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Drug Details

Famciclovir 125 mg Tablets

• Drug Class Description
  Nucleosides and nucleotides excluding reverse transcriptase inhibitors - ATC code: J05A B09
• Generic Name
  famciclovir
• Presentation
  Film-coated tablet. 125mg film-coated tablets: white, round, biconvex, film-coated tablets with diameter of 7.6 mm approximately.
• Description
  Each Famciclovir 125mg tablet contains 125mg of famciclovir.
• Indications
  

  Varicella zoster virus (VZV) infections – herpes zoster

  Famciclovir tablets are indicated for

  • the treatment of herpes zoster and ophthalmic zoster in immunocompetent adults

  • the treatment of herpes zoster in immunocompromised adults

  Herpes simplex virus (HSV) infections – genital herpes

  Famciclovir tablets are indicated for

  • the treatment of first and recurrent episodes of genital herpes in immunocompetent adults

  • the treatment of recurrent episodes of genital herpes in immunocompromised adults

  • the suppression of recurrent genital herpes in immunocompetent and immunocompromised adults

  Clinical studies have not been conducted in HSV-infected patients immunocompromised for other causes than HIV-infection

• Adult Dosage
  

  Herpes zoster in immunocompetent adults

  500 mg three times daily for seven days.

  Treatment should be initiated as soon as possible after a diagnosis of herpes zoster.

  Herpes zoster in immunocompromised adults

  500 mg three times daily for ten days.

  Treatment should be initiated as soon as possible after a diagnosis of herpes zoster.

  Genital herpes in immunocompetent adults

  First episode of genital herpes: 250 mg three times daily for five days. Initiation of treatment is recommended as soon as possible after a diagnosis of first episode of genital herpes.

  Episodic treatment of recurrent genital herpes: 125 mg twice daily for five days. Initiation of treatment is recommended as soon as possible after onset of prodromal symptoms (e.g. tingling, itching, burning, pain) or lesions.

  Recurrent genital herpes in immunocompromised adults

  Episodic treatment of recurrent genital herpes: 500 mg twice daily for seven days. Initiation of treatment is recommended as soon as possible after onset of prodromal symptoms (e.g. tingling, itching, burning, pain) or lesions.

  Suppression of recurrent genital herpes in immunocompetent adults

  250 mg twice daily. Suppressive therapy should be discontinued after a maximum of 12 months of continuous antiviral therapy to reassess recurrence frequency and severity. The minimum period of reassessment should include two recurrences. Patients who continue to have significant disease may restart suppressive therapy.

  Suppression of recurrent genital herpes in immunocompromised adults

  500 mg twice daily.

  Patients with renal impairment

  Because reduced clearance of penciclovir is related to reduced renal function, as measured by creatinine clearance, special attention should be given to doses in patients with impaired renal function. Dose recommendations for adult patients with renal impairment are provided in Table 1.

  Table 1 Dose recommendations for adult patients with renal impairment

  Indication and nominal dose regimen	Creatinine clearance [ml/min]	Adjusted dose regimen
  Herpes zoster in immunocompetent adults
  500 mg three times daily for 7 days	60	500 mg three times daily for 7 days
  	40 to 59	500 mg twice daily for 7 days
  	20 to 39	500 mg once daily for 7 days
  	< 20	250 mg once daily for 7 days
  	Haemodialysis patients	250 mg following each dialysis during 7 days
  Herpes zoster in immunocompromised adults
  500 mg three times daily for 10 days	60	500 mg three times daily for 10 days
  	40 to 59	500 mg twice daily for 10 days
  	20 to 39	500 mg once daily for 10 days
  	< 20	250 mg once daily for 10 days
  	Haemodialysis patients	250 mg following each dialysis during 10 days
  Genital herpes in immunocompetent adults – first episode of genital herpes
  250 mg three times daily for 5 days	40	250 mg three times daily for 5 days
  	20 to 39	250 mg twice daily for 5 days
  	< 20	250 mg once daily for 5 days
  	Haemodialysis patients	250 mg following each dialysis during 5 days
  Genital herpes in immunocompetent adults – episodic treatment of recurrent genital herpes
  125 mg twice daily for 5 days	20	125 mg twice daily for 5 days
  	< 20	125 mg once daily for 5 days
  	Haemodialysis patients	125 mg following each dialysis during 5 days
  Genital herpes in immunocompromised adults – episodic treatment of recurrent genital herpes
  500 mg twice daily for 7 days	40	500 mg twice daily for 7 days
  	20 to 39	500 mg once daily for 7 days
  	< 20	250 mg once daily for 7 days
  	Haemodialysis patients	250 mg following each dialysis during 7 days
  Suppression of recurrent genital herpes in immunocompetent adults
  250 mg twice daily	40	250 mg twice daily
  	20 to 39	125 mg twice daily
  	< 20	125 mg once daily
  	Haemodialysis patients	125 mg following each dialysis
  Suppression of recurrent genital herpes in immunocompromised adults
  500 mg twice daily	40	500 mg twice daily
  	20 to 39	500 mg once daily
  	< 20	250 mg once daily
  	Haemodialysis patients	250 mg following each dialysis

  Patients with renal impairment on haemodialysis

  Since 4 h haemodialysis resulted in up to 75% reduction in plasma penciclovir concentrations, famciclovir should be administered immediately following dialysis. The recommended dose regimens for haemodialysis patients are included in Table 1.

  Patients with hepatic impairment

  No dose adjustment is required in patients with mild or moderate hepatic impairment. No data are available for patients with severe hepatic impairment.

  Black patients

  A placebo-controlled study in immunocompetent black patients with recurrent genital herpes showed no difference in efficacy between patients receiving famciclovir 1000 mg twice daily for one day and placebo. There were no unexpected or new safety findings in this trial in Black patients.

  This lack of efficacy in the one-day treatment regimen cannot be extrapolated to the five-day treatment regimen for recurrent genital herpes (125 mg twice daily for five days) or other indications in Black patients.

  Method of administration

  Famciclovir tablets can be taken without regard to meals.

• Child Dosage
  

  The safety and efficacy of famciclovir in children and adolescents aged less than 18 years have not been established.

• Elderly Dosage
  

  Dose modification is not required unless renal function is impaired.

• Contra Indications
  

  Hypersensitivity to the active substance or to any of the excipients.

  Hypersensitivity to penciclovir.

• Special Precautions
  

  Use in patients with renal impairment

  In patients with impaired renal function dose adjustment is necessary.

  Use in patients with hepatic impairment

  Famciclovir has not been studied in patients with severe hepatic impairment. Conversion of famciclovir to its active metabolite penciclovir may be impaired in these patients resulting in lower penciclovir plasma concentrations, and thus a decrease of efficacy of famciclovir may occur.

  Use for zoster treatment

  Clinical response should be closely monitored, particularly in immunocompromised patients.

  Consideration should be given to intravenous antiviral therapy when response to oral therapy is considered insufficient.

  Patients with complicated herpes zoster, i.e. those with visceral involvement, disseminated zoster, motor neuropathies, encephalitis and cerebrovascular complications should be treated with intravenous antiviral therapy.

  Moreover, immunocompromised patients with ophthalmic zoster or those with a high risk for disease dissemination and visceral organ involvement should be treated with intravenous antiviral therapy.

  Transmission of genital herpes

  Patients should be advised to avoid intercourse when symptoms are present even if treatment with an antiviral has been initiated. During suppressive treatment with antiviral agents, the frequency of viral shedding is significantly reduced. However, transmission is still possible. Therefore, in addition to therapy with famciclovir, it is recommended that patients use safer sex practices.

• Interactions
  

  Effects of other medicinal products on famciclovir

  No clinically significant interactions have been identified.

  Concurrent use of probenecid may result in increased plasma concentrations of penciclovir, the active metabolite of famciclovir, by competing for elimination. Therefore, patients receiving famciclovir at a dose of 500 mg three times daily co-administered with probenecid, should be monitored for toxicity. If patients experience severe dizziness, somnolence, confusion or other central nervous system disturbances, a dose reduction of famciclovir to 250 mg three times daily may be considered.

  Famciclovir needs aldehyde oxidase to be converted into penciclovir, its active metabolite. Raloxifen has been shown to be a potent inhibitor of this enzyme in vitro. Co-administration of raloxifene could affect the formation of penciclovir and thus the efficacy of famciclovir. When raloxifen is co-administered with famciclovir the clinical efficacy of the antiviral therapy should be monitored.

• Adverse Drug Reactions
  

  Headache and nausea have been reported in clinical studies. These were generally mild or moderate in nature and occurred at a similar incidence in patients receiving placebo treatment. All other adverse reactions were added during postmarketing.

  A total of 1,587 patients have received famciclovir at recommended doses in placebo- (n= 657) and active- (n=930) controlled studies. These clinical studies were retrospectively reviewed to obtain a frequency category for all adverse reactions mentioned below. For adverse reactions which have never been observed in these studies, the upper limit of the 95% confidence interval is not expected to be higher than 3/X (based on the “rule of three”), with X representing the total sample size (n=1,587).

  Adverse reactions (Table 2) are ranked under headings of frequency, using the following convention: very common ( 1/10); common ( 1/100 to < 1/10); uncommon ( 1/1,000 to < 1/100); rare ( 1/10,000 to < 1/1,000); very rare (< 1/10,000); Not known (cannot be estimated from the available data).

  Blood and lymphatic system disorders
  Rare:	Thrombocytopenia.
  Psychiatric disorders
  Uncommon:	Confusion.
  Rare:	Hallucinations.
  Nervous system disorders
  Very common:	Headache.
  Common:	Dizziness, somnolence.
  Gastrointestinal disorders
  Common:	Nausea, vomiting.
  Hepatobiliary disorders
  Common:	Abnormal liver function tests.
  Rare:	Cholestatic jaundice.
  Skin and subcutaneous tissue disorders
  Common:	Rash, pruritus.
  Uncommon:	Urticaria, serious skin reactions* (e.g. erythema multiforme, Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis), angioedema (e.g. face oedema, eyelid oedema, periorbital oedema, pharyngeal oedema).

  * Never reported in clinical trials; category is based on the “rule of three”

  Overall, adverse reactions reported from clinical studies with immunocompromised patients were similar to those reported in the immunocompetent population. Nausea, vomiting and abnormal liver function tests were reported more frequently, especially at higher doses.