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Lamprene (Clofazimine) - Warnings and Precautions



Severe abdominal symptoms (see below) have necessitated exploratory laparotomies in some patients receiving Lamprene . Rare reports have included splenic infarction, bowel obstruction, and gastrointestinal bleeding. There have also been reports of death following severe abdominal symptoms. Autopsies have revealed crystalline deposits of clofazimine in various tissues including the intestinal mucosa, liver, spleen, and mesenteric lymph nodes.

      Lamprene should be used with caution in patients who have gastrointestinal problems such as abdominal pain and diarrhea. Dosages of Lamprene of more than 100 mg daily should be given for as short a period as possible and only under close medical supervision. If a patient complains of colicky or burning pain in the abdomen, nausea, vomiting, or diarrhea, the dose should be reduced, and if necessary, the interval between doses should be increased, or the drug should be discontinued.



Physicians should be aware that skin discoloration due to Lamprene may result in depression. Two suicides have been reported in patients receiving Lamprene.

      For skin dryness and ichthyosis, oil can be applied to the skin.

Information for Patients

Patients should be warned that Lamprene may cause a discoloration of the skin from red to brownish-black, as well as discoloration of the conjunctivae, lacrimal fluid, sweat, sputum, urine, and feces. Patients should be advised that skin discoloration, although reversible, may take several months or years to disappear after the conclusion of therapy with Lamprene.

      Patients should be told to take Lamprene with meals.

Drug Interactions

Preliminary data which suggest that dapsone may inhibit the anti-inflammatory activity of Lamprene have not been confirmed. If leprosy-associated inflammatory reactions develop in patients being treated with dapsone and clofazimine, it is still advisable to continue treatment with both drugs.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term carcinogenicity studies in animals have not been conducted with Lamprene. Results of mutagenicity studies (Ames test) were negative. There was some evidence of impaired fertility in one study in rats treated at a dose 25 times the usual human dose; the number of offspring was reduced and there was a lower proportion of implantations.

Pregnancy Category C

Lamprene was not teratogenic in laboratory animals at dose levels equivalent to 8 times (rabbit) and 25 times (rat) the usual human daily dose. However, there was evidence of fetotoxicity in the mouse at 12-25 times the human dose, i.e., retardation of fetal skull ossification, increased incidence of abortions and stillbirths, and impaired neonatal survival. The skin and fatty tissue of offspring became discolored approximately 3 days after birth, which was attributed to the presence of Lamprene in the maternal milk.

      It has been found that Lamprene crosses the human placenta. The skin of infants born to women who had received the drug during pregnancy was found to be deeply pigmented at birth. No evidence of teratogenicity was found in these infants. There are no adequate and well-controlled studies in pregnant women. Lamprene should be used during pregnancy only if the potential benefit justifies the risk to the fetus.

Nursing Mothers

Lamprene is excreted in the milk of nursing mothers. Lamprene should not be administered to a nursing woman unless clearly indicated.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established. Several cases of pediatric patients treated with Lamprene have been reported in the literature.

Page last updated: 2006-05-10

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