Clofazimine

Oral

Multibacillary leprosy

Adult: 300 mg Clofazimine with 600 mg rifampicin, both given once a mth together with daily doses of 50 mg Clofazimine and 100 mg dapsone for 12 mth.

Child: 10-14 yr: 150 mg Clofazimine with 450 mg rifampicin and 50 mg dapsone once a mth, taken with 50 mg dapsone daily and 50 mg Clofazimine on alternate days. Treatment is given for 12 mth.

Oral

Erythema nodosum leprosum (Type 2)

Adult: Treatment depends on severity. 100-200 mg daily for up to 3 mth. Doses >200 mg daily are not recommended. Gradually taper the dose to 100 mg daily as soon as the reactive episode is controlled. In general, continue with basic antileprosy treatment.

Oral

Dapsone-resistant leprosy

Adult: 100 mg daily with 1 or more other antileprosy drugs for 3 yr, then continue as a monotherapy at 100 mg daily.

Clofazimine is taken to treat leprosy (Hansen's disease). It is sometimes given with other medicines for leprosy. When Clofazimine is used to treat ``flare-ups'' of leprosy, it may be given with a cortisone-like medicine. Clofazimine may also be used for other problems as determined by your doctor.

Clofazimine is available only with your doctor's prescription.

Applies to the following strengths: 50 mg

Usual Adult Dose for:

• Leprosy - Dapsone-Resistant
• Leprosy - Dapsone-Sensitive
• Leprosy - Erythema Nodosum Leprosum

Usual Pediatric Dose for:

• Leprosy

Additional dosage information:

• Renal Dose Adjustments
• Liver Dose Adjustments
• Dose Adjustments
• Precautions
• Dialysis
• Other Comments

Usual Adult Dose for Leprosy - Dapsone-Resistant

100 mg orally once a day, in combination with one or more other antileprosy drugs, for 3 years, followed by monotherapy with Clofazimine 100 mg daily.

Usual Adult Dose for Leprosy - Dapsone-Sensitive

100 mg orally once a day for at least 2 years, as part of triple-drug antileprosy regimen. Once negative smears are obtained, monotherapy with an appropriate antileprosy drug may be started.

Usual Adult Dose for Leprosy - Erythema Nodosum Leprosum

In general, the basic antileprosy treatment should be continued. For leprosy - dapsone resistance: 100 mg orally once a day, in combination with one or more other antileprosy drugs, for 3 years, followed by monotherapy with Clofazimine 100 mg daily. For leprosy - dapsone-sensitive: 100 mg orally once a day for at least 2 years, as part of triple-drug antileprosy regimen. Once negative smears are obtained, monotherapy with an appropriate antileprosy drug may be started.

Usual Pediatric Dose for Leprosy

1 mg/kg/day (up to 100 mg) orally in combination with dapsone and rifampin.

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Dose Adjustments

In erythema nodosum leprosum when corticosteroids are needed for the control of nerve injury or skin ulceration, Clofazimine 100 to 200 mg orally once a day for up to 3 months may be administered to reduce or eliminate the corticosteroid requirements. Taper Clofazimine dose to 100 mg/day as quickly as possible.

Precautions

Severe abdominal symptoms have necessitated exploratory laparotomies in Clofazimine in various tissues including the intestinal mucosa, liver, spleen, and mesenteric lymph nodes. Splenic infarction, bowel obstruction, and gastrointestinal bleeding have been reported rarely. Reports of death following severe abdominal symptoms have also been reported. Clofazimine should be used with caution in patients who have gastrointestinal problems such as abdominal pain and diarrhea. Dosages of Clofazimine 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.

Prescribers should be aware that Clofazimine therapy may cause skin discoloration 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 treatment with Clofazimine. Skin discoloration due to Clofazimine may result in depression. Two suicides have been reported in patients administered Clofazimine.

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

In general, dosage selection for elderly patients should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Safety and efficacy in pediatric patients have not been determined. Several cases of pediatric patients administered Clofazimine therapy have been reported in the literature.

Dialysis

Data not available

Other Comments

Clofazimine should be taken with meals.

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

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer

More about Clofazimine

• Clofazimine Side Effects
• During Pregnancy or Breastfeeding
• Drug Interactions
• Compare Alternatives
• Support Group
• Drug class: leprostatics

Consumer resources

• Clofazimine
• Clofazimine (Advanced Reading)

Other brands: Clofazimine

Professional resources

• Clofazimine (AHFS Monograph)

Related treatment guides

• Leprosy
• Leprosy, Dapsone-Resistant
• Leprosy, Dapsone-Sensitive
• Leprosy, Erythema Nodosum Leprosum

There are no known contraindications.

Clofazimine is used to treat leprosy.

Preliminary data which suggest that dapsone may inhibit the anti-inflammatory activity of Clofazimine (Clofazimine) 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.

See also:
What are the possible side effects of Clofazimine?

Applies to Clofazimine: oral capsule

In addition to its needed effects, some unwanted effects may be caused by Clofazimine (the active ingredient contained in Clofazimine). In the event that any of these side effects do occur, they may require medical attention.

Major Side Effects

You should check with your doctor immediately if any of these side effects occur when taking Clofazimine:

Rare

• Bloody or black, tarry stools
• colicky or burning abdominal or stomach pain
• mental depression
• yellow eyes or skin—may be an orange color if already have a pink to brownish-black skin or eye discoloration

Minor Side Effects

Some of the side effects that can occur with Clofazimine may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

More common:

• Diarrhea
• dry, rough, or scaly skin
• loss of appetite
• nausea or vomiting
• pink or red to brownish-black discoloration of skin and eyes
• skin rash and itching

• Changes in taste
• dryness, burning, itching, or irritation of the eyes
• increased sensitivity of skin to sunlight

Clofazimine commonly causes discoloration of the feces, lining of the eyelids, sputum, sweat, tears, and urine. Usually this side effect does not require medical attention, but the discoloration may not go away. However, Clofazimine may also cause bloody or black, tarry stools. This side effect may be a symptom of serious bleeding problems that do require medical attention.

A fat-soluble riminophenazine dye used for the treatment of leprosy. It has been used investigationally in combination with other antimycobacterial drugs to treat Mycobacterium avium infections in AIDS patients. Clofazimine also has a marked anti-inflammatory effect and is given to control the leprosy reaction, erythema nodosum leprosum. (From AMA Drug Evaluations Annual, 1993, p1619)