Faviroks tab n / 500mg film about 7 pc

$16.94

Faviroks tab n / 500mg film about 7 pc

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Description

Composition
Active substance:
Famciclovir – 500.00 mg;
Excipients:
Pregelatinized starch – 74.80 mg, Microcrystalline Cellulose – 44.00 mg Croscarmellose sodium – 40.80 mg Sodium lauryl sulfate – 6.80 mg silica colloidal anhydrous – 6.80 mg stearic acid – 6.80 mg;
Film coating: Opadry White OY-S-28924 (hypromellose-5sR – 7.48 mg titanium dioxide – 4.08 mg hypromellose-15sR – 2.48 mg macrogol 4000 – 1.48 mg macrogol 6000 – 1.48 mg) – 17.00 mg.
Description:
Oval, biconvex tablets, film-coated, white with risks on both sides of the tablet.
Product form:
Tablets, film-coated, 500 mg:
7 tablets in PVC / PE / PVDC / Al blister.
1 blister with instructions for use in a cardboard package.
Contraindications
Hypersensitivity to famciclovir or any of the components. Hypersensitivity to penciclovir.
Children under 18 years of age due to lack of efficacy and safety data in patients in this age category.
Impaired function of the liver, severe due to lack of efficacy and safety data in patients in this category.
Carefully
Care should be taken when treating patients with renal dysfunction, which may require correction dosing regimen.
Special precautions in elderly patients and patients with impaired liver function and mild to moderate severity is not required.
Dosage
500 mg
Indications
Herpes zoster (infection caused by VZV):
-for the treatment of herpes zoster, including ophthalmoherpes in immunocompetent patients;
-for the treatment of herpes zoster in immunocompromised patients.
Genital herpes (infection caused by HSV):
-treatment and the first episode of genital herpes in immunocompetent patients relapse;
-treatment recurrences of genital herpes in immunocompromised patients;
-for the prevention of relapse of genital herpes (suppressive therapy) in immunocompetent and immunocompromised patients.
Labial herpes (infection caused by HSV):
-treatment recurrence of herpes labialis in immunocompetent patients;
-treatment herpes recurrences orolabialnogo immunocompromised patients.
Interaction with other drugs
The simultaneous use of probenecid may increase penciclovir concentrations in the blood plasma. To prevent the development of toxic reactions should be monitored for patients receiving the drug Faviroks 500 mg concurrently with probenecid, given the possibility of reducing the dose of famciclovir.
There were no clinically significant changes in pharmacokinetic penciclovir parameters following a single application (500 mg) immediately after receiving antacids (magnesium and aluminum hydroxide) or patients treated before treatment with allopurinol, cimetidine, theophylline, zidovudine, promethazine (multiple dose) . In single dose of famciclovir (500 mg) with emtricitabine or AZT showed no changes in the pharmacokinetic parameters of penciclovir, AZT, a metabolite of AZT (zidovudine glucuronide) and emtricitabine.
Following single and repeated application of famciclovir (500 mg 3 times daily) with digoxin no change pharmacokinetic parameters penciclovir and digoxin.
Given that the conversion of the inactive metabolite 6-dezoksipentsiklovira (formed by deacetylation of famciclovir) to penciclovir is catalysed by the enzyme aldehyde oxidase may develop drug interaction when used together with the drug Faviroks drugs metabolized with the participation of the enzyme or inhibiting its activity.
In applying famciclovir with cimetidine and promethazine, which are inhibitors of aldehyde oxidase in vitro, there was no evidence of violation of the formation of penciclovir famciclovir. However, when receiving famciclovir with potent inhibitor of aldehyde oxidase in vitro, raloxifene, may impair the formation of famciclovir, penciclovir, and hence reduced effectiveness of famciclovir. It is necessary to evaluate the clinical efficacy of antiviral therapy at the same time to demonstrate how to raloxifene.
Given that famciclovir is a weak inhibitor aldegidroksidazy in vitro, it may impact on the pharmacokinetic parameters of the drugs metabolized with the participation of the enzyme.
In experimental studies, famciclovir had no effect on inducing cytochrome P450 and does not inhibit the CYP3A4 enzyme.
Overdose
There are limited data on overdose famciclovir.
There are cases of overdose famciclovir (10.5 g) was not accompanied by clinical manifestations.
Treatment: symptomatic and supportive. Failure to comply with the recommendations to reduce the dose of famciclovir in view of kidney function in patients with kidney disease is rarely observed cases of acute renal failure. Penciclovir, which is the active metabolite of famciclovir, appear in hemodialysis. Penciclovir concentrations in plasma are reduced by 75% after dialysis for 4 hours.
pharmachologic effect
Pharmacological group:
an antiviral agent.
Pharmacodynamics:
After oral famciclovir is rapidly converted to penciclovir, which has activity against human herpes viruses including the virus Varicella Zoster (VZV) and Herpex Simplex (HSV) types 1 and 2, and Epstein-Barr virus and cytomegalovirus.
Penciclovir gets in virus-infected cells, where under the influence of viral temidinkinazy rapidly converted to monophosphate, which in turn goes to the triphosphate. Penciclovir triphosphate inhibits the replication of viral DNA (deoxyribonucleic acid).
Intracellular half-life period of penciclovir triphosphate cell culture infected with HSV 1 is 10 hours, HSV 2 – 20 hours; VZV – 7:00.
The concentration of penciclovir triphosphate in uninfected cells does not exceed the minimum determined, however at therapeutic concentrations penciclovir no effect on uninfected cells.
As with acyclovir, penciclovir resistance is often associated with mutations in the gene for viral thymidine kinase, leading to a deficiency or disruption of the substrate specificity of the enzyme. Significantly less frequent changes in the DNA polymerase gene.
The use of famciclovir for the treatment of shingles (caused by VZV) in immunocompetent patients and patients with reduced immunity marked acceleration of healing of skin and mucous membranes. Famciclovir is effective in treating various ophthalmic manifestations caused by VZV. Famciclovir significantly reduces the severity and duration of postherpetic neuralgia in patients with herpes zoster.
Day treatment with famciclovir immunocompetent patients at a dose of 1500 mg 1 time per day or 750 mg 2 times a day facilitates rapid resolution displays of recurrent labial herpes (caused by HSV).
Use of the drug in immunocompetent patients at a dose of 1000 mg two times a day for 1 day, 125 mg 2 times a day for 5 days or 500 mg 2 times a day for 3 days accelerates the healing of skin and mucous membranes for recurrent genital herpes (caused by HSV).
Famciclovir 500 mg 2 times a day for 7 days is effective in the treatment of various manifestations of herpes zoster in patients with reduced immunity due to the infection with the human immunodeficiency virus (HIV). In HIV-infected patients in the drug dose of 500 mg 2 times a day for 7 days accelerates the healing of skin and mucous membranes for recurrent genital herpes, and also reduces the number of days of isolation HSV (both symptomatic and without them). The use of famciclovir in patients with reduced immunity due to other reasons, has not been studied.
Efficiency of one-day famciclovir at a dose of 1000 mg two times a day for treatment of recurrent genital herpes in immunocompetent patients blacks not greater than that for placebo. The safety profile of the drug in a one-day dose of 1000 mg two times a day in these patients was similar to that previously established.
Pharmacokinetics:
Absorption
Famciclovir is a prodrug. After oral famciclovir is rapidly and almost completely absorbed and is rapidly converted to a pharmacologically active metabolite – penciclovir. Bioavailability of penciclovir after receiving famciclovir inside is 77%. Increasing penciclovir plasma concentration occurs in proportion to increase of a single dose of famciclovir in the range 125-1000 mg. According to research maximum concentration (Cmax) of penciclovir in plasma after ingestion of 125 mg, 250 mg or 500 mg of famciclovir is achieved on average after 45 minutes and an average of 0.8 ug / ml, 1.6 ug / ml and 3, 3 ug / ml, respectively. Another study shows the maximum concentration (Cmax) after oral administration of penciclovir 250 mg, 500 mg or 1000 mg of famciclovir in the values ​​of 1.5 ug / ml, 3.2 ug / ml and 5.8 ug / ml, respectively.
Systemic bioavailability (area under the curve “concentration – time» (AUC)) does not depend on penciclovir mealtime.
AUC with single dose penciclovir and famciclovir by dividing the daily dose into two or three doses are the same, indicating a lack of accumulation during repeated applications penciclovir famciclovir.
Metabolism
After oral famciclovir is rapidly and completely converted into a pharmacologically active metabolite – penciclovir.
Distribution
Plasma protein binding penciclovir and its 6-deoxy precursor is less than 20%.
breeding
Famciclovir is displayed substantially in the form of penciclovir, and its 6-deoxy precursor, which are excreted by the kidneys in unchanged form; famciclovir in the urine is detected. The half-life (T1 / 2) of penciclovir from the plasma in the final phase after a single and repeated doses of about 2 hours.
Pharmacokinetics in special cases
Patients with infections caused by VZV
Patients with uncomplicated infections caused by VZV, no significant change is detected pharmacokinetic parameters of penciclovir (T1 / 2 penciclovir from the plasma in the final phase after a single and repeated doses of famciclovir is 2.8 and 2.7 hours, respectively).
Patients with impaired renal function
Upon receiving single and repeated doses of famciclovir observed linear relationship between the decrease in plasma clearance, renal clearance, penciclovir release rate of blood plasma and the degree of renal function. The pharmacokinetic characteristics of the drug in patients with severe (decompensated) renal dysfunction has not been studied.
Patients with impaired liver function
Patients with impaired liver function mild to moderate degrees is not observed an increase in the AUC of penciclovir. The pharmacokinetics of penciclovir in patients with severe hepatic dysfunction have not been studied. Conversion of famciclovir, penciclovir the active metabolite in this patient population can be broken up, which leads to a lowering of penciclovir concentrations in plasma and, as a consequence, inefficiency of famciclovir.
Patients aged> 65 years
Patients aged 65 to 79 years there has been increase in the mean AUC of penciclovir by approximately 40% and a decrease in its renal clearance by approximately 20% compared with persons under the age of 65 years. These pharmacokinetic characteristics of penciclovir may be partly due to age-related changes in renal function in patients older than 65 years. No dose adjustment is required for patients in this age group in the absence of renal dysfunction.
Floor
Sex of the patient has no significant effect on the pharmacokinetic parameters of the drug (minor differences in the clearance of penciclovir in men and women). It does not require dose adjustment based on gender
Ethnicity
In applying famciclovir (single or multiple dose in a dose of 500 mg of 1, 2 or 3 times a day) pharmacokinetic parameters of the drug in healthy volunteers and patients blacks blacks with impaired renal or hepatic function were not different from those of Caucasian individuals.
Pregnancy and breast-feeding
In studies in animals embryotoxic and teratogenic action of famciclovir and penciclovir have not been identified. In studies with the use of famciclovir inwardly mentioned selection penciclovir milk of lactating rats. It is not known whether penciclovir is excreted in breast milk in humans.
However, since the data on the safety of famciclovir in pregnant and lactating women is not enough, its use in pregnancy and lactation is possible only if the benefit of treatment to the mother outweighs the potential risk to the fetus and child.
No data requiring specific recommendations for patients with preservation of reproductive potential.
Famciclovir has no pronounced effect on the semen analysis, morphology or motility of human sperm. Reduced fertility was observed in an experimental model of male rats treated with famciclovir 500 mg / kg body weight in female rats were expressed decrease fertility were observed.
Conditions of supply of pharmacies
On prescription.
side effects
In clinical studies it has shown good tolerability famciclovir, including in patients with reduced immunity. Reported cases of headaches and nausea, but these events were mild or moderately expressed and observed with the same frequency in patients treated with placebo. The other adverse effects (AEs) were identified in clinical practice for the use of the drug in the post-registration period.
AEs reported in clinical trials in patients with reduced immunity, coincided with those observed in patients with normal immune systems.
To evaluate the incidence of adverse reactions used the criteria of the World Health Organization (WHO): very common (> 1/10); often (by> 1/100, 1/1000,
special instructions
Treatment should be started immediately after diagnosis.
Genital herpes – a disease transmitted through sexual contact. During recurrence risk of infection increases. In the presence of clinical manifestations of the disease, even in the event of an antiviral treatment, patients should avoid sexual intercourse.
Time suppressive therapy with antiviral agents the frequency of viral shedding is markedly reduced, but, nevertheless, the risk of transmission is maintained. In connection with the above, the treatment of the drug during this period should follow the rules of safe sexual behavior.
Effect on the ability to drive and / or other mechanisms
It is not expected to influence the drug Faviroks on the ability to drive vehicles and / or use machines, however, patients who during treatment Faviroks drug appears dizziness, drowsiness, confusion, or other disorders of the central nervous system, it is necessary to refrain from road management and / or operate machinery during treatment.
Storage conditions
Store at a temperature not higher than 25 ° C in its original packaging
Dosing and Administration
The drug should be ingested, regardless of the meal, without chewing, drinking water. drug treatment should begin as soon as possible, immediately after the appearance of symptoms (tingling, itching and burning sensation).
Infection caused by VZV (shingles), including ophthalmoherpes in immunocompetent patients:
The recommended dose is 500 mg three times a day for 7 days.
Infection caused by VZV (shingles) in immunocompromised patients:
The recommended dose is 500 mg three times a day for 10 days.
Infection with HSV (labial or genital herpes) in immunocompetent patients:
-In the first episode of genital herpes recommended dosage is 250 mg three times a day for 5 days;
-When recurrent genital herpes administered 1000 mg 2 times a day for 1 day or 125 mg 2 times a day for 5 days or 500 mg dose, followed by application of 3 doses of 250 mg every 12 hours.
-When recurrent herpes labialis – 1500 mg once a day for 1 day or 750 mg 2 times a day for 1 day.
Infection with HSV (orolabialny or genital herpes) in immunocompromised patients:
The recommended dose is 500 mg 2 times a day for 7 days.
250 mg 2 times daily is used to prevent relapses of genital herpes (suppressive therapy). The duration of therapy depends on the severity of the disease. Recommended periodic assessment of possible changes of the disease after 12 months. In HIV-infected patients, the effective dose is 500 mg 2 times a day.
Patients aged> 65 years.
In elderly patients with normal renal function correction dosing regimen of famciclovir is not required.
Patients with impaired renal function.
In patients with impaired renal function observed decrease in clearance of penciclovir. Recommendations for the correct dosing regimen in immunocompetent patients with impaired renal function depending on creatinine clearance are presented below (1).
Recommendations for the correct dosing regimen in immunocompromised patients with impaired renal function, depending on the creatinine clearance is shown below (2).
1. Коррекция режима дозирования у иммунокомпетентных пациентов с нарушением функции почек – Инфекция, вызванная VZV (опоясывающий герпес) 500 мг 3 раза в сутки в течение 7 дней
КК >60 – 500 мг 3 раза в сутки в течение 7 дней
КК 40–59 – 500 мг 2 раза в сутки в течение 7 дней
КК 20–39 – 500 мг 1 раз в сутки в течение 7 дней
QC
КК Пациенты, находящиеся на гемодиализе, или получающие процедуру гемодиализа – 250 мг после каждого сеанса диализа в течение 7 дней
Инфекция, вызванная HSV
– Генитальный герпес, первый эпизод 250 мг 3 раза в сутки в течение 5 дней
КК >40 – 250 мг 3 раза в сутки в течение 5 дней
КК 20–39 – 250 мг 2 раза в сутки в течение 5 дней
QC
КК Пациенты, находящиеся на гемодиализе, или получающие процедуру гемодиализа – 250 мг после каждого сеанса диализа в течение 5 дней – При рецидивах генитального герпеса 1000 мг 2 раза в сутки в течение 1 дня
КК >60 – 1000 мг 2 раза в сутки в течение 1 дня
КК 40–59 – 500 мг 2 раза в сутки в течение 1 дня
КК 20–39 – 500 мг однократно
QC
КК Пациенты, находящиеся на гемодиализе, или получающие процедуру гемодиализа – 250 мг однократно после сеанса диализа – При рецидивах генитального герпеса 125 мг 2 раза в сутки в течение 5 дней
КК >20 – 125 мг 2 раза в сутки в течение 5 дней
QC
КК Пациенты, находящиеся на гемодиализе, или получающие процедуру гемодиализа – 125 мг после каждого сеанса диализа в течение 5 дней – При рецидивах генитального герпеса 500 мг однократно с последующим применением 3 доз по 250 мг каждые 12 ч
КК >40 – 500 мг однократно с последующим применением 3 доз по 250 мг каждые 12 ч
КК 20–39 – 250 мг однократно с последующим применением 3 доз по 250 мг каждые 12 ч
QC
КК Пациенты, находящиеся на гемодиализе, или получающие процедуру гемодиализа – 250 мг однократно после сеанса диализа – Для профилактики обострений генитального герпеса (супрессивная терапия) 250 мг 2 раза в сутки
КК >40 – 250 мг 2 раза в сутки
КК 20–39 – 125 мг 2 раза в сутки
QC
КК Пациенты, находящиеся на гемодиализе, или получающие процедуру гемодиализа – 125 мг после каждого сеанса диализа – Лабиальный герпес 1500 мг однократно
КК >60 – 1500 мг однократно
КК 40–59 – 750 мг однократно
КК 20–39 – 500 мг однократно
QC
КК Пациенты, находящиеся на гемодиализе, или получающие процедуру гемодиализа – 250 мг однократно после сеанса диализа – Лабиальный герпес 750 мг 2 раза в сутки
КК >60 – 750 мг 2 раза в сутки в течение 1 дня
КК 40–59 – 750 мг однократно
КК 20–39 – 500 мг однократно
QC
КК Пациенты, находящиеся на гемодиализе, или получающие процедуру гемодиализа – 250 мг однократно после сеанса диализа
2. Коррекция режима дозирования у иммунокомпрометированных пациентов с нарушением функции почек – Инфекция, вызванная VZV (опоясывающий герпес) 500 мг 3 раза в сутки в течение 10 дней
КК >60 – 500 мг 3 раза в сутки в течение 10 дней
КК 40–59 – 500 мг 2 раза в сутки в течение 10 дней
КК 20–39 – 500 мг 1 раз в сутки в течение 10 дней
QC
КК Пациенты, находящиеся на гемодиализе, или получающие процедуру гемодиализа – 250 мг после каждого сеанса диализа в течение 10 дней – Инфекция, вызванная HSV (оролабиальный или генитальный герпес) 500 мг 2 раза в сутки в течение 7 дней
КК >40 – 500 мг 2 раза в сутки в течение 7 дней
КК 20–39 – 500 мг 1 раз в сутки в течение 7 дней
QC
КК Пациенты, находящиеся на гемодиализе, или получающие процедуру гемодиализа – 250 мг после каждого сеанса диализа в течение 7 дней
Пациенты с почечной недостаточностью, находящиеся на гемодиализе, или получающие процедуру гемодиализа.
Поскольку после проведения 4-часового гемодиализа концентрация пенцикловира в плазме снижается на 75%, фамцикловир следует принимать непосредственно после процедуры гемодиализа. Рекомендуемая схема коррекции дозы описана в таблицах 1 и 2.
Patients with impaired liver function.
Для пациентов с нарушениями функции печени легкой и средней степеней тяжести коррекция дозы препарата не требуется. Опыта применения препарата у пациентов с нарушениями функции печени тяжелой степени нет.
Пациенты негроидной расы.
Эффективность однодневного приема фамцикловира в дозе 1000 мг 2 раза в сутки для лечения рецидива генитального герпеса у иммунокомпетентных пациентов негроидной расы не превышала таковую для плацебо. Клиническая значимость режимов дозирования препарата для лечения как рецидивов генитального герпеса (в течение 2 или 5 дней), так и других инфекционных поражений, вызванных VZV и HSV, неизвестна.
Information
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
Manufacturer

KSANTIS PHARMA

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