Famciclovir

What is Famciclovir?

• Famciclovir (Famvir), is a prodrug of penciclovir, is a deoxynucleoside analog DNA polymerase inhibitor.

Famciclovir structure

Famciclovir 200

What are the uses of this medicine?

Famciclovir (Famvir), is a prescription antiviral medicine used: In adults with a normal immune system to:

• treat outbreaks of cold sores
• treat outbreaks of genital herpes
• decrease the number of outbreaks of genital herpes
• treat shingles (herpes zoster)

• In adults with human immunodeficiency virus (HIV) to treat outbreaks of herpes in or around the mouth, genitals or anal area.

Limitations of use: It is not known if famciclovir is safe and effective for:

• the first outbreak of genital herpes
• shingles in the eye(s)
• people with weakened immune systems, other than for the treatment of outbreaks of herpes in people with HIV
• black and African American people with genital herpes outbreaks
• It is not known if famciclovir is effective in children.

How does this medicine work?

• Famciclovir (fam sye' kloe vir) is an acyclic purine nucleoside analogue with antiviral activity against many herpes viruses, including herpes simplex 1 and 2, cytomegalovirus, Ebstein-Barr virus and varicella-zoster.
• Famciclovir is a prodrug of [[]]penciclovir which is the active component.
• After absorption, famciclovir is converted in the liver to penciclovir which is phosphorylated intracellularly by viral kinases; the resultant triphosphate competes with guanosine for incorporation into viral DNA, blocking viral DNA polymerase activity.
• Famciclovir is indicated for therapy of varicella zoster and for mucocutaneous or genital herpes simplex infections, both type 1 and 2.

Who Should Not Use this medicine ?

This medicine cannot be used in patients:

• with known hypersensitivity to the product, its components, or Denavir ® (penciclovir cream).

What drug interactions can this medicine cause?

• Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Be sure to mention any of the following:

• probenecid (Benemid)

Is this medicine FDA approved?

• Famciclovir was approved for use in the United States in 1994 and is widely used in treatment of herpes zoster and prophylaxis of genital and mucocutaneous herpes simplex infection.

How should this medicine be used?

Recommended dosage:

Herpes labialis (cold sores):

• The recommended dosage of famciclovir tablets for the treatment of recurrent herpes labialis is 1500 mg as a single dose.
• Therapy should be initiated at the first sign or symptom of herpes labialis (e.g., tingling, itching, burning, pain, or lesion).

Genital herpes: Recurrent episodes:

• The recommended dosage of famciclovir tablets for the treatment of recurrent episodes of genital herpes is 1000 mg twice daily for 1 day.
• Therapy should be initiated at the first sign or symptom of a recurrent episode (e.g., tingling, itching, burning, pain, or lesion).

Suppressive therapy:

• The recommended dosage of famciclovir tablets for chronic suppressive therapy of recurrent episodes of genital herpes is 250 mg twice daily.

Herpes zoster (shingles):

• The recommended dosage of famciclovir tablets for the treatment of herpes zoster is 500 mg every 8 hours for 7 days.
• Therapy should be initiated as soon as herpes zoster is diagnosed.

In HIV-Infected Adult Patients: Recurrent orolabial or genital herpes:

• The recommended dosage of famciclovir tablets for the treatment of recurrent orolabial or genital herpes in HIV-infected patients is 500 mg twice daily for 7 days.
• Therapy should be initiated at the first sign or symptom of a recurrent episode (e.g., tingling, itching, burning, pain, or lesion).

Patients with renal impairment:

• Adjust dose based on creatinine clearance.

Administration:

• Take famciclovir exactly as prescribed by your healthcare provider.
• Your healthcare provider will tell you how many famciclovir tablets to take and when to take them. Your dose of famciclovir and how often you take it may be different depending on your condition.
• famciclovir may be taken with or without food.
• When famciclovir is used to treat shingles, it is usually taken every 8 hours (three times a day) for 7 days, starting within 3 days after the rash begins to appear.
• When famciclovir is used to treat cold sores and fever blisters, it is usually taken as one dose at the earliest sign or symptom (tingling, itching, or burning) of a cold sore.
• When famciclovir is used to treat repeat outbreaks of genital herpes, it is usually taken twice a day for one day, starting within 6 hours of the first sign or symptom of the condition.
• To keep genital herpes from returning, famciclovir is usually taken twice a day for up to 1 year.
• When famciclovir is used to treat herpes infection in people infected with HIV, it is usually taken twice a day for 7 days.
• Continue to take famciclovir even if you feel well.
• Do not stop taking famciclovir without talking to your doctor.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Tablets: 125 mg, 250 mg, 500 mg

This medicine is available in fallowing brand namesː

• Famvir

What side effects can this medication cause?

The most common side effects of this medicine include:

• headache and nausea
• vomiting
• diarrhea or loose stools
• gas
• stomach pain
• tiredness
• rash
• itching
• painful menstrual periods

Less common,but serious side effects may include:

• acute renal failure

What special precautions should I follow?

• Cases of acute renal failure have been reported in patients with underlying renal disease who have received inappropriately high doses of famciclovir for their level of renal function. Dosage reduction is recommended when administering famciclovir to patients with renal impairment.
• There is no evidence that famciclovir will affect the ability of a patient to drive or to use machines. However, patients who experience dizziness, somnolence, confusion or other central nervous system disturbances while taking famciclovir should refrain from driving or operating machinery.
• Because famciclovir contains lactose (famciclovir 125 mg, 250 mg and 500 mg tablets contain lactose 23.5 mg, 47.1 mg and 94.2 mg, respectively), patients with rare hereditary problems of galactose intolerance, a severe lactase deficiency or glucose-galactose malabsorption should be advised to discuss with their healthcare provider before taking famciclovir.
• Patients should be advised to initiate treatment at the earliest sign or symptom of a recurrence of cold sores (e.g., tingling, itching, burning, pain, or lesion). Patients should be instructed that treatment for cold sores should not exceed 1 dose. Patients should be informed that famciclovir is not a cure for cold sores.
• Patients should be informed that famciclovir is not a cure for genital herpes. There are no data evaluating whether famciclovir will prevent transmission of infection to others. Because genital herpes is a sexually transmitted disease, patients should avoid contact with lesions or intercourse when lesions and/or symptoms are present to avoid infecting partners. Therefore, patients should be counseled to use safer sex practices.
• There are no data on treatment initiated more than 72 hours after onset of zoster rash. Patients should be advised to initiate treatment as soon as possible after a diagnosis of herpes zoster.
• It is not known if famciclovir passes into your breastmilk or how it may affect your breast fed baby.
• Famciclovir is associated with a low rate of mild-to-moderate serum ALT elevations during therapy, but has not been associated with instances of clinically apparent liver injury.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.
• Appropriate symptomatic and supportive therapy should be given.
• Penciclovir is removed by hemodialysis.

Can this medicine be used in pregnancy?

• It is not known if famciclovir will harm your unborn baby.
• There is a pregnancy reporting system for women who take famciclovir during pregnancy. The purpose of this reporting system is to collect information about the health of you and your baby. Talk to your healthcare provider about how to report your pregnancy.

Can this medicine be used in children?

• It is not known if famciclovir is effective in children.

What are the active and inactive ingredients in this medicine?

• Active ingredient: famciclovir, USP
• Inactive ingredients: hydroxypropyl cellulose, lactose monohydrate, magnesium stearate and sodium starch glycolate. The tablets are coated with opadry white which contains hypromellose, polyethylene glycol, polysorbate 80 and titanium dioxide.

Who manufactures and distributes this medicine?

Manufactured for:

• Camber Pharmaceuticals, Inc.
• Piscataway, NJ

By:

• HETERO TM
• Hetero Labs Limited, Unit V, Polepally,
• Jadcherla, Mahabubnagar, India.

What should I know about storage and disposal of this medication?

• Store famciclovir at room temperature between 68°F to 77°F (20°C to 25°C).
• Keep famciclovir and all medicines out of reach from children.

Drugs for HIV Infection, in the Subclass Antiretroviral Agents

• Fusion Inhibitors (HIV)
  • Enfuvirtide, Maraviroc

• Integrase Inhibitors (HIV)
  • Dolutegravir, Elvitegravir, Raltegravir

• Monoclonal Antibodies
  • Ibalizumab

• Nonnucleoside Reverse Transcriptase Inhibitors (HIV)
  • Delavirdine, Efavirenz, Etravirine, Nevirapine, Rilpivirine

• Nucleoside Analogues (HIV)
  • Abacavir, Didanosine, Emtricitabine, Lamivudine, Stavudine, Tenofovir, Zidovudine

• Protease Inhibitors (HIV)
  • Amprenavir, Atazanavir, Darunavir, Fosamprenavir, Indinavir, Lopinavir, Nelfinavir, Ritonavir, Saquinavir, Tipranavir

Drugs for Hepatitis B

• Alpha Interferon, Adefovir, Emtricitabine, Entecavir, Lamivudine, Telbivudine, Tenofovir

Drugs for Hepatitis C

• Interferon Based Therapies
  • Alpha Interferon and Peginterferon, Ribavirin

HCV NS5A Inhibitors

• Daclatasvir, Elbasvir, Ledipasvir, Ombitasvir, Pibrentasvir, Velpatasvir

HCV NS5B Inhibitors (Polymerase inhibitors)

• Dasabuvir, Sofosbuvir

HCV Protease Inhibitors

• Asunaprevir, Boceprevir, Glecaprevir, Grazoprevir, Paritaprevir, Simeprevir, Telaprevir, Voxilaprevir

Combination Therapies

• Epclusa, Harvoni, Mavyret, Technive, Viekira Pak, Vosevi, Zepatier

Drugs for Herpes Virus

• infections (HSV), CMV, others

Acyclovir, Cidofovir, Famciclovir, Foscarnet, Ganciclovir, Valacyclovir, Valganciclovir

Drugs for Influenza

• Amantadine, Oseltamivir, Peramivir, Rimantadine, Zanamivir

• Dailymed label info on Famciclovir
• FDA Famciclovir

Famciclovir Resources
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