Famvir, tbl p/o 250 mg No. 21 (Novartis, United Kingdom of Great Britain and Northern Ireland)

Famvir®

Suction

Famciclovir is a prodrug. After oral administration, famciclovir is rapidly and almost completely absorbed and quickly converted into a pharmacologically active metabolite, penciclovir. The bioavailability of penciclovir after oral administration of famciclovir is 77%.

The increase in the concentration of penciclovir in the blood plasma occurs in proportion to the increase in a single dose of famciclovir in the range of 125-1000 mg.

According to the study, the maximum concentration (Cmax) of penciclovir after oral administration of 125 mg, 250 mg, 500 mg or 750 mg of famciclovir is achieved on average after 45 minutes and averages 0.8 mcg/ml, 1.6 mcg/ml and 3. 3 μg/ml and 5.1 μg/ml, respectively.

In another study, the Cmax of penciclovir after oral administration of 250 mg, 500 mg, or 1000 mg famciclovir was 1.5 μg/ml, 3.2 μg/ml, and 5.8 μg/ml, respectively.

Systemic bioavailability (area under the pharmacokinetic concentration-time curve - AUC) of penciclovir does not change when administered concomitantly with food.

The AUC of penciclovir with a single dose of famciclovir and when dividing the daily dose of the drug into two or three doses are the same, which indicates the absence of accumulation of penciclovir with repeated use of famciclovir.

Distribution

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

Metabolism and excretion

After oral administration, famciclovir is quickly and completely converted into a pharmacologically active metabolite, penciclovir, and is then excreted mainly in the form of penciclovir and its 6-deoxy precursor, which are excreted by the kidneys; unchanged famciclovir is not detected in the urine. The half-life (T1/2) of penciclovir from blood plasma in the final phase after taking a single and repeated doses is about 2 hours.

Pharmacokinetics in special cases

Patients with VZV infection

In patients with uncomplicated VZV infection, no significant changes in the pharmacokinetic parameters of penciclovir are detected (T1/2 in the final phase after taking single and repeated doses of famciclovir is 2.8 and 2.7 hours, respectively).

Patients with impaired renal function

After taking single and repeated doses of famciclovir, there is a linear relationship between a decrease in plasma clearance, renal clearance, the rate of elimination of penciclovir from blood plasma and the degree of renal dysfunction.

Patients with liver dysfunction

In patients with mild to moderate hepatic impairment, there is no increase in the AUC of penciclovir.

The pharmacokinetics of penciclovir in patients with severe hepatic impairment has not been studied. The conversion of famciclovir to the active metabolite penciclovir may be impaired in this group of patients, leading to a decrease in penciclovir plasma concentrations and, as a consequence, a decrease in the effectiveness of famciclovir.

Patients aged ≥ 65 years

Patients aged 65 to 79 years have an approximately 40% increase in mean penciclovir AUC and an approximately 20% decrease in penciclovir renal clearance compared with persons younger than 65 years. These pharmacokinetic characteristics of penciclovir may be partly due to age-related changes in renal function in patients over 65 years of age. No dose adjustment is required in patients of this age group in the absence of renal dysfunction.

Floor

The gender of the patient does not have a significant effect on the pharmacokinetic parameters of the drug (slight differences in the clearance of penciclovir in men and women). No dose adjustment is required depending on gender.

Race

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.

Famvir film-coated tablets 250 mg No. 21

Instructions for medical use of the drug Famvir® Registration number: ND 42-13102-04 Trade name : Famvir® International nonproprietary name (INN): famciclovir Dosage form: film-coated tablets Composition: 1 tablet contains: active ingredient – ​​famciclovir 125 mg, 250 mg or 500 mg; excipients: sodium starch glycolate 8.26 mg, 16.52 mg, 27.35 mg, hydroxypropylcellulose 3.86 mg, 7.73 mg, 15.48 mg, magnesium stearate 1.24 mg, 2.48 mg, 4.1 mg; shell (Opadray OY-S – 28924): hypromellose 2.42 mg, 4.84 mg, 8.01 mg, titanium dioxide 0.99 mg, 1.98 mg, 3.28 mg, polyethylene glycol 4000 – 0.36 mg, 0.72 mg, 1.20 mg, polyethylene glycol 6000 – 0.36 mg, 0.72 mg, 1.20 mg. Film-coated tablets, 125 mg and 250 mg, contain anhydrous lactose (excipient) 26.85 mg and 53.69 mg. Description : Tablets 125 and 250 mg are white, round, biconvex, film-coated tablets with beveled edges, engraved “FV” on one side and “125” or “250” on the other. 500 mg tablets are white, oval, biconvex, film-coated tablets with beveled edges and engraved “FV500” on one side. Pharmacotherapeutic group: antiviral agent ATX code: J05AB09.

Pharmacological properties Pharmacodynamics After oral administration, famciclovir quickly converts to penciclovir, which has activity against human herpes viruses, including Varicella zoster virus and Herpes simplex types 1 and 2, as well as Epstein-Barr viruses and cytomegalovirus. Penciclovir enters virus-infected cells, where, under the action of viral thymidine kinase, it is quickly converted into monophosphate, which in turn turns into triphosphate. Penciclovir triphosphate inhibits the replication of viral DNA (deoxyribonucleic acid). The intracellular half-life of penciclovir triphosphate for cell cultures infected with Herpes simplex 1 is 10 hours; Herpes simplex 2-20 hours; Varicella zoster – 7 hours. The concentration of penciclovir triphosphate in uninfected cells does not exceed the minimum detectable level, therefore, at therapeutic concentrations, penciclovir has no effect on uninfected cells. As with acyclovir, resistance to penciclovir is most often associated with mutations in the viral thymidine kinase gene, leading to deficiency or impairment of the substrate specificity of the enzyme. Changes in the DNA polymerase gene are much less common. The use of the drug for the treatment of herpes zoster (caused by the Varicella zoster virus) in immunocompetent patients and patients with reduced immunity accelerates the healing of the skin and mucous membranes. Famciclovir is effective in treating various manifestations of ophthalmoherpes caused by the Varicella zoster virus. The drug significantly reduces the severity and duration of postherpetic neuralgia in patients with herpes zoster. One-day treatment with famciclovir in immunocompetent patients at a dose of 1500 mg once a day or 750 mg twice a day promotes rapid resolution of the manifestations of recurrent labial herpes (caused by the Herpes simplex virus). The use of the drug in immunocompetent patients at a dose of 1000 mg 2 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 the skin and mucous membranes in case of relapse of genital herpes (caused by Herpes simplex virus). Famciclovir at a dose of 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 infection with the human immunodeficiency virus (HIV). In HIV-infected patients, the drug at a dose of 500 mg 2 times a day for 7 days accelerates the healing of the skin and mucous membranes during relapse of genital herpes, and also reduces the number of days of shedding of the Herpes simplex virus (both with and without clinical manifestations). The use of famciclovir in patients with compromised immunity due to other reasons has not been studied. The effectiveness of 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 of placebo. The safety profile of one-day administration of the drug at a dose of 1000 mg 2 times a day in this category of patients was similar to that previously established. Pharmacokinetics Absorption Famciclovir is a prodrug. After oral administration, famciclovir is rapidly and almost completely absorbed and quickly converted into a pharmacologically active metabolite, penciclovir. The bioavailability of penciclovir after taking Famvir orally is 77%. The increase in plasma concentrations of penciclovir occurs in proportion to the increase in a single dose of famciclovir in the range of 125-1000 mg. According to the study, the maximum concentration (Cmax) of penciclovir after oral administration of 125 mg, 250 mg or 500 mg of famciclovir is achieved on average after 45 minutes and averages 0.8 mcg/ml, 1.6 mcg/ml and 3.3 mcg/ml, respectively. Another study demonstrates the maximum concentration (Cmax) of penciclovir after oral administration of 250 mg, 500 mg or 1000 mg famciclovir at values ​​of 1.5 µg/ml, 3.2 µg/ml and 5.8 µg/ml, respectively. Systemic bioavailability (area under the concentration-time curve -AUC) of penciclovir is independent of the timing of meals. The AUC of penciclovir with a single dose of famciclovir and when dividing the daily dose of the drug into two or three doses are the same, which indicates the absence of accumulation of penciclovir with repeated use of famciclovir. Metabolism After oral administration, famciclovir is quickly and completely converted into a pharmacologically active metabolite, penciclovir. Distribution Plasma protein binding of penciclovir and its 6-deoxy precursor is less than 20%. Elimination Famciclovir is excreted primarily in the form of penciclovir and its 6-deoxy precursor, which are excreted unchanged through the kidneys; famciclovir is not detected in urine. The half-life (T1/2) of penciclovir from plasma in the final phase after taking a single and repeated doses is about 2 hours. Pharmacokinetics in special cases Patients with infection caused by the Varicella zoster virus In patients with uncomplicated infection caused by the Varicella zoster virus, no significant changes in the pharmacokinetic parameters of penciclovir are detected (T1/2 of penciclovir from plasma in the final phase after taking single and repeated doses of famciclovir is 2.8 and 2.7 hours, respectively). Patients with impaired renal function After taking single and repeated doses of famciclovir, there is a linear relationship between a decrease in plasma clearance, renal clearance, the rate of elimination of penciclovir from blood plasma and the degree of renal impairment. The pharmacokinetic features of the drug in patients with severe (decompensated) renal impairment have not been studied. Patients with impaired liver function In patients with mild to moderate hepatic impairment, there is no increase in the AUC value of penciclovir. The pharmacokinetics of penciclovir in patients with severe hepatic impairment has not been studied. The conversion of famciclovir to the active metabolite penciclovir may be impaired in this group of patients, leading to a decrease in penciclovir plasma concentrations and, as a consequence, a decrease in the effectiveness of famciclovir. Patients aged ≥65 years Patients aged 65 to 70 years have an approximately 40% increase in mean penciclovir AUC and an approximately 20% decrease in penciclovir renal clearance compared with persons younger than 65 years. These pharmacokinetic characteristics of penciclovir may be partly due to age-related changes in renal function in patients over 65 years of age. Gender The gender of the patient does not have a significant effect on the pharmacokinetic parameters of the drug (slight differences in the clearance of penciclovir in men and women). Race 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 for use Infections caused by the Varicella zoster virus (herpes zoster), including ophthalmic herpes; to reduce the risk of occurrence and duration of postherpetic neuralgia; Infections caused by the Herpes simplex virus type I and II: treatment of the primary infection; treatment and prevention of exacerbations of chronic infection; Infections caused by Varicella zoster and Herpes simplex viruses type I and II (labial and genital) in patients with reduced immunity. Contraindications Hypersensitivity to famciclovir or any of the components of the drug. Hypersensitivity to penciclovir. Caution: Caution should be exercised when treating patients with impaired renal function, for whom dosage adjustment may be required. No special precautions are required in elderly patients and patients with impaired liver function. There is no experience with the use of the drug in patients with severe (decompensated) liver dysfunction. Use during pregnancy and breastfeeding Experimental studies have not revealed the embryotoxic and teratogenic effects of famciclovir and penciclovir. However, since there is insufficient data on the safety of using Famvir in pregnant and lactating women, its use during pregnancy and lactation is possible only if the benefit of therapy for the mother outweighs the potential risk for the fetus and child. In experimental studies on animals when using famciclovir (orally), penciclovir was excreted in breast milk. It is not known whether penciclovir is excreted into breast milk in humans. Method of administration and dosage The drug should be taken orally, regardless of food intake, without chewing, with water. Treatment with the drug should begin as early as possible, immediately after the first symptoms of the disease appear (tingling, itching and burning). Infection caused by the Varicella zoster virus (herpes zoster) in patients with normal immunity. The recommended dose is 500 mg 3 times a day for 7 days. This method of use can reduce the duration of postherpetic neuralgia. In the acute phase of the disease, it is recommended to resolve skin manifestations; the dose is 250 mg 3 times a day or 500 mg 2 times a day or 750 mg 1 time a day for 7 days. Ophthalmoherpes caused by the Varicella zoster virus in patients with normal immunity. The recommended dose is 500 mg 3 times a day for 7 days. Infection caused by the Varicella zoster virus (herpes zoster) in immunocompromised patients. The recommended dose is 500 mg 3 times a day for 10 days. Infection caused by the Herpes simplex virus (labial or genital herpes), in patients with normal immunity: for primary infection of genital herpes, the recommended dose is 250 mg 3 times a day for 5 days; for relapses of genital herpes, 1000 mg is prescribed 2 times a day for 1 day or 125 mg 2 times a day for 5 days or 500 mg once, followed by 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. Infection caused by the Herpes simplex virus (labial or genital herpes), in patients with reduced immunity: the recommended dose is 500 mg 2 times a day for 7 days. To prevent exacerbations of recurrent infection caused by the Herpes simplex virus (suppressive therapy), 250 mg is prescribed 2 times a day. The duration of therapy depends on the severity of the disease. 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 aged ≥65 years. In elderly patients with normal renal function, no adjustment of the famciclovir dosage regimen is required. Patients with renal failure undergoing hemodialysis. Since penciclovir plasma concentrations decrease by 75% after 4-hour hemodialysis, famciclovir should be taken immediately after the hemodialysis procedure. The recommended dose is 250 mg (for patients with herpes zoster) and 125 mg (for patients with genital herpes). Patients with impaired liver function. For patients with mild to moderate liver dysfunction, no dose adjustment is required. Negroid patients. The effectiveness of one-day administration of the drug Famvir at a dose of 1000 mg 2 times a day for the treatment of recurrent genital herpes in immunocompetent patients of the Negroid race did not exceed that for placebo. The clinical significance of drug dosing regimens for the treatment of both relapses of genital herpes (within 2 or 5 days) and other infectious lesions caused by the Varicella zoster and Herpes simplex viruses is unknown. Side effects Clinical studies have shown that Famvir is well tolerated, including in patients with reduced immunity. Cases of headache and nausea were reported, but these events were mild to moderate and occurred with the same frequency as in patients receiving placebo. The remaining adverse events (AEs) were identified as a result of post-marketing observations. Adverse events reported in clinical studies in immunocompromised patients were consistent with those reported in immunocompromised patients. To assess the frequency of adverse reactions, the following criteria were used: very often (≥1/10); often (from ≥1/100, <1/10); uncommon (≥1/1000, <1/100); rare (≥ 1/10000, <1/1000); very rare (<1/10000), frequency unknown. Blood and lymphatic system disorders: rarely – thrombocytopenia. Mental disorders: infrequently – confusion (mainly in elderly patients); rarely – hallucinations. Nervous system disorders: very often – headache; often - dizziness; uncommon – drowsiness (mainly in elderly patients). Cardiac disorders: rarely – palpitations. Gastrointestinal disorders: often – nausea, vomiting, abdominal pain, diarrhea. Disorders of the liver and biliary tract: rarely, cholestatic jaundice. Disorders of the skin and subcutaneous tissues: often – rash, itching; uncommon – angioedema (swelling of the face, eyelids, periorbital area, pharynx), urticaria; frequency unknown - severe skin reactions* (including exudative erythema multiforme, Stevens-Johnson syndrome, Lyell's syndrome (toxic epidermal necrolysis), leukocytoclastic vasculitis (allergic). Laboratory and instrumental data: often - abnormalities in liver function tests. * - AEs, not observed in clinical studies, identified in post-marketing observations, and also described in the literature. Overdose There is limited data on overdose with famciclovir. Treatment: symptomatic and supportive. If recommendations for reducing the dose of famciclovir are not followed, taking into account renal function in patients with kidney disease cases of acute renal failure have been rarely reported. Penciclovir, which is an active metabolite of famciclovir, is eliminated by hemodialysis. Plasma concentrations of penciclovir are reduced by 75% after hemodialysis for 4 hours. Interaction with other drugs and other types of interactions . Concomitant use with probenecid can lead to increasing the concentration of penciclovir in blood plasma. To prevent the development of toxic reactions and possible dose reduction, it is necessary to monitor patients receiving Famvir at a dose of 500 mg simultaneously with probenecid. There were no clinically significant changes in the pharmacokinetic parameters of penciclovir with its single use (at a dose of 500 mg) immediately after taking antacids (magnesium or aluminum hydroxide) or in patients who had previously received treatment (multiple doses) with allopurinol, cimetidine, theophylline, zidovudine, promethazine . With a single dose of famciclovir (at a dose of 500 mg) together with emtricitabine or zidovudine, no changes in the pharmacokinetic parameters of penciclovir, zidovudine, zidovudine metabolite (zidovudine glucuronide) and emtricitabine were detected. With single or repeated use of famciclovir (at a dose of 500 mg 3 times a day) together with digoxin, no changes in the pharmacokinetic parameters of penciclovir and digoxin were observed. Considering that the conversion of the inactive metabolite 6-deoxypenciclovir (formed during the deacetylation of famciclovir) into penciclovir is catalyzed by the enzyme aldehyde oxidase, drug interactions may develop when Famvir is used together with drugs that are metabolized with the participation of this enzyme or inhibit its activity. When famciclovir was used together with cimetidine and promethazine, which are aldehyde oxidase inhibitors in vitro, there was no decrease in the formation of penciclovir from famciclovir. However, when taking famciclovir together with a powerful in vitro aldehyde oxidase inhibitor, raloxifene, the formation of penciclovir from famciclovir may be reduced, and as a result, the effectiveness of famciclovir. It is necessary to evaluate the clinical effectiveness of antiviral therapy when used concomitantly with raloxifene. Considering that famciclovir is a weak inhibitor of aldehyde oxidase in vitro, it may influence the pharmacokinetic parameters of drugs metabolized with the participation of this enzyme. In experimental studies, famciclovir did not have an inducing effect on the cytochrome P450 system and did not inhibit the CYP3A4 isoenzyme. Special instructions Treatment should begin 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 therapy with antiviral drugs, the incidence of viral infection is significantly reduced, however, the risk of transmission of infection theoretically exists. Therefore, patients should take appropriate protective measures during sexual intercourse. Tablets of the drug 125 mg, 250 mg and 500 mg contain 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 galactose intolerance, severe lactase deficiency or glucose-galactose malabsorption. Famciclovir does not have a significant effect on the spermogram, morphology or motility of human sperm. Decreased fertility was noted in an experimental model in male rats treated with famciclovir at a dose of 500 mg/kg body weight; There was no significant decrease in fertility observed in female rats. Tolerable doses of Famvir and duration of treatment. Famvir was well tolerated in the treatment of Herpes Zoster when used at a dose of up to 750 mg 3 times a day for 7 days; in patients with genital herpes when used at a dose of up to 750 mg 3 times a day for 5 days and at a dose of up to 500 mg 3 times a day for 10 days. The drug was also shown to be well tolerated when given as suppressive therapy at a dose of 250 mg three times daily for 12 months for the treatment of genital herpes. Famvir was well tolerated in patients with reduced immunity when treating Varicella zoster when taken 500 mg 3 times a day for 10 days, as well as Herpes Simplex, when taken up to 500 mg 2 times a day for 7 days or 500 mg twice a day within 8 weeks. Effect on the ability to drive vehicles and operate machines. Famvir is not expected to affect the ability to drive vehicles and/or operate machines. However, patients who experience dizziness, drowsiness, confusion, or other disorders of the central nervous system while using Famvir. You should refrain from driving vehicles and/or operating machinery while using the drug. Release form Film-coated tablets, 125 mg, 250 mg, 7 or 10 pcs. in a blister. 1, 2, 3 or 4 blisters along with instructions for use in a cardboard box. Film-coated tablets, 500 mg, 3, 7 or 10 pcs. in a blister. 1, 2, 3 or 4 blisters along with instructions for use in a cardboard box. Storage conditions At a temperature not exceeding 25°C. Store in original packaging. The drug should be stored out of the reach of children. Shelf life: 3 years. The drug should not be used after the expiration date. Conditions for dispensing from pharmacies By prescription. Novartis Pharma AG, Switzerland, manufactured by Novartis Pharma AG, Switzerland, manufactured by Novartis Farmaceutica SA, Spain Address: Lichtstrasse 35, 4056 Basel, Switzerland Additional information about the drug can be obtained at the address: 125315, Moscow, Leningradsky Prospekt, building 72, building 3.
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Famvir

Use during pregnancy and breastfeeding

Since the safety of Famvir in pregnant and lactating women has not been studied, its use during pregnancy and lactation is not recommended unless the possible benefits of treatment outweigh the potential risks.
It is not known whether penciclovir is excreted into breast milk in humans.

Famciclovir does not have a significant effect on sperm count, morphology or motility of human sperm.

Experimental studies did not reveal the embryotoxic and teratogenic effects of famciclovir and penciclovir.

Studies in rats administered oral famciclovir have shown that penciclovir is excreted in breast milk.

A decrease in fertility was noted in an experimental model in male rats receiving famciclovir at a dose of 500 mg/kg body weight; in female rats, no pronounced decrease in fertility was noted.

Use for liver dysfunction

Patients with impaired liver function. In patients with liver diseases in the compensation stage, no dose adjustment is required. There are no data on the use of famciclovir in severe decompensated chronic liver diseases, therefore there are no exact recommendations on the dosage of famciclovir in this category of patients.

Use for renal impairment

Patients with impaired renal function. In patients with impaired renal function, a decrease in the clearance of penciclovir is observed.

Adequate adjustment of the dosage regimen is recommended depending on QC

Use in children

The effectiveness and safety of Famvir in children has not been established. Therefore, the use of famciclovir in children is not recommended unless the expected benefit of treatment justifies the potential risk associated with the drug.

Use in elderly patients

Elderly patients. Provided renal function is preserved, the famciclovir dosage regimen does not change.

special instructions

Treatment should begin immediately after diagnosis.

Caution should be exercised when treating patients with impaired renal function, for whom dosage adjustment may be required.

No special precautions are required in elderly patients.

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 maintenance treatment with antiviral drugs, the incidence of viral infection is significantly reduced, but the risk of transmission of infection theoretically exists. Therefore, patients should take appropriate protective measures during sexual intercourse.

Tablets of the drug 125 mg, 250 mg and 500 mg contain 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 galactose intolerance, severe lactase deficiency or glucose-galactose malabsorption.

Tolerable doses of Famvir and duration of treatment. Famvir was well tolerated in the treatment of infection caused by the Varicella zoster virus when used at a dose of 750 mg 3 times a day for 7 days; in patients with genital herpes when using the drug at a dose of up to 750 mg 3 times / day for 5 days and at a dose of up to 500 mg 3 times / day for 10 days. The drug was also shown to be well tolerated when administered at 250 mg three times daily for 12 months for the treatment of genital herpes. Famvir was well tolerated in patients with reduced immunity when treating infections caused by the Varicella zoster virus when taken 500 mg 3 times a day for 10 days, as well as infections caused by Herpes simplex viruses when taken up to 500 mg 2 times a day for 7 days or 500 mg 2 times a day for 8 weeks.

Use in pediatrics

The effectiveness and safety of Famvir in children has not been established. Therefore, the use of famciclovir in children is not recommended unless the expected benefit of treatment justifies the potential risk associated with the drug.

Impact on the ability to drive vehicles and operate machinery

Famvir is not expected to affect the ability of patients to drive a car or use other machinery, however, patients who experience dizziness, drowsiness, confusion or other central nervous system disorders while using Famvir should refrain from driving a car or operating machinery during the period of use of the drug.

Famvir, tbl p/o 250 mg No. 21 (Novartis, United Kingdom of Great Britain and Northern Ireland)

Compound.

Pharmachologic effect. Antiviral.

Method of administration and dose.

Inside,

regardless of food intake, without chewing, with water. Treatment with the drug should begin as early as possible, immediately after the first symptoms of the disease appear (tingling, itching and burning).

Infection caused by the Varicella zoster virus (herpes zoster) in patients with normal immunity.

The recommended dose is 500 mg 3 times a day for 7 days. This method of use can reduce the duration of postherpetic neuralgia. In the acute phase of the disease, to resolve skin manifestations, the recommended dose is 250 mg 3 times a day or 500 mg 2 times a day or 750 mg 1 time a day for 7 days.

Ophthalmoherpes caused by the Varicella zoster virus in patients with normal immunity.

The recommended dose is 500 mg 3 times a day for 7 days.

Infection caused by the Varicella zoster virus (herpes zoster) in immunocompromised patients.

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

Infection caused by the Herpes simplex virus (labial or genital herpes) in patients with normal immunity.

For primary genital herpes, the recommended dose is 250 mg 3 times a day for 5 days. For relapses of genital herpes, 1000 mg is prescribed 2 times a day for 1 day or 125 mg 2 times a day for 5 days or 500 mg once, followed by 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.

Infection caused by the Herpes simplex virus (labial or genital herpes) in patients with reduced immunity.

The recommended dose is 500 mg 2 times a day for 7 days.

To prevent exacerbations of recurrent infection caused by the Herpes simplex virus, suppressive therapy

- Prescribe 250 mg 2 times a day. The duration of therapy depends on the severity of the disease. 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 aged ≥65 years.

In elderly patients with normal renal function, no adjustment of the famciclovir dosage regimen is required.

Patients with impaired renal function.

In patients with impaired renal function, a decrease in the clearance of penciclovir is observed. Correction of the dosage regimen depending on Cl creatinine is presented in the tables.

Table 1

Correction of the dosage regimen depending on Cl creatinine for infection caused by the Varicella zoster

(herpes zoster), in patients with normal immunity

table 2

Correction of the dosage regimen depending on Cl creatinine for infection caused by the Varicella zoster

(herpes zoster), in patients with reduced immunity

Table 3

Correction of the dosage regimen depending on Cl creatinine for infection caused by the Herpes simplex

, in patients with normal immunity

Table 4

Correction of the dosage regimen depending on Cl creatinine in the prevention of exacerbations of recurrent infection caused by the Herpes simplex

(suppressive therapy)

Table 5

Correction of the dosage regimen depending on Cl creatinine for infection caused by the Herpes simplex

(labial or genital herpes), in patients with reduced immunity

Patients with renal failure undergoing hemodialysis.

Since penciclovir plasma concentrations decrease by 75% after 4-hour hemodialysis, famciclovir should be taken immediately after the hemodialysis procedure. The recommended dose is 250 mg (for patients with herpes zoster) and 125 mg (for patients with genital herpes).

Patients with impaired liver function.

For patients with mild to moderate liver dysfunction, no dose adjustment is required.

Negroid patients.

The effectiveness of one-day administration of the drug Famvir® at a dose of 1000 mg 2 times a day for the treatment of recurrent genital herpes in immunocompetent patients of the Negroid race did not exceed that for placebo.
The clinical significance of drug dosing regimens for the treatment of both relapses of genital herpes (within 2 or 5 days) and other infectious lesions caused by the Varicella zoster
and
Herpes simplex
is unknown.

Release form.

Film-coated tablets, 125 mg and 250 mg.

7 or 10 tablets each. in a blister; 1, 2, 3 or 4 blisters in a cardboard box.

Film-coated tablets, 500 mg.

3, 7 or 10 tablets. in a blister; 1, 2, 3 or 4 blisters in a cardboard box.

Manufacturer.

Novartis Pharma AG. Switzerland, Lichtstrasse 35, 4056 Basel.

Manufactured by: Novartis Pharmaceuticals S.A. Spain.

Additional information about the drug can be obtained at the address: 115035, Moscow, Sadovnicheskaya st., 82/2.

Tel.; Fax.

Promotion on the territory of the Russian Federation: representation. 115035, Moscow, Ovchinnikovskaya embankment, 20, building 1.

Tel., 783-29-01; Fax.

Conditions for dispensing from pharmacies.

On prescription.