Favirox, 500 mg 7 pcs

Herpes zoster (infection caused by VZV):

• to treat herpes zoster, including ophthalmoherpes in immunocompetent patients;
• to treat herpes zoster in immunocompromised patients.

Genital herpes (infection caused by HSV):

• treatment of first episode and recurrence of genital herpes in immunocompromised patients;
• treatment of recurrence of genital herpes in immunocompromised patients;
• to prevent exacerbations of genital herpes (suppressive therapy) in immunocompromised and immunocompromised patients.

Labial herpes (infection caused by HSV):

• treatment of recurrent labial herpes in immunocompromised patients;
• treatment of recurrent orolabial herpes in immunocompromised patients.

Indications

Herpes zoster (VZV infection):

for the treatment of herpes zoster, including ophthalmoherpes in immunocompetent patients;
for the treatment of herpes zoster in immunocompromised patients.

Genital herpes (infection caused by HSV):

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.

Herpes labialis (infection caused by HSV):

treatment of relapses of labial herpes in immunocompetent patients;
treatment of relapses of orolabial herpes in immunocompromised patients.

Pharmacological effect

Pharmacotherapeutic group:

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 contact.

During suppressive therapy with antiviral drugs, the frequency of viral shedding is markedly reduced, but, nevertheless, the risk of transmission of infection remains. In connection with the above, when treating with the drug during this period, you should follow the rules of safe sexual behavior.

Impact on the ability to drive vehicles. Wed and fur.:
The drug Favirox is not expected to affect the ability to drive vehicles and/or operate machinery, however, patients who experience dizziness, drowsiness, confusion or other disorders of the central nervous system while using the drug Favirox should refrain from driving vehicles and/or operating machinery during the period of use of the drug.

Active ingredient

Famciclovir

Composition

Each 500 mg film-coated tablet contains:

active ingredient:

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 silicon dioxide anhydrous – 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.

Pregnancy

In animal studies, the embryotoxic and teratogenic effects of famciclovir and penciclovir were not revealed. In studies of oral administration of famciclovir, penciclovir was excreted in the milk of lactating rats. It is not known whether penciclovir is excreted into human breast milk.

However, since there is insufficient data on the safety of the use of famciclovir in pregnant and lactating women, its use during pregnancy and breastfeeding is possible only if the benefit of therapy for the mother outweighs the potential risk to the fetus and child.

There is no data requiring special recommendations for patients with preserved reproductive potential.
Famciclovir does not have a significant effect on sperm count, morphology or motility of human sperm. 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.

Contraindications

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 in this category.

With 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 mild to moderate hepatic impairment.

Side Effects

Clinical studies have shown good tolerability of famciclovir, incl. in patients with reduced immunity.

Cases of headache and nausea have been reported, but these events were mild to moderate and occurred with the same frequency in patients receiving placebo. The remaining 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 were consistent with those reported in immunocompromised patients.

To assess the frequency of adverse reactions, the World Health Organization (WHO) criteria were used: very often (> 1/10); often (from> 1/100, 1/1000, 1/10000, < 1/1000); very rare (< 1/10000), frequency unknown.Disorders of the blood and lymphatic system: rarely – thrombocytopenia;Mental disorders: infrequently – confusion (mainly in elderly patients); rarely – hallucinations;Nervous system disorders: very often – headache, often – dizziness, infrequently – drowsiness (mainly in elderly patients), frequency unknown – convulsions *;Cardiac disorders: rarely – a feeling of “palpitations”;Gastrointestinal disorders: often – nausea, vomiting, abdominal pain, diarrhea;Disorders of the liver and biliary tract: rarely – cholestatic jaundice;Immune system disorders: frequency unknown – anaphylactic shock*, anaphylactic reaction*;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 erythema multiforme exudative, Stevens-Johnson syndrome, Lyell’s syndrome (toxic epidermal necrolysis), allergic vasculitis).Laboratory and instrumental data: often – abnormal liver function parameters* – AEs that were not observed during clinical trials, identified in post-marketing observations, and also described in the literature. Since information on these AEs was obtained by spontaneous reports and the exact number of patients taking the drug has not been determined, it is not possible to estimate the frequency of occurrence of these reactions, and therefore “frequency unknown” is indicated for these AEs
If any of the side effects indicated in the instructions get worse, or you notice any other side effects not listed in the instructions, tell your doctor.

Interaction

Concomitant use with probenecid may lead to increased plasma concentrations of penciclovir. To prevent the development of toxic reactions, patients receiving Favirox at a dose of 500 mg simultaneously with probenecid should be monitored, taking into account the possibility of reducing the dose of famciclovir.

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 and aluminum hydroxide) or in patients who had previously received treatment 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 changes in the pharmacokinetic parameters of penciclovir, zidovudine, zidovudine metabolite (zidovudine glucuronide) and emtricitabine were detected.

With single and 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, the development of drug interactions is possible when using the drug Favirox 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 impairment 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 impaired, and as a result, the effectiveness of famciclovir may be reduced. It is necessary to evaluate the clinical effectiveness of antiviral therapy when administered concomitantly with raloxifene.

Considering that famciclovir is a weak inhibitor of aldehydroxydase 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 enzyme.

Overdose

There is limited data on overdose with famciclovir.

Cases of overdose of famciclovir (10.5 g) were described and were not accompanied by clinical manifestations.

Treatment: symptomatic and supportive. Cases of acute renal failure have rarely been reported in patients with renal disease when recommendations for dose reduction of famciclovir are not followed based on renal function. Penciclovir, which is an active metabolite of famciclovir, is eliminated by hemodialysis. Penciclovir plasma concentrations are reduced by 75% after hemodialysis for 4 hours.

Storage conditions

Store at a temperature not exceeding 25 °C, in the original packaging.

Shelf life

2 years.

Manufacturer

Spetsifar S.A., Greece