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LAMISIL
(generic name: Terbinafine)

Pharmacological category: antifungal
Reviews

Terbinafinum

Eur J Clin Pharmacol. 2005 Feb 4.
Co-prescription of cytochrome(P450) 2D6/3A4 inhibitor-substrate pairs in clinical practice. A retrospective analysis of data from Norwegian primary pharmacies.
Molden E, Garcia BH, Braathen P, Eggen AE.
School of Pharmacy, University of Oslo, PO Box 1068, Blindern, 0316, Oslo, Norway, emolden@farmasi.uio.no.

OBJECTIVE: Inhibition of cytochrome P(P450) (CYP) enzymes, in particular CYP3A4 and CYP2D6, is an important drug-interacting mechanism. The objective of our study was to assess how frequently CYP3A4 and CYP2D6 inhibitors are co-prescribed with substrates of the respective enzymes.METHODS: Included inhibitors were clarithromycin, erythromycin, fluconazole, itraconazole, ketoconazole and nefazodone (CYP3A4 inhibitors) and bupropion, fluoxetine, paroxetine and terbinafine (CYP2D6 inhibitors). The inhibitors were combined with substrates shown to be pharmacokinetically sensitive towards inhibition (190 drug pairs in total). Lists of patients receiving inhibitors and substrates were drawn from prescription databases (~43,500 patients) of three Norwegian primary pharmacies during a 6-month period (July 2002 to January 2003). The lists were matched on name and date of birth to identify patients using drug pairs. Concurrent use was made probable from dates of purchase and drug profiles.RESULTS: Inhibitors were prescribed to 2,062 patients. Altogether, 369 events of substrate co-prescription were registered. The highest frequencies of co-prescribed substrates were found for paroxetine (101 events per 267 patients, 38%), fluoxetine (36 events per 110 patients, 33%) and clarithromycin (59 events per 242 patients, 24%). The drugs most often detected in combination with inhibitors were codeine (116 events) and metoprolol (38 events) for CYP2D6 and zopiclone (45 events) and simvastatin (26 events) for CYP3A4.CONCLUSION: Several commonly used CYP2D6 and CYP3A4 inhibitors are frequently co-prescribed with substrates in Norwegian clinical practice. Alertness when inhibitors are prescribed would aid physicians and pharmacists to detect many drug combinations with potential interaction risk.
Dermatol Clin. 2003 Jul;21(3):511-20.
The efficacy and safety of terbinafine in children.
Gupta AK, Cooper EA, Lynde CW.
Division of Dermatology, Department of Medicine, Sunnybrook and Women's College Health Science Center (Sunnybrook Site), University of Toronto, 2075 Bayview Avenue, Toronto, Ontario M4N 3M5, Canada.

In summary, terbinafine is a broad-spectrum allylamine, which has been used to treat superficial fungal infections including onychomycosis, and some systemic mycoses in adults. With a fungicidal activity, low minimum inhibitory concentration value, and high selectivity for fungal squalene epoxidase, terbinafine has demonstrated good efficacy in superficial fungal infections. Its lipophilic nature provides excellent, widespread absorption into hair, skin, and nails where it can eradicate fungal infection. Terbinafine has been shown to be effective and safe in several studies of the treatment of tinea capitis and onychomycosis in children. When treating Trichophyton tinea capitis the length of therapy may be 2 or 4 weeks. Microsporum tinea capitis may require somewhat higher or longer doses of terbinafine for adequate efficacy. These regimens still tend to be shorter than treatment with griseofulvin, and terbinafine may provide a higher compliance and a more cost-effective means of managing tinea capitis. It is possible that even higher cure rates and a shorter duration of therapy may be achieved following further optimization of treatment regimens that use a higher daily dosage of terbinafine than is currently recommended. The evidence is strongly in favor of using terbinafine to treat superficial fungal infections in children.
Manag Care. 2003 Mar;12(3):47-54.
Economic analysis of oral and topical therapies for onychomycosis of the toenails and fingernails.
Firooz A, Khamesipour A, Dowlati Y.
Columbia University, New York, N.Y., USA.

OBJECTIVE: Several antifungal agents are indicated for onychomycosis, a fungal infection of the toenails and fingernails. These agents differ in their dosing regimen, efficacy, adverse events profile, potential for drug interaction, and cost. We conducted a pharmacoeconomic analysis of oral and topical therapies for onychomycosis from the perspective of a hypothetical managed care payer to determine the most cost-effective agent. DESIGN: A decision analytic model was developed to evaluate the pharmacoeconomic profiles of itraconazole-continuous (Sporanox, Janssen Pharmaceutica), itraconazole-pulse (Sporanox, Janssen Pharmaceutica), terbinafine (Lamisil, Novartis Pharmaceuticals), and ciclopirox (Penlac, Dermik Laboratories) in the treatment of fingernail and toenail onychomycosis. METHODOLOGY: We conducted a meta-analysis of the available literature to populate the decision analytic model with clinical point estimates for success, failure, and relapse. A panel of expert dermatologists defined resources consumed during the onychomycosis treatment process. These resources were then assigned values, using publicly available data sources, to reflect the U.S. managed care perspective. These clinical and economic data elements were integrated in the decision analytic model to arrive at the expected cost of treatment for each drug. Additionally, incremental cost-effectiveness was calculated for treatment success and disease-free days achieved by each therapy. Finally, a policy-level analysis of the budgetary impact of using the therapies for onychomycosis in a managed care setting was conducted. RESULTS: The meta-analysis demonstrated terbinafine to be the therapeutic alternative with the highest success rate for both fingernails (96.55 percent) and toenails (81.15 percent). Terbinafine also had the lowest relapse rate (6.42 percent) and the highest number of disease-free days for both fingernails and toenails. Subsequently, in terms of cost-effectiveness, terbinafine dominated all other comparators for fingernails and toenails. CONCLUSIONS: Based on the patient-level analysis, we concluded that terbinafine is the most cost-effective therapy in the treatment of onychomycosis from a managed care perspective. Furthermore, at the policy level, increased utilization of terbinafine among onychomycosis patients is likely to reduce the managed care organizations' per member per month cost.
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Drug information

GENERIC NAME: terbinafine
BRAND NAME: Lamisil


DRUG CLASS AND MECHANISM: Terbinafine is an antifungal agent that is taken by mouth or applied to the skin. Terbinafine acts by interfering with the ability of fungi to make chemicals called sterols that are an important part of the membrane that surrounds fungal cells and holds them together. This weakens the cell membrane. Oral terbinafine is more effective for treating fungal nail infections than griseofulvin (Fulvicin; Gris-Peg) and itraconazole (Sporanox), two other antifungal agents used for treating fungal nail infections. Topical terbinafine was approved by the FDA in 1993. Terbinafine oral tablets were approved in 1996.

PREPARATIONS: Tablets containing 250mg. Cream containing 1% terbinafine, 15gm and 30gm size tubes.

STORAGE: The tablets and the cream should be kept at room temperature, 15-30°C (59-86°F).

PRESCRIBED FOR: Tablets: Fungal infections of the toe, or fingernail, caused by the fungus, tinea unguium.

Cream: Fungal infections of the skin including tinea pedis ("athlete's foot"), tinea corporis, and tinea cruris ("jock itch").

DOSING: Tablets: The usual dose is 250 mg once daily for 6 weeks for treatment of the fingernails, and 12 weeks for treatment of toenails. Alternatively, terbinafine may be given as two tablets (500 mg) once daily for 7 days during the first week of each month for 3 months for toenail infections. For children under 20kg (44 pounds), a dose of 62.5 mg/day and for children between 20 and 40kg (44 and 88 pounds) a dose of 125 mg/day have been recommended. Terbinafine may be taken with or without food.

Cream: The cream is rubbed gently into the affected area (s). The cream usually is applied twice daily for 1 to 4 weeks.

DRUG INTERACTIONS: Rifampin reduces terbinafine blood concentrations, potentially reducing the efficacy of terbinafine, and cimetidine (Tagamet) may increase terbinafine blood levels. The latter effect would not be expected to lead to problems.

PREGNANCY: Studies in animals using large dosages of terbinafine have not demonstrated toxic effects on the fetus; however, there have not been conclusive studies in humans. Since fungal infections of the skin and nails usually are not a serious problem, the manufacturer of terbinafine does not recommend therapy during pregnancy.

NURSING MOTHERS: There is no data on the use of terbinafine during breast-feeding. Nursing mothers should avoid using terbinafine on the breast or taking the drug orally.

SIDE EFFECTS: Terbinafine is a very safe medication. The need to discontinue therapy because of side effects is quite rare. The most frequently reported side effects are diarrhea, and abdominal pain. Increases in liver enzymes, hives, itching and altered taste sensation also have been observed.


Caution! Before starting to take this medicine, it is vital that you should consult your doctor! Do not use it on your own initiative, without medical advice.

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LAMISIL
Generic name: Terbinafinum
Manufacturer: Novartis

Dosage
Packing
Price
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250 mg
14 tab
USD 62.00
250 mg
28 tab
USD 114.00
 

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