Valavir film-coated tablets 500 mg 42 pcs.

The active substance is valaciclovir (one tablet contains valaciclovir hydrochloride 556 mg, equivalent to valaciclovir 100% anhydrous substance 500 mg).

Excipients: microcrystalline cellulose (101), povidone, colloidal anhydrous silica, crospovidone, magnesium stearate; shell composition: Sepifilm 050 (methylhydroxypropylcellulose, microcrystalline cellulose, acetylated (or ester acetates) mono- and diglycerides)), candurin.

“Valavir” is contraindicated in patients with hypersensitivity to valacyclovir, acyclovir, or any component of the drug.

Treatment of herpes zoster

Adults should be prescribed 1000 mg (two tablets) of the drug “Valavir” 3 times a day for 7 days.

Treatment of infections caused by the herpes simplex virus

Patients with normal immunity (adults): 500 mg (one tablet) of the drug 2 times a day.

For recurrent cases, treatment should last 3 or 5 days. In the case of the primary course of the disease, which may be more severe, treatment should be continued for 5 to 10 days. Treatment should be started as early as possible. For recurrent forms of infections caused by the herpes simplex virus, the ideal would be to use the drug in the prodromal period or immediately after the first symptoms appear. “Valavir” can prevent the development of lesions in recurrent infections caused by the herpes simplex virus, provided that treatment is started immediately after the first symptoms of the disease appear.

An alternative effective dose of Valavir for the treatment of herpes labialis (cold sores) is 2000 mg (4 tablets) 2 times a day for one day. The second dose should be administered approximately 12 hours (not earlier than 6 hours) after the first dose. With this dosage regimen, the duration of treatment should not exceed one day, since it has been proven that longer use does not increase the clinical effectiveness of treatment. Treatment should be started at the first early symptoms of herpes labialis (tingling, itching or burning sensation in the lip area).

Preventive treatment (suppression) of recurrences of infections caused by the herpes simplex virus

Recommended dosage:

• Patients with normal immunity (adults) should be prescribed 500 mg (one tablet) of the drug once a day;
• Immunocompromised patients (adults) should be prescribed a dose of 500 mg (one tablet) 2 times a day.

Reducing transmission of genital herpes virus

For heterosexual adults with normal immunity who have 9 or fewer exacerbations per year, Valavir should be prescribed to the infected partner at a dose of 500 mg once a day.

There is no data on the reduction of genital herpes virus transmission in other patient populations.

Prevention of cytomegalovirus infection and disease

Adults and children over 12 years of age: Valavir should be administered at a dose of 2000 mg (4 tablets) 4 times a day as early as possible after transplantation. In case of renal failure, the dose is reduced. The duration of treatment is usually 90 days, but may be increased for patients with a high risk.

Pregnant women

“Valavir” can be used in the treatment of pregnant women only when the potential benefit of treatment for the mother outweighs the possible risk to the fetus.

Valavir should be prescribed with caution to women during breastfeeding, only in cases of clinical necessity.

Clinical studies to study the effect of valacyclovir on human fertility have not been conducted, however, after 6 months of daily use of acyclovir at a dose of 400 mg to 1 g, no changes in the number, morphology, and motility of sperm were observed.

Children

It is used in children from 12 years of age to prevent cytomegalovirus infection and disease.

Drivers

There are no clinical trial data on this issue, and the pharmacology of valacyclovir does not suggest any adverse effects. However, when assessing a patient’s ability to drive or operate machinery, the patient’s clinical condition and the side-effect profile of Valacyclovir should be taken into account.

Symptoms

Acute renal failure and neurological symptoms, including confusion, hallucinations, agitation, decreased mental capacity, and coma, have been reported with valacyclovir overdose. Nausea and vomiting may occur. Caution should be exercised when administering valacyclovir to patients with renal impairment and the elderly, in whom the dose was not reduced appropriately.

Treatment

Patients should be closely monitored for signs of toxicity. Hemodialysis significantly accelerates the removal of acyclovir from the blood and may therefore be considered the optimal treatment for symptomatic overdose.

Among the more serious adverse reactions were reports of thrombotic thrombocytopenic purpura/hemolytic uremic syndrome, acute renal failure, and neurological disorders.

Store in the original packaging at a temperature not exceeding 25 °C, out of the reach of children.

Shelf life – 3 years.