FAMCICLOVIR tablet film coated

Valsts: Amerikas Savienotās Valstis

Valoda: angļu

Klimata pārmaiņas: NLM (National Library of Medicine)

Aktīvā sastāvdaļa:

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

Pieejams no:

Mylan Pharmaceuticals Inc.

SNN (starptautisko nepatentēto nosaukumu):

FAMCICLOVIR

Kompozīcija:

FAMCICLOVIR 125 mg

Receptes veids:

PRESCRIPTION DRUG

Autorizācija statuss:

Abbreviated New Drug Application

Produkta apraksts

FAMCICLOVIR- FAMCICLOVIR TABLET, FILM COATED
MYLAN PHARMACEUTICALS 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
INDICATIONS AND USAGE
Famciclovir, a prodrug of penciclovir, is a nucleoside analog DNA
polymerase inhibitor indicated for:
Immunocompetent Adult Patients (1.1)
•
•
•
HIV-Infected Adult Patients (1.2)
•
Limitation of Use (1.3)
The efficacy and safety of famciclovir tablets have not been
established for:
•
•
•
DOSAGE AND ADMINISTRATION
IMMUNOCOMPETENT ADULT PATIENTS (2.1)
Herpes labialis (cold sores)
1500 mg as a single dose
Genital herpes
Treatment of recurrent episodes
1000 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 tablets for their level of renal function. Reduce dosage
in patients with renal impairment. (2.3, 8.6)
ADVERSE REACTIONS
The most common adverse events reported in at least 1 indication by >
10% of adult patients are headache and nausea.
(6.1)
Herpes labialis (cold sores)
o
Treatment of recurrent episodes
Genital herpes
o
o
Treatment of recurrent episodes
Suppressive therapy of recurrent episodes
Herpes zoster (shingles)
Treatment of recurrent episodes of orolabial or genital herpes
Patients < 18 years of age
Immunocompromised patients other than for the