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TERBINAFINE HYDROCHLORIDE | TERBINAFINE HYDROCHLORIDE [DirectRX] | BioPortfolio

13:39 EST 27th January 2019 | BioPortfolio

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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.

Fingernail onychomycosis: One 250 mg tablet once daily for 6 weeks.

Toenail onychomycosis: One 250 mg tablet once daily for 12 weeks.

The optimal clinical effect is seen some months after mycological cure and cessation of treatment. This is related to the period required for outgrowth of healthy nail.

Tablet, 250 mg white, circular biconvex tablets debossed with "C134" on one side and plain on the other side.

Terbinafine tablets, USP are contraindicated in individuals with a history of allergic reaction to oral terbinafine because of the risk of anaphylaxis.

Clinical experience regarding overdose with oral terbinafine is limited. Doses up to 5 grams (20 times the therapeutic daily dose) have been taken without inducing serious adverse reactions. The symptoms of overdose included nausea, vomiting, abdominal pain, dizziness, rash, frequent urination, and headache.

The efficacy of terbinafine tablets in the treatment of onychomycosis is illustrated by the response of subjects with toenail and/or fingernail infections who participated in 3 US/Canadian placebo-controlled clinical trials.

Results of the first toenail trial, as assessed at week 48 (12 weeks of treatment with 36 weeks follow-up after completion of therapy), demonstrated mycological cure, defined as simultaneous occurrence of negative KOH plus negative culture, in 70% of subjects. Fifty-nine percent (59%) of subjects experienced effective treatment (mycological cure plus 0% nail involvement or >5mm of new unaffected nail growth); 38% of subjects demonstrated mycological cure plus clinical cure (0% nail involvement).

In a second toenail trial of dermatophytic onychomycosis, in which nondermatophytes were also cultured, similar efficacy against the dermatophytes was demonstrated. The pathogenic role of the nondermatophytes cultured in the presence of dermatophytic onychomycosis has not been established. The clinical significance of this association is unknown.

Results of the fingernail trial, as assessed at week 24 (6 weeks of treatment with 18 weeks follow-up after completion of therapy), demonstrated mycological cure in 79% of subjects, effective treatment in 75% of the subjects, and mycological cure plus clinical cure in 59% of the subjects.

The mean time to overall success was approximately 10 months for the first toenail trial and 4 months for the fingernail trial. In the first toenail trial, for subjects evaluated at least 6 months after achieving clinical cure and at least 1 year after completing therapy with terbinafine tablets, the clinical relapse rate was approximately 15%.

Manufacturer

DirectRX

Active Ingredients

Source

Drugs and Medications [314 Associated Drugs and Medications listed on BioPortfolio]

Terbinafine hydrochloride [dr.reddys laboratories limited]

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 USP, 250 ...

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Terbinafine tablets, USP 250 mg for oral use These highlights do not include all the information needed to use Terbinafine Hydrochloride safely and effectively. See full prescribing information for Te...

Terbinafine hydrochloride [bryant ranch prepack]

Terbinafine tablets, USP 250 mg for oral useThese highlights do not include all the information needed to use Terbinafine Hydrochloride safely and effectively. See full prescribing information for Ter...

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Terbinafine tablets, USP 250 mg for oral useThese highlights do not include all the information needed to use Terbinafine Hydrochloride safely and effectively. See full prescribing information for Ter...

Terbinafine hydrochloride [camber pharmaceuticals, inc.]

Terbinafine tablets, USP 250 mg for oral useThese highlights do not include all the information needed to use Terbinafine Hydrochloride safely and effectively. See full prescribing information for Ter...

Clinical Trials [2185 Associated Clinical Trials listed on BioPortfolio]

Fed Study of Terbinafine Hydrochloride Tablets 250 mg and Lamisil® 250 mg

The objective of this study was to investigate the bioequivalence of Mylan's terbinafine hydrochloride tablets to Novartis' Lamisil® tablets following a single, oral 250 mg (1 x 250 mg) d...

Fasting Study of Terbinafine Hydrochloride Tablets 250 mg and Lamisil® Tablets 250 mg

The objective of this study was to investigate the bioequivalence of Mylan's terbinafine hydrochloride 250 mg tablets to Novartis' Lamisil® 250 mg tablets following a single, oral 250 mg ...

Terbinafine Compared to Griseofulvin in Children With Tinea Capitis

Tinea capitis is a dermatophyte infection of the scalp hair follicles, which occurs primarily in children. Hair loss, hair breakage, scaling, plus various degrees of erythema, pustules and...

Terbinafine Compared to Griseofulvin in Children With Tinea Capitis

Tinea capitis is a dermatophyte infection of the scalp hair follicles, which occurs primarily in children. Hair loss, hair breakage, scaling, plus various degrees of erythema, pustules and...

Iontophoretic Application of Terbinafine Gel to the Large Toe Nail

Terbinafine is recognized as one of the most effective drugs for the treatment of toe nail fungus (onychomycosis). This trial will be the first test of a new device to improve the deliver...

PubMed Articles [242 Associated PubMed Articles listed on BioPortfolio]

Utility of Laboratory Test Result Monitoring in Patients Taking Oral Terbinafine or Griseofulvin for Dermatophyte Infections.

Terbinafine hydrochloride and griseofulvin are effective oral treatments for dermatophyte infections but have been associated with hepatic and hematologic abnormalities. The prevalence of alanine amin...

Quantitative investigation of Terbinafine Hydrochloride Absorption into a Living Skin Equivalent Model by MALDI-MSI.

The combination of microspotting of analytical and internal standards, matrix sublimation and recently developed software for quantitative mass spectrometry imaging has been used to develop a high res...

The role of HLA-A ∗33:01 in Patients with Cholestatic Hepatitis attributed to Terbinafine.

Terbinafine is an antifungal agent that has been associated with rare instances of hepatotoxicity. Study aims include a description of the presenting features and outcomes of patients with terbinafine...

Photostability of Terbinafine Under UVA Irradiation: The Effect of UV Absorbers.

The photostability of drugs administered topically on unprotected skin is a complex phenomenon that could be connected with the loss of activity or, rather rarely, the occurrence of toxic degradation ...

Protective effects of berberine hydrochloride on DSS-induced ulcerative colitis in rats.

Berberine hydrochloride is one the effective compound among Rhizoma Coptidis, Cortex Phellodendri, and other plants. There are several clinical functions of berberine hydrochloride including anti-infl...

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