - 0.18 mg, ferric oxide black oxide - 0.03 mg).

7 pcs.
- blisters (1) - packs of cardboard.
7 pcs.
- blisters (2) - packs of cardboard.
7 pcs.
- blisters (4) - packs of cardboard.
10 pieces.
- blisters (1) - packs of cardboard.
10 pieces.
- blisters (2) - packs of cardboard.
10 pieces.
- blisters (3) - packs of cardboard.
10 pieces.
- blisters (9) - packs of cardboard.
10 pieces.
- blisters (10) - packs of cardboard.
14 pcs.
- blisters (4) - packs of cardboard.
14 pcs.
- blisters (7) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2016.

PHARMACHOLOGIC EFFECT

Combined antihypertensive drug, consisting of an angiotensin II receptor blocker and a thiazide diuretic.

Valsartan - a peripheral vasodilator, has an antihypertensive and diuretic effect.
The specific blocker of AT 1 -receptor angiotensin II, does not inhibit ACE; does not affect the content of total cholesterol, TG, 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, not accompanied by a change in the pulse rate.
Hydrochlorothiazide is a thiazide diuretic of medium strength.
Reduces sodium reabsorption 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 the convoluted tubules, strengthens excretion in the urine of potassium (in the distal tubules sodium is exchanged for potassium), 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). Increases the excretion of magnesium; ions of calcium and urates in the body. The diuretic effect develops after 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 by reducing bcc, changing the reactivity of the vascular wall, reducing the pressor effect of endogenous catecholamines (epinephrine, norepinephrine) and increasing the depressor effect on the ganglion.
The maximum antihypertensive effect of Valz N is observed in the first 2-4 weeks of treatment.

PHARMACOKINETICS

Valsartan

Suction and distribution

After ingestion absorption - fast, the degree of absorption is variable.
Bioavailability - 23%. The time to reach C max is 2 hours. When taken with food, the AUC is reduced by 48%, which is not accompanied by a clinically significant decrease in the therapeutic effect.
Binding to blood plasma proteins - 94-97%.

When the equilibrium state is reached, V d is 17 liters.

Metabolism and excretion

The drug is metabolized with the participation of the CYP2C9 isoenzyme.

T 1/2 - 9 hours. It is excreted through the intestine - 70%, by the kidneys - 30%, mostly unchanged.

Hydrochlorothiazide

Suction and distribution

After ingestion, hydrochlorothiazide is rapidly absorbed.
Bioavailability is 60-80%. The time to reach C max is 2-5 hours. Binding to plasma proteins is 60-80%.Penetrates through the hematoplacental barrier and into breast milk.
Metabolism and excretion

It is not metabolized by the liver.
T 1/2 - 6-15 hours. 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-m-benzene disulfonamide.
Valsartan / hydrochlorothiazide

When combined with valsartan, the systemic bioavailability of hydrochlorothiazide is reduced by about 30%, hydrochlorothiazide itself does not significantly affect 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).

DOSING MODE

The drug is taken orally, regardless of the time of ingestion, with a sufficient amount of liquid.

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

The recommended dose is 1 tablet.
80 / 12.5 mg once a day. If the drug is ineffective at this dose, 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 renal dysfunction with CK> 30 ml / min , as well as patients with mild or moderate liver function impairment in the absence of the phenomena of cholestasis do not need a dose adjustment of the drug Valz N.

SIDE EFFECT

From the nervous system: dizziness, a sense of fatigue.

On the part of the digestive system: diarrhea, abdominal pain, nausea.

On the part of the respiratory system: cough, rhinitis, pharyngitis.

From the side of the urinary system: a violation of kidney function, hypercreatininaemia.

From the side of metabolism: hyperkalemia.

Allergic reactions: skin rash, angioedema, itching, serum sickness, vasculitis.

Other: viral infections, decreased hematocrit, arthralgia, chest pain.

Potentially possible with valsartan: edema, insomnia, asthenia, decreased libido (less than 1%).

Potentially possible with the use of hydrochlorothiazide: a disturbance of the water-electrolyte balance;
often - hives, 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 resembling SLE, exacerbation of skin manifestations SLE, pancreatitis, leukopenia, agranulocytosis, bone marrow depression, hemolytic anemia, pneumonitis, pulmonary edema.
CONTRAINDICATIONS

- violations of the liver, associated with obstruction of the biliary tract (including biliary cirrhosis, cholestasis);

anuria;

- chronic renal failure (CC less than 30 ml / min), incl.
patients on hemodialysis;
- hyponatremia, hypokalemia, hypercalcemia, hyperuricemia with clinical manifestations, refractory to adequate therapy;

- systemic lupus erythematosus;

- age under 18 years (safety and efficacy not established);

- Pregnancy;

- lactation period (breastfeeding);

- Hypersensitivity to the components of the drug.

Caution should be used for renal artery stenosis (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); simultaneously 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); simultaneously with thiazide diuretics; weak or moderately expressed violations of liver function in the absence of phenomena of cholestasis.
PREGNANCY AND LACTATION

The drug is contraindicated in pregnancy and lactation (breastfeeding).

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

APPLICATION FOR FUNCTIONS OF THE LIVER

Patients with renal dysfunction with CK> 30 ml / min do not need a dose adjustment for Valz N.

Contraindicated in chronic renal failure (KK less than 30 ml / min), incl.
in patients on hemodialysis.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS

Patients with mild or moderate liver function impairment in the absence of cholestasis do not require a dose adjustment of Valz N.

Contraindicated use in violations of liver function associated with obstruction of the biliary tract (including biliary cirrhosis, cholestasis).

APPLICATION FOR CHILDREN

Contraindicated in children and adolescents under 18 years.

SPECIAL INSTRUCTIONS

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

During the period of treatment, regular monitoring of the content of potassium ions, glucose, uric acid, lipid profile and creatinine in the blood plasma is necessary, since
Thiazide diuretics can cause a change in glucose tolerance, as well as an increase in the concentration of cholesterol, TG and uric acid in the 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.

During treatment, a dose adjustment of insulin or an oral hypoglycemic drug may be required.

There are reports that thiazide diuretics can exacerbate 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.

Impact on the ability to drive vehicles and manage mechanisms

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

OVERDOSE

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

Treatment: gastric lavage, intake of a sufficient amount of activated carbon, iv - 0.9% solution of sodium chloride.
Valsartan is not excreted during dialysis due to active binding to plasma proteins. Hemodialysis is effective against hydrochlorothiazide.
DRUG INTERACTION

It is possible to intensify the antihypertensive effect with the joint use of Valz H with other antihypertensive agents (including with vasodilators, beta-blockers).

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

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

The drug increases the frequency of allergic reactions to allopurinol;
reduces the excretion of cytotoxic agents by the kidneys (cyclophosphamide, methotrexate) and leads to an increase in their myelosuppressive effect.
Drugs that intensely bind to blood proteins (indirect anticoagulants, clofibrate, 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.

Kolestyramine reduces the absorption of the drug.

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

Increased bioavailability of the thiazide diuretic is observed with simultaneous administration of m-holinoblokatorov (for example, atropine, biperidena), which, apparently, is associated with a decrease in motor activity of the gastrointestinal tract and slowing down 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 can lead to an increase in the concentration of uric acid in the blood, which increases the risk of hyperuricemia, and can also trigger a gout attack.

TERMS OF RELEASE FROM PHARMACY

The drug is released by prescription.

TERMS AND CONDITIONS OF STORAGE

The drug should be stored out of reach of children at a temperature of no higher than 30 ° C.
Shelf life - 3 years.
Alphabetical index of medicines:
A  B  V  G  D  E  J
Z  I  Y  K  L  M  N
O  P  R  S  T  U  F
H  C  CH  SH  E  U  Y
Rambler's Top100
Privacy policy:
Copyright 2009 - 2017. Universal reference book of medicines. All rights reserved.
When using site materials, an active hyperlink is required!