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:

Wockhardt USA LLC.

INN (International Name):

TERBINAFINE HYDROCHLORIDE

Composition:

TERBINAFINE 250 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Terbinafine hydrochloride 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 hydrochloride 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 hydrochloride tablets not be initiated during pregnancy. Oral reproduction studies

Product summary:

Terbinafine hydrochloride tablets 250 mg, supplied as white circular, bi-convex, bevelled tablets embossed with 'W' on one side and '743' on other side. Bottles of 30 tablets                                        NDC 64679-743-01 Bottles of 100 tablets                                      NDC 64679-743-03 Bottles of 1000 tablets                                    NDC 64679-743-02 Unit-dose blister pack of 10 x 10 tablets        NDC 64679-743-04 Store between 20°-25°C (68°-77°F) (See USP Controlled Room Temperature) in a tight container. Protect from light.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

TERBINAFINE HYDROCHLORIDE- TERBINAFINE HYDROCHLORIDE TABLET
Wockhardt USA LLC.
----------
MEDICATION GUIDE
Terbinafine (ter-BIN-ah-fin)
hydrochloride tablets
What is the most important information I should know about terbinafine
hydrochloride tablets?
Terbinafine hydrochloride 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:
o nausea
o upper right stomach-area (abdomen) pain
o poor appetite
o yellowing of your skin or eyes (jaundice)
o tiredness
o dark (tea-colored) urine
o vomiting
o pale or light colored stools
Your doctor should do a blood test to check you for liver problems
before you start treatment with
terbinafine hydrochloride tablets. Your doctor may also check you for
liver problems during treatment,
and tell you to stop taking terbinafine hydrochloride tablets if you
develop liver problems.
What are terbinafine hydrochloride tablets?
Terbinafine hydrochloride tablet is 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
hydrochloride tablets.
It is not known if terbinafine hydrochloride tablets are safe and
effective in children for the treatment of
onychomycosis.
Who should not take terbinafine hydrochloride tablets?
Do not take terbinafine hydrochloride 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 hydrochloride
tablets?
Before taking terbinafine hydrochloride tablets, tell your doctor
about all of your medical conditions,
including if you:
•
have or had liver problems
•
have a weakened immu

Summary of Product characteristics

TERBINAFINE HYDROCHLORIDE- TERBINAFINE HYDROCHLORIDE TABLET
WOCKHARDT USA LLC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
TERBINAFINE HYDROCHLORIDE
TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
TERBINAFINE HYDROCHLORIDE
TABLETS.
TERBINAFINE HYDROCHLORIDE 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 hydrochloride tablets are an allylamine antifungal
indicated for the treatment of onychomycosis of the toenail
or fingernail due to dermatophytes (tinea unguium). (1) (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) (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 hydrochloride tablets if liver injury
develops. (5.1)
Taste disturbance, including taste loss, has been reported with the
use of terbinafine hydrochloride tablets. Taste
disturbance can be severe, may be prolonged, or may be permanent.
Discontinue terbinafine hydrochloride tablets if
taste disturbance occurs. (5.2)
Smell disturbance, including loss of smell, has been reported with the
use of terbinafine hydrochloride tablets. Smell
disturbanc