(Valaciclovir)
Manufacturer:
GlaxoSmithKline Pharmaceuticals SA
The composition and the form of
Tablets, coated in white, biconvex, oblong, without the risks on one side in blue ink affixed to the "GX CF1"; core tablets of white or nearly white.
1 tab.
valaciclovir hydrochloride 556 mg,
including valaciclovir 500 mg
Other ingredients valtrex: microcrystalline cellulose, krospovidon, povidone K90, magnesium stearate, silica colloidal anhydrous, carnauba wax, a concentrate of white dye, ink for printing, containing brilliant blue 5312 (FT 203).
10 pcs. - Blisters (1) - packs cardboard.
Registration number №:
Tab., cover. shell, 500 mg: 10 pcs. - P № 015441/01 25.12.03
Pharmacological action
Antiviral. In humans, valaciclovir is rapidly and completely converted to acyclovir influenced valatsiklovirgidrolazy. Acyclovir in vitro has a specific inhibitory activity against Herpes simplex virus types 1 and 2, Varicella zoster and Epstein-Barr, cytomegalovirus and herpes virus type 6 human. Acyclovir inhibits viral DNA after phosphorylation and conversion to the active triphosphate form of acyclovir. The first stage of phosphorylation occurs with the participation of virus enzymes. For the virus Herpes simplex, Varicella zoster and Epstein-Barr virus in this enzyme is thymidine kinase, which is present in virus infected cells. Partial selectivity of phosphorylation remains with cytomegalovirus and is mediated through the gene product fosfotransferazy UL 97. Activation of acyclovir specific viral enzyme to a great extent explains its selectivity.
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The process of phosphorylation of acyclovir (conversion from mono-to triphosphate) is completed by cellular kinases. Acyclovir triphosphate competitively inhibits viral DNA polymerase and, as a nucleoside analog, embedded in the viral DNA, which leads to obligate (full) break the chain termination of DNA synthesis and, consequently, to block the replication of the virus.
In patients with preserved immune viruses Herpes simplex and Varicella zoster with reduced sensitivity to valaciclovir are extremely rare (less than 0.1%), but can sometimes be detected in patients with severely impaired immunity, such as bone marrow transplant, the receiving chemotherapy for malignant tumors and in HIV-infected.
Resistance is caused by deficiency virus thymidine kinase, which leads to excessive spread of the virus in the host organism. Sometimes reducing the sensitivity to acyclovir by the appearance of strains of the virus in violation of the structure of viral thymidine kinase or DNA polymerase. The virulence of these varieties of the virus resembles that of its wild strain.
Statement
- Treatment of herpes zoster, caused by the virus Varicella zoster, (speeds up the disappearance of pain, reduces its duration and the percentage of patients with pain, including acute and postherpetic neuralgia);
- Treatment of infections of the skin and mucous membranes caused by Herpes simplex virus types 1 and 2 (including the first identified and recurrent genital herpes);
- Treatment Labial herpes (lip fever);
- Valtrex can prevent the formation of lesions, if it is taken at the first symptoms of recurrence of herpes simplex;
- Prevention (suppression) of relapses of the skin and mucous membranes caused by Herpes simplex virus types 1 and 2, including genital herpes;
- Valtrex can reduce genital herpes infection of the healthy partner, if taken as suppressive therapy in combination with safe sex;
- Prevention of cytomegalovirus infection arising in organ transplantation (reduces the severity of the reaction of acute graft rejection in patients with kidney transplants, the development of opportunistic infections and other viral infections caused by viruses Herpes simplex and Varicella zoster).
Dosage regimen Generic Valtrex
For the treatment of herpes zoster adults appoint 1 g 3 times / day for 7 days.
For the treatment of diseases caused by the virus Herpes simplex, adult valtrex prescribed for 500 mg 2 times / day. In the case of relapse treatment should be carried out within 3 or 5 days. In more severe cases, the initial treatment should be started as early as possible, and its duration should be increased from 5 to 10 days. When relapse of the disease is considered to be the best appointment valtrex in prodromal period or immediately after the first symptoms of the disease.
As an alternative for the treatment Labial herpes (lip fever,) effectively appointment valtrex dose of 2 g 2 times during 1 day. The second dose should be taken approximately 12 hours (but not earlier than 6 h) after the first dose. In this mode, dosing duration of treatment should not exceed 1 day, because it does not provide additional clinical benefits. Therapy should begin with the appearance of the earliest symptoms of lip fever (ie tingling, itching, burning).
For the prevention (suppression) of recurrences of infections caused by the virus Herpes simplex, adults with normal immune indices appoint a dose of 500 mg 1 time / day. With very frequent recurrences (more than 10 times a year) may be more effective valtrex appointment in a daily dose of 500 mg divided into 2 divided doses (250 mg 2 times / day). Adults with immunodeficiency are encouraged to nominate for the 500 mg 2 times / day.
Generic Valtrex: Treatment duration - 4-12 months.
To prevent infection with genital herpes have healthy partner heterosexual adult patients with preserved immunity and the number of exacerbations to 9 per year should be prescribed for valtrex 500 mg 1 time per day during the year and more every day with regular sexual intercourse, with non-regular sexual contact reception valtrex should be started 3 days before the alleged sexual contact.
Data on the prevention of infection in other populations of patients available.
For the prevention of cytomegalovirus infection in adults and adolescents over 12 years, the recommended dose is 2 g 4 times / day. The drug is prescribed as soon as possible after transplantation. The dose should be reduced depending on the spacecraft. Course duration is 90 days, but can be increased in patients with high risk of infection.
In renal insufficiency, dosing regimen set according to creatinine clearance and testimony.
Indications Creatinine clearance Dose valtrex
Herpes Zoster 15-30 ml / min 1 g 2 times / day
less than 15 mL / min 1 g 1 time / day
Treatment of infections caused by Herpes simplex at least 15 ml / min 500 mg 1 time / day
Treatment of Labial Herpes (2 g in 2 divided doses for 1 day) 31-49 ml / min for 1 g 2 times during 1 Day
15-30 ml / min, 500 mg 2 times / day for 1 day
less than 15 ml / min 500 mg once
Prevention (suppression) of infections caused by Herpes simplex:
with normal immune status less than 15 ml / min 250 mg 1 time / day
immunodeficiency with 500 mg of 1 times / day
To reduce genital herpes infection of less than 15 ml / min 250 mg 1 time / day
Patients who are on hemodialysis is recommended to appoint valtrex immediately after hemodialysis in a dose intended for patients with CC than 15 ml / min. The drug should be used after the end of hemodialysis.
For the prevention of cytomegalovirus infection valtrex recommended to appoint the following doses.
Creatinine clearance (ml / min) Dose valtrex
75 or more than 2 g 4 times / day
50 - less than 75 1.5 g 4 times / day
25 - less than 50 1.5 g 3 times / day
10 - less than 25 1.5 g 2 times / day
less than 10 or dialysis, 1.5 g 1 time / day
Patients who are on hemodialysis, valtrex be appointed after the end of hemodialysis.
Required frequent monitoring of spacecraft, especially at a time when renal function is changing rapidly (including immediately after transplantation or engraftment of the transplant); valtrex dosage should be adjusted in accordance with the spacecraft.
Side effect valtrex
Contraindications
- Hypersensitivity to valaciclovir, acyclovir, and any other components of the drug.
Precautions should be used when clinically expressed forms of HIV infection.
Pregnancy and lactation
There are limited data on the use valtrex during pregnancy. valtrex used only in cases where the potential benefits for the mother exceeds potential risk to the fetus.
The data recorded on the outcome of pregnancy in women taking valtrex or Zoviraks (acyclovir is the active metabolite of valaciclovir), showed no increase in birth defects among their children compared with the general population. Since the register includes a small number of women who took valaciclovir in pregnancy, the reliable and definitive conclusions about the safety of valaciclovir in pregnancy can be done.
Acyclovir, valaciclovir major metabolite, is excreted in breast milk. After receiving valaciclovir oral dose of 500 mg Cmax of acyclovir in breast milk at 0.5-2.3 times (average of 1.4 times) exceeded the corresponding concentrations of acyclovir in the blood plasma of the mother. The ratio of AUC of acyclovir, is located in the breast milk to plasma AUC of acyclovir in the mother ranged from 1.4 to 2.6 (average 2.2).
Median concentration of acyclovir in breast milk was 2.24 mg / ml (9.95 mg / M). When you receive a mother valaciclovir oral dose of 500 mg 2 times / day a child exposed to the same effect of acyclovir, when receiving it orally at a dose of about 0.61 mg / kg / day. T1 / 2 of acyclovir from breast milk is the same as from blood plasma. Valaciclovir in unmodified form was not detected in the plasma of mothers, breast milk or urine of the child.
Given this, care should be taken to appoint valtrex mother during lactation (breastfeeding). However, in / in the introduction Zoviraks a dose of 30 mg / kg / day used in infants for treatment of diseases caused by herpes simplex virus.
In experimental studies with valaciclovir is not teratogenic in rats and rabbits. P / to the introduction of acyclovir in conventional tests for teratogenicity did not cause teratogenic effects in rats and rabbits. In additional studies in rats, fetal malformations were detected in the sc injection of the drug in doses that have induced an increase in plasma concentrations of acyclovir up to 100 ug / ml and toxic effects in the mother's body.
When taken orally, valaciclovir did not cause violations of fertility in male and female rats.
Cautions
Patients at risk of dehydration, especially elderly patients, during treatment valtrex necessary to ensure adequate hydration of the body.
In patients with renal failure have an increased risk of neurological complications.
When violations of liver function in patients with mild to moderate hepatic cirrhosis (liver synthetic function maintained) valtrex dose adjustment is required. In the study of pharmacokinetics in patients with severe liver cirrhosis (in violation of synthetic liver function and the presence of shunts between the portal system and the overall vascular bed) also obtained evidence of the need to correct dosing regimen, but clinical experience with the drug valtrex in this patient is organic.
No data on the use of valtrex in high doses (4 g / day and more) in patients with liver disease, so care should be taken to designate the drug in high doses, this category of patients.
Elderly patients dose adjustment is required, except in cases of significant renal dysfunction. Necessary to maintain an adequate water-electrolyte balance.
Special studies on the effect of valtrex in patients with liver transplants was carried out. However, it was shown that prophylactic acyclovir at high doses reduces cytomegalovirus infection.
Suppressive therapy valtrex reduces the risk of transmission of genital herpes, but does not exclude it completely and does not lead to complete recovery. During therapy valtrex patient should take measures to ensure the safety of a partner during sexual intercourse.
Use in Pediatrics
Experience of clinical use of the drug in children is missing.
Effects on ability to drive vehicles and operate machinery
Special precautions are required.
Overdose
Currently, data on overdose valtrex enough.
Symptoms: after a single oral administration of acyclovir in excessive dose to 20 g happened partial absorption from the gastrointestinal tract, which was not accompanied by toxic effects of the drug. Ingestion of acyclovir in excessive doses over several days followed by gastrointestinal (nausea, vomiting) and neurological symptoms (headache, confusion). In / to the introduction of acyclovir in excessive doses was accompanied by increased levels of serum creatinine and subsequent development of renal failure, with neurological complications included confusion, hallucinations, agitation, convulsions and coma.
Treatment: Patients should be under close medical observation for signs of toxic action. Haemodialysis significantly enhances the removal of aciclovir from the blood and can be considered the method of choice in the management of patients with an overdose valtrex.
Drug Interactions
Clinically significant drug interactions valtrex with other drugs has not been established.
Acyclovir is excreted in the urine mainly as unchanged as a result of active tubular secretion. After taking valtrex dose of 1 g cimetidine and probenecid, which block the tubular secretion of acyclovir AUC increase and decrease its renal clearance. However, correction doses valtrex while not required, because Acyclovir has a wide therapeutic index.
Caution valtrex used in higher doses (4 g / day) simultaneously with drugs, which compete with aciclovir for elimination of the path, because there is a risk increase in plasma levels of one or both drugs or their metabolites. It was observed increase in AUC of acyclovir and the inactive metabolite of mycophenolate mofetil (immunosuppressant, used in transplantation), while the use of these drugs.
Be careful when combined valtrex in the high dose (4 g / day and above) with drugs that impair the function of the kidneys (including cyclosporine, tacrolimus).
Terms and Conditions of storage
List B. The product should be stored at temperatures not above 30 ° C in the reach of children. Shelf life - 3 years.
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