Famvir Tablets 500 mg 3 pcs
Condition: New product
1000 Items
Rating:
Be the first to write a review!
More info
Active ingredients
Famciclovir
Release form
Pills
Composition
1 tab. contains famciclovir 500 mg. Excipients: Sodium starch glycolate - 27.35 mg; hydroxypropylcellulose - 15.48 mg; magnesium stearate - 4.1 mg. Shell (Opadry OY-S-28924): hypromellose - 8.01 mg; titanium dioxide - 3.28 mg; polyethylene glycol 4000 - 1.2 mg; polyethylene glycol 6000 - 1.2 mg
Pharmacological effect
Antiviral drug. After oral administration, famciclovir is rapidly converted to penciclovir, which is active against human herpes viruses, including the Varicella zoster virus (herpes zoster virus) and Herpes simplex types 1 and 2 (labial and genital herpes simplex virus), as well as Epstein-Barr virus and the cytomegalovirus virus . Penciclovir enters the virus-infected cells, where under the action of viral thymidine kinase quickly turns into monophosphate, which, in turn, with the participation of cellular enzymes, goes into triphosphate. Penciclovir triphosphate is found in virus-infected cells for more than 12 hours, inhibiting viral DNA replication. The concentration of penciclovir triphosphate in uninfected cells does not exceed the minimum detectable, so penciclovir has no effect on uninfected cells at therapeutic concentrations. Penciclovir is active against recently detected acyclovir-resistant strains of Herpes simplex virus with altered DNA polymerase. The frequency of occurrence of resistance to famciclovir (penciclovir) does not exceed 0.3%, in patients with impaired immunity - 0.19%. Resistance was detected at the beginning of treatment and did not develop in the course of treatment or after termination of therapy. Famciclovir has been shown to significantly reduce the severity and duration of postherpetic neuralgia in patients with herpes zoster. It has been shown that in immunocompromised patients due to HIV infection, famciclovir at a dose of 500 mg 2 times / day reduces the number of days for the release of the herpes simplex virus (as with clinical manifestations, and without them).
Pharmacokinetics
Absorption After ingestion, famciclovir is rapidly and almost completely absorbed and quickly becomes active penciclovir. Penciclovir bioavailability after oral administration of Famvir is 77%.Cmax penciclovir after oral administration in doses of 125 mg, 250 mg or 500 mg of famciclovir is reached after an average of 45 minutes and amounts to 0.8 mcg / ml, 1.6 mcg / ml and 3.3 mcg / ml, respectively. Distribution The concentration-time pharmacokinetic curves coincide at a single dose. taking famciclovir and splitting the daily dose into 2 or 3 doses. The binding of penciclovir and its 6-deoxy-precursor to plasma proteins is less than 20%. There is no cumulation during repeated doses of the drug. Removal of T1 / 2 penciclovir from the plasma in the final phase after taking a single dose and repeated doses is about 2 hours. Famciclovir is derived mainly in the form of penciclovir and its 6-deoxy precursor, which are excreted in the urine unchanged; famciclovir is not detected in the urine
Indications
Infections caused by the virus Varicella zoster (herpes zoster), including ophthalmic herpes and postherpetic neuralgia; - infections caused by the Herpes simplex virus (type 1 and 2): primary infection, exacerbation of chronic infection, suppression of recurrent infection (to prevent exacerbations); - infection, caused by viruses Varicella zoster and Herpes simplex (type 1 and 2) in patients with reduced immunity
Contraindications
Hypersensitivity to famciclovir or any of the components of the drug; - hypersensitivity to penciclovir
Precautionary measures
Patients with impaired renal function. In patients with impaired renal function, there is a decrease in clearance of penciclovir. Adequate correction of the dosing regimen is recommended depending on the CCAApplication in children. The effectiveness and safety of Famvir use in children has not been established. Thus, famciclovir is not recommended for use in children, except in cases where the expected benefit of treatment justifies the potential risk associated with the use of the drug. Use in elderly patients. Elderly patients. Subject to the maintenance of renal function, famciclovir dosing regimen does not change.
Use during pregnancy and lactation
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 potential benefits of treatment exceed the potential risk.
Dosage and administration
The drug is taken orally, regardless of the meal, without chewing, drinking 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). For ophthalmic herpes, 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 immunocompromised patients The recommended dose is 500 mg 3 times / day for 10 days. Infections caused by the virus Herpes simplex type 1 and 2 in patients with normal immunity In primary infection, the recommended dose is 250 mg 3 times / day for 5 days. Treatment should begin as soon as possible, immediately after the appearance of the first symptoms of the disease. With the recurrence of chronic infection, adults are prescribed 125 mg 2 times / day for 5 days. Treatment should begin in the prodromal period or immediately after the onset of symptoms. Herpes simplex type 1 and 2 infections in immunocompromised patients The recommended dose is 500 mg 2 times / day for 7 days. Treatment should begin as soon as possible, immediately after the onset of the first symptoms of the disease. As a suppressive therapy for recurrent herpetic infection, 250 mg are prescribed 2 times / day. The duration of therapy depends on the severity of the disease. A periodic discontinuation of the drug every 12 months is recommended to assess possible changes in the course of the disease. In HIV-infected patients, the effective dose is 500 mg 2 times / day. Elderly patients. Provided that the renal function is intact, the famciclovir dosing regimen does not change. Patients with impaired renal function. In patients with impaired renal function, there is a decrease in clearance of penciclovir. Patients with renal failure who are on hemodialysis. Since after 4 h of hemodialysis, the concentration of penciclovir in plasma decreases by approximately 75%, the drug 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 dose adjustment is not required.
Side effects
In clinical trials, Famvir is well tolerated, incl. in patients with reduced immunity.Cases of headache and nausea were reported, however, these events were mild or moderate and were observed with the same frequency in patients who received placebo. The unwanted reactions and their incidence are shown below on the basis of 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 during clinical trials in patients with reduced immunity coincided with those observed in patients with normal immunity. The following criteria were used to assess the incidence of adverse reactions: very often (more than 1/10); often (from more than 1/100, less than 1/10); sometimes (more than 1/1000, less than 1/100); rarely (more than 1/10000, less than 1/1000); very rarely (less than 1/10000), including individual messages. From the hematopoietic system: very rarely - thrombocytopenia. From the CNS: rarely - headache, confusion (mainly in elderly patients); very rarely - dizziness, drowsiness (mainly in elderly patients), hallucinations. On the part of the digestive system: rarely - nausea; very rarely - vomiting, jaundice. Dermatological reactions: very rarely - rash, itching, severe skin reactions. Allergic reactions: very rarely - urticaria, severe skin reactions (including erythema multiforme).
Overdose
The described cases of overdose (10.5 g) of Famvir were not accompanied by clinical manifestations. Treatment: symptomatic and supportive therapy. When non-compliance with the recommendations to reduce the dose of famciclovir with regard to renal function in patients with kidney disease, cases of acute renal failure were noted. Penciclovir is excreted by hemodialysis. Plasciclovir concentrations in plasma are reduced by 75% after hemodialysis for 4 hours.
Interaction with other drugs
No clinically significant pharmacokinetic interaction of famciclovir with other drugs was noted. No effects of famciclovir on the cytochrome P450 system have been identified. Medicinal preparations blocking tubular secretion may increase the concentration of penciclovir in plasma. During the clinical studies conducted, no interaction of zidovudine and famciclovir was observed when they were taken together
special instructions
Treatment should begin immediately after diagnosis. Care should be taken when treating patients with impaired renal function, which may require correction of the dosage regimen. Special precautions are not 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 when antiviral treatment is initiated, patients should avoid sexual intercourse. During supportive treatment with antiviral agents, the frequency of viral infection spreads significantly, but the risk of transmission of infection theoretically exists. Therefore, patients should take appropriate protective measures during sexual intercourse. The pills 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 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 the infection caused by the Varicella zoster virus, when applied at a dose of 750 mg 3 times / day for 7 days; in patients with genital herpes with the use of the drug in a dose of up to 750 mg 3 times / day for 5 days and in a dose of up to 500 mg 3 times / day for 10 days. It was also shown that the drug was well tolerated when receiving 250 mg 3 times / day for 12 months for the treatment of genital herpes. Famvir was well tolerated in patients with reduced immunity in the treatment of infections caused by the virus Varicella zoster, 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 efficacy and safety of Famvir in children has not been established. Thus, it is not recommended to use famciclovir in children, except when the expected benefit of treatment justifies the potential risk associated with the use of the drug. Effect on the ability to drive vehicles and control mechanisms It is not expected Famvir’s influence on the ability of patients to drive and other mechanisms, but patients ,in which, against the background of the use of the drug Famvir, dizziness, drowsiness, confusion or other disorders of the central nervous system occur, one should refrain from driving a car or controlling the mechanisms during the period of using the drug