Generic Famvir

For the use of a Registered Medical Practitioner or a Hospital or a Laboratory only

 

Famtrex-250

Composition Famtrex-250

Each film-coated tablet contains Famciclovir.................................... 250 mg

 

Colour: Titanium Dioxide

 

Famtrex-500

Each film-coated tablet contains

Famciclovir.................................... 500 mg

 

Colour: Titanium Dioxide

 

Description

Famciclovir is an orally administered prodrug of the antiviral agent penciclovir. Famciclovir undergoes rapid biotransformation to the active antiviral compound penciclovir. which has inhibitory activity against herpes simplex virus types 1 (HSV-1) and 2 (HSV-2) and varicella zoster virus (VZV). In cells infected with HSV-1, HSV-2 or VZV, viral thymidine kinase phosphorylates penciclovir to a monophosphate form that, in turn, is converted to penciclovir triphosphate by cellular kinases. In vitro studies demonstrate that penciclovir triphosphate inhibits herpes viral DNA polymerase competitively with deoxyguanosine triphosphate. Consequently, herpes viral DNA synthesis and, therefore, replication are selectively inhibited. Penciclovir triphosphate has an intracellular half-life of 10 hours in HSV-1-, 20 hours in HSV-2-and 7 hours in VZV-infected cells cultured in vitro: however, the clinical significance is unknown.

 

Indication

Famtrex (famciclovir) is indicated for the treatment of acute herpes zoster (shingles), treatment or suppression of recurrent genital herpes in immunocompetent patients ,treatment of recurrent mucocutaneous herpes simplex infections in HIV-infected patients.

 

Dosage and administration

 

 

Herpes zoster

In the treatment of herpes zoster infection the recommended oral dosage of famciclovir is 500 mg every 8 hours for 7 days.

 

Herpes Simplex Infections

The recommended dosage is 125 mg twice daily for 5 days

Suppression of recurrent gential herpes

The recommended dosage is 250 mg twice daily for up to 1 years.

 

HIV-infected Patients

For recurrent orolabial ore genital herpes simplex infection, the recommended dosage is 500 mg twice daily for 7 days.

Famciclovir does not require administration before meals, since the systemic bioavailability of the drug is not impaired by the presence of food. In patients with reduced renal function, dosage reduction is recommended as follows:

Indications and Normal Dosage Regimen	Creatinine Clearance (mL/min.)	Adjusted Dosage Regimen Dose (mg;	Dosing Interval
Herpes Zoster
500 mg every 8 hours	-60	500	every 8 hours
	40-59	500	every 12 hours
	20-39	500	every 24 hours
	<20	250	every 24 hours
	HD'	250	following each dialysis
Recurrent Genital Herpes
125 mg every 12 hours	>40	125	every 12 hours
	20-39	125	every 24 hours
	<20	125	every 24 hours
	HD'	125	following each dialysis
Suppression of Recurrent Genital Herpes
250 mg every 12 hours	>40	250	every 12 hours
	20-39	125	every 12 hours
	■ 20	1 2 -	every 24 hours
	HD'	125	following each dialysis
Recurrent Orolabial and Genital Herpes Simplex Infection in HIV Intected Patients
500 mg every 12 hours	240	500	every 12 hours
	20-39	500	every 24 hours
	■ 20	250	every 24 hours
	HD*	250	following each dialysis

*HD Hemodialysis

 

Contraindications

Famtrex is contraindicated in patients with known hypersensitivity to the product, and its components

 

Warnings and precautions

 

General

The efficacy of Famtrex (famciclovir,) has not been established for initial episode genital herpes infection, ophthalmic zoster, disseminated zoster or in immunocompromised patients with herpes zoster. Dosage adjustment is recommended in patient having creatinin clearance of < 60 ml/ min.

 

Drug interactions

Cocurrent use with probenecid or other drugs significantly eliminated by active renal tubular secretion may result in increased plasma concentrations of penciclovir.

 

Pregnancy

There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, famciclovir should be used during pregnancy only if the benefit to the patient clearly exceeds the potential risk to the foetus.

 

Lactation

It is not known whether it is excreted in human milk. There are no data on the safety of famciclovir in infants.

 

Paediatric use

The pharmacokinetics of famciclovir or penciclovir have not been evaluated in patients below 18 years of age.

 

Geriatric use

No overall difference was observed in the incidence or types of adverse events between younger and older patients.

 

Side effects

Immunocompetent patients

Nervous system: Headache, paresthesia, migraine

Gastrointestinal: Nausea, diarrhoea, vomiting, flatulence, abdominal pain

Body as a whole: Fatigue

Skin and Appendages: Pruritus, rash

Reproductive (Female): Dysmenorrhoea

HIV-infected patients: In HIV-infected patients, the most frequently reported adverse events for famciclovir were headache, nausea , diarrhoea, vomiting, fatigue, and abdominal pain.

211 AD MK3

 

Overdosage

Appropriate symptomatic and supportive therapy should be given. Penciclovir is removed by haemodialysis.

Storage:

Store in a cool dry place. Presentation

Famtrex 250: ............Blister Pack of 10 tablets

Famtrex 500: ...........Blister Pack of 7 tablets