In the U.S.—

• Antibacterial, antimycobacterial

Clofazimine (kloe-FA-zi-meen) is taken to treat leprosy (Hansen's disease). It is sometimes given with other medicines for leprosy. When this medicine 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.

This medicine is available only with your doctor's prescription, in the following dosage form:

Oral
• Capsules (U.S.)

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For clofazimine, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to clofazimine. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Clofazimine has not been studied in pregnant women. Although the skin of babies born to mothers who took clofazimine during pregnancy was deeply discolored, this medicine has not been shown to cause birth defects or other problems in humans. A gradual fading of the discoloration may occur over a period of about a year. Some animal studies have not shown that clofazimine causes birth defects. However, studies in mice have shown that clofazimine may cause slow bone formation of the skull and a decrease in successful pregnancies. Before you take clofazimine, make sure your doctor knows if you are pregnant or if you may become pregnant.

Breast-feeding—Clofazimine passes into the breast milk. Use is not recommended in nursing mothers.

Children—Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of clofazimine in children with use in other age groups.

Older adults—Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of clofazimine in the elderly with use in other age groups.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your health care professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

• Liver disease—Clofazimine may on rare occasion cause hepatitis and liver disease

• Stomach or intestinal problems, history of—Clofazimine often causes some stomach upset, but on rare occasion may cause severe, sharp abdominal pain and burning, which may be a sign of a serious side effect

Clofazimine should be taken with meals or milk.

To help clear up your leprosy completely, it is very important that you keep taking clofazimine for the full time of treatment , even if you begin to feel better after a few months. You may have to take it every day for as long as 2 years to life. If you stop taking this medicine too soon, your symptoms may return.

This medicine works best when there is a constant amount in the blood. To help keep the amount constant, do not miss any doses. Also, it is best to take each dose at the same time every day. If you need help in planning the best time to take your medicine, check with your health care professional.

Dosing—

The dose of clofazimine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of clofazimine. If your dose is different, do not change it unless your doctor tells you to do so.

The number of capsules that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are taking clofazimine.

• For the treatment of leprosy (Hansen's disease) :
  • Adults and teenagers: 50 to 100 milligrams once a day. This medicine must be taken with other medicines for the treatment of Hansen's disease.
  • Children: Dose must be determined by the doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

To store this medicine:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Do not store in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

If your symptoms do not improve within 1 to 3 months, or if they become worse, check with your doctor. It may take up to 6 months before the full benefit of this medicine is seen.

Clofazimine may cause pink or red to brownish-black discoloration of the skin within a few weeks after you start taking it. Because of the skin discoloration, some patients may become depressed. The discoloration will go away when you stop taking this medicine. However, it may take several months or years for the skin to clear up completely. If skin discoloration causes you to feel very depressed or to have thoughts of suicide, check with your doctor immediately.

This medicine may cause some people to become dizzy, drowsy, or less alert than they are normally. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or are not alert or able to see well. If these reactions are especially bothersome, check with your doctor.

Clofazimine may cause your skin to become more sensitive to sunlight than it is normally. Exposure to sunlight, even for brief periods of time, may cause a skin rash, itching, redness or other discoloration of the skin, or a severe sunburn. When you begin taking this medicine:

• Stay out of direct sunlight, especially between the hours of 10:00 a.m. and 3:00 p.m., if possible.
• Wear protective clothing, including a hat. Also, wear sunglasses.
• Apply a sun block product that has a skin protection factor (SPF) of at least 15. Some patients may require a product with a higher SPF number, especially if they have a fair complexion. If you have any questions about this, check with your health care professional.
• Apply a sun block lipstick that has an SPF of at least 15 to protect your lips.
• Do not use a sunlamp or tanning bed or booth.

If you have a severe reaction, check with your doctor .

Clofazimine may also cause dry, rough, or scaly skin. A skin cream, lotion, or oil may help to treat this problem.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

• 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 
  
  

Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome:

• 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 
  
  

• Less common or rare
  • 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.

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.