Product Overview
Composition
Each 500 mg film-coated tablet contains:
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,
colloidal anhydrous silicon dioxide - 6.80 mg,
stearic acid - 6.80 mg;
film coating :
Opadry white OY-S-28924 (hypromellose-5cP - 7.48 mg, titanium dioxide - 4.08 mg, hypromellose-15cP - 2.48 mg, macrogol-4000 - 1.48 mg, macrogol-6000 - 1.48 mg) - 17.00 mg.
pharmachologic effect
ATX:
Famciclovir is a prodrug. After oral administration, famciclovir is rapidly and almost completely absorbed and rapidly converted into the pharmacologically active metabolite - penciclovir.
After taking a single and repeated doses of famciclovir, there is a linear relationship between a decrease in plasma clearance, renal clearance, the rate of release of penciclovir from blood plasma and the degree of impaired renal function.
When using famciclovir (single or multiple doses of 500 mg 1, 2 or 3 times a day), the pharmacokinetic parameters of the drug in healthy black volunteers and black patients with impaired renal or liver function did not differ from those in Caucasians.
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 recurrence of genital herpes in immunocompetent patients;
- treatment of recurrent 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 recurrent orolabial herpes in immunocompromised patients.
Application during pregnancy and lactation
Contraindications
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Hypersensitivity to famciclovir or any of the components of the drug. Hypersensitivity to penciclovir.
-
Children under 18 years of age due to the lack of data on efficacy and safety in patients of this age category.
-
Severe liver dysfunction due to the lack of data on efficacy and safety in patients of this category.
Caution should be exercised when treating patients with impaired renal function, for whom a dosage adjustment may be required.
Special precautions are not required in elderly patients and patients with mild to moderate hepatic impairment.
Side effects
Interaction
How to take, course of administration and dosage
The drug should be taken orally, regardless of food intake, without chewing, drinking water. Treatment with the drug should be started as early as possible, immediately after the first symptoms of the disease appear (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 (labial or genital herpes) infection in immunocompetent patients:
- For the first episode of genital herpes, the recommended dose is 250 mg 3 times a day for 5 days;
- In case of recurrence 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 is prescribed, followed by 3 doses of 250 mg every 12 hours.
- With relapses of labial herpes - 1500 mg once a day for 1 day or 750 mg 2 times a day for 1 day.
HSV (orolabial or genital herpes) infection in immunocompromised patients:
The recommended dose is 500 mg 2 times a day for 7 days.
For the prevention of exacerbations of genital herpes (suppressive therapy), 250 mg is used 2 times a day. 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 ≥ 65 years of age
In elderly patients with normal renal function, dosage adjustment of famciclovir is not required.
Patients with impaired renal function
In patients with impaired renal function, there is a decrease in the clearance of penciclovir.
Recommendations for adjusting the dosage regimen in immunocompetent patients with impaired renal function, depending on creatinine clearance, are presented in Table 1.
Recommendations for adjusting the dosage regimen in immunocompromised 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 (herpes zoster) infection | ||
Dosage regimen | Creatinine clearance | Corrected dosing regimen |
500 mg 3 times a day for 7 days
| ≥ 60 | 500 mg 3 times a day for 7 days |
40-59 | 500 mg 2 times a day for 7 days | |
20-39 | 500 mg once a day for 7 days | |
<20 | 250 mg once a day for 7 days | |
Patients on hemodialysis or receiving a hemodialysis procedure | 250 mg after each dialysis session for 7 days | |
HSV infection | ||
Genital herpes, first episode | ||
250 mg 3 times a day for 5 days | ≥ 40 | 250 mg 3 times a day for 5 days |
20-39 | 250 mg 2 times a day for 5 days | |
<20 | 250 mg once a day for 5 days | |
Patients on hemodialysis or receiving a hemodialysis procedure | 250 mg after each dialysis session for 5 days | |
With relapses of genital herpes | ||
1000 mg 2 times a day for 1 day | ≥ 60 | 1000 mg 2 times a day for 1 day |
40-59 | 500 mg 2 times a day for 1 day | |
20-39 | 500 mg once | |
<20 | 250 mg once | |
Patients on hemodialysis or receiving a hemodialysis procedure | 250 mg once after dialysis session | |
125 mg 2 times a day for 5 days | ≥ 20 | 125 mg 2 times a day for 5 days |
<20 | 125 mg once a day for 5 days | |
Patients on hemodialysis or receiving a hemodialysis procedure | 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 |
20-39 | 250 mg once, followed by 3 doses of 250 mg every 12 hours | |
<20 | 250 mg once, followed by 250 mg the next day | |
Patients on hemodialysis or receiving a hemodialysis procedure | 250 mg once after 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 |
20-39 | 125 mg 2 times a day | |
<20 | 125 mg once a day | |
Patients on hemodialysis or receiving a hemodialysis procedure | 125 mg after each dialysis session | |
Labial herpes | ||
1500 mg once | ≥ 60 | 1500 mg once |
40-59 | 750 mg once | |
20-39 | 500 mg once | |
<20 | 250 mg once | |
Patients on hemodialysis or receiving a hemodialysis procedure | 250 mg once after dialysis session | |
750 mg 2 times a day | ≥ 60 | 750 mg 2 times a day for 1 day |
40-59 | 750 mg once | |
20-39 | 500 mg once | |
<20 | 250 mg once | |
Patients on hemodialysis or receiving a hemodialysis procedure | 250 mg once after dialysis session |
Table 2. Correction of the dosage regimen in immunocompromised patients with impaired renal function
VZV (herpes zoster) infection | ||
Dosage regimen | Creatinine clearance | Corrected dosing regimen |
500 mg 3 times a day for 10 days | ≥ 60 | 500 mg 3 times a day for 10 days |
40-59 | 500 mg 2 times a day for 10 days | |
20-39 | 500 mg once a day for 10 days | |
<20 | 250 mg once a day for 10 days | |
Patients on hemodialysis or receiving a hemodialysis procedure | 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 |
20-39 | 500 mg once a day for 7 days | |
<20 | 250 mg once a day for 7 days | |
Patients on hemodialysis or receiving a hemodialysis procedure | 250 mg after each dialysis session for 7 days |
Patients with renal impairment who are on hemodialysis or receiving a hemodialysis procedure
Since after a 4-hour hemodialysis, the plasma concentration of penciclovir is reduced by 75%, famciclovir should be taken immediately after the hemodialysis procedure. The recommended dose adjustment regimen is described in Tables 1 and 2.
Patients with impaired liver function
For patients with mild to moderate hepatic impairment, dose adjustment is not required.
There is no experience of using the drug in patients with severe liver dysfunction.
Black patients
The efficacy of a one-day administration of famciclovir at a dose of 1000 mg 2 times a day for the treatment of recurrent genital herpes in immunocompetent black patients did not exceed that for placebo. The clinical significance of dosing regimens for the treatment of both recurrent genital herpes (within 2 or 5 days) and other infections caused by VZV and HSV is unknown.