Valvir, 500 mg 42 pcs

Genital itching and dryness, Cytomegalovirus infection, Skin itching, Herpes

Adults and adolescents aged 12 to 18 years

.p> – Treatment of infections of the skin and mucous membranes caused by HPV, including newly diagnosed and recurrent genital herpes (Herpes genitalis), and labial herpes (Herpes labialis);

– prevention (suppression) of recurrent infections of the skin and mucous membranes caused by HPV, including genital herpes, including in adults with immunodeficiency;

– prevention of infections caused by cytomegalovirus (CMV) and diseases after parenchymal organ transplantation.

Adults

– Treatment of herpes zoster (Herpes zoster) and ophthalmic herpes zoster.

Active ingredient

Composition

1 tablet contains:

acting substance: valacyclovir hydrochloride hydrate 611.70 mg or 1223.40 mg, corresponding to valacyclovir 500 mg or 1000 mg;

excipients: microcrystalline cellulose 59.60/119.20 mg, povidone-K30 24.50/49.00 mg, magnesium stearate 4.20/8.40 mg;

film coating: Opadray White Y-5-7068 (hypromellose 3cP 7.35/14.70 mg, hyprolose 6.30/12.60 mg, titanium dioxide 4.20/8.40 mg, macrogol/PEG 400 2.10/4.20 mg, hypromellose 50cP 1.05/2.10 mg) 21.00/42.00 mg.

How to take, the dosage

The drug Valvir can be taken regardless of meals, the tablets should be washed down with water.

Treatment of infections of the skin and mucous membranes caused by HPV, including newly detected and recurrent genital herpes (Herpes genitalis) as well as labial herpes (Herpes labialis)

Immunocompetent adults and adolescents aged 12 to 18 years

The recommended dose is 500 mg twice daily.

In cases of relapses, treatment should continue for 3 or 5 days. In the case of primary herpes, which may be more severe, treatment should be started as soon as possible and its duration should be increased from 5 to 10 days. In relapses of HPV, it is most correct to prescribe Valvir in the prodromal period or immediately after the appearance of the first symptoms of the disease. Valacyclovir can prevent lesions if used at the first signs and symptoms of relapse caused by HPV.

As an alternative treatment for labial herpes, Valvir is effective at a dose of 2,000 mg twice daily for 1 day. The second dose should be taken approximately 12 hours (but not earlier than 6 hours) after the first dose. When using this dosing regimen, the duration of treatment should not exceed 1 day, because exceeding this duration of treatment does not lead to additional clinical benefit.

The therapy should be started when the earliest symptoms of labial herpes (i.e., tingling, itching, burning) appear.

Prevention (suppression) of recurrent infections of the skin and mucous membranes caused by HPV, including genital herpes, including. In immunocompetent adults

Immunocompetent adults and adolescents aged 12 to 18 years

In immunocompetent patients, the recommended dose is 500 mg once daily. After 6-12 months of treatment it is necessary to evaluate the effectiveness of therapy.

Adults with immunodeficiency

In adult patients with immunodeficiency, the recommended dose is 500 mg 2 times daily. The effectiveness of therapy should be evaluated after 6-12 months of treatment.

Prevention of infections caused by CMV and disease after parenchymal organ transplantation

Prevention of infections caused by CMV.Adults and adolescents aged 12 to 18 years

The recommended dose is 2000 mg 4 times daily, administered as soon as possible after transplantation. The dose should be reduced depending on creatinine clearance. The duration of treatment is usually 90 days, but in high-risk patients the course of treatment may be extended.

Treatment of herpes zoster and ophthalmicherpes zoster

Adults

The recommended dose is 1000 mg 3 times daily for 7 days.

Special patient groups

.Children

The efficacy of Valvir treatment in children has not been studied.

Elderly patients

Possible impairment of renal function in elderly patients should be considered, the dose of Valvir should be adjusted accordingly. Adequate water-electrolyte balance must be maintained.

Patients with impaired renal function

The dose of Valvir should be reduced in patients with severe impaired renal function (see dosing regimen in Table 2). Adequate water-electrolyte balance should be maintained in these patients.

Table 2. Valvir dosage adjustment for use in adults and adolescents aged 12 to 18 years with impaired renal function

Recautions

/td>

Creatinine blood pressure, ml/min

Creatinine lysis, ml/min

.Herpes zoster and ophthalmic herpes zoster in immunocompetent adults (treatment)

at least 50

1000 mg 3 times daily

30 to 49

1000 mg 2 times daily

10 to 29

1000 mg once daily

less than 10

500 mg once daily

VPG (treatment)

immunocompetent adults and adolescents ages 12 to 18

at least 30

500 mg 2 times daily

less than 30

500 mg once daily

Labial herpes in immunocompetent adults and adolescents aged 12 to 18 years (treatment)

at least 50

2000 mg 2 times daily

30 to 49

1000 mg 2 times daily

10 to 29

500 mg 2 times daily

less than 10

500 mg once a day

HPG (prevention (suppression))

immunocompetent adults and adolescents ages 12 to 18

at least 30

500 mg once daily

less than 30

500 mg once daily

Adults with immunodeficiency

at least 30

500 mg 2 times daily

less than 30

500 mg once daily

Prevention of infections caused by CMV in adults and adolescents aged 12 to 18 years

/p>

at least 75

2000 mg 4 times a day

/p>

50 to 75

1500 mg 4 times daily

25 to 50

1500 mg 3 times daily

10 to 25

1500 mg 2 times daily

less than 10 or in patients on hemodialysis

1500 mg once daily

Additional information for the indication: Treatment of skin and mucous membrane infections caused by HPV, including newly diagnosed and recurrent genital herpes (Herpes genitalis) as well as labial herpes (Herpes labialis)

Interaction

Special Instructions

Hydration

In patients at risk of dehydration, especially elderly patients, an adequate water-electrolyte balance is necessary.

Application in patients with impaired renal function and in elderly patients

As acyclovir is excreted by the kidneys, the dose of Valvir should be reduced in patients with impaired renal function. Elderly patients may have impaired renal function, so dose reduction should be considered for this group of patients. Both elderly patients and patients with impaired renal function are at increased risk of neurological complications, and these patients should be closely monitored by a physician. As a rule, these reactions are mostly reversible when the drug is withdrawn.

Treatment of labial herpes and prevention of CMV infections and disease

Application of high doses of Valvir in liver dysfunction and after liver transplantation. There are no data on the use of Valvir at high doses (4000 mg or more per day) in patients with liver disease, so high doses of Valvir should be prescribed with caution in these patients. No special studies have been conducted to study the effect of Valvir in liver transplant patients. However, prophylactic administration of acyclovir in high doses has been found to reduce manifestations of CMV infection and disease.

Use in genital herpes

Patients should be advised to refrain from sexual intercourse in the presence of symptoms, even if treatment with the antiviral drug Valvir has already been initiated. Suppressive therapy with Valvir reduces the risk of genital herpes transmission, but does not completely eliminate the risk of infection or lead to complete cure. Therapy with Valvir is recommended in combination with reliable barrier contraception.

Drug reactions with eosinophilia and systemic manifestations (DRESS syndrome)

DRESS syndrome, which can be life-threatening or fatal, has been reported in connection with Valacyclovir treatment. Patients should be made aware of the signs and symptoms of DRESS syndrome at the time of prescribing the drug and should be closely monitored for skin reactions. If signs and symptoms suggestive of DRESS syndrome occur, Valacyclovir should be discontinued immediately and alternative treatment (if necessary) should be considered. If a patient develops DRESS while using valacyclovir, the patient should not be re-treated with valacyclovir.

Pediatric use

There is no experience with clinical use in children under 12 years of age.

Synopsis

Tablets 500 mg: oval biconvex white or almost white tablets with VC2 marking on one side.

Tablets 1000 mg: oval biconvex tablets white or almost white with VC3 marking on one side.

Contraindications

Side effects

The following criteria (according to the World Health Organization (WHO) classification) are used to assess frequency: Very frequently (> 1/10); frequently (≥ 1/100 and < 1/10); infrequently (≥ 1/1000 and < 1/100); rarely (> 1/10000 and < 1/1000); very rare (< 1/10000), frequency unknown (frequency of development cannot be determined from available data).

Data from clinical studies

Nervous system disorders: often – headache.

Gastrointestinal tract disorders: frequently – nausea.

Data of post-registration studies

Disorders of the blood and lymphatic system: very rarely – leukopenia, thrombocytopenia. In general, leukopenia was observed in patients with reduced immunity.

Disorders of the immune system: very rarely – anaphylaxis.

Mental disorders: very rarely – confusion, hallucinations, depression of consciousness; very rarely – agitation, psychotic symptoms.

Nervous system disorders: rarely – dizziness; very rarely – tremor, ataxia, dysarthria, seizures, encephalopathy, coma.

The above symptoms are mostly reversible and are usually seen in patients with impaired renal function or other predisposing conditions. Adult patients with an organ transplant who receive high doses (8 g per day) of valacyclovir to prevent CMV infection develop more neurologic reactions than those who receive lower doses.

Disorders of the respiratory system, thorax and mediastinum: infrequently – dyspnea.

Gastrointestinal tract disorders: frequently – abdominal discomfort, vomiting, diarrhea.

Hepatic and biliary tract disorders: very rarely – reversible liver function tests, which are sometimes regarded as manifestations of hepatitis.

Skin and subcutaneous tissue disorders: frequently – rashes, including photosensitivity; rare – itching; very rare – urticaria, angioedema; frequency unknown – drug reaction with eosinophilia and systemic manifestations (DRESS).

Renal and urinary tract disorders: infrequent – hematuria (often associated with other renal disorders); rare – impaired renal function; very rare – acute renal failure, renal colic.

Renal colic may be associated with impaired renal function. Cases of acyclovir crystal deposition in the lumen of the renal tubules have been reported. It is necessary to observe an adequate drinking regimen during treatment.

Others: In patients with severe immune disorders, especially in adult patients with advanced HIV infection receiving high doses of valacyclovir (8 g daily) over a long period of time, cases of renal failure, microangiopathic hemolytic anemia and thrombocytopenia (sometimes in combination) have been observed. Similar complications have been noted in patients with the same underlying and/or comorbidities but not receiving valacyclovir.

Overdose

Pregnancy use

Fertility

In animal studies, valacyclovir had no effect on fertility. However, the use of high doses of acyclovir when administered parenterally caused testicular effects in rats and dogs.

The studies of valacyclovir effect on fertility in humans were not conducted. However, no changes in sperm count, motility and morphology were recorded in 20 patients after 6 months of daily use of valacyclovir in doses from 400 mg to 1000 mg.

Pregnancy

There are limited data on the use of Valvir in pregnancy. The drug should be used in pregnancy only if the potential benefit to the mother outweighs the potential risk to the fetus.

Pregnancy outcomes in women taking valacyclovir or other drugs containing acyclovir (acyclovir is the active metabolite of valacyclovir) were documented in pregnancy registries, 111 and 1246 observations, respectively (of which 29 and 756 took the drugs in the first trimester of pregnancy), representing pregnancy outcomes reported prospectively. Analysis of the data presented in the registry of pregnant women exposed to acyclovir showed no increase in birth defects in their children compared to the general population, and no specificity or pattern indicating a common cause was found for any of the malformations. Because the pregnancy registry included a small number of women who took valacyclovir during pregnancy, reliable and definitive conclusions about the safety of valacyclovir in pregnancy cannot be drawn.

Breastfeeding period

Acyclovir, the main metabolite of valacyclovir, passes into breast milk. After oral administration of valacyclovir at a dose of 500 mg, Cmax in breast milk was 0.5-2.3 times (1.4 times on average) higher than the corresponding concentrations of acyclovir in maternal blood plasma. The ratio of AUC values of acyclovir in breast milk to the AUC in maternal blood serum ranged from 1.4 to 2.6 (mean value 2.2).

The mean concentration of acyclovir in breast milk was 2.24 µg/mL (9.95 µmol/L). When the mother takes valacyclovir at a dose of 500 mg twice daily, breastfed infants are exposed to the same amount of acyclovir as when it is taken orally at a dose of about 0.61 mg/kg/day. The half-life of acyclovir from breast milk is the same as that of blood plasma.

Valacyclovir in unchanged form was not determined in plasma of mother, breast milk or urine of the child. Valacyclovir preparations should be administered with caution to women during breastfeeding. However, IV acyclovir is used to treat HPV in infants at a dose of 30 mg/kg/day.

Similarities