TERBINAFINE HYDROCHLORIDE tablet

国: アメリカ合衆国

言語: 英語

ソース: NLM (National Library of Medicine)

有効成分:

Terbinafine Hydrochloride (UNII: 012C11ZU6G) (Terbinafine - UNII:G7RIW8S0XP)

から入手可能:

Aphena Pharma Solutions - Tennessee, LLC

投与経路:

ORAL

処方タイプ:

PRESCRIPTION DRUG

適応症:

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: 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 [12× to 23× the maximum recommended human dose (MRHD), in rabbits and rats, respectively, based on body surface area (BSA) comparisons] and have revealed no evidence of impaired

製品概要:

Terbinafine Tablets, USP are supplied as white, oblong, unscored tablets debossed "B" and "526" on one side and plain on the other side. Bottles of 30 tablets NDC 60429-222-30 Store Terbinafine Tablets, USP at 20° - 25°C (68° - 77°F) [See USP Controlled Room Temperature].

認証ステータス:

Abbreviated New Drug Application

情報リーフレット

TERBINAFINE HYDROCHLORIDE- TERBINAFINE HYDROCHLORIDE TABLET
Aphena Pharma Solutions - Tennessee, LLC
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MEDICATION GUIDE
TERBINAFINE (ter' bin a feen) hydrochloride Tablets
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: 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.
•
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
What are Terbinafine tablets?
Terbinafine tablets are a 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 a severe allergic reaction to terbinafine hydrochloride when
taken by mouth.
•
have had liver disease for a long time (chronic) or have active liver
disease.
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 know

製品の特徴

TERBINAFINE HYDROCHLORIDE- TERBINAFINE HYDROCHLORIDE TABLET
APHENA PHARMA SOLUTIONS - TENNESSEE, LLC
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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, FOR ORAL USE
INITIAL U.S. APPROVAL: 1992
RECENT MAJOR CHANGES
Dosage and Administration: Assessment Prior to Initiation (2.1)
8/2016
Contraindications (4)
8/2016
Warnings and Precautions: Hepatotoxicty (5.1)
8/2016
Warnings and Precautions: Thrombotic Microangiopathy (5.8)
1/2017
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
•
•
•
DOSAGE FORMS AND STRENGTHS
•
CONTRAINDICATIONS
•
•
WARNINGS AND PRECAUTIONS
•
•
•
•
•
•
ADVERSE REACTIONS
Common (greater than 2% of patients treated with Terbinafine tablets)
reported adverse events include headache,
diarrhea, rash, dyspepsia, liver enzyme abnormalities, pruritus, taste
disturbance, nausea, abdominal pain, and flatulence.
(6.1).
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT BRECKENRIDGE
PHARMACEUTICAL, INC. AT 1-800-367-3395,
OR GO TO WWW.BPIRX.COM, OR FDA AT 1-800-FDA-1088 OR
WWW.FDA.GOV/MEDWATCH.
Prior to administering, evaluate patients for evidence of chronic or
active liver disease. (2.1)
Fingernail onychomycosis: One 250 mg tablet, once daily for 6 weeks.
(2.2)
Toenail onychomycosis: One 250 mg tablet, once daily for 12 weeks.
(2.2)
Tablet, 250 mg (3)
History of allergic reaction to oral terbinafine because of the risk
of anaphylaxis. (4)
Chronic or active liver disease. (4)
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 tablet