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:

NuCare Pharmaceuticals,Inc.

INN (שם בינלאומי):

TERBINAFINE HYDROCHLORIDE

הרכב:

TERBINAFINE HYDROCHLORIDE 250 mg

מסלול נתינה (של תרופות):

ORAL

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

Terbinafine tablets are indicated for the treatment of onychomycosis of the toenail or fingernail due to dermatophytes (tinea unguium). Prior to initiating treatment, appropriate nail specimens for laboratory testing [potassium hydroxide (KOH) preparation, fungal culture, or nail biopsy] should be obtained to confirm the diagnosis of onychomycosis. Terbinafine tablets are contraindicated in individuals with a history of allergic reaction to oral terbinafine because of the risk of anaphylaxis. Pregnancy Category B There are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, and because treatment of onychomycosis can be postponed until after pregnancy is completed, it is recommended that terbinafine tablets not be initiated during pregnancy. Oral reproduction studies have been performed in rabbits and rats at doses up to 300 mg/kg/day [12× to 23× the maximum recommended human dose (MRHD), in rabbits and rats, respectively,

leaflet_short:

Terbinafine tablets, USP 250 mg are supplied as white, circular biconvex tablets debossed with C134 on one side and plain on the other side. NDC 68071-1640 Bottles of 30 Store Terbinafine tablets, USP at 20°C to 25°C (68° to 77°F) [See USP Controlled Room Temperature]; in a tight container. Protect from light.

מצב אישור:

Abbreviated New Drug Application

מאפייני מוצר

TERBINAFINE HYDROCHLORIDE- TERBINAFINE HYDROCHLORIDE TABLET
NUCARE PHARMACEUTICALS,INC.
----------
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, FOR ORAL USE
INITIAL U.S. APPROVAL: 1992
INDICATIONS AND USAGE
Terbinafine 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 (
2)
Toenail onychomycosis: One 250 mg tablet, once daily for 12 weeks ( 2)
DOSAGE FORMS AND STRENGTHS
Tablet, 250 mg ( 3)
CONTRAINDICATIONS
Terbinafine 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 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
≤1000 cells/mm
, terbinafine tablets
should be discontinued. ( 5.5)
Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema
multiforme, exfoliative dermatitis,
bullous dermatitis, and drug