Universal reference book for medicines
Product name: FAMVIR ® (FAMVIR ® )

Active substance: famciclovir

Type: Antiviral drug

Manufacturer: NOVARTIS PHARMA (Switzerland) produced NOVARTIS FARMACEUTICA (Spain) promotion in the Russian Federation DR.REDDY`S LABORATORIES (India)
Composition, form of production and packaging
The tablets covered with a cover of
white color, round, biconcave, with bevelled edges, with engraving "FV" on one side and "125" - on another.

1 tab.

famciclovir 125 mg

Excipients: hydroxypropylcellulose, lactose anhydrous, sodium starch glycolate, magnesium stearate.

Sheath composition: hypromellose, titanium dioxide, polyethylene glycol 4000 (macrogol), polyethylene glycol 6000 (macrogol).

7 pcs.
- blisters (1) - packs of cardboard.
7 pcs.
- blisters (2) - packs of cardboard.
7 pcs.
- blisters (3) - packs of cardboard.
7 pcs.
- blisters (4) - packs of cardboard.
10 pieces.
- blisters (1) - packs of cardboard.
10 pieces.
- blisters (2) - packs of cardboard.
10 pieces.
- blisters (3) - packs of cardboard.
10 pieces.
- blisters (4) - packs of cardboard.
The tablets covered with a cover of white color, round, biconcave, with bevelled edges, with engraving "FV" on one side and "250" on the other.

1 tab.

famciclovir 250 mg

Excipients: hydroxypropylcellulose, lactose anhydrous, sodium starch glycolate, magnesium stearate.

Sheath composition: hypromellose, titanium dioxide, polyethylene glycol 4000 (macrogol), polyethylene glycol 6000 (macrogol).

7 pcs.
- blisters (1) - packs of cardboard.
7 pcs.
- blisters (2) - packs of cardboard.
7 pcs.
- blisters (3) - packs of cardboard.
7 pcs.
- blisters (4) - packs of cardboard.
10 pieces.
- blisters (1) - packs of cardboard.
10 pieces.
- blisters (2) - packs of cardboard.
10 pieces.
- blisters (3) - packs of cardboard.
10 pieces.
- blisters (4) - packs of cardboard.
The tablets covered with a cover of white color, oval, biconcave, with bevelled edges, with engraving "FV500" on one side.

1 tab.

famciclovir 500 mg

Excipients: hydroxypropylcellulose, lactose anhydrous, sodium starch glycolate, magnesium stearate.

Sheath composition: hypromellose, titanium dioxide, polyethylene glycol 4000 (macrogol), polyethylene glycol 6000 (macrogol).

3 pcs.
- blisters (1) - packs of cardboard.
3 pcs.
- blisters (2) - packs of cardboard.
3 pcs.
- blisters (3) - packs of cardboard.
3 pcs.
- blisters (4) - packs of cardboard.
7 pcs.
- blisters (1) - packs of cardboard.
7 pcs.
- blisters (2) - packs of cardboard.
7 pcs.
- blisters (3) - packs of cardboard.
7 pcs.
- blisters (4) - packs of cardboard.
10 pieces.
- blisters (1) - packs of cardboard.
10 pieces.
- blisters (2) - packs of cardboard.
10 pieces.
- blisters (3) - packs of cardboard.
10 pieces.
- blisters (4) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.

The product description was approved by the manufacturer for the 2009 print edition.

PHARMACHOLOGIC EFFECT

Antiviral drug.
After oral administration, famciclovir rapidly turns into penciclovir, which has activity against human herpes viruses, including the Varicella zoster virus and herpes simplex types 1 and 2 (labial and genital herpes simplex virus), as well as the Epstein-Barr virus and cytomegalovirus .
Penzyclovir enters the virus-infected cells, where, under the action of viral thymidine kinase, it rapidly converts to monophosphate, which in turn, with the participation of cellular enzymes, turns into triphosphate.
Penciclovir triphosphate is found in virus-infected cells for more than 12 hours, suppressing the replication of viral DNA in them.
The concentration of penciclovir triphosphate in uninfected cells does not exceed the minimum determined, therefore in therapeutic concentrations penciclovir does not affect uninfected cells.

Penciclovir is active against recently detected aciclovir-resistant strains of the Herpes simplex virus with altered DNA polymerase.

The incidence of resistance to famciclovir (penciclovir) does not exceed 0.3%, in patients with impaired immunity it is 0.19%.

Resistance was detected at the beginning of treatment and did not develop during treatment or after the termination of therapy.
It has been shown that famciclovir significantly reduces the severity and duration of postherpetic neuralgia in patients with herpes zoster .
It has been shown that in patients with impaired immunity due to HIV infection, famciclovir 500 mg 2 times / day reduces the number of days of isolating the herpes simplex virus (with or without clinical manifestations).

PHARMACOKINETICS

Suction

After oral administration, famciclovir is rapidly and almost completely absorbed and rapidly converted to active penciclovir.
Bioavailability of penciclovir after oral administration of Famvir is 77%. C max penciclovir after oral administration at doses of 125 mg, 250 mg or 500 mg of famciclovir is achieved on average 45 minutes and is 0.8 μg / ml, 1.6 μg / ml and 3.3 μg / ml, respectively.
Distribution

Pharmacokinetic curves "concentration-time" coincide with a single administration of famciclovir and when dividing the daily dose by 2 or 3 doses.

The binding to plasma proteins of penciclovir and its 6-deoxy precursor is less than 20%.

At repeated receptions of a preparation of a cumulation it is not noted.

Excretion

T 1/2 of penciclovir from the plasma in the final phase after taking single and repeated doses is about 2 hours.

Famciclovir is excreted mainly in the form of penciclovir and its 6-deoxy progenitor, which are excreted in the urine unchanged;
famciclovir in the urine is not detected.
INDICATIONS

- infections caused by the virus Varicella zoster (herpes zoster), including ophthalmoherpes and postherpetic neuralgia;

- infections caused by the Herpes simplex virus (type 1 and 2): primary infection, exacerbation of chronic infection, suppression of recurrent infection (for prevention of exacerbations);

- infections caused by the viruses Varicella zoster and Herpes simplex (type 1 and 2) in patients with reduced immunity.

DOSING MODE

The drug is taken orally, regardless of food intake, without chewing, washing with water.

Infections caused by the Varicella zoster virus in patients with normal immunity

The recommended dose is 250 mg 3 times / day, or 500 mg 2 times / day, or 750 mg 1 time / day, for 7 days (acute phase of the disease).
When ophthalmoherpes the recommended dose is 500 mg 3 times / day for 7 days. To reduce the duration and frequency of postherpetic neuralgia, the recommended dose is 250-500 mg 3 times / day for 7 days.
Infections caused by the Varicella zoster virus in patients with reduced immunity

The recommended dose is 500 mg 3 times / day for 10 days.

Infections caused by the Herpes simplex virus type 1 and 2, in patients with normal immunity

With the primary infection, the recommended dose is 250 mg 3 times / day for 5 days.
Treatment should be started as soon as possible, immediately after the appearance of the first symptoms of the disease.
With recurrences of chronic infection, adults are prescribed 125 mg twice daily for 5 days.
Treatment should begin already in the prodromal period or immediately after the onset of symptoms of the disease.
Infections caused by the Herpes simplex virus type 1 and 2, in patients with reduced immunity

The recommended dose is 500 mg 2 times / day for 7 days.
Treatment should be started as soon as possible, immediately after the appearance of the first symptoms of the disease.
As a suppressive therapy for recurrent herpetic infection 250 mg 2 times / day are prescribed.
The duration of therapy depends on the severity of the disease. It is recommended that the drug be given a periodic withdrawal every 12 months to assess possible changes in the course of the disease. In HIV-infected patients, theeffective dose is 500 mg 2 times / day.
Patients of advanced age .
If the renal function is preserved, the dose of famciclovir does not change.
Patients with impaired renal function .
In patients with impaired renal function, there is a decrease in clearance of penciclovir.
An adequate correction of the dosing regimen is recommended depending on the CK:

Infections caused by the Varicella zoster virus (regardless of the patient's immune status)

KK (ml / min / 1.73 m 2 ) Dosing regimen

• 40 250 mg / 500 mg 3 times / day or 500 mg 2 times / day

30-39 250 mg 2 or 3 times / day

10-29 125 mg 2 or 3 times / day

Infections caused by the Herpes simplex virus, in patients with normal immunity

- the first episode

KK (ml / min / 1.73 m 2 ) Dosing regimen

? 30 250 mg 3 times / day

10-29 125 mg 3 times / day

- recurrent infection

KK (ml / min / 1.73 m 2 ) Dosing regimen

? 10 125 mg 3 times / day

Infections caused by the Herpes simplex virus, in patients with reduced immunity

KK (ml / min / 1.73 m 2 ) Dosing regimen

? 40 500 mg 2 times / day

30-39 250 mg 2 times / day

10-29 125 mg 2 times / day

Suppressive therapy for recurrent herpetic infection

KK (ml / min / 1.73 m 2 ) Dosing regimen

? 30 250 mg 2 times / day

10-29 125 mg 2 times / day

Patients with renal insufficiency who are on hemodialysis.
Since after 4 h of hemodialysis the concentration of penciclovir in the plasma is reduced by approximately 75%, the drug should be taken immediately after the procedure of hemodialysis. The recommended dose is 250 mg (for patients with herpes zoster) and 125 mg (for patients with genital herpes).
Patients with violations of the function of the liver dose adjustment is not required.

SIDE EFFECT

In clinical trials, Famvir's good tolerability is shown, including.
in patients with reduced immunity. Cases of headache and nausea have been reported, but these events were mild or moderate and were noted with the same frequency in patients receiving a placebo.
Below are the undesirable reactions and the frequency of their occurrence, based on data on spontaneous reports, as well as cases described in the literature, for the entire period during which Famvir is applied in clinical practice.
The adverse events reported in clinical trials in patients with reduced immunity coincided with those observed in patients with normal immunity.
To assess the incidence of adverse reactions, the following criteria were used: very often (> 1/10);
often (from> 1/100, <1/10); sometimes (> 1/1000, <1/100); rarely (> 1/10000, <1/1000); very rarely (<1/10000), including individual messages.
From the hemopoietic system: very rarely - thrombocytopenia.

From the side of the central nervous system: rarely - headache, confusion (mainly in elderly patients);
very rarely - dizziness, drowsiness (mainly in elderly patients), hallucinations.
From the digestive system: rarely - nausea;
very rarely vomiting, jaundice.
Dermatological reactions: very rarely - rash, itching, severe skin reactions.

Allergic reactions: very rarely - hives, severe skin reactions (including erythema multiforme).

CONTRAINDICATIONS

- hypersensitivity to famciclovir or any of the components of the drug;

- hypersensitivity to penciclovir.

PREGNANCY AND LACTATION

Because Famvir's safety in pregnant and lactating women has not been studied, its use in pregnancy and lactation is not recommended unless the possible benefits of treatment exceed the potential risk.

It is not known whether penciclovir is excreted in human milk.

Famciclovir does not have a pronounced effect on spermogram, morphology or motility of human spermatozoa.

In experimental studies, embryotoxic and teratogenic effects of famciclovir and penciclovir have not been revealed.

Studies on rats administered famciclovir orally showed that penciclovir is excreted in breast milk.

A decrease in fertility was noted in the experimental model in male rats receiving famciclovir at a dose of 500 mg / kg of body weight, in female rats, a pronounced decrease in fertility was not observed.

APPLICATION FOR FUNCTIONS OF THE LIVER

Patients with impaired renal function .
In patients with impaired renal function, there is a decrease in clearance of penciclovir.
An adequate correction of the dosing regimen is recommended depending on the QC



APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS

Patients with impaired liver function.
In patients with liver disease in the stage of compensation, dose adjustment is not required. Data on the use of famciclovir in severe decompensated chronic liver diseases are absent, so there are no precise recommendations for dosing famciclovir in this category of patients.
APPLICATION FOR CHILDREN

The effectiveness and safety of Famvir in children is not established.
Thus, famciclovir is not recommended in children, except when the expected benefit of the treatment justifies the potential risk associated with the use of the drug.
APPLICATION IN ELDERLY PATIENTS

Patients of advanced age .
If the renal function is preserved, the dose of famciclovir does not change.
SPECIAL INSTRUCTIONS

Treatment should be started immediately after diagnosis.

Caution should be exercised in the treatment of patients with impaired renal function, which may require correction of the dosing regimen.

Special precautions in elderly patients are not required.

Genital herpes is a sexually transmitted disease.
During relapse, the risk of infection increases. In the presence of clinical manifestations of the disease, even in the case of the initiation of antiviral treatment, patients should avoid sexual contact.
During the maintenance treatment with antiviral agents, the frequency of the spread of the viral infection is significantly reduced, but the risk of transmission of infection theoretically exists.
Therefore, patients should take appropriate protective measures during sexual intercourse.
The tablets of the drug 125 mg, 250 mg and 500 mg include lactose (26.9 mg, 53.7 mg and 107.4 mg respectively).
Famvir should not be used in patients with rare hereditary disorders associated with intolerance to galactose, severe lactase deficiency, or glucose-galactose malabsorption.
Carried doses of Famvir and duration of treatment.
Famvir was well tolerated in the treatment of infection caused by the virus Varicella zoster, when applied at a dose of 750 mg 3 times / day for 7 days; in patients with genital herpes when using the drug in a dose of 750 mg 3 times / day for 5 days and at a dose of up to 500 mg 3 times / day for 10 days. It was also shown that the drug was well tolerated when taken 250 mg 3 times / day for 12 months to treat genital herpes. Famvir was well tolerated in patients with reduced immunity in the treatment of infection caused by the Varicella zoster virus, when taken 500 mg 3 times / day for 10 days, as well as infections caused by Herpes simplex viruses, when taken up to 500 mg 2 times / day for 7 days or 500 mg 2 times / day for 8 weeks.
Use in Pediatrics

The effectiveness and safety of Famvir in children is not established.
Thus, famciclovir is not recommended in children, except when the expected benefit of the treatment justifies the potential risk associated with the use of the drug.
Impact on the ability to drive vehicles and manage mechanisms

It is not expected that Famvir will influence the ability of patients to drive a car and other mechanisms, but patients who experience dizziness, drowsiness, confusion, or other CNS abnormalities should not refrain from driving a car or controlling the mechanisms during the use of the drug.

OVERDOSE

The described cases of overdose (10.5 g) of Famvir were not accompanied by clinical manifestations.

Treatment: symptomatic and maintenance therapy.
If the recommendations for diminishing the dose of famciclovir are not taken into account, taking into account the kidney function in patients with kidney diseases, cases of acute renal failure are noted.
Penciclovir is excreted by hemodialysis.
Concentrations of penciclovir in plasma are reduced by 75% after hemodialysis for 4 hours.
DRUG INTERACTION

Clinically significant pharmacokinetic interaction of famciclovir with other drugs was not noted.
No effect of famciclovir on the cytochrome P450 system was detected.
Drugs that block tubular secretion can increase the concentration of penciclovir in plasma.

In the course of the clinical studies, no interaction of zidovudine and famciclovir was observed during their joint administration.

TERMS OF RELEASE FROM PHARMACY

The drug is released by prescription.

TERMS AND CONDITIONS OF STORAGE

The drug should be stored out of reach of children at a temperature of no higher than 30 ° C.
Shelf life - 3 years.
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