TERBINAFINE- terbinafine hydrochloride tablet

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

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

可用日期:

NorthStar Rx LLC

给药途径:

ORAL

处方类型:

PRESCRIPTION DRUG

疗效迹象:

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: - Chronic or active liver disease [see Warnings and Precautions (5.1)] - History of allergic reaction to oral terbinafine because of the risk of anaphylaxis [see Adverse Reactions (6.2)] 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 outcomes. The background risk of major birth defects and miscarriage for the indicated population is unknown; however, in the U.S. general population, the estimated background risk of major birth defects is 2% to 4% and of miscarriage is 15% to 20% of clinically recognized pregnancies.    Data Animal Data In embryo-fetal development studies in rats and rabbits, pregnant animals received orally (by gavage) doses of terbinafine up to 300 mg/kg/day, during the period of organogenesis. There were no maternal or embryo-fetal effects in either species up to the maximum dose tested. The 300 mg/kg/day dose level in rats and rabbits corresponds to 23 and 12 times the MRHD [based on body surface area (BSA) comparisons], respectively. In a rat peri- and postnatal development study, terbinafine doses of up to 300 mg/kg/day (12 times the MRHD based on BSA comparisons) given by oral gavage during late pregnancy and lactation (Day 15 of gestation to day 20 post-partum) had no adverse effects on parturition and lactation. Risk Summary After oral administration, terbinafine is present in human milk. However, there are no data on the effects on the breastfed child or on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for terbinafine tablets and any potential adverse effects on the breastfed child from terbinafine tablets or from the underlying maternal condition. The safety and efficacy of terbinafine tablets have not been established in pediatric patients with onychomycosis. Clinical studies of terbinafine tablets did not include sufficient numbers of subjects aged 65 years and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. In patients with renal impairment (creatinine clearance less than or equal to 50 mL/min), the use of terbinafine tablets has not been adequately studied. Terbinafine tablets are contraindicated for patients with chronic or active liver disease [see Contraindications (4) and Warnings and Precautions (5.1)] . Cases of liver failure, some leading to liver transplant or death, have occurred with the use of terbinafine tablets in individuals with and without preexisting liver disease. The severity of hepatic events and/or their outcome may be worse in patients with active or chronic liver disease.

產品總結:

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 16714-795-01                Bottles of 100                      NDC 16714-795-02                 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.

授权状态:

Abbreviated New Drug Application

资料单张

TERBINAFINE - TERBINAFINE HYDROCHLORIDE TABLET
NorthStar Rx LLC
----------
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 may har

产品特点

TERBINAFINE - TERBINAFINE HYDROCHLORIDE TABLET
NORTHSTAR RX LLC
----------
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
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)
DOSAGE FORMS AND STRENGTHS
Tablet, 250 mg (3)
CONTRAINDICATIONS
Chronic or active liver disease. (4)
History of allergic reaction to oral terbinafine because of the risk
of anaphylaxis. (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
tablets if liver injury develops. (5.1)
Taste disturbance, including taste loss, has been reported with the
use of terbinafine tablets. Taste
disturbance can be severe, may be prolonged, or may be permanent.
Discontinue terbinafine tablets if
taste disturbance occurs. (5.2)
Smell disturbance, including loss of smell, has been reported with the
use of terbinafine tablets. Smell
disturbance may be prolonged, or may be permanent. Discontinue
terbinafine tablets if smell
disturbance occurs. (5.3)
Depressive symptoms have been reported with terbinafine use.
Prescribers should be alert to the
development of depressive symptoms. (5.4)
Severe neutropenia has been reported. If the neutrophil count is less
than or equal to 1000 cells/mm ,
terbinafine tablets should be discontinu