Lamisil (terbinafine hydrochloride) Oral Granules is indicated for the treatment of tinea capitis in patients four years of age and older.

Lamisil (terbinafine hydrochloride) Oral Granules should be taken once a day for 6 weeks based upon body weight [See Table 1]. Sprinkle the contents of each packet on a spoonful of pudding or other soft, non-acidic food such as mashed potatoes and swallow the entire spoonful (without chewing); do not use applesauce or fruit-based foods. Take with food. If two packets (250 mg) are required with each dose, either the content of both packets may be sprinkled on one spoonful, or the contents of both packets may be sprinkled on two spoonfuls of non-acidic food as directed above.

Table 1: Dosage by Body Weight

Dosage Forms And Strengths

Lamisil (terbinafine hydrochloride) Oral Granules are supplied in cartons containing 14 laminated aluminum packets. Each packet contains approximately either 30 or 45 off-white to yellowish, round, biconvex, film-coated granules, corresponding to a single total dose of 125 mg or 187.5 mg (terbinafine base equivalent) per packet.

Lamisil Oral Granules are manufactured using a tablet compression process, followed by film-coating. The film-coated granules are off-white to yellowish, round, biconvex, each having a diameter of approximately 2.1 mm. Each individual granule contains 4.6875 mg of terbinafine hydrochloride, corresponding to 4.167 mg of terbinafine base.

Storage And Handling

Lamisil (terbinafine hydrochloride ) Oral Granules 125 mg and 187.5 mg

Lamisil Oral Granules is supplied in cartons containing 14 laminated aluminum packets. Each packet contains approximately either 30 or 45 off-white to yellowish, round, biconvex, film-coated granules, corresponding to a single total dose of 125 mg or 187.5 mg (terbinafine base equivalent) per packet.

125 mg per packet

Carton of 14 packets....................................NDC 0078-0499-58 Pack of 3 cartons each containing 14 packets (42 packets) ......... NDC 0078-0499-59

187.5 mg per packet

Carton of 14 packets....................................NDC 0078-0500-58 Pack of 3 cartons each containing 14 packets (42 packets) .......... NDC 0078-0500-59

Storage conditions of Lamisil Oral Granules 125 mg and 187.5 mg: Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].

Manufactured by: Novartis Pharma Stein AG Stein, Switzerland. Distributed by: Novartis Pharmaceuticals Corporation, East Hanover, New Jersey 07936. FDA Rev date: 9/28/2007

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