Clofazimine (Oral route)
Uses of This Medicine:
Clofazimine 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.
Before Using This Medicine:
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 this medicine, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
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.
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.
|All Trimesters||C||Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.|
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
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. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Aluminum Hydroxide
- Magnesium Hydroxide
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.
- Orange Juice
Other medical problems—
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- 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
Proper Use of This Medicine:
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.
The dose of this medicine 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 this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine 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 using the medicine.
- 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.
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.
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Precautions While Using This Medicine:
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.
Side Effects of This Medicine:
- 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
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:
- More common
- 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
Some 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. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
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 may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Last Updated: 11/4/2014