TERBINAFINE tablet

Riik: Ameerika Ühendriigid

keel: inglise

Allikas: NLM (National Library of Medicine)

Toimeaine:

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

Saadav alates:

Proficient Rx LP

Manustamisviis:

ORAL

Retsepti tüüp:

PRESCRIPTION DRUG

Näidustused:

Terbinafine tablets, USP 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

Toote kokkuvõte:

Terbinafine tablets, USP are supplied as white, round, flat faced beveled edge tablets debossed with IG on one side and 209 on the other. Bottles of 15 tablets                    NDC 71205-152-15 Bottles of 30 tablets                  NDC 71205-152-30 Bottles of 35 tablets                  NDC 71205-152-35 Bottles of 45 tablets                  NDC 71205-152-45 Bottles of 60 tablets                  NDC 71205-152-60 Bottles of 90 tablets                  NDC 71205-152-90 Store tablets at 20° to 25°C (68° F to 77°F) [See USP Controlled Room Temperature]; in a tight container. Protect from light.

Volitamisolek:

Abbreviated New Drug Application

Infovoldik

TERBINAFINE- TERBINAFINE TABLET
Proficient Rx LP
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MEDICATION GUIDE
Terbinafine Tablets, USP
(ter' bin a 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 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
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 your
unborn baby. You shoul

Toote omadused

TERBINAFINE- TERBINAFINE TABLET
PROFICIENT RX LP
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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 CIPLA LTD. AT
1-866-604-3268 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
pretreatment serum transamina