FAMCICLOVIR tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

FAMCICLOVIR (UNII: QIC03ANI02) (FAMCICLOVIR - UNII:QIC03ANI02)

Available from:

Physicians Total Care, Inc.

INN (International Name):

FAMCICLOVIR

Composition:

FAMCICLOVIR 500 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Herpes labialis (cold sores): Famciclovir tablets are indicated for the treatment of recurrent herpes labialis. 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. 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. The efficacy of famciclovir tablets 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 episodes of orolabial or genital herpes in HIV-infected adults. The

Product summary:

Famciclovir tablets are supplied as follows: 500 mg – White, capsule-shaped, film-coated tablets, debossed with “8119” on one side and “93” on the other side; available in Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

FAMCICLOVIR - FAMCICLOVIR TABLET, FILM COATED
PHYSICIANS TOTAL CARE, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
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
RECENT MAJOR CHANGES
Indications and Usage (1.3) 01/2011
INDICATIONS AND USAGE
Famciclovir tablets, a prodrug of penciclovir, is a nucleoside 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)
HIV-Infected Adult Patients (1.2)
Treatment of recurrent episodes of orolabial or genital herpes
Limitation of Use (1.3)
The efficacy and safety of famciclovir tablets has not been
established for:
Patients < 18 years of age
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)
1500 mg as a single dose
Genital herpes
Treatment of recurrent episodes
Suppressive therapy
1000 mg twice daily for 1 day
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 of renal function. Reduce dosage in
patie