TERBINAFINE- 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:

Proficient Rx LP

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: 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 times to 23 times the maximum recommended human dose (MRHD), in rabbits and rats, respectively, based on body surface area (BSA) comparisons] and have revealed no evidenc

Product summary:

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 71205-061-30                Bottles of 60                   NDC 71205-061-60                Bottles of 90                   NDC 71205-061-90 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.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

TERBINAFINE- terbinafine hydrochloride tablet
Proficient Rx LP
----------
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 tablets will harm yo

Summary of Product characteristics

TERBINAFINE- TERBINAFINE HYDROCHLORIDE TABLET
PROFICIENT RX LP
----------
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
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
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)
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)
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