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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)

Comparative study of 250 mg/day terbinafine and 100 mg/day itraconazole for the treatment of cutaneous sporotrichosis. [2011.05]
Itraconazole is currently used for the treatment of cutaneous sporotrichosis. Terbinafine at a daily dose of 250 mg has been successfully applied to the treatment of cutaneous sporotrichosis. OBJECTIVE: To compare the efficacy of 250 mg/day terbinafine and 100 mg/day itraconazole for the treatment of cutaneous sporotrichosis... CONCLUSION: Terbinafine administered at a daily dose of 250 mg is an effective and well-tolerated option for the treatment of cutaneous sporotrichosis.

Iontophoretic delivery of terbinafine in onychomycosis: a preliminary study. [2010.01]
Background Onychomycosis is a common disease; topical treatment is usually poorly effective, while systemic treatment is more effective but may be associated with side-effects... Conclusions The delivery of terbinafine under an electrical current of 100 microA cm(-2) appears to be efficacious and safe and is well tolerated for the treatment of nail onychomycosis.

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.

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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.

more trials >>

Reports of Suspected Lamisil (Terbinafine) Side Effects

Alanine Aminotransferase Increased (17)Aspartate Aminotransferase Increased (16)Malaise (14)Pyrexia (13)Rash (12)Hepatic Function Abnormal (10)Pruritus (10)OFF Label USE (9)Fatigue (9)Ageusia (9)more >>


PATIENT REVIEWS / RATINGS / COMMENTS

Based on a total of 14 ratings/reviews, Lamisil has an overall score of 6.93. The effectiveness score is 8 and the side effect score is 8. The scores are on ten point scale: 10 - best, 1 - worst. Below are selected reviews: the highest, the median and the lowest rated.
 

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 35 year old female patient

  Rating
Overall rating:  
Effectiveness:   Considerably Effective
Side effects:   Mild Side Effects
  
Treatment Info
Condition / reason:   fingernail fungus
Dosage & duration:   1 pill per day taken once a day for the period of still taking it
Other conditions:   I had fingernail fungus to the extent of the fingernail had to be clipped off.
Other drugs taken:   No other drugs right now.
  
Reported Results
Benefits:   My fingernails have grown back to where the nail hits the end of where it should be instead of clipped down. I cant wait for the nail to grow back all the way to where I can pick up a piece of thin paper with my fingernail, as I work at an office!.Also, the little black splinters under my thumb nail are starting to go away, as is the yellowing and thickness of the nail, due to the infection.
Side effects:   A long time ago, 10 years, when I was prescribed lamisil by my doctor, I had dark circles under my eyes and was tired lots of time. When I went back to teh doctor he told me he had to take me off the lamisil because it was harming my liver function. But by that time, the effect of teh medicine was enough for my nails to grow back after that. I think it was a change in climate, moving away from Astoria to a dryer climate of Portland.
Comments:   When I saw the doctor 10 or so years ago, My nails were so bad, it was hard to look at them. The nails were thin and undernieth there was the infection of pus, so much that I had to clip the nails down and even pull one off; which wasnt difficult, because it was so weak, it just came right off. But after I took the lamisil, they grew back better, eventually.

 

Lamisil review by 50 year old female patient

  Rating
Overall rating:  
Effectiveness:   Ineffective
Side effects:   Severe Side Effects
  
Treatment Info
Condition / reason:   fungal toenails
Dosage & duration:   250 mg taken once a day for the period of 4 doses
Other conditions:   misc
Other drugs taken:   misc
  
Reported Results
Benefits:   None
Side effects:   after the 4th dose, I had blurred and double vision. I had to go and be evaluated by an opthalmologist, family practioner, and a neurologist since they thought my blurred vision was a result of something else. I was prescribed glasses, had to have extensive testing and FINALLY after 3-1/2 weeks, my normal vision return. I contacted the pharmacy, the drug manufacturer, the FDA and a toxicologist and none were able to tell me how long the side effects would last. I am grateful to have my sight back but this drug should not be on the market if even only 1& of the population can have visual disturbances...It was hell to not see clearly and have to submit to so many tests and be so dependent on others for getting around. DO NOT TAKE THIS MEDICATION!
Comments:   None

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Page last updated: 2011-12-09

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