Lamisil (Terbinafine) - Summary

LAMISIL SUMMARY

Lamisil

LAMISIL® (terbinafine hydrochloride tablets) Tablets contain the synthetic allylamine antifungal compoundterbinafine hydrochloride.

LAMISIL® (terbinafine hydrochloride tablets) Tablets are indicated for the treatment of onychomycosis of the toenail or fingernail due to dermatophytes (tinea unguium) (see DOSAGE AND ADMINISTRATION and CLINICAL STUDIES).

Prior to initiating treatment, appropriate nail specimens for laboratory testing (KOH preparation, fungal culture, or nail biopsy) should be obtained to confirm the diagnosis of onychomycosis.

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NEWS HIGHLIGHTS

Published Studies Related to Lamisil (Terbinafine)

The use of an intermittent terbinafine regimen for the treatment of dermatophyte toenail onychomycosis. [2009.03]
OBJECTIVE: To compare the efficacy and safety of intermittent terbinafine with standard courses of terbinafine and itraconazole for dermatophyte toenail onychomycosis... CONCLUSIONS: A TOT intermittent terbinafine regimen provided similar efficacy and safety to the gold standard continuous terbinafine regimen and better effective cure rates than pulse itraconazole therapy.

Terbinafine hydrochloride oral granules versus oral griseofulvin suspension in children with tinea capitis: results of two randomized, investigator-blinded, multicenter, international, controlled trials. [2008.07]
CONCLUSIONS: Data from this largest pediatric trial of terbinafine to date indicate that terbinafine is efficacious and well tolerated in the treatment of tinea capitis. Terbinafine is an effective alternative to griseofulvin against T. tonsurans tinea capitis.

Terbinafine hydrochloride oral granules versus oral griseofulvin suspension in children with tinea capitis: Results of two randomized, investigator-blinded, multicenter, international, controlled trials. [2008.03.29]
CONCLUSIONS: Data from this largest pediatric trial of terbinafine to date indicate that terbinafine is efficacious and well tolerated in the treatment of tinea capitis. Terbinafine is an effective alternative to griseofulvin against T tonsurans tinea capitis.

Effect of terbinafine and voriconazole on the pharmacokinetics of the antidepressant venlafaxine. [2008.02]
This study investigated the effect of terbinafine and voriconazole on the pharmacokinetics of venlafaxine in healthy volunteers. Plasma concentrations of venlafaxine and O-desmethylvenlafaxine (ODV) were measured after ingestion of 75 mg venlafaxine without pretreatment (control), after terbinafine pretreatment, or after voriconazole pretreatment.

Pharmacokinetics and comparative bioavailability of two terbinafine hydrochloride formulations after single-dose administration in Chinese healthy subjects. [2008]
The bioavailability of a new terbinafine (CAS 91161-71-6) preparation was compared with a commercially available original preparation (reference) of the drug in 19 Chinese healthy male volunteers. The study was performed in an open, randomized, single blind two-sequence, two-period crossover design...

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Clinical Trials Related to Lamisil (Terbinafine)

Safety and Pharmacokinetics of Terbinafine Hydrogen Chloride (HCl) Nail Lacquer in Patients With Onychomycosis [Completed]
In this study, the safety and pharmacokinetics of 10 % terbinafine hydrogen chloride (HCl) nail lacquer wre investigated by comparison with vehicle control and 1% terbinafine cream

Fed Study of Terbinafine Hydrochloride Tablets 250 mg and Lamisil® 250 mg [Completed]
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) dose administered under fed conditions.

Fasting Study of Terbinafine Hydrochloride Tablets 250 mg and Lamisil® Tablets 250 mg [Completed]
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 (1 x 250 mg) dose administered under fasting conditions.

Efficacy Safety, and Tolerability of Topical Terbinafine in Patients With Mild to Moderate Toenail Fungus of the Big Toenail [Active, not recruiting]
This study is designed to assess the efficacy, safety and tolerability of a topical formulation of terbinafine solution applied daily in patients with toenail fungus. This trial will study patients with mild to moderate toenail fungus disease of the big toenail and their responses to two treatment durations, 24 or 48 weeks.

Efficacy, Safety, and Tolerability of Topical Terbinafine in Patients With Mild to Moderate Toenail Fungus of the Big Toenail [Active, not recruiting]
This study is designed to assess the efficacy, safety and tolerability of a topical formulation of terbinafine solution applied daily in patients with toenail fungus. This trial will study patients with mild to moderate toenail fungus disease of the big toenail and their responses to two treatment durations, 24 or 48 weeks.

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PATIENT REVIEWS / RATINGS / COMMENTS

Lamisil review by 24 year old male patient
		Rating
Overall rating:
Effectiveness:		Highly Effective
Side effects:		No Side Effects
		Treatment Info
Condition / reason:		Athletes Foot
Dosage & duration:		10mg taken 1/day for the period of 40 days
Other conditions:		none
Other drugs taken:		none
		Reported Results
Benefits:		Completely cleared up the condition. Without using messy creams, or powders. Prevented it from spreading to other body parts.
Side effects:		I experienced no side effects. Although I had too take some blood tests in order to make sure it wasn't damaging my liver. It can cause liver damage.
Comments:		Took one pill orally per day for a period of 40 days.

Lamisil review by 57 year old female patient
		Rating
Overall rating:
Effectiveness:		Considerably Effective
Side effects:		Severe Side Effects
		Treatment Info
Condition / reason:		toenail fungus
Dosage & duration:		250mg taken 1x / day for the period of From 4/1 to to 6/10
Other conditions:		None
Other drugs taken:		Climara Pro, acyclovir, gabapentin, sertraline
		Reported Results
Benefits:		Fungus dead
Side effects:		Skin rash over 70% of body
Comments:		The terbinafine was taken to eradicate nail fungus, which had aggressively attacked 2 toenails and was spreading to nearby digits. The terbinafine 250mg tablets were taken, 1 per day, for a little over 2 months. The first symptoms of the rash were noticed as slight, itchy redness on the skin around the chest and stomach area. These symptoms were noticed on 5/21, about 7 weeks into the treatment, but the condition not diagnosed as an allergic reaction until 6/10. By that time it had spread to 70% of the body, on the torso, back, and legs. The diagnosing physician suspected the terbinafine, and the patient immediately stopped taking the drug. Assessment of the original condition (toenail fungus) was that the terbinafine had already successfully resolved it.

Lamisil review by 57 year old female patient
		Rating
Overall rating:
Effectiveness:		Marginally Effective
Side effects:		No Side Effects
		Treatment Info
Condition / reason:		toenail fungus
Dosage & duration:		250mg taken once a day for the period of 12 weeks
Other conditions:		none
Other drugs taken:		none
		Reported Results
Benefits:		I did not see a change in the condition of the toenail. Only about a quarter if the left great toenail was affected. After taking the drug for the 12 weeks, the physician recommended another 12 week course, however my insurance company would not cover the extended treatment and I could not afford the cost of Lamisil. Perhaps a positive effect would have been realized if I was able to continue the treatment
Side effects:		none
Comments:		I was to take the drug for 12 weeks after having liver function studies performed. I did not experience any untowards side effects having taken the medication for ther prescribed 12 weeks. I did not miss any doses during that time.