CLOFAZIMINE (Systemic)?
Some commonly used brand names are:
In the U.S.?
? Not commercially available in Canada.
Category
- Antibacterial, antimycobacterial
Description
Clofazimine (kloe-FA-zi-meen)is taken to treat leprosy (Hansen's disease). It is sometimes given with othermedicines for leprosy. When this medicine is used to treat ``flare-ups'' ofleprosy, it may be given with a cortisone-like medicine. Clofazimine may alsobe used for other problems as determined by your doctor.
This medicine is available only with your doctor's prescription, in thefollowing dosage form:
Before Using This Medicine
In deciding to use a medicine,the risks of taking the medicine must be weighed against the good it willdo. This is a decision you and your doctor will make. For clofazimine, thefollowing should be considered:
Allergies?Tell your doctor if you have ever had any unusual orallergic reaction to clofazimine. Also tell your health care professionalif 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 pregnancywas deeply discolored, this medicine has not been shown to cause birth defectsor other problems in humans. A gradual fading of the discoloration may occurover a period of about a year. Some animal studies have not shown that clofaziminecauses birth defects. However, studies in mice have shown that clofaziminemay 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 pregnantor if you may become pregnant.
Breast-feeding?Clofazimine passes into the breast milk. Use isnot recommended in nursing mothers.
Children?Studies on this medicine have been done only in adultpatients, and there is no specific information comparing use of clofaziminein children with use in other age groups.
Older adults?Many medicines have not been studied specificallyin older people. Therefore, it may not be known whether they work exactlythe same way they do in younger adults or if they cause different side effectsor problems in older people. There is no specific information comparing useof clofazimine in the elderly with use in other age groups.
Other medicines?Although certain medicines should not be usedtogether at all, in other cases two different medicines may be used togethereven if an interaction might occur. In these cases, your doctor may want tochange the dose, or other precautions may be necessary. Tell your health careprofessional if you are taking any other prescription or nonprescription (over-the-counter[OTC]) medicine.
Other medical problems?The presence of other medicalproblems may affect the use of clofazimine. Make sure you tell your doctorif you have any other medical problems, especially:
- Liver disease?Clofazimine may on rare occasion cause hepatitisand liver disease
- Stomach or intestinal problems, history of?Clofazimine oftencauses some stomach upset, but on rare occasion may cause severe, sharp abdominalpain and burning, which may be a sign of a serious side effect
Proper Use of This Medicine
Clofazimineshould be taken with meals or milk.
To help clear up your leprosy completely, it is veryimportant that you keep taking clofazimine for the full time of treatment, even if you begin to feel better after a few months. You may haveto take it every day for as long as 2 years to life. If you stop taking thismedicine 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 youneed help in planning the best time to take your medicine, check with yourhealth care professional.
Dosing?The dose of clofazimine will be different fordifferent patients. Follow your doctor's orders or thedirections on the label. The following information includes only theaverage 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 timeallowed between doses, and the length of time you take the medicine dependon 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 medicinemust 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 assoon as possible. However, if it is almost time for your next dose, skip themissed 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 otherdamp places. Heat or moisture may cause the medicine to break down.
- Do not keep outdated medicine or medicine no longer needed. Be surethat any discarded medicine is out of the reach of children.
Precautions While Using This Medicine
If yoursymptoms do not improve within 1 to 3 months, or if they become worse, checkwith your doctor. It may take up to 6 months before the full benefit of thismedicine is seen.
Clofazimine may cause pink or red to brownish-black discoloration of theskin 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 youstop taking this medicine. However, it may take several months or years forthe skin to clear up completely. If skin discolorationcauses you to feel very depressed or to have thoughts of suicide, check withyour doctor immediately.
This medicine may cause some people to become dizzy, drowsy, or less alertthan they are normally. Make sure you know how you reactto this medicine before you drive, use machines, or do anything else thatcould 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 thanit is normally. Exposure to sunlight, even for brief periods of time, maycause a skin rash, itching, redness or other discoloration of the skin, ora severe sunburn. When you begin taking this medicine:
- Stay out of direct sunlight, especially between the hours of 10:00a.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 aboutthis, check with your health care professional.
- Apply a sun block lipstick that has an SPF of at least 15 to protectyour 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.
Side Effects of This Medicine
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 mayneed medical attention.
Check with your doctor immediately if any ofthe following side effects occur:
Other sideeffects may occur that usually do not need medical attention. These side effectsmay 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 arebothersome:
Less common or rare
Changes in taste; dryness, burning,itching, or irritation of the eyes; increased sensitivityof skin to sunlight
Clofazimine commonlycauses discoloration of the feces, lining of the eyelids, sputum, sweat, tears,and urine. Usually this side effect does not require medical attention, butthe discoloration may not go away. However, clofaziminemay also cause bloody or black, tarry stools. This side effect may be a symptomof serious bleeding problems that do require medical attention.
Other side effects not listed above may also occur insome patients. If you notice any other effects, check with your doctor.
Revised: 02/23/1993
