Vayrova tab n / 500mg film about 10 pc


Vayrova tab n / 500mg film about 10 pc


SKU: 01316964075 Categories: , , Tags: ,


Active substance:
1 tablet contains: 556.275 mg valacyclovir hydrochloride equivalent to 500 mg valacyclovir.
Microcrystalline cellulose (PH 101), crospovidone, dye indigo carmine (E132), povidone (K 30), povidone (K 90D), magnesium stearate, Opadray02S50740 blue dye, purified water. Dye Composition Opadry blue 02C50740: hypromellose 5 cP (E464), titanium dioxide (E171), Macrogol / PEG 400, Macrogol / PEG 6000, dye indigo carmine (E132), polysorbate 80 (E433).
From light blue to light blue, oval, biconvex tablets, film-coated; on one side of the tablet «V» engraving and “5” on each side of the risks and notches on both sides of risks.
Product form:
Film-coated tablet 500 mg. 10 tablets in a blister made of aluminum foil and PVC / PVDC film. 1, 2, 3 or 4 blisters with instructions for use in a cardboard package.
Hypersensitivity HIV infection in CD4 + lymphocytes content of less than 100 / microliter, child (under 12 years of cytomegalovirus infection (CMV), to 18 years – for other indications).
Precautions: Hepatic / renal failure, pregnancy, lactation, children and elderly, hypohydration, simultaneous nephrotoxic drugs.
500 mg
In adults: labial herpes, genital herpes (primary and recurrent infections, long-term suppressive therapy of recurrent genital herpes in patients with immunodeficiency, including HIV infection, reducing the risk of transmission of infection sexual partner), herpes zoster. In adults and children over 12 years: prevention of cytomegalovirus infection in organ transplantation.
Interaction with other drugs
Acyclovir is excreted mainly unchanged in the urine by active tubular secretion. Any drugs administered concurrently with valacyclovir and having the inference engine can increase the concentration of acyclovir in plasma.
Cimetidine and Probenecid increase AUC value acyclovir by reducing its renal clearance, however, the need for dose adjustment offline because of the wide therapeutic index of acyclovir. Caution must be exercised, assigning valacyclovir in high doses (4 g / d.) For the prevention of cytomegalovirus infection spreparatami simultaneously that compete for satsiklovirom elimination pathway, as this may lead to increased blood levels vplazme one or both drugs andtheir metabolites. Together with the admission mycophenolate mofetil increases the concentration of acyclovir and the inactive metabolite of mycophenolate mofetil in blood plasma. It is also to be careful with concomitant administration of valacyclovir in high doses and other drugs that affect renal function (e.g., cyclosporine, tacrolimus).
Symptomatology: the occurrence of acute renal failure and neurological symptoms, including confusion, hallucinations, agitation, loss of consciousness and in patients who overdose valaciclovir, nausea and vomiting. To prevent an overdose need to be careful when using the drug. Many of the described cases of repeated overdoses in patients with impaired renal function and in elderly patients were caused by insufficient reduction of the dose of the drug. Treatment: Patients are subject to careful monitoring for timely diagnosis of toxic effects. Hemodialysis greatly accelerates the removal of acyclovir from the blood and may be considered the optimal method of treatment in the case of symptomatic overdose.
pharmachologic effect
Pharmacological group:
An antiviral agent.
Valaciclovir: (2S) – [2- [2-Amino-6-oxo-1,6-dihydro-9H-purin-9-yl) methoxy] ethyl] -2-amino-3-methylbutanoate hydrochloride – antiviral drug. Blocks the synthesis of viral DNA and viral replication. In humans, valaciclovir is converted to aciclovir and valine. Acyclovir has a specific invitro activity against herpes simplex virus types I and II virus, Varicella zoster, cytomegalovirus, Epstein-Barr virus and human herpes virus type VI. Because phosphorylation of acyclovir is converted into the active acyclovir triphosphate competitively ingibiruyushego viral DNA synthesis. In the first step of phosphorylation required virus-specific enzyme activity. For herpes simplex virus, Varicella zoster virus and Epstein-Barr virus is a viral thymidine kinase, available only in cells infected with the virus. Cytomegalovirus infection acyclovir phosphorylation mediated gene product phosphotransferase UL97.
After oral administration valaciclovir is well absorbed in the gastrointestinal (GI) tract, is rapidly and almost completely converted to aciclovir and valine. The bioavailability of acyclovir when receiving 1 g of valacyclovir is 54% and is not reduced while eating. The maximum concentration of acyclovir after a single dose of 250 mg – 1 g of valacyclovir is on average 15-25 mol / l and is achieved through 1.6-2.1 h after administration; after 3 hours the plasma valacyclovir not determined. Binding of valaciclovir to plasma proteins 13-18%. The half-life of acyclovir after single and repeated application of approximately 3 hours Valaciclovir excreted by the kidneys, mainly in the form of acyclovir and its metabolite 9 -. Karboksimetoksimetilguanina. Acyclovir is widely distributed in tissues and body fluids, including the brain, kidneys, lungs, liver, aqueous humor, lacrimal fluid, intestine, muscle, spleen, uterus, mucous membranes, and the secret of the vagina, semen, amniotic fluid, cerebrospinal fluid (CSF) ( 50% of plasma concentration), the liquid herpetic vesicles. Highest concentrations are in the kidneys, liver and intestines. It crosses the placenta and breast milk.
Pregnancy and breast-feeding
There are limited data on the use of valaciclovir in pregnancy. Valacyclovir is used only in cases where the potential benefit to the mother outweighs the potential risk to the fetus. Recorded data on the outcome of pregnancy in women taking valacyclovir or acyclovir, which is the active metabolite of valaciclovir, showed no increase in the number of birth defects in their children compared to the general population. Since the register included a small number of women taking valacyclovir during pregnancy, it is reliable and specific on the safety of the use of valaciclovir in pregnancy can not be done. Acyclovir, the main metabolite of valaciclovir, is excreted in breast milk. Upon receiving valaciclovir oral dose of 500 mg acyclovir Cmax in breast milk in 0,5-2,3 times (an average 1.4 times) higher than the corresponding concentration of acyclovir in plasma, maternal blood. The ratio of the area under the curve “concentration-time» (AUC) in the blood plasma of acyclovir present in breast milk to the area under the curve “concentration-time» (AUC) of acyclovir in maternal plasma ranged from 1.4 to 2.6 (average value of 2 2). The mean value of the concentration of acyclovir in breast milk was 2.24 micrograms / ml (9.95 mg / M). When receiving valaciclovir mother oral dose of 500 mg of 2 times / day. child undergo a similar treatment of acyclovir as when taking it orally at a dose of about 0.61 mg / kg / day. The half-life (T1 / 2) of acyclovir from breast milk is the same as from the blood plasma. Valacyclovir in unchanged form was not detected in maternal plasma, breast milk, or in the child’s urine. During breastfeeding the drug is used only if the expected benefit to the mother outweighs the potential risk to the child. With this in mind, it should be used with caution in valacyclovir mother during lactation (breastfeeding). However, intravenous (i / v) administration of acyclovir at a dose of 30 mg / kg / day. It is used in infants for the treatment of diseases caused by the herpes simplex virus. In experimental studies, valacyclovir is not teratogenic in rats and rabbits. The subcutaneous (s / c) administering acyclovir in conventional teratogenicity tests did not cause teratogenic effects in rats and rabbits. In additional studies in rats of fetal development were identified as n / to the introduction of the drug in doses which induced an increase in the plasma concentration of acyclovir to 100 .mu.g / mL and the toxic effects in the mother. When oral valacyclovir did not cause disturbances of fertility in male and female rats.
Conditions of supply of pharmacies
On prescription.
side effects
Very often greater than or equal to 1 to 10, often greater than or equal to 1 100 and
special instructions
Hydration. Elderly patients, people suffering from dehydration during treatment with valacyclovir need to increase fluid intake. In the absence of functional disorders of kidney correction dosing regime is not required. Application for violations of renal function and in elderly patients. Valaciclovir eliminated via the kidneys, therefore elderly patients with decreased renal function probability is necessary to reduce the dose. In patients with renal disease, a history of nephrology risk of complications increases, and with a view to the timely identification of such patients should be closely monitored. Reduction of transmission of genital herpes. Suppressive valacyclovir therapy decreases the risk of transmission of genital herpes, but it does not cure herpes infections and completely eliminates the risk of transmission of the virus, it is recommended to avoid sexual intercourse. Lactation. Recommended with caution valacyclovir women during lactation. Impact on the ability to drive vehicles and other mechanisms. No special precautions. If you have side effects from the central nervous system (including agitation, hallucinations, confusion, delirium, seizures, and encephalopathy) drug overturned.
Storage conditions
At a temperature of not higher than 30 ° C. Keep out of the reach of children.
Dosing and Administration
Inside (regardless of the meal). For the treatment of herpes zoster adults appoint 1 g of 3 times / day. for 7 days. For the treatment of diseases caused by the virus Herpes simplex, adults valacyclovir administered 500 mg of 2 times / day. In the case of relapse, treatment should be conducted for 3 or 5 days. In more severe cases, the primary treatment should be started as early as possible, and its duration should be increased from 5 to 10 days. In recurrent disease is considered optimal assignment valaciclovir prodromal period or immediately after the first symptoms. Alternatively, for the treatment of herpes of the lips (lip fever) effectively assignment valaciclovir dose of 2 g of 2 times for 1 day. The second dose should take approximately 12 hours (but not earlier than 6 hours) after the first dose. With such a treatment duration dosing regimen should not exceed 1 day as provide no additional clinical benefit. Therapy should be initiated with the appearance of the earliest symptoms of fever lip (ie, tingling, itching, burning). For the prevention (suppression) of relapse of infections caused by the virus Herpes simplex, adults with normal immunity indices administered in a dose of 500 mg 1 time / day. Adults with immunodeficiency recommended to appoint 500 mg of 2 times / day. Duration of treatment – 4-12 months. Data on the prevention of infection in other populations of patients with absent. In renal insufficiency, the dosage regimen set depending on the creatinine clearance (CC) and indications. With herpes zoster and creatinine clearance of 15-30 ml / min – 1 g 2 times / day. With herpes zoster and creatinine clearance less than 15 mL / min – 1 g 1 / d. In the treatment of infections caused by Herpes simplex and creatinine clearance less than 15 mL / min – 500 mg 1 time / day. In the treatment of herpes labialis and creatinine clearance 31-49 ml / min – 1 g 2 times for 1 day. In the treatment of herpes labialis and creatinine clearance of 15-30 ml / min – 500 mg 2 times / day. within 1 day. In the treatment of herpes labialis and creatinine clearance less than 15 mL / min – 500 mg once. When prevention (suppression) of infections caused Herpessimplex and creatinine clearance less than 15 mL / min – in the normal state of immunity: 250 mg 1 time / day. When prevention (suppression) of infections caused Herpessimplex and creatinine clearance less than 15 mL / min – in immunodeficiency: 500 mg 1 time / day. For reducing infection and genital herpes creatinine clearance less than 15 mL / min – 250 mg 1 time / day. Patients in hemodialysis, it is recommended to appoint valacyclovir immediately after hemodialysis session closure in a dose intended for patients with CC less than 15 ml / min. The preparation should be applied after closure hemodialysis. 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 administered as soon as possible after transplantation. The dose should be reduced according to the creatinine clearance (CC). The course duration is 90 days but can be increased in patients with high risk of infection. Requires frequent monitoring QC, particularly at a time when kidney function is changing rapidly (including immediately after transplantation or engraftment); dose of valaciclovir should be adjusted in accordance with the CC.
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist

Additional information

Weight0.100 kg

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