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Valtrex

Valtrex
Valtrex is used to treat herpes zoster. It is also used to treat or suppress genital herpes in people who are immunocompetent.

Brand: Valacyclovir

Availability: In Stock
Average Delivery Time: 9 Days
Exp. Date: May 2024
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Valtrex 1000 mg
90 pills - 1000 mg
+ 12 free Viagra 100 mg, 7% discount for future orders
$315.19 $3.50 $224.44 Add to cart
60 pills - 1000 mg
+ 8 free Viagra 100 mg, 5% discount for future orders
$214.48 $3.57 $145.27 Add to cart
48 pills - 1000 mg
+ 4 free Viagra 100 mg, 3% discount for future orders
$185.13 $3.86 $102.67 Add to cart
36 pills - 1000 mg
+ 4 free Viagra 100 mg, 3% discount for future orders
$153.03 $4.25 $62.82 Add to cart
24 pills - 1000 mg
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$113.93 $4.75 $29.97 Add to cart
12 pills - 1000 mg $71.95 $6.00 No Add to cart
Valtrex 500 mg
90 pills - 500 mg
+ 8 free Viagra 100 mg, 5% discount for future orders
$207.27 $2.30 $166.38 Add to cart
60 pills - 500 mg
+ 4 free Viagra 100 mg, 3% discount for future orders
$165.99 $2.77 $83.11 Add to cart
48 pills - 500 mg
+ 4 free Viagra 100 mg, 3% discount for future orders
$141.03 $2.94 $58.25 Add to cart
36 pills - 500 mg
+ 4 free Viagra 100 mg, 3% discount for future orders
$111.07 $3.09 $38.39 Add to cart
24 pills - 500 mg $83.75 $3.49 $15.89 Add to cart
12 pills - 500 mg $49.82 $4.15 No Add to cart

Product description

Drug Title

Valtrex (Valacyclovir)

Pharmacological action

Mechanism of action


Valacyclovir is an antiviral agent, which is the L-valine ester of acyclovir. Acyclovir is an analog of the purine nucleoside (guanine).


In humans, valacyclovir is rapidly and almost completely converted into acyclovir and valine, presumably by the enzyme valacyclovirhydrolase.


Acyclovir is a specific herpes virus inhibitor with in vitro activity against herpes simplex virus (HPV) types 1 and 2, Varicella zoster virus (VZV), cytomegalovirus (CMV), Epstein-Barr virus (EBV) and human herpes virus type 6. Acyclovir inhibits the synthesis of viral DNA immediately after phosphorylation and conversion to the active form, acyclovirtriphosphate.


The first stage of phosphorylation requires the activity of virus-specific enzymes. For HPV, VZV, and VEB, this enzyme is viral thymidine kinase, which is present only in virus-affected cells. Part of the phosphorylation selectivity is maintained in cytomegalovirus indirectly through the product of the phosphotransferase gene UL97. This need for activation of acyclovir by a specific viral enzyme largely explains its selectivity. The process of acyclovir phosphorylation (conversion from mono- to triphosphate) is completed by cellular kinases.


Acyclovir triphosphate competitively inhibits viral DNA polymerase and, being a nucleoside analog, is incorporated into viral DNA, which leads to obligate chain breaking, termination of DNA synthesis and, consequently, to blocking of virus replication.


Resistance to acyclovir is usually due to thymidine kinase deficiency, which leads to excessive spread of the virus in the host. In rare cases, decreased sensitivity to acyclovir is due to the emergence of virus strains with disrupted viral thymidine kinase or DNA polymerase structure. The virulence of these strains is similar to that of the wild strain.


An extensive study of HPV and EHV strains sampled from patients treated with acyclovir or used as prophylaxis found that viruses with hypersensitivity to valacyclovir are extremely rare but may be found in rare cases in patients with severe immune disorders, such as bone marrow or organ transplant recipients, patients receiving chemotherapy for malignancies, and HIV-infected individuals.


Valacyclovir contributes to pain syndrome: reduces its duration and reduces the percentage of patients with pain caused by herpes zoster, including acute post-herpetic neuralgia.


Pharmacokinetics

Absorption


After oral administration, valacyclovir is well absorbed from the gastrointestinal tract, being rapidly and almost completely converted to acyclovir and valine. This conversion is probably carried out by the liver enzyme valacyclovirhydralase.


The bioavailability of acyclovir is 54% when taking valacyclovir at a dose of 1000 mg or more and is not reduced by food intake. Valacyclovir pharmacokinetics is not dose-dependent. The rate and extent of absorption decrease with increasing dose, resulting in a less proportional increase in plasma Cmax compared to the therapeutic dose range and decreased bioavailability at doses above 500 mg.

Distribution


The degree of binding of valacyclovir to plasma proteins is very low (15%). Cerebrospinal fluid (CSF) penetration is defined as the ratio of the AUC in CSF to the AUC in plasma and is approximately 25% for acyclovir and the metabolite 8-hydroxyaciclovir (8-OH-ACV); approximately 2.5% for the metabolite 9-(carboxymethoxy)methylguanine (CMMG).


Metabolism


After oral administration, valacyclovir is converted to acyclovir and L-valine via presystemic metabolism in the intestine and/or hepatic metabolism. Acyclovir is converted to minor metabolites: CMMG by ethyl alcohol and aldehyde dehydroheuase; 8-OH-ACV by aldehydoxidase. Approximately 88% of the total cumulative plasma exposure is to acyclovir, 11% to CMMG, and 1% to 8-OH-ACV. Valacyclovir and acyclovir are not metabolized by cytochrome P450 isoenzymes.


Excretion


In patients with normal renal function, the T1/2 of acyclovir from plasma after a single or multiple doses of valacyclovir is about 3 hours. Less than 1% of the administered dose of valacyclovir is excreted unchanged by the kidneys. Valacyclovir is excreted by the kidneys primarily as acyclovir (more than 80% of the dose taken) and acyclovir metabolite - CMMG.


Special patient groups


Patients with impaired renal function. Excretion of acyclovir correlates with renal function, exposure to acyclovir increases with increasing severity of renal failure. In patients with end-stage renal failure, the average T1/2 of acyclovir after valacyclovir administration is about 14 h, compared to about 3 h in normal renal function.


Exposure of acyclovir and its metabolites CMMG and 8-OH-ACV in plasma and CSF was assessed at steady state after multiple doses of valacyclovir in 6 patients with normal renal function (mean CK 111 ml/min, range 91-144 ml/min) who received 2000 mg every 6 h, and in 3 patients with severe renal failure (mean CK 26 ml/min, range 17-31 ml/min) who received 1500 mg every 12 h. In severe renal failure compared with normal renal function, plasma concentrations of acyclovir, CMMG, and 8-OH-ACV were 2, 4, and 5-6 times higher in plasma as well as in CSF, respectively. There was no difference in the penetration rate of acyclovir in CSF (defined as the ratio of AUC in CSF to AUC in plasma), CMMG, or 8-GH-ACV between the two populations with severe renal impairment and normal renal function.


Patients with impaired liver function. Pharmacokinetic data show that in patients with hepatic impairment the rate of conversion of valacyclovir to acyclovir is reduced, but not the extent of this conversion. T1/2 of acyclovir does not depend on hepatic function.


Pregnancy. In a study of valacyclovir and acyclovir pharmacokinetics in late pregnancy, there was an increase in the steady state daily AUC of valacyclovir at a daily dose of 1000 mg/day, which was approximately 2 times higher than the AUC when acyclovir was taken orally at a dose of 1200 mg/day.


HIV infection. In patients with HIV infection, the distribution and pharmacokinetic characteristics of acyclovir after oral administration of one or more doses of 1000 mg or 2000 mg of valacyclovir remain unchanged compared to healthy volunteers.


Organ transplantation. The cmax of acyclovir in patients after organ transplantation who received 2000 mg valacyclovir 4 times/day was comparable or higher than the cmax observed in healthy volunteers receiving the same dose. The established daily AUC values can be characterized as markedly higher.

Contraindications for use

  • Hypersensitivity to valacyclovir, acyclovir or any other component of the drug;
  • Children under 12 years of age;
  • Children under 18 years of age during treatment of herpes zoster and herpes zoster of the ophthalmic.

With caution: in patients with renal insufficiency; patients with clinically manifested forms of HIV infection; in concomitant use of nephrotoxic drugs.


Application in pregnancy and lactation

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.


Studies on the effect of valacyclovir on fertility in humans have not been conducted. However, no changes in sperm count, motility, or morphology were reported in 20 patients after 6 months of daily valacyclovir doses ranging from 400 mg to 1,000 mg.


Pregnancy


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


Pregnancy outcomes in women taking Valtrex or other drugs containing acyclovir (acyclovir is the active metabolite of Valtrex®) were documented in pregnancy registries, 111 and 1246 observations, respectively (of which 29 and 756 were taken in the first trimester of pregnancy), were prospectively reported pregnancy outcomes. 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, 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 a 500-mg oral dose of valacyclovir, cmax in breast milk was 0.5-2.3 times (1.4 times on average) higher than the corresponding concentrations of acyclovir in maternal plasma. The ratio of AUC values of acyclovir in breast milk to AUC values 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 approximately 0.61 mg/kg/day. The T1/2 of acyclovir from breast milk is the same as that from blood plasma.


Valacyclovir was not detected unchanged in maternal plasma, breast milk or urine. Valtrex® should be administered with caution to women during breastfeeding. Nevertheless, acyclovir for IV administration is used to treat HPV in infants at a dose of 30 mg/kg/day.


Use in liver dysfunction

In adult patients with mild to moderate liver cirrhosis (with preserved synthetic liver function), correction of the drug dose is not required.


Pharmacokinetic data in adult patients with severe liver dysfunction (decompensated cirrhosis), with impaired hepatic synthetic function and with the presence of portocaval anastomoses also do not indicate the necessity of the preparation dose adjustment, but clinical experience in these pathologies is limited.


Use in impaired renal function

The drug should be used with caution in patients with renal insufficiency.

Administration in children

It is contraindicated in children under 12 years old; in children under 18 years old in treatment of herpes zoster and herpes zoster of the ophthalmic.


Use in elderly patients

Dosage adjustment is not required in elderly patients, except in cases of significant renal dysfunction.

Indications for Valtrex

Adults and adolescents between 12 and 18 years of age


  • 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
  • Infections caused by cytomegalovirus (CMV) and disease after transplantation of parenchymatous organs.

Adults


Treatment of herpes zoster and ophthalmic herpes zoster.


Dosing regimen

Valtrex can be taken without meals and the tablets should be washed down with water.


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)


Immunocompetent adults and adolescents 12 to 18 years of age


The recommended dose is 500 mg twice daily.


In cases of relapses, treatment should be continued for 3 or 5 days. In the case of primary herpes, which may be more severe, treatment should be started as early as possible and its duration should be increased from 5 to 10 days. In case of recurrent herpes virus, Valtrex is considered to be the most correct drug to prescribe 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 of relapse caused by HPV.


As an alternative treatment for labial herpes, Valtrex 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, since exceeding this duration of treatment does not lead to additional clinical benefit.


Therapy should be initiated 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 immunodeficient adults


Immunocompetent adults and adolescents between the ages of 12 and 18


In immunocompetent patients, the recommended dose is 500 mg once daily. The efficacy of therapy should be evaluated after 6-12 months of treatment.


Adults with immunodeficiency


In adult patients with immunodeficiency, the recommended dose is 500 mg 2 times/day. In 6-12 months of treatment it is necessary to evaluate the effectiveness of therapy.


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


Adults and adolescents between 12 and 18 years of age.


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 ophthalmic herpes zoster


Adults


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


Special patient groups


Children


The efficacy of Valtrex® treatment in children has not been investigated.


Elderly patients


Possible kidney dysfunction in elderly patients should be taken into account, and the dose of Valtrex® should be adjusted accordingly. Adequate water-electrolyte balance should be maintained.


Patients with impaired renal function


The dose of Valtrex should be reduced in patients with significant renal impairment (see dosing regimen in Table 2). An adequate water-electrolyte balance should be maintained in such patients.

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)


No experience with Valtrex in children with IQ values less than 50 ml/min/1.73 m2.


Additional information for indication: Prophylaxis of infections caused by CMV and disease after parenchymal organ transplantation


CK should be determined frequently, especially during periods when renal function changes rapidly, such as immediately after transplantation or engraftment, and the dose of Valtrex® adjusted according to CK rates.


Additional information for the indication: Treatment of herpes zoster and ophthalmic herpes zoster


Valtrex® should be used after hemodialysis in patients undergoing intermittent hemodialysis.


Patients with impaired liver function


Based on a study using a single dose of Valacyclovir 1000 mg in adult patients with mild to moderate liver cirrhosis (with preserved synthetic liver function), no dose adjustment is required for Valtrex.


Pharmacokinetic data in adult patients with severe hepatic impairment (decompensated cirrhosis), impaired hepatic synthetic function and portocaval anastomoses also do not indicate the need for dose adjustment of Valtrex®, but clinical experience with these pathologies is limited.


Information on doses above 4000 mg/day for patients with infections caused by HPV and CMV is given in the section "Special Indications".