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:

Harris Pharmaceutical, Inc.

INN (International Name):

Terbinafine Hydrochloride

Composition:

Terbinafine Hydrochloride 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 [potassium hydroxide (KOH) preparation, fungal culture, or nail biopsy] should be obtained to confirm the diagnosis of onychomycosis. Terbinafine tablets are contraindicated in patients with: - Chronic or active liver disease [see Warnings and Precautions (5.1)] - History of allergic reaction to oral terbinafine because of the risk of anaphylaxis [see Adverse Reactions (6.2)] . Risk Summary Available data from postmarketing cases on the use of terbinafine tablets in pregnant women. are insufficient to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. In animal reproduction studies, terbinafine did not cause malformations or any harm to the fetus when administered to pregnant rabbits and rats during the period of organogenesis at oral doses

Product summary:

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

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

TERBINAFINE HYDROCHLORIDE- TERBINAFINE HYDROCHLORIDE TABLET
Harris Pharmaceutical, Inc.
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MEDICATION GUIDE
Terbinafine (ter BIN na feen) Tablets, USP
What is the most important information I should know about terbinafine
tablets?
Terbinafine tablets may cause serious side effects, including:
•
Liver problems that can lead to the need for a liver transplant or
death. This can happen in people
who have liver problems and in people who have never had liver
problems. Tell your doctor right
away if you get any of these symptoms of liver problems:
•
nausea
•
poor appetite
•
tiredness
•
vomiting
•
upper right stomach-area (abdomen)
pain
•
yellowing of your skin or eyes
(jaundice)
•
dark (tea-colored) urine
•
pale or light colored stools
Your doctor should do a blood test to check you for liver problems
before you start treatment with
terbinafine tablets.
Your doctor may also check you for liver problems during treatment,
and tell you to stop taking
terbinafine tablets if you develop liver problems.
What are Terbinafine tablets?
Terbinafine tablets are prescription medicine used to treat fungal
infections of the fingernails and toenails
(onychomycosis).
Your doctor should do tests to check you for fungal infection of your
nails before you start terbinafine
tablets.
It is not known if terbinafine tablets are safe and effective in
children for the treatment of onychomycosis.
Who should not take terbinafine tablets?
Do not take terbinafine tablets if you
•
have had liver disease for a long time (chronic) or have active liver
disease.
•
have had a severe allergic reaction to terbinafine hydrochloride when
taken by mouth.
What should I tell my doctor before taking terbinafine tablets?
Before taking terbinafine tablets, tell your doctor about all of your
medical conditions, including if you:
•
have or had liver problems
•
have a weakened immune system (immunocompromised)
•
have lupus (an autoimmune disease)
•
are pregnant or plan to become pregnant. It is not known if
terbinafine tablets

Summary of Product characteristics

TERBINAFINE HYDROCHLORIDE- TERBINAFINE HYDROCHLORIDE TABLET
HARRIS PHARMACEUTICAL, 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
Prior to administering, evaluate patients for evidence of chronic or
active liver disease. (2.1)
Fingernail onychomycosis: One tablet, once daily for 6 weeks. (2.2)
Toenail onychomycosis: One tablet, once daily for 12 weeks. (2.2)
DOSAGE FORMS AND STRENGTHS
Tablet, 250 mg (3)
CONTRAINDICATIONS
Chronic or active liver disease. (4)
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. Prior to initiating treatment and
periodically during therapy, assess liver function
tests. Discontinue terbinafine tablets if liver injury develops. (5.1)
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 less
than or equal to 1000 cells/mm , terbinafine
tabl