TERBINAFINE- terbinafine tablet

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

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

Disponível em:

HARRIS Pharmaceutical, Inc.

DCI (Denominação Comum Internacional):

TERBINAFINE HYDROCHLORIDE

Composição:

TERBINAFINE 250 mg

Via de administração:

ORAL

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

Terbinafine tablets, USP 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, USP 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 [12x to 23x the maximum recommended human dose (MRHD), in rabbits and rats, respe

Resumo do produto:

Terbinafine tablets, USP, 250 mg, are supplied as white to off-white, round tablets debossed ‘AN’ above ‘543’ on one side and plain on the other side. Bottles of 30 tablets                                                                NDC 67405-543-03 Bottles of 100 tablets                                                              NDC 67405-543-10 Store tablets at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]; in a tight container. Protect from light.

Status de autorização:

Abbreviated New Drug Application

Características técnicas

TERBINAFINE- TERBINAFINE TABLET
HARRIS PHARMACEUTICAL, 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