Valogard VIR tablets p/o 500mg №6×7

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Valogard VIR tab.p/o 500mg in box unitary enterprise No. 6×7
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Tablets of oblong shape with a biconvex surface, with a risk (the risk is intended for dividing the tablet into equal doses), coated with a pearlescent film shell, almost white. Main active ingredient Valaciclovir Form of release tablets Dosage Varicela Zoster virus infections – herpes zoster and ophthalmoherpes Patients should be advised to start treatment as soon as possible after diagnosis. There are no data on treatment started more than 72 hours after the onset of the zoster rash. Immunocompetent adults The dose is 1000 mg 3 times a day for 7 days (3000 mg is the total daily dose). This dose must be adjusted according to creatinine clearance (see Renal Insufficiency below). Immune-compromised adults The dose is 1000 mg 3 times a day for at least 7 days (3000 mg total daily dose) and for 2 days after lesions have crusted. This dose must be adjusted according to creatinine clearance (see Renal Insufficiency below). In these patients, antiviral treatment is suggested within 1 week of vesicle formation or anytime after crusting of the affected area. Treatment of herpes simplex virus (HSV) infection in adults and adolescents (≥12 years of age) Immunocompetent adults and adolescents (≥12 years of age) The dose is 500 mg 2 times a day (1000 mg is the total daily dose). This dose must be adjusted according to creatinine clearance (see Renal Insufficiency below). In case of recurrence, the duration of treatment is from 3 to 5 days. For primary episodes, which may be more severe, treatment may be extended up to 10 days. Treatment should begin as soon as possible. For recurrent episodes of herpes simplex, treatment should begin in the prodromal period or immediately after the onset of the first signs or symptoms, which can prevent the development of the lesion. Herpes labialis For the treatment of herpes labialis (herpes), valaciclovir is prescribed 2000 mg 2 times a day for 1 day. The second dose should be taken 12 hours (but not earlier than 6 hours) after the first dose. This dose must be adjusted according to creatinine clearance (see Renal Insufficiency below). Therapy should be initiated at early symptoms of herpes (eg, tingling, itching, or burning). Immune-compromised adults For the treatment of HSV infection in immunocompromised adults, the dose is 1000 mg twice daily for 5 days after assessing the clinical severity and immunological status of the patient. For primary episodes, which may be more severe, treatment may be extended up to 10 days. Treatment should begin as soon as possible. This dose must be adjusted according to creatinine clearance (see Renal Insufficiency below). To achieve the maximum clinical effect, treatment should be started within 48 hours. Strict monitoring of the development of lesions is recommended. Suppression of recurrence of herpes simplex virus (HSV) infection in adults and adolescents (≥12 years of age) Immunocompetent adults and adolescents (≥12 years of age) The dose is 500 mg once daily. In some patients with very frequent relapses (?10/year if untreated), a daily dose of 500 mg divided into 2 doses (250 mg 2 times a day) may be preferable. This dose must be adjusted according to creatinine clearance (see Renal Insufficiency below). Treatment should be reviewed after 6-12 months of therapy. Adults with a weakened immune system The dose is 500 mg 2 times a day. This dose must be adjusted according to creatinine clearance (see Renal Insufficiency below). Treatment should be reviewed after 6-12 months of therapy. Prevention of Cytomegalovirus (CMV) Infection in Adults and Adolescents (≥12 years) The dosage is 2000 mg 4 times a day, treatment should be started as soon as possible after transplantation. This dose must be adjusted according to creatinine clearance (see Renal Insufficiency below). The duration of treatment is usually 90 days, but may be extended in high-risk patients. Special Populations Children. The effectiveness of the drug in children under the age of 12 years has not been studied. Elderly people. In the presence of renal insufficiency in the elderly, the dose should be adjusted accordingly (see renal insufficiency below). Adequate hydration must be maintained. Patients with impaired renal function. Caution is advised when prescribing Valogard VIR to patients with impaired renal function. Adequate hydration must be maintained. The dose should be adjusted in patients with impaired renal function as shown in Table 1. Table 1 Therapeutic indications Creatinine clearance (ml/min) Dose of Valogard VIR Treatment of herpes zoster ?50 1000 mg 3 times a day 30-49 1000 mg 2 times a day days 10-29 1000 mg 1 time per day <10 500 mg 1 time per day Treatment of herpes simplex - immunocompetent adults Ipod - ≥ 30 500 mg 2 times per day adolescents < 30 500 mg 1 time per day - immunocompromised adults ≥ 30 1000 mg twice daily <30 1000 mg once daily Treatment of herpes labialis in immunocompetent adults and adolescents (alternative one-day regimen) 500 mg 1 time per day Suppression of recurrent HSV infections - immunocompetent adults and adolescents ?30<30 500 mg 1 time per day *250 mg 1 time per day - immunocompromised adults ?30<30 500 mg 2 times a day 500 mg 1 time per day Prevention of cytomegalovirus infection in adults and adolescents (≥12 years) >7550-7525-5010-25<10 or on dialysis 2000 mg 4 times a day 1500 mg 4 times a day 1500 mg 3 times a day 1500 mg 2 times a day 1500 mg 1 time a day * For suppression of HSV in immunocompetent patients with frequent relapses (≥10 per year), best results may be obtained with 250 mg twice daily. For patients who are on hemodialysis, Valogard VIR is prescribed after a hemodialysis session. Creatinine clearance should be monitored frequently, especially during periods when kidney function changes rapidly, such as immediately after kidney transplantation or engraftment. The dosage of Valogard VIR should be adjusted accordingly. Patients with impaired liver function. There is no need to change the dose in patients with mild or moderate liver cirrhosis (synthesizing function of the liver is preserved). Clinical experience with the use of the drug in the late stages of cirrhosis (with impaired liver synthesizing function and the presence of signs of portal block) is limited, but pharmacokinetic indicators indicate that there is no need to change the dose. There are no data on the use of higher doses (4000 mg or more per day). At higher doses (4000 mg or more per day), see section "Precautions". Pharmacological action Antiviral agents for systemic use. Nucleosides and nucleotides, excluding reverse transcriptase inhibitors. Indications for use Varicela zoster virus (VZV) infection - herpes zoster: treatment of herpes zoster (shingles) and ophthalmic herpes in immunocompetent adults; treatment of herpes zoster in adults with mild to moderate immunosuppression. Herpes simplex virus (HIV) infections: Valoguard VIR is indicated *For the treatment and suppression of HSV infection of the skin and mucous membranes, including: - treatment of the first episode of genital herpes in immunocompetent adults and adolescents, and in immunocompromised adults; treatment of recurrences of genital herpes in immunocompetent adults and adolescents, and in immunocompromised adults; suppression of recurrence of genital herpes in immunocompetent adults and adolescents, and in immunocompromised adults. *Treatment and suppression of recurrent HSV eye infections in immunocompetent adults and adolescents, and in immunocompromised adults; Clinical studies have not been conducted in HSV-infected patients with reduced immunity due to causes other than HIV infection. Cytomegalovirus (CMV) infections: - prevention of CMV infection and diseases after solid organ transplantation in adults and adolescents. Dosing and Administration Varicela Zoster Virus Infections - Herpes Zoster and Herpes Ophthalmoherpes Patients should be advised to start treatment as soon as possible after diagnosis. There are no data on treatment started more than 72 hours after the onset of the zoster rash. Immunocompetent adults The dose is 1000 mg 3 times a day for 7 days (3000 mg is the total daily dose). This dose must be adjusted according to creatinine clearance (see Renal Insufficiency below). Immune-compromised adults The dose is 1000 mg 3 times a day for at least 7 days (3000 mg total daily dose) and for 2 days after lesions have crusted. This dose must be adjusted according to creatinine clearance (see Renal Insufficiency below). In these patients, antiviral treatment is suggested within 1 week of vesicle formation or anytime after crusting of the affected area. Treatment of herpes simplex virus (HSV) infection in adults and adolescents (≥12 years of age) Immunocompetent adults and adolescents (≥12 years of age) The dose is 500 mg 2 times a day (1000 mg is the total daily dose). This dose must be adjusted according to creatinine clearance (see Renal Insufficiency below). In case of recurrence, the duration of treatment is from 3 to 5 days. For primary episodes, which may be more severe, treatment may be extended up to 10 days. Treatment should begin as soon as possible. For recurrent episodes of herpes simplex, treatment should begin in the prodromal period or immediately after the onset of the first signs or symptoms, which can prevent the development of the lesion. Herpes labialis For the treatment of herpes labialis (herpes), valaciclovir is prescribed 2000 mg 2 times a day for 1 day. The second dose should be taken 12 hours (but not earlier than 6 hours) after the first dose. This dose must be adjusted according to creatinine clearance (see Renal Insufficiency below). Therapy should be initiated at early symptoms of herpes (eg, tingling, itching, or burning). Immune-compromised adults For the treatment of HSV infection in immunocompromised adults, the dose is 1000 mg twice daily for 5 days after assessing the clinical severity and immunological status of the patient. For primary episodes, which may be more severe, treatment may be extended up to 10 days. Treatment should begin as soon as possible. This dose must be adjusted according to creatinine clearance (see Renal Insufficiency below). To achieve the maximum clinical effect, treatment should be started within 48 hours. Strict monitoring of the development of lesions is recommended. Suppression of recurrence of herpes simplex virus (HSV) infection in adults and adolescents (≥12 years of age) Immunocompetent adults and adolescents (≥12 years of age) The dose is 500 mg once daily. In some patients with very frequent relapses (?10/year if untreated), a daily dose of 500 mg divided into 2 doses (250 mg 2 times a day) may be preferable. This dose must be adjusted according to creatinine clearance (see Renal Insufficiency below). Treatment should be reviewed after 6-12 months of therapy. Adults with a weakened immune system The dose is 500 mg 2 times a day. This dose must be adjusted according to creatinine clearance (see Renal Insufficiency below). Treatment should be reviewed after 6-12 months of therapy. Prevention of Cytomegalovirus (CMV) Infection in Adults and Adolescents (≥12 years) The dosage is 2000 mg 4 times a day, treatment should be started as soon as possible after transplantation. This dose must be adjusted according to creatinine clearance (see Renal Insufficiency below). The duration of treatment is usually 90 days, but may be extended in high-risk patients. Special Populations Children. The effectiveness of the drug in children under the age of 12 years has not been studied. Elderly people. In the presence of renal insufficiency in the elderly, the dose should be adjusted accordingly (see renal insufficiency below). Adequate hydration must be maintained. Patients with impaired renal function. Caution is advised when prescribing Valogard VIR to patients with impaired renal function. Adequate hydration must be maintained. The dose should be adjusted in patients with impaired renal function as shown in Table 1. Table 1 Therapeutic indications Creatinine clearance (ml/min) Dose of Valogard VIR Treatment of herpes zoster ?50 1000 mg 3 times a day 30-49 1000 mg 2 times a day days 10-29 1000 mg 1 time per day <10 500 mg 1 time per day Treatment of herpes simplex - immunocompetent adults Ipod - ≥ 30 500 mg 2 times per day adolescents < 30 500 mg 1 time per day - immunocompromised adults ≥ 30 1000 mg twice daily <30 1000 mg once daily Treatment of herpes labialis in immunocompetent adults and adolescents (alternative one-day regimen) 500 mg 1 time per day Suppression of recurrent HSV infections - immunocompetent adults and adolescents ?30<30 500 mg 1 time per day *250 mg 1 time per day - immunocompromised adults ?30<30 500 mg 2 times a day 500 mg 1 time per day Prevention of cytomegalovirus infection in adults and adolescents (≥12 years) >7550-7525-5010-25<10 or on dialysis 2000 mg 4 times a day 1500 mg 4 times a day 1500 mg 3 times a day 1500 mg 2 times a day 1500 mg 1 time a day * For suppression of HSV in immunocompetent patients with frequent relapses (≥10 per year), best results may be obtained with 250 mg twice daily. For patients who are on hemodialysis, Valogard VIR is prescribed after a hemodialysis session. Creatinine clearance should be monitored frequently, especially during periods when kidney function changes rapidly, such as immediately after kidney transplantation or engraftment. The dosage of Valogard VIR should be adjusted accordingly. Patients with impaired liver function. There is no need to change the dose in patients with mild or moderate liver cirrhosis (synthesizing function of the liver is preserved). Clinical experience with the use of the drug in the late stages of cirrhosis (with impaired liver synthesizing function and the presence of signs of portal block) is limited, but pharmacokinetic indicators indicate that there is no need to change the dose. There are no data on the use of higher doses (4000 mg or more per day). At higher doses (4000 mg or more per day), see section "Precautions". Use during pregnancy and lactation Pregnancy. The experience of using valaciclovir in pregnant women is limited, the experience of using acyclovir (the active metabolite of valaciclovir) in pregnant women is not numerous (111 and 1246 patients, respectively, of which 29 and 756 patients took the drug during the first trimester of pregnancy). The use of Valogard VIR during pregnancy is possible if the potential benefit of treatment outweighs the potential risk to the fetus. Lactation. Aciclovir, the main metabolite of valaciclovir, is excreted in breast milk. However, valaciclovir in therapeutic doses does not affect children who are breastfed, because. its amount is less than 2% of the therapeutic dose in the intravenous treatment of neonatal herpes with acyclovir. Valaciclovir should be used with caution during breastfeeding, only if clinically indicated. Fertility. According to animal studies, valaciclovir had no effect on fertility. However, testicular atrophy and aspermatogenesis have been observed with high parenteral doses of acyclovir in rats and dogs. Clinical studies on 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 spermatozoa were observed. PrecautionsHydration. An adequate fluid level should be maintained, which is administered, in patients at increased risk of dehydration, especially in elderly patients. Application for violations of kidney function and in elderly patients. Valaciclovir is excreted by the kidneys, so the dose of valaciclovir should be reduced in patients with impaired renal function (see section "Method of administration and doses"). In elderly patients, renal function is reduced, so they need a dose adjustment. In patients with impaired renal function and in elderly patients, the risk of developing neurological complications is increased, so they are subject to careful medical supervision. The above reactions in most cases are reversible after stopping treatment. There are no data on the use of higher doses (4 g or more per day) of Valogard VIR in liver failure and liver transplantation. Therefore, caution should be exercised when prescribing higher doses of Valogard VIR to such patients. It has been found that prophylaxis with high doses of valaciclovir reduces the incidence of infection and disease caused by cytomegalovirus. In the treatment of herpes zoster, clinical response should be closely monitored, especially in immunocompromised patients. If there is insufficient clinical response to oral therapy, intravenous antiviral therapy should be considered. In severe cases of herpes zoster, i.e. with visceral disease, common herpes, neuropathy, encephalitis, and cerebrovascular complications, intravenous antiviral therapy should be considered. Intravenous antiviral therapy should also be considered in patients with ophthalmic herpes who are immunocompromised or at high risk of disease spread and visceral involvement. Reducing the transmission of the genital herpes virus. Suppressive therapy with valaciclovir reduces the risk of transmission of genital herpes. It does not cure a herpes infection, nor does it completely eliminate the risk of transmission of the virus. In addition to therapy with Valogard VIR, it is recommended that patients follow the rules of safe sex. In the treatment of ophthalmic HSV infections, the clinical response should be closely monitored. If there is insufficient clinical response to oral therapy, intravenous antiviral therapy should be considered. Prevention of cytomegalovirus infection. Valaciclovir should only be used in transplant patients at high risk of CMV disease if safety concerns preclude the use of valganciclovir or ganciclovir. A high dose of valaciclovir may lead to more frequent adverse reactions, incl. CNS disorders. Changes in renal function should be closely monitored and doses adjusted accordingly. Interaction with other drugs Care must be taken when combining valaciclovir with nephrotoxic drugs, especially in patients with impaired renal function, regular monitoring of renal function is recommended. This provision applies to the co-administration of valaciclovir with aminoglycosides, platinum compounds, iodinated contrast agents, methotrexate, pentamidine, foscarnet, cyclosporine, tacrolimus. Aciclovir is excreted mainly unchanged in the urine by active secretion. After taking 1000 mg of valacyclovir, cimetidine and probenecid reduce the renal clearance of acyclovir and increase the AUC of acyclovir by approximately 25% and 45%, respectively, by blocking the tubular secretion of acyclovir. Cimetidine and probenecid, when co-administered with valacyclovir, increase the AUC of acyclovir by approximately 65%. Other drugs (eg, tenofovir) taken concomitantly that compete with or interfere with active tubular secretion may increase aciclovir concentrations through these mechanisms. In addition, valaciclovir may increase plasma concentrations of co-administered agents. In patients with a higher exposure to acyclovir while taking valaciclovir (for example, for the treatment of herpes zoster or the prevention of CMV), caution should be exercised in case of simultaneous use with drugs that inhibit active renal tubular secretion. An increase in the AUC of acyclovir and the inactive metabolite of the immunosuppressive drug mycophenolate mofetil has been noted with the simultaneous use of these drugs in patients after transplantation. No changes in peak concentrations or AUC were observed with the co-administration of valaciclovir and mycophenolate mofetil in healthy volunteers. There is limited clinical experience with this combination. Contraindications Hypersensitivity to the components of the drug and to acyclovir. Composition 1 tablet contains valaciclovir - 500 mg (in the form of valaciclovir hydrochloride - 556 mg); Excipients: microcrystalline cellulose (101), povidone, anhydrous colloidal silicon dioxide, crospovidone, magnesium stearate; shell composition: Sepifilm 050 (methylhydroxypropyl cellulose, microcrystalline cellulose, acetylated (or ester acetates) mono- and diglycerides), kandurin (potassium aluminum silicate (E 555), titanium dioxide (E 171)). Overdose Symptoms. With an overdose of valaciclovir, the development of acute renal failure and neurological symptoms, including confusion, hallucinations, agitation, mental decline and coma, has been reported. Nausea and vomiting may occur. To prevent unintentional overdose, care should be taken when using. Many cases of overdose have been associated with the use of the drug in the treatment of patients with renal insufficiency and elderly patients who have not been dose reduced accordingly. Treatment. Patients should be under close medical supervision to detect signs of toxicity. Hemodialysis significantly accelerates the elimination of acyclovir from the blood and therefore can be considered the best treatment option in case of symptomatic overdose. Side effectsAccording to the frequency of occurrence, adverse reactions are divided into the following categories: very often (?1/10), often (?1/100 and <1/10), infrequently (?1/1000 and <1/100), rarely (?1 /10000 and <1/1000), very rarely (<1/10000). Clinical Trial Data The most common adverse reactions observed in clinical trials were headache and nausea. More serious adverse reactions have included reports of thrombotic thrombocytopenic purpura/hemolytic uremic syndrome, acute renal failure, and neurological impairment. From the nervous system Very often: headache. From the gastrointestinal tract Often: nausea. Post-marketing data From the blood and lymphatic system Infrequently: leukopenia (mainly observed in patients with immunodeficiency), thrombocytopenia. On the part of the immune system Rarely: anaphylaxis. From the nervous system and mental disorders Often: dizziness. Uncommon: confusion, hallucinations, mental decline, agitation, tremor. Rare: ataxia, dysarthria, psychotic symptoms, convulsions, encephalopathy, coma. The above symptoms are in most cases reversible and are observed mainly in patients with renal insufficiency or other predisposing factors (see section "Precautions"). In patients after organ transplantation receiving valaciclovir for the prevention of cytomegalovirus infection in high doses (8 g per day), neurological reactions occur more often than in patients receiving lower doses. On the part of the respiratory system and organs of the chest and mediastinum Infrequently: shortness of breath. From the digestive tract Often: vomiting, diarrhea. Uncommon: abdominal discomfort. On the part of the hepatobiliary system Infrequently: a reversible increase in the level of hepatic functional tests. It is periodically described as hepatitis. On the part of the skin and subcutaneous tissues Often: rash, including photosensitivity phenomena, itching. Uncommon: urticaria. Rare: angioedema. From the side of the kidneys and urinary system Infrequently: pain in the kidneys (may be associated with renal failure), hematuria (often associated with other renal dysfunction). Rarely: impaired renal function, acute renal failure. The formation of precipitates of acyclovir in the tubules of the kidneys has been reported. During treatment, an adequate level of fluid intake should be ensured (see section "Precautions"). Others: There have been reports of renal failure, microangiopathic hemolytic anemia and thrombocytopenia (sometimes in combination) in severely immunocompromised patients, especially in patients with advanced HIV disease, who received high doses (8000 mg per day) of valaciclovir for a long time in clinical research. These phenomena have been seen in patients with the same disease who were not treated with val acyclovir. If you experience any of these or any other adverse reactions not listed in this leaflet, you should consult a doctor. Storage conditions Store in a place protected from light at a temperature not exceeding 25 ° C. Keep out of the reach of children. Buy Valogard VIR tablets p/o 500mg No. 6x7