TERBINAFINE HYDOCHLORIDE- 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:

Physicians Total Care, Inc.

INN (International Name):

TERBINAFINE HYDROCHLORIDE

Composition:

TERBINAFINE 250 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Terbinafine hydrochloride 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 (KOH preparation, fungal culture, or nail biopsy) should be obtained to confirm the diagnosis of onychomycosis. Terbinafine hydrochloride 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 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 reve

Product summary:

Terbinafine Hydrochloride Tablets, USP 250 mg are available for oral administration as white, round, biconvex tablets with beveled edges, engraved “APO” on one side, “TER” over “250” on the other side. They are supplied as follows: Store at 20° to 25°C (68° to 77°F) excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].  Dispense in a tight, light-resistant container [see USP].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

TERBINAFINE HYDOCHLORIDE - TERBINAFINE HYDROCHLORIDE TABLET
PHYSICIANS TOTAL CARE, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
TERBINAFINE TABLETS, USP SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR TERBINAFINE TABLETS,
USP.
TERBINAFINE HYDROCHLORIDE TABLETS, USP
INITIAL U.S. APPROVAL: 1992
RECENT MAJOR CHANGES
Warnings and Precautions
Taste Disturbance Including Loss of Taste (5.2) 10/2010
Smell Disturbance Including Loss of Smell (5.3) 03/2011
Depressive Symptoms (5.4) 10/2010
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
(2)
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) (4)
WARNINGS AND PRECAUTIONS
(5)
Liver failure, sometimes leading to liver transplant or death, has
occured with the use of oral terbinafine. Obtain
pretreatment serum transaminases. Discontinue terbinafine tablets if
liver injury develops. (5.1, 5.8)
(5)
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)
(5)
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 tablets if smell disturbance occurs. (5.3)
(5)
Depressive symptoms have been reported with terbinafine use.
Prescribers should be alert to development of
depressive symptoms. (5.4)
(5)
Severe neutropenia has been report