TERBINAFINE HYDROCHLORIDE tablet

Riik: Ameerika Ühendriigid

keel: inglise

Allikas: NLM (National Library of Medicine)

Toimeaine:

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

Saadav alates:

Preferred Pharmaceuticals Inc.

Manustamisviis:

ORAL

Retsepti tüüp:

PRESCRIPTION DRUG

Näidustused:

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: 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 up to 12 and 23 times the maximum recommended human dose (MRHD) of 250 mg/day, respectively (see Error! Hyperlink reference not valid. ). All pregnancies have a background risk of birth de

Toote kokkuvõte:

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 68788-7187-3 Store Terbinafine Tablets, USP at 20° - 25°C (68° - 77°F) [See USP Controlled Room Temperature].

Volitamisolek:

Abbreviated New Drug Application

Infovoldik

TERBINAFINE HYDROCHLORIDE- TERBINAFINE HYDROCHLORIDE TABLET
Preferred Pharmaceuticals Inc.
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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:
nausea
upper right stomach-area (abdomen) pain
•
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 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 may harm your unborn
baby. Tell your doctor right away if you become pregnant during
treatment with Terbinafine tablets.
•
are breastfeeding

Toote omadused

TERBINAFINE HYDROCHLORIDE- TERBINAFINE HYDROCHLORIDE TABLET
PREFERRED PHARMACEUTICALS 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
•
•
•
DOSAGE FORMS AND STRENGTHS
•
CONTRAINDICATIONS
•
•
WARNINGS AND PRECAUTIONS
•
•
•
•
•
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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 FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
Terbinafine is an inhibitor of CYP450 2D6 isozyme and has an effect on
metabolism of desipramine. Drug
interactions have also been noted with cimetidine, fluconazole,
cyclosporine, rifampin, and caffeine. (7.1)
SEE 17 FOR PATIENT COUNSELING INFORMATION AND MEDICATION GUIDE.
REVISED: 10/2022
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)
Tablet, 250 mg (3)
Chronic or active liver disease. (4)
History of allergic reaction to oral terbinafine because of the risk
of anaphylaxis. (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. Discont