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Lamisil

Terbinafine hydrochloride, sold as Lamisil tablets in the U.S., is often prescribed for the treatment of onychomycosis of the toenail or fingernail due to dermatophytes (Tinea unguium). more...

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It is also sold as a 1% cream or powder for use on suface infections such as jock itch (Tinea cruris) or athlete's foot (Tinea pedis).

Nail fungus infections live deep under the nail in the nail bed. Surface treatments may not be able to reach it in sufficient amounts, so terbinafine hydrochloride is given orally in tablet form, which is absorbed through the bloodstream to reach the infection; this method can cause hepatotoxicity, or liver damage, as well as other serious side effects, so those taking Lamisil tablets often have blood screenings every month. Many health insurance companies consider these infections to be a cosmetic problem, and either do not cover the cost of the months-long course of Lamisil, which can run into the thousands of dollars, or recommend use of less expensive alternatives like fluconazole.

The tablets contain the synthetic allylamine antifungal compound terbinafine hydrochloride, which is a white fine crystalline powder that is freely soluble in methanol and methylene chloride, soluble in ethanol, and slightly soluble in water. Chemically, it is (E)-N-(6,6-dimethyl-2-hepten-4-ynyl)-N-methyl-1- naphthalenemethanamine hydrochloride. The empirical formula C21H26CIN with a molecular weight of 327.90

  • Active Ingredients: Terbinafine hydrochloride (equivalent to 250 mg base)
  • Inactive Ingredients: Colloidal silicon dioxide, Hydroxypropyl methylcellulose USP, Sodium starch glycolate, Magnesium stearate, Microcrystalline cellulose.

Read more at Wikipedia.org


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Lamisil, Nizoral the Next Rx Brands To Get Big-buck Budgets as OTC
From Brandweek, 4/5/99 by Christine Bittar

In the next wave of Rx-to-over-the-counter product switches, Novartis is prepping a $20 million ad campaign for Lamisil AT athlete's foot and jock itch creams, while Johnson & Johnson/McNeil is spending $10-15 million to herald the arrival of its long-awaited OTC Nizoral dandruff shampoo.

Nizoral TV spots will break May 17, likely talking up Nizoral's Rx strength plus gentleness. J&J/ McNeil will drop a national full page FSI on May 23 for $1, and another $1 half-page on Oct. 24. The product in blue-to-white graded package (right) designed by The Coleman Group, N.Y., will ship at the end of April.

"We wanted to create an image that would clearly represent Nizoral's efficacy, without making it seem too medicinal" said Jonathan Asher, managing partner at design shop The Coleman Group.

Touting Lamisil as the biggest advancement in OTC antifungal treatments in 20 years, Novartis' ads, via Grey, N.Y., will likely boast its ability to treat athletes foot in one week compared to the competition, which take up to four weeks. TV airing on primetime network, cable and sports programming breaks in May, with print in men's monthlies starting in June.

According to Novartis, Rx Lamisil is the most widely prescribed athlete's foot medication by doctors, and a campaign targeting healthcare professionals is already underway to make it the most widely recommended.

"At one time or another, 75% of the population will get athletes foot, and a third of them don't treat it with over the counter medications," said Phil Kantor, senior brand manager.

A buyer at one major drug chain said since Lamisil is likely to eat into shares of Lotrimin, Tinactin and Novartis' own Desenex in the $280 million category. Novartis will gird Desenex with updated packaging, fewer SKUs and an estimated $10 million in TV support starting mid-April. "Each brand will be marketed separately and has its own distinct markets," Kantor said.

Lamisil will also have a jock itch formulation. Novartis will offer a $4 mail-in-rebate on-pack and deliver 135 million coupons, including a $1 national FSI dropping in May.

COPYRIGHT 1999 BPI Communications, Inc.
COPYRIGHT 2000 Gale Group

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