A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Lamprene Warnings, Precautions, Pregnancy, Nursing, Abuse - Clofazimine
Lamprene Warnings, Precautions, Pregnancy, Nursing, Abuse - Clofazimine
WARNINGS
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.
PRECAUTIONS
General
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.
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