TERBINAFINE- terbinafine hydrochloride tablet

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

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

Dostupné s:

Lake Erie Medical DBA Quality Care Products LLC

Podání:

ORAL

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

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: - History of allergic reaction to oral terbinafine because of the risk of anaphylaxis [see Adverse Reactions (6.2)] - Chronic or active liver disease [see Warnings and Precautions (5.1)] 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 3

Přehled produktů:

Terbinafine Tablets USP, 250 mg are supplied as white to off-white, round uncoated, biconvex beveled edge tablets having ‘D’ debossed on one side and ‘74’ on the other side. 55700-344-60 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]. Protect from light.

Stav Autorizace:

Abbreviated New Drug Application

Informace pro uživatele

TERBINAFINE- TERBINAFINE HYDROCHLORIDE TABLET
Lake Erie Medical DBA Quality Care Products LLC
----------
MEDICATION GUIDE
Terbinafine Tablets, USP
[Terbinafine (ter BIN na feen)]
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 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 known if

Charakteristika produktu

TERBINAFINE- TERBINAFINE HYDROCHLORIDE TABLET
LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC
----------
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: Hepatotoxicity (5.1) 8/2016
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 250 mg tablet, once daily for 6 weeks.
(2.2)
Toenail onychomycosis: One 250 mg tablet, once daily for 12 weeks.
(2.2)
DOSAGE FORMS AND STRENGTHS
Tablet, 250 mg (3)
CONTRAINDICATIONS
History of allergic reaction to oral terbinafine because of the risk
of anaphylaxis. (4)
Chronic or active liver disease. (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.