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:

Preferred Pharmaceuticals, Inc

INN (International Name):

TERBINAFINE HYDROCHLORIDE

Composition:

TERBINAFINE HYDROCHLORIDE 250 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Terbinafine hydrochloride (HCl) 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 HCl 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 HCl 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 n

Product summary:

Terbinafine HCl tablets 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.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

TERBINAFINE HYDROCHLORIDE- TERBINAFINE HYDROCHLORIDE TABLET
PREFERRED PHARMACEUTICALS, INC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
TERBINAFINE HYDROCHLORIDE TABLETS SAFELY
AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR TERBINAFINE
HYDROCHLORIDE.
TERBINAFINE HYDROCHLORIDE (TERBINAFINE HYDROCHLORIDE) TABLET FOR ORAL
USE.
INITIAL U.S. APPROVAL: 1992
RECENT MAJOR CHANGES
Warnings and Precautions
Smell Disturbance Including Loss of Smell (5.3) 03/2011
Taste Disturbance Including Loss of Taste (5.2) 10/2010
Depressive Symptoms (5.4) 10/2010
INDICATIONS AND USAGE
Terbinafine hydrochloride 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 hydrochloride 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
hydrochloride tablets if liver injury develops. (5.1,5.8)
Taste disturbance, including taste loss, has been reported with the
use of terbinafine hydrochloride tablets. Taste
disturbance can be severe, may be prolonged, or may be permanent.
Discontinue terbinafine hydrochloride tablets if
taste disturbance occurs. (5.2)
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 hydrochloride tablets if smell disturbance
occurs. (5.3)
Depressive symptoms have been reported with terbinafine use.