FAMCICLOVIR tablet, film coated

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

FAMCICLOVIR (UNII: QIC03ANI02) (PENCICLOVIR - UNII:359HUE8FJC)

Tilgængelig fra:

Golden State Medical Supply, Inc.

INN (International Name):

FAMCICLOVIR

Sammensætning:

FAMCICLOVIR 125 mg

Indgivelsesvej:

ORAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

Herpes labialis (cold sores) Famciclovir tablets are indicated for the treatment of recurrent herpes labialis in adult patients.   Genital herpes Recurrent episodes Famciclovir tablets are indicated for the treatment of recurrent episodes of genital herpes. The efficacy of famciclovir tablets when initiated more than 6 hours after onset of symptoms or lesions has not been established. Suppressive therapy Famciclovir tablets are indicated for chronic suppressive therapy of recurrent episodes of genital herpes in adult patients. The efficacy and safety of famciclovir tablets for the suppression of recurrent genital herpes beyond 1 year have not been established. Herpes zoster (shingles) Famciclovir tablets are indicated for the treatment of herpes zoster in adult patients. The efficacy of famciclovir when initiated more than 72 hours after onset of rash has not been established. Recurrent orolabial or genital herpes   Famciclovir tablets are indicated for the treatment of recurrent episo

Produkt oversigt:

Famciclovir tablets, USP are supplied as follows: Famciclovir 125 mg tablets are white, round, biconvex, film-coated tablets, engraved “APO” on one side and “FAM” over “125” on the other side Famciclovir 250 mg tablets are white, round, biconvex, film-coated tablets engraved “APO” on one side and “FAM” over “250” on the other side. Famciclovir 500 mg tablets are white, oval, biconvex film-coated tablets, engraved “APO” on one side and “FAM500” on the other side. Store at 20°C to 25°C (68°F to 77°F); excursions permitted from 15°C to 30°C (59°F to 86°F) [see USP controlled room temperature]. Dispense in a tight container [see USP].

Autorisation status:

Abbreviated New Drug Application

Produktets egenskaber

FAMCICLOVIR- FAMCICLOVIR TABLET, FILM COATED
GOLDEN STATE MEDICAL SUPPLY, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
FAMCICLOVIR TABLETS. THESE HIGHLIGHTS DO NOT INCLUDE ALL THE
INFORMATION NEEDED TO USE
FAMCICLOVIR TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
FAMCICLOVIR TABLETS.
FAMCICLOVIR TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1994
INDICATIONS AND USAGE
Famciclovir, a prodrug of penciclovir, is a deoxynucleoside analog DNA
polymerase inhibitor indicated for:
Immunocompetent Adult Patients (1.1)
Herpes labialis (cold sores)
Treatment of recurrent episodes
Genital herpes
Treatment of recurrent episodes
Suppressive therapy of recurrent episodes
Herpes zoster (shingles)
Human Immunodeficiency Virus (HIV)-Infected Adult Patients (1.2)
Treatment of recurrent episodes of orolabial or genital herpes
Limitation of Use
The efficacy and safety of famciclovir have not been established for:
Patients with first episode of genital herpes
Patients with ophthalmic zoster
Immunocompromised patients other than for the treatment of recurrent
episodes of orolabial or genital
herpes in HIV-infected patients
Black and African American patients with recurrent genital herpes
DOSAGE AND ADMINISTRATION
IMMUNOCOMPETENT ADULT PATIENTS ( 2.1)
Herpes labialis (cold sores)
1,500 mg as a single dose
Genital herpes
Treatment of recurrent episodes
1,000 mg twice daily for 1 day
Suppressive therapy
250 mg twice daily
Herpes zoster (shingles)
500 mg every 8 hours for 7 days
HIV-INFECTED ADULT PATIENTS ( 2.2)
Recurrent episodes of orolabial or genital herpes
500 mg twice daily for 7 days
Patients with renal impairment: Adjust dose based on creatinine
clearance. (2.3)
DOSAGE FORMS AND STRENGTHS
Tablets: 125 mg, 250 mg, 500 mg ( 3)
CONTRAINDICATIONS
Known hypersensitivity to the product, its components, or Denavir
(penciclovir cream). ( 4)
WARNINGS AND PRECAUTIONS
Acute renal failure: May occur in patients with underlying renal
disease who receive higher than
recommended doses of famciclovir for their level