Valavir
Instructions for use:
- 1. Release form and composition
- 2. Indications for use
- 3. Contraindications
- 4. Method of application and dosage
- 5. Side effects
- 6. Special instructions
- 7. Drug interactions
- 8. Analogs
- 9. Terms and conditions of storage
- 10. Terms of dispensing from pharmacies
Valavir is a direct-acting antiviral drug.
Release form and composition
The dosage form of the drug is film-coated tablets: oblong, biconvex, with a risk on one side, the shell is almost white with a mother-of-pearl tint (6 pcs. In blisters, in a cardboard box 7 blisters; 10 pcs. In blisters, in pack of cardboard 1 blister).
1 tablet contains:
- active substance: valacyclovir (in the form of valacyclovir hydrochloride) - 0.5 g (0.556 g);
- auxiliary components: povidone, microcrystalline cellulose, anhydrous colloidal silicon dioxide, magnesium stearate, crospovidone;
- film shell: Sepifilm 050 [acetates of esters (acetylated mono - and diglycerides), microcrystalline cellulose, methylhydroxypropyl cellulose], kandurin.
Indications for use
- herpes zoster (herpes zoster) - for therapy;
- infection of the mucous membranes and skin caused by the herpes simplex virus, including genital (primary and recurrent) - for therapy;
- re-infection of mucous membranes and skin caused by the herpes simplex virus, including genital - for preventive therapy / suppression;
- labial herpes (labial fever, "cold" on the lips) - for therapy;
- genital herpes - for suppressive therapy, provided that safe sex is used, to reduce the likelihood of transmitting the virus to a healthy partner;
- condition after organ transplantation - for the prevention of cytomegalovirus (CMV) infection in adult patients and children over 12 years old.
Contraindications
Reception of Valavir is contraindicated in children and adolescents under 18 years of age (when used for the prevention of cytomegalovirus, the age limit is 12 years) and with hypersensitivity to acyclovir, valacyclovir and any of the components of the drug.
Since clinical observation data on the use of the drug during pregnancy and lactation are limited, and the main metabolite of valacyclovir, acyclovir, penetrates into breast milk, Valavir is prescribed to pregnant and lactating women if the potential benefit of therapy significantly outweighs the possible risks to the fetus / child.
Method of administration and dosage
Valavir tablets are intended for oral administration, the therapeutic efficacy of the drug does not depend on food intake.
Dosing regimen according to indications:
- herpes zoster (Herpes zoster virus): for treatment, adults are prescribed 2 tablets (1 g of valacyclovir) 3 times / day, the course of treatment is 7 days;
- herpes simplex (Herpes simplex virus): for the treatment of adult patients with normal immunity - 1 tablet (0.5 g) 2 times / day, the course of treatment for relapses - 3-5 days, the course of treatment for the primary disease (possibly more severe course) - up to 10 days;
- herpes simplex (Herpes simplex virus): for the preventive treatment (suppression) of recurrent infection in adult patients with normal immunity - 1 tablet (0.5 g) 1 time / day, for adult patients with immunodeficiency - 1 tablet (0.5 g) 2 times /day;
- labial herpes (lip fever, Herpes labialis virus): for an alternative treatment, an effective dose of valacyclovir is 4 tablets (2 g) 2 times / day (taking the second dose after the first after about 12, but not earlier than 6 hours), the course of treatment is 1 day (it has been proven that longer use does not increase the clinical efficacy of therapy). It is necessary to start treatment when the very first symptoms of infection appear in the lip area: itching, tingling, burning;
- genital herpes (Human alphaherpesvirus 2): to reduce the likelihood of infection of a sexual partner for adult infected heterosexual partners with normal immunity, with the number of exacerbations per year ≤ 9 times - 1 tablet (0.5 g) 1 time / day. The study of the effect of valacyclovir on the transmission of genital herpes virus in other groups of patients (except for heterosexuals) has not been carried out;
- cytomegalovirus (Human betaherpesvirus 5): for the prevention and treatment of adult patients and children over the age of 12 years - 4 tablets (2 g) 4 times / day immediately after transplantation, according to indications; the course of treatment is 90 days, it is possible to increase the duration of treatment for patients with a high degree of risk of infection. Patients with impaired renal function require dose adjustment downward.
Dosing Valavir for impaired renal function, depending on creatinine clearance (CC), provided that an adequate level of hydration is maintained:
- Herpes zoster (therapy of adult patients with normal immunity and patients with immunodeficiency): CC ≥ 50 ml / min - 2 tablets 3 times / day, CC 30-49 ml / min - 2 tablets 2 times / day, CC 10-29 ml / min - 2 tablets 1 time / day, CC <10 ml / min - 1 tablet 1 time / day;
- Herpes simplex (therapy for adult patients with normal immunity): CC ≥ 30 ml / min - 1 tablet 2 times / day, CC <30 ml / min - 1 tablet 1 time / day;
- Herpes labialis (therapy for adult patients with normal immunity): CC ≥ 50 ml / min - 4 tablets 2 times / day, CC 30-49 ml / min - 2 tablets 2 times / day, CC 10-29 ml / min - 1 tablet 2 times / day, CC <10 ml / min - 1 tablet 1 time / day;
- Herpes simplex (prophylaxis in adult patients with normal immunity): CC ≥ 30 ml / min - 1 tablet 1 time / day, with CC <30 ml / min, you should choose a drug produced in tablets with a dose of valacyclovir - 0.25 g, take - 1 time / day;
- Herpes simplex (prophylaxis in adult patients with immunodeficiency): CC ≥ 30 ml / min - 1 tablet 2 times / day, CC <30 ml / min - 1 tablet 1 time / day;
- Human betaherpesvirus 5 (prevention of cytomegalovirus infection in adults and children over the age of 12 years): CC ≥ 75 ml / min - 4 tablets 4 times / day, CC 50-74 ml / min - 3 tablets 4 times / day, CC 25-49 ml / min - 3 tablets 3 times / day, CC 10-24 ml / min - 3 tablets 2 times / day, CC <10 ml / min or patients on dialysis - 3 tablets 1 time / day …
Patients on intermittent hemodialysis should use Valavir in the same doses as recommended for CC <15 ml / min, tablets are taken after hemodialysis.
Constant monitoring of QC is required, especially during a rapid change in the modes of kidney functioning (for example, immediately after transplantation), and a corresponding adjustment of the valacyclovir dose.
With mild to moderate hepatic impairment, there is no need to adjust the Valavir dose. Clinical experience with the drug in patients with severe liver dysfunction is limited.
Elderly patients, taking into account the weakening of renal function, need a dose adjustment of the drug.
Side effects
The most serious adverse reactions observed with Valavir therapy are thrombotic thrombocytopenic purpura / hemolytic uremic syndrome, acute renal failure and neurological disorders.
Side effects from systems and organs:
- blood and lymphatic system: thrombocytopenia, leukopenia (mainly with immunodeficiency);
- immune system: anaphylaxis;
- nervous system and mental disorders: hallucinations, confusion, headache, dizziness, decreased mental performance, agitation, ataxia, tremor, dysarthria, convulsions, symptoms of psychotic disorder, encephalopathy, coma;
- respiratory system and chest organs: shortness of breath;
- digestive tract: nausea / vomiting, abdominal discomfort, diarrhea;
- liver, gallbladder and bile ducts: a reversible increase in liver enzymes, sometimes diagnosed as hepatitis;
- skin and subcutaneous tissues: skin rash, including symptoms of photosensitivity, urticaria, itching, Quincke's edema;
- kidneys and urinary system: renal failure (including in acute form), hematuria and pain in the kidney area (may be due to renal failure), formation of acyclovir precipitates in the renal tubules (isolated information);
- other reactions: according to clinical studies, during therapy with high doses [16 tablets of Valavir (8 g of valaciclovir) per day] for a long time, severe patients with immunodeficiency (especially in the late stages of HIV infection) develop: renal failure, hemolytic microangiopathic anemia and thrombocytopenia (including combined). The same side effects were observed in this category of patients not taking valacyclovir.
The consequence of an overdose of valacyclovir can be: nausea / vomiting, acute renal failure and increased neurological symptoms such as hallucinations, confusion, agitation, decreased mental performance and coma. To avoid unintentional overdose, special care should be taken and dose adjustments should be made in a timely manner, especially in renal failure and in elderly patients.
During treatment, careful medical monitoring of the patient's condition is required in order to identify signs of toxicity. Since hemodialysis clinically significantly accelerates the elimination of acyclovir from the blood, it can be used as the optimal therapy for symptomatic overdose with valacyclovir.
special instructions
It is very important with an increased risk of dehydration to consistently maintain an adequate level of fluid received by the patient, especially in old age.
In case of impaired renal function and in elderly patients, the risk of developing complications from the psyche and the nervous system is increased, such patients require careful monitoring in order to identify side effects. For the most part, these reactions are reversible after completion of therapy.
Treatment for herpes simplex virus (Herpes simplex) should be started as early as possible. For recurrent forms of herpes simplex virus infections, it would be ideal to use the drug in the prodromal period or immediately after the first symptoms appear. Valavir can prevent the development of lesions in case of recurrence of infections caused by the herpes simplex virus, provided that treatment is started immediately after the first symptoms of the disease appear.
There are no data on the treatment of patients with hepatic insufficiency with the drug in higher doses of ≥ 8 tablets of Valavir (4 g of valacyclovir), therefore such doses should be prescribed with caution to patients with impaired liver function.
There have been no specific studies on the use of valacyclovir after liver transplantation. But when carrying out preventive treatment with high doses of acyclovir, a decrease in the frequency of infection with cytomegalovirus and a decrease in the number of diseases caused by it were found.
Treatment of herpes zoster, especially in immunocompromised patients, requires careful monitoring of the clinical response. If there is insufficient response to therapy, it is recommended to switch to intravenous antiviral drugs. In the case of complicated herpes zoster, for example, with damage to the visceral organs, dissemination of the virus, motor neuropathy, encephalitis, and cerebrovascular disorders, intravenous antiviral therapy is also necessary.
Treatment of herpetic lesions of the eyes in patients with weakened immunity or with a high risk of dissemination of the disease and damage to the visceral organs is carried out with antiviral agents for intravenous administration.
Preventive therapy (suppression) with Valavir only reduces the risk of transmission of genital herpes, without curing herpes infection and not completely eliminating the possibility of transmission of the virus. In addition to the course of treatment, you must adhere to the rules of safe sex.
With a high risk of cytomegalovirus infection, the effectiveness of valacyclovir for prophylaxis after organ transplantation has shown that it should be used if valganciclovir or ganciclovir is discontinued for safety reasons. The use of valacyclovir in high doses required for the prevention of cytomegalovirus may cause more frequent side effects, including disorders of the psyche and nervous system, in comparison with the use of lower doses of the drug for other indications.
To assess the patient's ability to perform types of work requiring the speed of psychomotor reactions and increased concentration of attention, under the influence of valaciclovir, it is important to take into account its clinical condition and the profile of side effects of Valavir.
Drug interactions
No significant clinically significant forms of interaction of valacyclovir with other medicinal substances have been identified.
Since the active metabolite of valaciclovir - acyclovir - is mainly excreted unchanged from the body in the urine, any drugs taken simultaneously with Valavir and using active tubular secretion for excretion can increase the plasma concentration of acyclovir. Thus, cimetidine and probenecid after taking 1 g of valacyclovir increase the area under the concentration / time curve of acyclovir and decrease its renal clearance. However, there is no need for dose adjustment, since acyclovir has a wide therapeutic index.
When treating with higher doses of valacyclovir (≥ 4 g per day), care must be taken when combined with drugs that use one route of elimination with acyclovir, since this can lead to an increase in plasma concentration of one or both drugs, and their metabolites. Simultaneous use with the immunosuppressive drug Mycophenolate Mofetil used after organ transplantation increases the level of acyclovir and the inactive metabolite of mycophenolate mofetil in the blood plasma.
With caution, drugs affecting renal function (cyclosporine, tacrolimus) are prescribed simultaneously with Valavir in doses ≥ 4 g per day. If necessary, such a joint application is required to monitor changes in renal function.
Analogs
Valavir's analogues are: Valtsikon, Valtrex, Vairova, Valacyclovir, Valvir, Virdel, Valmik.
Terms and conditions of storage
Store at a temperature not exceeding 25 ° C in its original packaging. Keep out of the reach of children!
The shelf life is 3 years.
Terms of dispensing from pharmacies
Dispensed by prescription.
Information about the drug is generalized, provided for informational purposes and does not replace the official instructions. Self-medication is hazardous to health!
