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Lamprene (Clofazimine) - Indications and Dosage

 
 



INDICATIONS AND USAGE

Lamprene is indicated in the treatment of lepromatous leprosy, including dapsone-resistant lepromatous leprosy and lepromatous leprosy complicated by erythema nodosum leprosum. Lamprene has not been demonstrated to be effective in the treatment of other leprosy-associated inflammatory reactions.

      Combination drug therapy has been recommended for initial treatment of multibacillary leprosy to prevent the development of drug resistance.

DOSAGE AND ADMINISTRATION

Lamprene should be taken with meals.

      Lamprene should be used preferably in combination with one or more other antileprosy agents to prevent the emergence of drug resistance.

      For the treatment of proven dapsone-resistant leprosy, Lamprene should be given at a dosage of 100 mg daily in combination with one or more other antileprosy drugs for 3 years, followed by monotherapy with 100 mg of Lamprene daily. Clinical improvement usually can be detected between the first and third months of treatment and is usually clearly evident by the sixth month.

      For dapsone-sensitive multibacillary leprosy, a combination therapy with two other antileprosy drugs is recommended. The triple-drug regimen should be given for at least 2 years and continued, if possible, until negative skin smears are obtained. At this time, monotherapy with an appropriate antileprosy drug can be instituted.

      The treatment of erythema nodosum leprosum reactions depends on the severity of symptoms. In general, the basic antileprosy treatment should be continued, and if nerve injury or skin ulceration is threatened, corticosteroids should be given. Where prolonged corticosteroid therapy becomes necessary, Lamprene administered at dosages of 100 to 200 mg daily for up to 3 months may be useful in eliminating or reducing corticosteroid requirements. Dosages above 200 mg daily are not recommended, and the dosage should be tapered to 100 mg daily as quickly as possible after the reactive episode is controlled. The patient must remain under medical surveillance.

      For advice about combination drug regimens, contact the USPHS Gillis W. Long Hansen’s Disease Center, Carville, LA (504-642-7771).

HOW SUPPLIED

Soft Gelatin Capsules 50 mg–brown, spherical

Bottles of 100...............................NDC 0028-0108-01

Store below 30˚C (86˚F). Protect from moisture.

Dispense in tight container (USP).

667753           C98-38 (Rev. 9/98)

Distributed by

Novartis Pharmaceuticals Corporation

East Hanover, New Jersey 07936

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