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:

Preferred Pharmaceuticals, Inc.

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: 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 data) . All pregnancies have a background risk of birth defect, loss, or other adverse

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.                Bottles of 30                        NDC 68788-7450-03                Bottles of 100                      NDC 68788-7450-01 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
Preferred Pharmaceuticals, Inc.
----------
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
terbinafine t

Charakteristika produktu

TERBINAFINE- 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
Tablet, 250 mg (3)
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 AUROBINDO PHARMA USA, INC. AT
1-866-850-2876 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: 9/2023
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)
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. Discontinue terbinafine
tablets i