Valsartan

Brand Krka dd Novo mesto AO

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Available since: 2019-09-19

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Clinical Pharmacology

Valsacor is an angiotensin II receptor antagonist.
Valsartan is a selective antagonist of angiotensin II receptors (type AT1) for oral administration, non-protein nature.
It has a selective antagonistic effect on receptors of the AT1 subtype. The consequence of the blockade of AT1 receptors is an increase in the plasma concentration of angiotensin II, which can stimulate unlocked receptors of the AT2 subtype, which presumably regulates the effects of AT1 receptors. Valsartan has no agonistic activity on AT1 receptors. Its affinity for the AT1 receptor subtype is about 20,000 times higher than that for the AT2 receptor subtype.
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 angiotensin II antagonists, the development of dry cough is unlikely. 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.
In the treatment of hypertension, valsartan lowers blood pressure without affecting heart rate.
After ingestion of a single dose of the drug, the antihypertensive effect develops within 2 hours, and the maximum decrease in blood pressure is reached within 4-6 hours. The antihypertensive effect of the drug persists for 24 hours after taking it. With repeated prescriptions of valsartan, the maximum reduction in blood pressure, regardless of the dose, is achieved in 2-4 weeks and is maintained at the achieved level during long-term 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 sharp rise in blood pressure or other undesirable clinical consequences.
Exercise tolerance
When assessing the effect of valsartan (prescribed in addition to standard therapy of heart failure) on exercise tolerance in patients with chronic heart failure of the II-IV functional classes according to the NYHA classification and with the left ventricular ejection fraction (LVEF), there is no "withdrawal" syndrome when the administration suddenly stops.
Use after acute myocardial infarction
The use of valsartan in patients 12 hours to 10 days after the development of myocardial infarction can reduce the incidence of cardiovascular mortality and the development of recurrent myocardial infarction.

Indications

- Arterial hypertension;
- chronic heart failure (NYHA classification II-IV functional class) as part of complex therapy (against the background of standard therapy) and in patients not receiving ACE inhibitors;
- reduction of cardiovascular mortality in stable patients who developed left ventricular failure / dysfunction due to myocardial infarction.

Composition

1 tab .:
- valsartan 160 mg.
Excipients: lactose monohydrate, microcrystalline cellulose, povidone, croscarmellose sodium, colloidal silicon dioxide, anhydrous, magnesium stearate.
Shell composition: hypromellose, titanium dioxide (E171), iron dye yellow oxide (E172), iron dye red oxide (E172), macrogol 4000.

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

Brand name	Manufacturer	Country	Dosage form
Valsacor	Krka dd Novo mesto AO	Slovenia	pills
Diovan	Novartis	Switzerland	pills

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Dosage and Administration

Co-Diovan appoint 1 tab. 1 time / day

Use in violation of liver function: Patients with mild or moderately severe hepatic insufficiency of non-biliary genesis without concomitant effects of cholestasis do not need to change the dose of the drug.

Use in violation of renal function: Patients with mild or moderately pronounced impaired renal function (creatinine clearance> 30 ml / min) do not require changes in the dose of the drug.

Adverse reactions

With an incidence of less than 1%, adverse effects such as abdominal pain, visual disturbances, anxiety, arthralgia, arthritis, bronchitis, dyspepsia, shortness of breath, impotence, insomnia, cramps of lower extremity muscles, frequent urination, feeling of palpitations, rashes, sprains, urinary infections were observed pathways, viral infections, edema, asthenia, vertigo. The causal relationship of these phenomena with the use of Co-Diovan has not been established.
Postmarketing studies indicate very rare cases of angioedema, rash, pruritus, and other hypersensitivity / allergic reactions, including serum sickness and vasculitis. In some cases, impaired renal function was observed.
From the laboratory indicators: in 2.2% of patients treated with Co-Diovan, serum potassium concentrations decreased by more than 20% (the decrease in this indicator in the group of patients who received placebo was 3.3%). In controlled clinical trials, an increase in serum creatinine concentration was observed in 1.4% of patients who received Co-Diovan (compared to 1.1% for the group of patients who received placebo).
In those clinical studies where valsartan was used as monotherapy, other adverse events were also noted (the causal relationship of these phenomena using valsartan has not been established): arthralgia with a frequency of more than 1%; with a frequency of less than 1% - edema, asthenia, insomnia, rash, decreased libido, vertigo.
Hydrochlorothiazide is widely used for many years, more often in doses exceeding that which is part of Co-Diovan. The following adverse reactions were reported during monotherapy with thiazide diuretics, incl. hydrochlorothiazide. Often - urticaria and other rashes, loss of appetite, nausea and vomiting, postural hypotension (the severity of which increases with alcohol intake, the use of anesthetics or sedatives), impotence. Rarely - photosensitivity, abdominal pain, constipation, diarrhea, discomfort in the gastrointestinal tract, intrahepatic cholestasis, jaundice, arrhythmias, headache, dizziness, sleep disturbances, depression, paresthesia, visual disturbances, thrombocytopenia, sometimes with purpura. Very rarely - necrotizing vasculitis, toxic epidermal necrolysis, lupus-like reactions, exacerbation of the skin manifestations of systemic lupus erythematosus, pancreatitis, leukopenia, agranulocytosis, bone marrow hemopoiesis suppression, hemolytic anemia, hypersensitivity reactions, disorders of the respiratory systems. pulmonary edema). Possible water electrolyte and metabolic disorders.

Contraindications

- Severe abnormal liver function, biliary cirrhosis and cholestasis.
- Anuria, marked renal impairment (creatinine clearance <30 ml="" min="" br="">- Hypokalemia, hyponatremia, hypercalcemia, hyperuricemia with clinical manifestations, refractory to adequate therapy.
- Pregnancy.
- Hypersensitivity to Co-Diovan components.

Drug interactions

It is possible to enhance the antihypertensive effect when combined with other antihypertensive drugs.

With simultaneous use of potassium salts, potassium-sparing diuretics, potassium-containing substitutes for edible salt, or any other drugs that may cause an increase in the concentration of potassium in the blood (for example, heparin), caution and frequent determination of the concentration of potassium in the blood is required.

With simultaneous administration of lithium preparations with ACE inhibitors or thiazide diuretics, there was a reversible increase in serum lithium concentration and an increase in toxic manifestations in connection with this.The experience of joint use of valsartan and lithium preparations is not yet available, therefore, in this case, it is recommended to control the concentration of lithium in the serum.

There was no clinically significant interaction during the monotherapy with valsartan while using the following drugs: cimetidine, warfarin, furosemide, digoxin, atenolol, indomethacin, hydrochlorothiazide, amlodipine, glibenclamide.

Since co-diovan contains thiazide diuretic, the following drug interaction is potentially possible.

Thiazides potentiate the action of curare-like muscle relaxants.

It is possible to reduce the diuretic and antihypertensive effects of hydrochlorothiazide, which is part of Co-Diovan, with simultaneous use with NSAIDs (for example, with salicylic acid derivatives, indomethacin). Concomitant hypovolemia can lead to the development of acute renal failure.

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

Thiazide diuretics can cause undesirable effects such as hypokalemia or hypomagnesemia, which, in turn, increase the risk of developing arrhythmias while using cardiac glycosides.

Dose adjustment of insulin or oral hypoglycemic drug may be required.

The simultaneous appointment of thiazide diuretics may increase the frequency of hypersensitivity reactions to allopurinol; increase the risk of side effects of amantadine; enhance the hyperglycemic effect of diazoxide; reduce the kidney excretion of cytotoxic drugs (eg, cyclophosphamide, methotrexate) and lead to the potentiation of their myelosuppressive action.

An increase in the bioavailability of thiazide diuretic is observed with the simultaneous administration of anticholinergics (for example, atropine, biperidine), which seems to be associated with a decrease in gastrointestinal motility and slowing gastric emptying.

Cases of hemolytic anemia have been reported with simultaneous administration of thiazide diuretic and methyldopa.

Kolestiramin reduces the absorption of thiazide diuretics.

When combined use of thiazide diuretics with vitamin D or calcium salts, potentiation of an increase in serum calcium concentration is possible.

Simultaneous administration of cyclosporine may increase the risk of developing hyperuricemia and the appearance of symptoms resembling the worsening of gout.

Pregnancy and Lactation

Given the mechanism of action of angiotensin II antagonists, the risk of negative effects on the fetus cannot be ruled out when using drugs of this group. It is known that the effect of ACE inhibitors on the uterus in the case of their appointment to pregnant women in the second and third trimesters, leads to damage or death of the developing fetus. The introduction of thiazide diuretic into the uterus led to the development of thrombocytopenia in the fetus or in the neonatal period, as well as the development of other adverse events that are noted later in adults. Therefore, Co-Diovan, like any other drug that has a direct effect on the RAAS, should not be used during pregnancy and lactation. If pregnancy is detected during the period of treatment with Co-Diovan, the drug should be canceled as soon as possible.

It is not known whether valsartan passes into breast milk in humans.

Hydrochlorothiazide penetrates the placental barrier and is excreted in breast milk. Therefore, it is not recommended to use Co-Diovan in nursing mothers.

Experimental studies have shown that valsartan is excreted in breast milk in rats.

Special instructions

Changes in the balance of serum electrolytes: Co-Diovan should be used with caution simultaneously with potassium salts, potassium-saving diuretics, potassium-containing substitutes for edible salt, and also with drugs that can cause an increase in the concentration of potassium in the blood (for example, heparin). There are reports of the development of hypokalemia in the treatment of thiazide diuretics. Recommended frequent monitoring of the concentration of potassium in the blood. When using thiazide diuretics, hyponatremia and hypochloraemic alkalosis can develop. Thiazides cause an increase in urinary magnesium excretion, which can lead to hypomagnesemia.

Deficiency in the body of sodium and / or circulating blood volume (BCC): In patients with marked deficiency of sodium and / or BCC in the body, for example, receiving high doses of diuretics, in rare cases arterial hypotension with clinical manifestations may occur at the beginning of treatment with Co-Diovan. Before starting treatment with Co-Diovan, correction of the sodium content in the body and / or BCC should be carried out. If hypotension develops, the patient should be laid down and, if necessary, should be given by IV infusion of saline. After stabilization of blood pressure, treatment with Co-Diovan can be continued.

Renal artery stenosis: The drug should be used with caution in patients with unilateral or bilateral renal artery stenosis or arterial stenosis of a single kidney. The safety of using Co-Diovan in patients with unilateral or bilateral stenosis of the renal artery or arterial stenosis of a single kidney has not been established.

Application for violations of liver function: Do not require changes in the dose of Co-Diovan in patients with mild or moderately severe liver function in the absence of cholestasis, although in this category of patients the drug should be used with caution. Liver diseases do not have a significant effect on the pharmacokinetics of hydrochlorothiazide, so its dose reduction is not required. Currently there are no data on the use of valsartan in patients with severely impaired liver function.

Application for impaired renal function: Patients with impaired renal function with creatinine clearance (CK) of more than 30 ml / min do not require dose adjustment of the drug. Currently, there are no data on the use of Co-Diovan in patients with severe impaired renal function (CC less than 30 ml / min) and in patients on hemodialysis.

Other metabolic disorders: Thiazide diuretics can cause changes in glucose tolerance, as well as an increase in serum levels of cholesterol, triglycerides and uric acid.

Use in pediatrics: The safety and efficacy of Co-Diovan in children have not yet been established.

Impact on the ability to drive vehicles and control mechanisms: When appointing Co-Diovan, it is recommended to use caution when driving a car and operating mechanisms.

Overdosage

- Symptoms: although at present there is no information about an overdose of Co-Diovan, the main manifestation that one would expect is severe arterial hypotension.
- Treatment: if the drug has been taken recently, it should induce vomiting. For arterial hypotension, intravenous saline is the usual method of therapy. Valsartan cannot be removed from the body through hemodialysis due to its significant binding to plasma proteins. At the same time, hemodialysis is effective for removing hydrochlorothiazide from the body.