TERBINAFINE HYDROCHLORIDE tablet

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

TERBINAFINE HYDROCHLORIDE (UNII: 012C11ZU6G) (TERBINAFINE - UNII:G7RIW8S0XP)

זמין מ:

AvKARE, Inc.

INN (שם בינלאומי):

TERBINAFINE HYDROCHLORIDE

הרכב:

TERBINAFINE 250 mg

סוג מרשם:

PRESCRIPTION DRUG

מצב אישור:

Abbreviated New Drug Application

מאפייני מוצר

TERBINAFINE HYDROCHLORIDE - TERBINAFINE HYDROCHLORIDE TABLET
AVKARE, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
TERBINAFINE HYDROCHLORIDE TABLETS SAFELY
AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR TERBINAFINE
HYDROCHLORIDE.
TERBINAFINE HYDROCHLORIDE (TERBINAFINE HYDROCHLORIDE) TABLET FOR ORAL
USE.
INITIAL U.S. APPROVAL 1992
RECENT MAJOR CHANGES
Warnings and Precautions
Smell Disturbance Including Loss of Smell (5.3) 03/2011
Taste Disturbance Including Loss of Taste (5.2) 10/2010
Depressive Symptoms (5.4) 10/2010
INDICATIONS AND USAGE
Terbinafine hydrochloride tablets are an allylamine antifungal
indicated for the treatment of onychomycosis of the toenail
or fingernail due to dermatophytes (tinea unguium). (1)
DOSAGE AND ADMINISTRATION
Fingernail onychomycosis: One 250 mg tablet, once daily for 6 weeks.
Toenail onychomycosis: One 250 mg tablet, once daily for 12 weeks.
DOSAGE FORMS AND STRENGTHS
Tablet, 250 mg (3)
CONTRAINDICATIONS
Terbinafine hydrochloride tablets are contraindicated in individuals
with a history of allergic reaction to oral terbinafine
because of the risk of anaphylaxis. (4)
WARNINGS AND PRECAUTIONS
Liver failure, sometimes leading to liver transplant or death, has
occurred with the use of oral terbinafine. Obtain
pretreatment serum transaminases. Discontinue terbinafine
hydrochloride tablets if liver injury develops. (5.1,5.8)
Taste disturbance, including taste loss, has been reported with the
use of terbinafine hydrochloride tablets. Taste
disturbance can be severe, may be prolonged, or may be permanent.
Discontinue terbinafine hydrochloride tablets if
taste disturbance occurs. (5.2)
Smell disturbance, including loss of smell, has been reported with the
use of terbinafine hydrochloride tablets. Smell
disturbance may be prolonged, or may be permanent. Discontinue
terbinafine hydrochloride tablets if smell disturbance
occurs. (5.3)
Depressive symptoms have been reported with terbinafine use.
Prescribers should