Buy Valsacor H80 pills 80 mg + 12.5 mg, 30 pcs

Valsartan, Hydrochlorothiazide

Brand Krka dd Novo mesto AO

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Clinical Pharmacology

Pharmacodynamics

Valsacor N - combined antihypertensives.

Valsartan. Is a selective antagonist of angiotensin II receptors for oral administration, non-protein nature.

Has a selective antagonistic effect on receptors of the AT subtype₁. The result of blockade AT₁receptors is an increase in the plasma concentration of angiotensin II, which can stimulate unblocked receptors of the AT subtype₂that balances the effects of the AT blockade₁-receptors. Valsartan does not have agonistic activity against AT₁-receptors. Its affinity for receptors of the AT subtype₁ about 20,000 times more than the receptor subtype AT₂. Valsartan does not inhibit ACE, also known as kininase II, which converts angiotensin I to angiotensin II and destroys bradykinin. Due to the lack of effect on ACE, the effects of bradykinin and substance P are not potentiated, therefore, when taking antagonists of angiotensin II receptors, it is unlikely that dry cough develops. Valsartan does not interact and does not block the receptors of other hormones or ion channels involved in the regulation of the function of the cardiovascular system.

In the treatment of hypertension, valsartan lowers blood pressure without affecting heart rate.

After ingestion of a single dose of valsartan, the antihypertensive effect develops within 2 hours, and the maximum decrease in blood pressure is achieved within 4-6 hours. The antihypertensive effect of valsartan persists for 24 hours. With repeated prescriptions of valsartan, the maximum reduction in blood pressure, regardless of the dose, is achieved in 2–4 weeks and remains at the level reached during prolonged therapy. The combination with hydrochlorothiazide makes it possible to achieve a significant additional decrease in blood pressure.

Sudden cessation of valsartan is not accompanied by a "withdrawal" syndrome (a sharp rise in blood pressure or other undesirable clinical consequences).

Hydrochlorothiazide. Thiazide diuretic, the diuretic effect of which is associated with impaired reabsorption of sodium, chlorine, potassium, magnesium ions, and water in the distal nephron; delays the excretion of calcium ions, uric acid. It has a hypotensive effect, which is caused by the expansion of arterioles. Virtually no effect on normal blood pressure. The diuretic effect develops 1–2 hours after ingestion, reaches a maximum after 4 hours and lasts for 6–12 hours. The antihypertensive effect occurs after 3-4 days, but it may take 3-4 weeks to achieve the optimal therapeutic effect.

Pharmacokinetics

Valsartan

Rapidly absorbed after ingestion, however, the degree of absorption varies widely. The average absolute bioavailability of valsartan is 23%. T_max - 2 hours. When taking the drug inside, once a day, its accumulation is insignificant. Plasma concentrations of valsartan are the same in men and women.

Valsartan is actively associated with serum proteins (94–97%), mainly with serum albumin. The equilibrium volume of distribution of the drug is small, about 17 liters. Plasma clearance is relatively low (about 2 l / h) when compared with hepatic blood flow (about 30 l / h).

Metabolized by isoenzyme CYP2C9.

T_1/2 is 9 hours. Excreted mainly unchanged through the intestines (70%) and kidneys (30%). When taking valsartan with food, the AUC is reduced by 48%. However, 8 hours after ingestion, plasma concentrations of valsartan taken on an empty stomach and with food are the same. AUC reduction is not accompanied by a clinically significant decrease in the therapeutic effect of valsartan, so the drug can be used regardless of the meal.

Hydrochlorothiazide

After ingestion, the absorption of hydrochlorothiazide is 60–80%. C_max hydrochlorothiazide in the blood is achieved 2 hours after ingestion. Binding to plasma proteins - 40–70%.

Hydrochlorothiazide is not metabolized and is rapidly eliminated through the kidneys (more than 95%). T_1/2 makes 6–15 hours.

Special patient groups

Patients with impaired renal function. Considering that renal clearance is only 30% of the total clearance, patients with impaired renal function do not require dose adjustment. Since the degree of binding of valsartan to plasma proteins is high, its removal during hemodialysis is unlikely.

Patients with impaired liver function. About 83% of valsartan is excreted through the intestines, mostly unchanged. Valsartan does not undergo significant biotransformation, therefore its systemic action does not correlate with the degree of impaired liver function. In this regard, patients with hepatic insufficiency of nonbiliary origin and in the absence of cholestasis do not require a dose change of valsartan. In patients with biliary cirrhosis or obstruction of the biliary tract, the AUC of valsartan is increased approximately 2 times. Valsacor N 160 is not recommended for patients with impaired liver function.

Elderly patients. Some elderly patients showed a slightly greater systemic effect of valsartan compared with young volunteers; however, it is not established whether these differences have clinical significance. Systemic clearance of hydrochlorothiazide is reduced in older patients compared with younger patients.

Indications

Arterial hypertension in patients for whom combination therapy is indicated.

Composition

1 tablet, film coated, contains:
active ingredients: valsartan 80 mg, hydrochlorothiazide 12.5 mg,
Excipients: MCC; lactose monohydrate; magnesium stearate; croscarmellose sodium; Povidone; silicon dioxide colloidal anhydrous,
film cover: hypromellose; titanium dioxide (E171); macrogol 4000; iron dye red oxide (E172); iron dye yellow oxide (E172)

Valsartan, Hydrochlorothiazide is marketed under different brands and generic names, and comes in different dosage forms:

Brand name	Manufacturer	Country	Dosage form
Valsacor H80	Krka dd Novo mesto AO	Slovenia	pills
Valsacor ND160	Krka dd Novo mesto AO	Slovenia	pills
Co-diovan	Novartis	Switzerland	pills

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Dosage and Administration

Inside regardless of the meal, the frequency of admission - 1 time per day. Valsacor N can be combined with other antihypertensive drugs. Treatment must begin with minimal doses of the drug.

Patients who have not reached the target level of blood pressure on the background of monotherapy with valsartan or hydrochlorothiazideA fixed combination is recommended - Valsacor H 80 (80 / 12.5 g). In case of insufficiency of the hypotensive effect, it is possible to increase the dose of the drug up to a maximum daily dose of 2 pills Valsacor H 80.

The maximum antihypertensive effect of the drug Valsacor H 80 (80 / 12.5 mg) develops within 2-4 weeks.

Patients with impaired renal function (creatinine clearance> 30 ml / min (0.5 ml / s)) does not require a dose change.

The maximum recommended daily dose of valsartan in patients with mild or moderate liver dysfunction of nonbiliary origin is 80 mg (1 tablet / day of Valsacor H 80).

Elderly patients dose adjustment is not required.

Adverse reactions

The classification of the incidence of side effects of the World Health Organization (WHO): very often -> 1/10; often from> 1/100 to 1/1000 to 1 / 10,000 to

Adverse events were generally mild and transient in nature.

From the central and peripheral nervous system: often - general weakness; sometimes - increased fatigue, asthenia, dizziness, incl. postural, vertigo, insomnia; rarely - headache, depression, paresthesia, neuralgia; very rarely - fainting (when used after myocardial infarction).

On the part of the respiratory system: often nasopharyngitis; sometimes - infections of the upper respiratory tract, rhinitis, sinusitis, cough; very rarely - respiratory distress syndrome with pneumonitis and pulmonary edema.

Since the cardiovascular system: sometimes chest pain; often - marked reduction in blood pressure and orthostatic hypotension; very rarely, arrhythmias; potentially possible - peripheral edema.

From the digestive tract: often - diarrhea; sometimes nausea, dyspepsia, abdominal pain; rarely - gastroenteritis, loss of appetite, constipation; very rarely - pancreatitis, intrahepatic cholestasis, jaundice.

From the skin and subcutaneous fat: rarely - skin rash, photosensitivity; very rarely - alopecia.

From the musculoskeletal system: sometimes - pain in the back, limbs, sprain and tears of ligaments and muscles or muscle tendons, arthritis, arthralgia; rarely - myalgia, muscle weakness, muscle cramps.

From the genitourinary system: sometimes - decreased libido, impotence (less than 1%), urinary tract infection, viral infections, an increase in the frequency of urination; very rarely - impaired renal function.

From the senses: sometimes - blurred vision; rarely - tinnitus, conjunctivitis.

Allergic reactions: very rarely - angioedema, urticaria, skin rash, itching, hypersensitivity reactions, including serum sickness and necrotizing vasculitis, toxic epidermal necrolysis (Lyell's syndrome), lupus-like reactions, exacerbation of the course of SLE.

Laboratory indicators: often - hyperkalemia, hypokalemia, hyponatremia, hypomagnesemia, hypercalcemia; rarely - anemia, incl. hemolytic, leukopenia, agranulocytosis, bone marrow suppression, decrease in hemoglobin and hematocrit, neutropenia, thrombocytopenia (sometimes with purpura), hypercreatininemia, hyperbilirubinemia, increased activity of hepatic transaminases, increased concentration of serum urea nitrogen.

Other: rarely, increased sweating; very rarely - bleeding (epistaxis).

Contraindications

Carefully: simultaneous administration of potassium preparations, potassium-saving diuretics, potassium-containing substitutes for edible salt, and other means,capable of increasing the level of potassium in the blood (for example, heparin), chronic heart failure - IV functional class according to the NYHA classification, renal failure (Cl creatinine> 30 ml / min (0.5 ml / s)), bilateral or unilateral renal artery stenosis or stenosis arteries of a single kidney, condition after kidney transplantation, conditions accompanied by a decrease in BCC and / or hyponatremia (including diarrhea, vomiting), primary hyperaldosteronism, aortic and mitral stenosis, hypertrophic obstructive cardiomyopathy ia (GOKMP), systemic lupus erythematosus (SLE), hypersensitivity to other angiotensin II receptor antagonists, allergic reactions and bronchial asthma.

Drug interactions

Valsartan

Clinically significant pharmacokinetic interactions with drugs: cimetidine, warfarin, digoxin, atenolol, indomethacin, hydrochlorothiazide, amlodipine and glibenclamide are not observed.

Since valsartan does not undergo significant metabolism, no significant drug interactions associated with induction or inhibition of the cytochrome P450 system should be expected.

Simultaneous intake of potassium-sparing diuretics (spironolactone, triamterene, amiloride), potassium-containing food additives, drugs that increase the level of potassium in the blood serum (ACE inhibitors, heparin, cyclosporine), can lead to hyperkalemia, and therefore caution is required.

Simultaneous use with other antihypertensive drugsincluding diuretics, leading to increased hypotensive effect.

While taking lithium preparations and angiotensin II receptor antagonists registered cases of reversible increase in the content of lithium ions in the serum and increase its toxicity. Regular monitoring of lithium ions in the blood is recommended.

Hydrochlorothiazide

With thiazide diuretics, drugs such as ethanol, barbiturates and narcotic drugs can potentiate the risk of orthostatic hypotension.

Hypoglycemic agents (for oral and insulin) - may require dose adjustment hypoglycemic agents.

Other antihypertensive drugs - additive effect.

Anticholinergics (for example atropine, biperiden) increase the bioavailability of thiazide diuretics.

Kolestiramin and Kolestipol - in the presence of anionic exchange resins the absorption of hydrochlorothiazide decreases.

Corticosteroids, ACTH, laxatives, amphotericin B, carbenoxolone, benzathine benzylpenicillin, salicylic acid and salicylates - possible reduction of electrolytes, in particular hypokalemia (it is recommended to regularly monitor the content of potassium ions in the blood).

Antiarrhythmics class ia (quinidine) , droperidol), other drugs (bepridil, cisapride, diphemanil, erythromycin IV, halofantrine, ketanserin, mizolastine, pentamidine, sparfloxacin, terfenadine, vincamine v / v) - the risk of developing arrhythmias of the “pirouette” type against the background of possible hypokalemia and hypomagnesemia (it is recommended to monitor the content of potassium ions in the blood).

Cardiac glycosides - the risk of arrhythmia on the background of hypokalemia and hypomagnesemia.

Beta blockers and diazo oxide - increased hypoglycemic effect of these funds.

Uricosuric drugs (probenecid, sulfinpyrazon, allopurinol) - it is possible to increase the concentration of uric acid in the blood, as well as an increase in the frequency of development of hypersensitivity reactions to allopurinol (if necessary, dose adjustment of uricosuric drugs).

Pressor amines (for example, epinephrine, norepinephrine) - may decrease the effect of pressor amines.

Amantadine - the risk of side effects of amantadine increases.

Cytotoxic drugs (for example, cyclophosphamide, methotrexate) - decreases the elimination of cytotoxic agents and potentiates the myelosuppressive effect.

Muscle relaxants non-depolarizing type of action (for example tubocurarine) - enhancing the effect of muscle relaxants.

Cyclosporine - the risk of hyperuricemia and gouty-like complications increases.

Tetracyclines (except doxycycline) - the risk of increasing the concentration of urea in the blood serum.

Methyldopa - Cases of hemolytic anemia are described.

Lithium - diuretics reduce renal clearance of lithium and increase the risk of the development of the toxic effect of lithium; It is recommended to control the content of lithium in the blood.

NSAIDs (including COX-2 inhibitors; for example, salicylic acid, derivatives of indole acetic acid) - can reduce the diuretic, natriuretic and hypotensive effects of diuretics, may develop acute renal failure.

Simultaneous reception with calcium supplements, vitamin D can lead to an increase in the content of calcium ions in the blood, which may distort the results of the study of the function of the parathyroid glands.

Pregnancy and Lactation

Valsartan. The use of angiotensin II receptor antagonists is not recommended during the first trimester of pregnancy. The drug is contraindicated in the II – III trimesters of pregnancy, because the use during this period of pregnancy can cause fetotoksicheskie effects (reduced renal function, oligohydramnios, delayed ossification of the fetal skull bones) and neonatal toxic effects (renal failure, arterial hypotension, hyperkalemia). If, nevertheless, the drug was used in the II – III trimesters of pregnancy, then an ultrasound of the kidneys and bones of the fetal skull must be performed.

When planning a pregnancy, it is recommended to transfer the patient to alternative antihypertensive therapy taking into account the safety profile.

If pregnancy is confirmed, the drug should be canceled as soon as possible.

No data on the allocation of valsartan in breast milk. However, it is known that valsartan penetrates the milk of lactating rats.

Hydrochlorothiazide excreted in breast milk. Therefore, if necessary, drug therapy during lactation should be canceled breastfeeding.

Special instructions

Patients with severe chronic heart failure in the stage of decompensation or other conditions, accompanied by stimulation of the renin-angiotensin-aldosterone system (RAAS)

The use of Valsacor H drugs in this group of patients is usually accompanied by a more pronounced decrease in blood pressure, however, if the guidelines for dose selection are observed, treatment rarely requires discontinuation due to arterial hypotension. Therapy with Valsacor H should be carried out with caution. Due to the suppression of the RAAS activity in some patients, the development of a renal dysfunction may develop. In severe chronic heart failure, oliguria and / or progressive azotemia may develop, up to (in rare cases) acute renal failure and / or death.

In patients with chronic heart failure, regular monitoring of renal function is necessary, while the combination of 3 classes of drugs — ACE inhibitors, beta-blockers and angiotensin II receptor antagonists — is prescribed simultaneously (AT₁). May be prescribed in combination with other drugs prescribed after myocardial infarction: thrombolytics, acetylsalicylic acid, beta-blockers and statins.

Patients with hyponatremia and / or reduced BCC

In patients with severe hyponatremia and / or reduced BCC, for example, due to the administration of large doses of diuretics, in rare cases severe arterial hypotension may develop in the beginning of therapy with Valsacor H.Before starting treatment, it is recommended to correct violations of water and electrolyte balance, in particular, by reducing the dose of diuretics. With the development of arterial hypotension with clinical manifestations, it is necessary to give the patient a horizontal position with the legs elevated, fill the BCC and correct the disturbances of water and electrolyte balance. Therapy with Valsacor H can be continued only after stabilization of blood pressure indicators.

Renal artery stenosis

The safety of the use of Valsacor H in patients with bilateral or unilateral stenosis of the renal arteries, as well as stenosis of the artery of the single kidney, has not been established (elevated serum concentrations of urea and creatinine are possible).

Renal dysfunction

Patients with impaired renal function (Cl creatinine> 30 ml / min (more than 0.5 ml / s)) do not need to change doses of the drug. It is recommended to periodically monitor the content of potassium ions, the concentration of creatinine and uric acid in the serum. Experience with the use of Valsacor H preparations in patients with recent kidney transplantation is absent.

Liver dysfunction

In patients with impaired liver function is recommended to take no more than 80 mg of valsartan per day.

Primary hyperaldosteronism

Valsacor H is not recommended for patients with primary hyperaldosteronism.

Hard currency

There are reports of exacerbation of the course of SLE when using thiazide diuretics.

Other metabolic disorders

Thiazide diuretics can alter glucose tolerance and increase serum concentrations of cholesterol, triglycerides and uric acid.

Valsacor N contain lactose, so they should not be prescribed to patients with hereditary intolerance to galactose, Lappa lactase deficiency or glucose-galactose impaired absorption syndrome.

Influence on ability to manage transport and other difficult mechanical means. Patients need to be careful when driving and working with other complex mechanisms that require increased attention, because possible development of dizziness or weakness on the background of arterial hypotension.

Overdosage

Valsartan

Symptoms: pronounced decrease in blood pressure, which can lead to dizziness, collapse and / or fatal shock.

Treatment: symptomatic, induction of vomiting and gastric lavage, the appointment of activated carbon. With the development of arterial hypotension, it is necessary: to give the patient a horizontal position with raised legs, fill the BCC and correct the violations of water and electrolyte balance. Hemodialysis is ineffective.

Hydrochlorothiazide

Symptoms: the most frequent symptoms are due to electrolyte deficiency (hypokalemia, hypochloremia, hyponatremia) and dehydration due to excessive diuresis: nausea, drowsiness, arrhythmia, muscle spasm. With simultaneous intake of cardiac glycosides, hypokalemia may aggravate the course of arrhythmias.

Treatment: symptomatic.