Description
Description
Film-coated tablets, 250 mg:
Round, biconvex film-coated tablets, white with a chamfer and a risk on one side of the tablet.
Release form
Film-coated tablets, 250 mg:
7 tablets in PVC / PE / PVDC / Al blister.
3 blisters with instructions for use in a cardboard box.
Indications
· Herpes zoster (VZV infection):
– for the treatment of herpes zoster, including ophthalmic herpes in immunocompetent patients
– for the treatment of herpes zoster in immunocompromised patients.
· Genital herpes (HSV infection):
– treatment of the first episode and relapses of genital herpes in immunocompetent patients
– treatment of relapses of genital herpes in immunocompromised patients
– for the prevention of exacerbations of genital herpes (suppressive therapy) in immunocompetent and immunocompromised patients.
· Labial herpes (HSV infection):
– treatment of relapses of labial herpes in immunocompetent patients
– treatment of relapses of orolabial herpes of immunocompromised patients.
Contraindications
· Hypersensitivity to famciclovir or any of the components of the drug. Hypersensitivity to penciclovir.
· Children under 18 years of age due to a lack of data on efficacy and safety in patients of this age category.
· Severely impaired hepatic function due to lack of data on efficacy and safety in patients of this category.
Caution
Caution should be exercised in the treatment of patients with impaired renal function, which may require dosage adjustment.
Special precautions in elderly patients and patients with impaired liver function of mild to moderate severity are not required.
Recommendations for use
The drug should be taken orally, regardless of food intake, without chewing, with water. Treatment with the drug should begin as soon as possible, immediately after the onset of the first symptoms of the disease (tingling, itching and burning).
VZV (herpes zoster) infection, including ophthalmic herpes in immunocompetent patients:
The recommended dose is 500 mg 3 times a day for 7 days.
VZV (herpes zoster) infection in immunocompromised patients:
The recommended dose is 500 mg 3 times a day for 10 days.
HSV infection (labial or genital herpes) in immunocompetent patients:
– For the first episode of genital herpes, the recommended dose is 250 mg 3 times a day for 5 days
– For relapses of genital herpes, 1000 mg 2 times a day for 1 day or 125 mg 2 times a day for 5 days or 500 mg once with the subsequent use of 3 doses of 250 mg every 12 hours.
– For relapses of labial herpes – 1500 mg once for 1 day or 750 mg 2 times a day for 1 day.
HSV infection (orolabial or genital herpes) in immunocompromised patients:
The recommended dose is 500 mg 2 times a day for 7 days.
250 mg 2 times a day are used to prevent exacerbations of genital herpes (suppressive therapy). The duration of therapy depends on the severity of the disease. A periodic assessment of possible changes in the course of the disease after 12 months is recommended. In HIV-infected patients, the effective dose is 500 mg 2 times a day.
Patients ² °Ò65 years of age.
In elderly patients with normal renal function, famciclovir dosage regimen adjustment is not required.
Patients with impaired renal function.
In patients with impaired renal function, there is a decrease in clearance of penciclovir. Recommendations for correcting the dosage regimen in immunocompetent patients with impaired renal function depending on creatinine clearance are presented in table 1.
Recommendations for correcting the dosage regimen in immunocompetent patients with impaired renal function depending on creatinine clearance are presented in table 2.
Table 1. Correction of the dosage regimen in immunocompetent patients with impaired renal function
VZV infection (herpes zoster)
within 7 days
40 ² 59
500 mg 2 times a day for 7 days
20 ² 39
500 mg 1 time per day for 7 days
<20 250 mg 1 time per day for 7 days Patients who are on hemodialysis, or receiving hemodialysis 250 mg after each eansa dialysis for 7 days Infection with HSV Genital herpes, the first episode of 250 mg 3 times a day for 5 days 40 250 mg 3 times a day for 5 days 20 ² 39 250 mg 2 times a day for 5 days <20 250 mg 1 time per day for 5 days Patients on hemodialysis or receiving hemodialysis 250 mg after each dialysis session for 5 days For relapses of genital herpes 1000 mg 2 times a day for 1 day 60 1000 mg 2 times a day for 1 day 40 ² 59 500 mg 2 times a day for 1 day 20 ² 39 500 mg once <20 250 mg once atsienty on hemodialysis, or receiving hemodialysis procedure 250 mg once after a dialysis session 125 mg 2 times a day for 5 days 20 125 mg 2 times a day for 5 days <20 125 mg 1 time per day for 5 days Hemodialysis patients or receiving hemodialysis 125 mg after each dialysis session for 5 days 500 mg once, followed by 3 doses of 250 mg every 12 hours 40 500 mg once, followed by 3 doses of 250 mg every 12 hours 20 ² 39 250 mg once, followed by 3 doses about 250 mg every 12 hours <20 250 mg dose followed using 250 mg per day following Patients on dialysis, or receiving hemodialysis procedure 250 mg once after a dialysis session For the prevention of exacerbations of genital herpes (suppressive therapy) 250 mg 2 times a day 40 250 mg 2 times a day 20 ² 39 125 mg 2 times a day srd <20 125 mg 1 time per day Hemodialysis patients or receiving hemodialysis 125 mg after each dialysis Lab herpes 1500 mg once 60 1500 mg once 40 ² 50 40 ² 59 40 ² 59 20 ² 39 500 mg single dose <20 250 mg single dose Patient Options on hemodialysis, caused by VZV (herpes zoster) Dosing schedule Creatinine clearance Adjusted dosing schedule 500 mg 3 times a day for 10 days 60 500 mg 3 times a day for 10 days 40 ² 59 500 mg per day for 10 days 20 ² 39 500 mg 1 time per day for 10 days <20 250 mg 1 time per day for 10 days Patients on hemodialysis or receiving hemodialysis 250 mg after each dialysis session for 10 days HSV infection (orolabial or genital herpes) 500 mg 2 times a day for 7 days 40 500 mg 2 times a day for 7 days 20 ² 39 500 mg 1 time per day for 7 days < 20 250 mg once daily for 7 days Patients undergoing hemodialysis or receiving hemodialysis 250 mg after each dialysis session for 7 days Patients with renal failure undergoing hemodialysis or receiving hemodialysis. Since plasma concentration of penciclovir decreases by 75% after 4-hour hemodialysis, famciclovir should be taken immediately after the hemodialysis procedure. The recommended dose adjustment scheme is described in Tables 1 and 2. Patients with impaired liver function. For patients with impaired hepatic function of mild to moderate severity, dose adjustment is not required. There is no experience with the use of the drug in patients with severe liver dysfunction. Patients of the Negroid race. The efficacy of famciclovir 1000 mg 2 times daily for the treatment of recurrence of genital herpes in immunocompetent patients of the Negroid race did not exceed that for placebo. The clinical significance of dosing regimens for the treatment of both relapses of genital herpes (within 2 or 5 days) and other infectious lesions caused by VZV and HSV is unknown. Special instructions Treatment should be started immediately after diagnosis. Genital herpes is a sexually transmitted disease. During relapses, the risk of infection increases. In the presence of clinical manifestations of the disease, even if antiviral treatment is started, patients should avoid sexual intercourse. During suppressive antiviral therapy, the frequency of virus release decreases markedly, but, nevertheless, the risk of transmission of infection remains. In connection with the foregoing, during treatment with the drug during this period, the rules of safe sexual behavior should be observed. Effect on the ability to drive a car and / or other mechanisms Favirox is not expected to affect the ability to drive vehicles and / or work with mechanisms, however, patients who experience dizziness, drowsiness, confusion, or other disturbances on the side of Favirox central nervous system should refrain from driving and / or working with mechanisms during the period of use of the drug. Composition Each film-coated tablet 250 mg contains: active ingredient: famciclovir – 250.00 mg excipients: pregelatinized starch – 37.40 mg, microcrystalline cellulose – 22.00 mg, croscarmellose sodium 40 mg, sodium lauryl sulfate – 3.40 mg, anhydrous colloidal silicon dioxide – 3.40 mg, stearic acid – 3.40 mg film coating: Opadry white OY-S-28924 (hypromellose-5cP – 3.74 mg, titanium dioxide – 2.04 mg, hypromellose-15cP – 1.24 mg, macrogol-4000 – 0.74 mg, macrogol-6000 – 0.74 mg) – 8.50 mg Side effects of Clinical studies have shown good tolerance to famciclovir, including in patients with reduced immunity. Cases of headache and nausea were reported, however, these phenomena were mild or moderate and were observed with the same frequency in patients receiving placebo. Other adverse events (AEs) were identified in clinical practice when using the drug in the post-registration period. AEs reported in clinical trials in immunocompromised patients coincided with those observed in patients with normal immunity. The World Health Organization (WHO) criteria were used to assess the incidence of adverse reactions: very often (> 1/10) often (from> 1/100, <1/10) infrequently (> 1/1000, <1/100) rarely (> 1/10000, <1/1000) is very rare (<1/10000), the frequency is unknown. Disorders from the blood and lymphatic system: rarely – thrombocytopenia Mental disorders: infrequently – confusion (mainly in elderly patients) rarely – hallucinations Disorders from the nervous system: very often – headache, often – dizziness, infrequently – drowsiness (mainly in elderly patients), frequency unknown – cramps * Disorders from the heart: rarely – sensation of a heartbeat Disorders from the gastrointestinal tract: often – nausea, vomiting, abdominal pain, diarrhea Disorders from the liver and biliary tract: rarely – cholestatic jaundice Disorders from the immune system: frequency unknown – anaphylactic shock *, anaphylactic reaction * Disorders from the skin and skin tissue: often – a rash, itching infrequently – angioedema (swelling of the face, eyelids, periorbital region, pharynx), urticaria, frequency unknown – severe skin reactions * (including erythema multiforme, Steven-Johnson syndrome, Lyell’s syndrome (toxic epidermal necrolysis), allergic vasculitis). Laboratory and instrumental data: often – impaired liver function indicators * – AEs not observed during clinical trials, identified in post-marketing observations, as well as described in the literature. Since information on AE data was obtained by the method of spontaneous reporting and the exact number of patients taking the drug was not determined, it is not possible to estimate the frequency of occurrence of these reactions, and therefore, frequency is unknown is indicated for AE data aggravated, or you notice any other side effects not listed in the instructions, notify your doctor. Drug Interactions Concomitant use with probenecid may lead to an increase in the concentration of penciclovir in blood plasma. To prevent the development of toxic reactions, patients receiving Favirox 500 mg at the same time as probenecid should be monitored, given the possibility of reducing the dose of famciclovir. There were no clinically significant changes in the pharmacokinetic parameters of penciclovir when it was used once (at a dose of 500 mg) immediately after taking antacids (magnesium and aluminum hydroxide) or in patients who had previously been treated with allopurinol, cimetidine, theophylline, zidovudine, promethazine (multiple doses ) With a single dose of famciclovir (at a dose of 500 mg) together with emtricitabine or zidovudine, no pharmacokinetic parameters of penciclovir, zidovudine, a metabolite of zidovudine (zidovudine glucuronide), and emtricitabine were detected. With a single and multiple use of famciclovir (at a dose of 500 mg 3 times a day), no changes in the pharmacokinetic parameters of penciclovir and digoxin were observed with digoxin. considering Since the conversion of the inactive metabolite of 6-deoxypenciclovir (formed during the deacetylation of famciclovir) to penciclovir is catalyzed by the aldehyde oxidase enzyme, drug interaction may occur when using the drug Favirox along with drugs metabolized by this enzyme or inhibiting its activity. When using famciclovir together with cimetidine and promethazine, which are inhibitors of aldehyde oxidase in vitro, there was no violation of the formation of penciclovir from famciclovir. However, when taking famciclovir together with a powerful in vitro aldehyde oxidase inhibitor, raloxifene, there may be a disruption in the formation of penciclovir from famciclovir, and as a result, a decrease in the effectiveness of famciclovir. It is necessary to evaluate the clinical efficacy of antiviral therapy while using raloxifene. Given that famciclovir is a weak inhibitor of aldehydroxidase in vitro, its effect on the pharmacokinetic parameters of drugs metabolized by this enzyme is possible. In experimental studies, famciclovir did not have an inducing effect on the cytochrome P450 system and did not inhibit the CYP3A4 enzyme. Overdose There is limited evidence of an overdose of famciclovir. Cases of overdose of famciclovir (10.5 g) have been described and have not been accompanied by clinical manifestations. Treatment: symptomatic and supportive. In cases of non-compliance with the recommendations to reduce the dose of famciclovir taking into account the renal function in patients with kidney diseases, cases of acute renal failure have rarely been reported. Penciclovir, an active metabolite of famciclovir, It is excreted during hemodialysis. The concentration of penciclovir in plasma is reduced by 75% after hemodialysis for 4 hours. Storage conditions Store at a temperature not exceeding 25 ° C in the original packaging. Term hodnosty 2 years Active ingredient Famciclovir s14 zptu Form of Treatment tablets
