VALTREX PILLS 500MG

- treatment of shingles (Herpes zoster) (the drug helps relieve pain, reduces its duration and the percentage of patients with pain caused by shingles, including acute and postherpetic neuralgia);

- treatment of infections of the skin and mucous membranes caused by HSV, including newly diagnosed and recurrent genital herpes (Herpes genitalis), and also labial herpes (Herpes labialis);

- prevention (suppression) of recurrent infections of the skin and mucous membranes caused by HSV, including genital herpes;

- prevention of transmission of genital herpes to a healthy partner when taken as a suppressive therapy in combination with safe sex.

- prevention of cytomegalovirus (CMV) infection, as well as acute graft rejection reaction (in patients with kidney transplants), opportunistic infections and other herpes virus infections (HSV, VZV) after organ transplantation.

Dosage and administration

Drug Valtrex® taken regardless of the meal, the pills should be washed down with water.

Shingles treatment (Herpes zoster)

The recommended dose is 1 g 3 times / day for 7 days.

Treatment of infections caused by HSV

The recommended dose for episode treatment is 500 mg 2 times / day for 5 days.

In more severe cases of onset of the disease, treatment should begin as early as possible, and its duration can be increased from 5 to 10 days. In case of recurrence, treatment should last 3 or 5 days. When recurrent HSV is considered the ideal purpose of the drug Valtrex® in the prodromal period or immediately after the onset of the first symptoms of the disease.

As an alternative for treating herpes simplex, Valtrex is effective.® at a dose of 2 g 2 times / day. The second dose should be taken approximately 12 hours (but not earlier than 6 hours) after taking the first dose. When using this dosing regimen, the duration of treatment is one day. Therapy should be started when the earliest symptoms of cold sores appear (ie tingling, itching, burning).

Prevention (suppression) of recurrent infections caused by HSV

In patients with preserved immunity The recommended dose is 500 mg 1 time / day.

In patients with immunodeficiency The recommended dose is 500 mg 2 times / day.

Preventing the transmission of genital herpes to a healthy partner

Infected immunocompetent persons with relapses no more than 9 times a year, the recommended dose of the drug Valtrex® is 500 mg 1 time per day for a year or more each day.

Data on the prevention of infection in other populations of patients are not available.

Prevention of cytomegalovirus (CMV) infection after transplantation

The recommended dose is 2 g 4 times / day, appointed as soon as possible after transplantation.

The dose should be reduced depending on the clearance of creatinine.

The duration of treatment is 90 days, but in patients at high risk, treatment may be extended.

Special patient groups

Treatment of shingles and infections caused by HSV, prevention (suppression) of recurrent infections caused by HSV, prevention of transmission of genital herpes to a healthy partner

The dose of the drug Valtrex® it is recommended to decrease patients with a significant reduction in renal function (see dosing regimen in Table 1). In such patients, it is necessary to maintain adequate hydration.

Experience with the drug Valtrex® at children with KK values ​​less than 50 ml / min / 1.73 m2 not.

Table 1.

Valtrex recommended® immediately after the end of the hemodialysis session in the same dose as in patients with creatinine clearance less than 15 ml / min.

Prevention of cytomegalovirus (CMV) infection after transplantation

Regimen Valtrex® at patients with impaired renal function Must be installed in accordance with Table 2 below.

Table 2.

* For patients on hemodialysis, Valtrex® should be administered after the end of the hemodialysis session.

It is often necessary to determine CC, especially during the period when the kidney function changes rapidly, for example, immediately after transplantation or transplant engraftment, while the dose of the drug Valtrex® adjusted in accordance with the indicators of QC.

Have adult patients with mild or moderate hepatic impairment with intact synthetic function dose adjustment of the drug Valtrex® not required.Pharmacokinetic data adult patients with severely impaired liver function (decompensated cirrhosis), in violation of the synthetic function of the liver and the presence of porto-caval anastomoses also do not indicate the need to adjust the dose of Valtrex®however, clinical experience with this pathology is limited.

No data on the use of the drug Valtrex® in children.

Dose adjustment is not required, with the exception of significant renal dysfunction. It is necessary to maintain an adequate water-electrolyte balance.

Adverse effects

Adverse reactions are listed below in accordance with the classification by major systems and organs and by frequency of occurrence: very often (≥1 / 10), often (≥1 / 100, <1/10), rarely (≥1 / 1000, <1 / 100), rarely (≥1 / 10 000, <1/1000), very rarely (<10 000).

From the nervous system: often - a headache.

From the digestive tract: often nausea.

On the part of the blood system and the blood-forming organs: very rarely - leukopenia, thrombocytopenia. In general, leukopenia was observed in patients with reduced immunity.

On the part of the immune system: very rarely - anaphylaxis.

From the nervous system and psyche: rarely - dizziness, confusion, hallucinations, depression of consciousness; very rarely - agitation, tremor, ataxia, dysarthria, psychotic symptoms, convulsions, encephalopathy, coma.The above symptoms are mostly reversible and are usually observed in patients with impaired renal function or in comparison with other predisposing conditions. In adult patients with a transplanted organ receiving high doses (8 g / day) of the drug Valtrex® for the prevention of CMV infection, neurological reactions develop more often than when receiving lower doses.

On the part of the respiratory system and mediastinal organs: infrequently - shortness of breath.

From the digestive system: rarely - abdominal discomfort, vomiting, diarrhea.

Liver and biliary tract: very rarely - reversible violations of functional liver tests, which are sometimes regarded as manifestations of hepatitis.

On the part of the skin and subcutaneous fat: infrequently - rashes, including manifestations of photosensitivity; rarely itching; very rarely - urticaria, angioedema.

From the urinary system: rarely, impaired renal function; very rarely - acute renal failure , renal colic. Renal colic may be associated with impaired renal function..

Other: in patients with severe impaired immunity, especially in adult patients with an advanced stage of HIV infection, receiving high doses of Valaciclovir (8 g / day) for a long period of time, there have been cases of renal failure, microangiopathic hemolytic anemia and thrombocytopenia (sometimes in combination) .Similar complications were noted in patients with the same primary and / or concomitant diseases, but not receiving valacyclovir.

Contraindications

- children's age up to 12 years with the prevention of cytomegalovirus (CMV) infection after transplantation;

- children's age up to 18 years for all other indications (due to the insufficient amount of data on clinical studies for the specified age group);

- Hypersensitivity to valacyclovir, Acyclovir and any other component that is included in the preparation.

WITH caution

- in patients with renal failure;

- patients with clinically significant forms of HIV infection;

- while taking nephrotoxic drugs;

- with clinically expressed forms of HIV infection.

Use during pregnancy and lactation

Data on the use of the drug Valtrex® during pregnancy is not enough. The drug should be used during pregnancy only if the potential benefit to the mother exceeds the potential risk to the fetus.

The data of registration records about the outcome of pregnancy in women who took Valtrex® or other drugs containing acyclovir (acyclovir is an active metabolite of the drug Valtrex®), did not reveal an increase in the number of birth defects in their children compared to the general population. Since the register includes a small number of women who took valacyclovir during pregnancy,then reliable and definitive conclusions about the safety of valaciclovir during pregnancy cannot be made.

Acyclovir, the main metabolite of valaciclovir, is excreted by breast milk. After the appointment of valacyclovir in a dose of 500 mg orally Cmax acyclovir in breast milk was 0.5–2.3 times (on average 14 times) higher than the corresponding concentrations of acyclovir in the mother’s blood plasma. The average concentration of acyclovir in breast milk was 2.24 µg / ml (9.95 µmol / l). When a mother takes valaciclovir at a dose of 500 mg 2 times / day, the child is exposed to the same effect of acyclovir as when taken orally at a dose of about 0.61 mg / kg / day. T1/2 breast milk acyclovir is the same as blood plasma.

Valaciclovir in unchanged form was not detected in the plasma of the mother, breast milk or urine of the child.

Drug Valtrex® should be prescribed with caution nursing women.

Application for violations of the liver

In patients with impaired liver function in patients with mild or moderate liver cirrhosis (synthetic liver function is maintained), Valtrex dose adjustment is not required. In the study of pharmacokinetics in patients with severe cirrhosis of the liver (with a violation of the synthetic function of the liver and the presence of shunts between the portal system and the general vascular bed), there is also no evidence of the need to correct the dosage regimen; however, clinical experience with the use of the drug Valtrex in this category of patients is organic.

There is no data on the use of Valtrex in high doses (4 g / day or more) in patients with liver disease, so you should be careful to prescribe the drug in high doses of this category of patients.

Application for violations of kidney function

At renal failure dosing regimen set depending on creatinine clearance and indications.

It is recommended that Valtrex be administered immediately after the end of the hemodialysis session in a dose intended for patients with QC less than 15 ml / min. The drug should be used after the end of the hemodialysis session.

For prevention of cytomegalovirus infections Valtrex is recommended to be given in the following doses.

Valtrex should be administered after the end of the hemodialysis session.

Frequent control of QC is needed, especially during the period when the kidney function is changing rapidly (including immediately after transplantation or transplant engraftment); Valtrex dose should be adjusted according to CC.

Use in children

Experience with the clinical use of the drug in children is missing.

Use in elderly patients

Elderly patients do not require dose adjustment, except in cases of significant impaired renal function. It is necessary to maintain an adequate water-electrolyte balance.

special instructions

In patients at risk of dehydration, especially in elderly patients, it is necessary to ensure adequate fluid replenishment.

Since acyclovir is excreted by the kidneys, the dose of Valtrex® should be adjusted according to the degree of impaired renal function. In patients with renal failure, there is an increased risk of developing neurological complications, such patients should be carefully monitored. As a rule, these reactions are mostly reversible after drug withdrawal.

No data on the use of the drug Valtrex® in high doses (4 g / day and higher) in patients with liver disease, therefore, high doses of the drug Valtrex® they must be appointed with caution. Special studies on the action of the drug Valtrex® no liver transplantation was performed. However, it has been shown that prophylactic intravenous administration of high doses of acyclovir reduces the manifestations of CMV infection.

Suppressive therapy with Valtrex® reduces the risk of transmission of genital herpes, but does not completely eliminate the risk of infection and does not lead to complete cure. Therapy with Valtrex® recommended in combination with safe sex.

Influence on ability to drive motor transport and control mechanisms

It is necessary to take into account the clinical condition of the patient and the adverse reaction profile of valacyclovir when assessing the patient's ability to drive a car or moving machinery.

Overdose

Symptoms: acute renal failure and neurological disorders, including confusion, hallucinations, agitation, depression of consciousness and coma, as well as nausea and vomiting, were observed in patients who received doses higher than the recommended valaciclovir. Similar conditions were more common in patients with impaired renal function and elderly patients who received repeated higher than recommended doses of valaciclovir, due to non-compliance with the dosing regimen.

Treatment: patients must be under close medical supervision. Hemodialysis contributes significantly to the removal of acyclovir from the blood and can be considered the method of choice when managing patients with an overdose of Valtrex®.

Drug interaction

Clinically significant interactions not established.

Acyclovir is excreted by the kidneys, mostly unchanged by active renal secretion. The combined use of drugs with this mechanism of elimination can lead to an increase in plasma acyclovir concentration.

After the appointment of the drug Valtrex® at a dose of 1 g, cimetidine and probenecid, which are derived in the same way as the drug Valtrex®, increase the AUC of acyclovir and, thus, reduce its renal clearance. However, due to the wide therapeutic index of acyclovir, dose adjustment of the drug Valtrex® in this case is not required.

Care must be taken in the case of simultaneous use of the drug Valtrex.® at higher doses (4 g / day and above) and drugs that compete with acyclovir for the route of elimination, since there is a potential threat of an increase in plasma concentrations of one or both drugs or their metabolites. An increase in the AUC of acyclovir and the inactive metabolite of mycophenolate mofetil, an immunosuppressive drug used in transplantation, while using these drugs, was noted.

Care must also be taken (monitoring kidney function) with the combination drug Valtrex® in higher doses (4 g / day and above) with drugs that affect other kidney functions (for example, cyclosporine, tacrolimus).

Terms and conditions of storage

The drug should be stored at a temperature not exceeding 30 ° C out of the reach of children.