TERBINAFINE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

PD-Rx Pharmaceuticals, Inc.

INN (International Name):

TERBINAFINE HYDROCHLORIDE

Composition:

TERBINAFINE 250 mg

Prescription type:

PRESCRIPTION DRUG

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

TERBINAFINE- TERBINAFINE TABLET
PD-RX PHARMACEUTICALS, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
TERBINAFINE TABLETS SAFELY AND EFFECTIVELY.
SEE FULL PRESCRIBING INFORMATION FOR TERBINAFINE TABLETS.
TERBINAFINE TABLETS, USP, 250 MG
FOR ORAL USE.
INITIAL U.S. APPROVAL: 1992
INDICATIONS AND USAGE
Terbinafine tablets, USP 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
(2)
Toenail onychomycosis: One 250 mg tablet, once daily for 12 weeks (2)
DOSAGE FORMS AND STRENGTHS
Tablet, 250 mg (3)
CONTRAINDICATIONS
Terbinafine tablets, USP 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 tablets if
liver injury develops. (5.1,5.8)
Taste disturbance, including taste loss, has been reported with the
use of terbinafine tablets. Taste disturbance can be
severe, may be prolonged, or may be permanent. Discontinue terbinafine
tablets if taste disturbance occurs. (5.2)
Smell disturbance, including loss of smell, has been reported with the
use of terbinafine tablets. Smell disturbance may
be prolonged, or may be permanent. Discontinue terbinafine tablets if
smell disturbance occurs. (5.3)
Depressive symptoms have been reported with terbinafine use.
Prescribers should be alert to the development of
depressive symptoms. (5.4)
Severe neutropenia has been reported. If the neutrophil count is
≤1,000 cells/mm
, terbinafine tablets should be
discontinued. (5.5)
Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema
multiforme, exfoliative dermatitis, bullous dermatitis
and drug reaction with e