TERBINAFINE HYDROCHLORIDE- terbinafine hydrochloride tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Dr.Reddys Laboratories Limited

INN (International Name):

TERBINAFINE HYDROCHLORIDE

Composition:

TERBINAFINE 250 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 (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 hydrochloride 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 MRHD, in rabbits and rats, respectively, based on BSA) and have revealed no evidence

Product summary:

Terbinafine tablets USP, 250 mg are white, round, flat, beveled edged tablets embossed ‘250’ on one side and ‘RDY’ on other side and are supplied in bottles of 30, 90,100, 500 and unit dose packages of 100 (10 x 10).  Bottles of 30                                                               NDC 55111-250-30 Bottles of 90                                                               NDC 55111-250-90 Bottles of 100                                                                         NDC 55111-250-01 Bottles of 500                                                                         NDC 55111-250-05 Unit dose packages of 100 (10 x 10)                          NDC 55111-250-78  Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]; in a tight container. Protect from light.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

TERBINAFINE HYDROCHLORIDE - TERBINAFINE HYDROCHLORIDE TABLET
DR.REDDYS LABORATORIES LIMITED
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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 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 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 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 and toxic epidermal necrolysis have been
reported with oral terbinafine use. If progressive
skin rash occ