Dapsone (Oral Route)

Dapsone is used to treat leprosy (Hansen`s disease) and to help control dermatitis herpetiformis, a skin problem . When it is used to treat leprosy, dapsone may be given with one or more other medicines. Dapsone may also be used for other conditions as determined by your doctor .

Dapsone is available only with your doctor`s prescription.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems . Although these uses are not specifically included in product labeling, dapsone is used in certain patients with the following medical conditions:

• Actinomycotic mycetoma


• Granuloma annulare


• Malaria (prevention of)


• Pemphigoid


• Pneumocystis carinii pneumonia


• Pyoderma gangrenosum


• Relapsing polychondritis


• Subcorneal pustular dermatosis


• Systemic lupus erythematosus

For patients taking this medicine for Pneumocystis carinii pneumonia (PCP):

• To help clear up PCP completely or to keep it from coming back, it is very important that you keep taking this medicine for the full time of treatment .


• If you miss a dose of this medicine, take it as soon as possible. This will help keep a constant amount of medicine in the blood . 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.


• If your symptoms do not improve within 1 week, or if they become worse, check with your doctor .

This product is available in the following dosage forms:

• Tablet

Before Using

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:

Allergies

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.

Pediatric

Although there is no specific information comparing use of dapsone in children with use in other age groups, this medicine is not expected to cause different side effects or problems in children than it does in adults.

Geriatric

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 dapsone in the elderly with use in other age groups.

Pregnancy

Breastfeeding

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.

Drug Interactions

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.

• Zidovudine

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.

• Amprenavir


• Rifabutin


• Rifapentine


• Saquinavir

Other Interactions

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. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

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:

• Anemia (severe) or


• Glucose-6-phosphate dehydrogenase (G6PD) deficiency or


• Methemoglobin reductase deficiencya€”There is an increased risk of severe blood disorders and a decrease in red blood cell survival

• Liver diseasea€”Dapsone may on rare occasion cause liver damage

Proper Use

For patients taking dapsone for leprosy:

• To help clear up your leprosy completely or to keep it from coming back, it is very important that you keep taking this medicine for the full time of treatment, even if you begin to feel better after a few weeks or months. You may have to take it every day for as long as 3 years or more, or for 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 .

For patients taking dapsone for dermatitis herpetiformis:

• Your doctor may want you to follow a gluten-free diet. If you have any questions about this, check with your doctor .

Dosing

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 oral dosage form (tablets):
  
  
  
  • For Hansen`s disease (leprosy):
    
    
    
    • Adults and teenagersa€”50 to 100 milligrams (mg) once a day; or 1.4 mg per kilogram (kg) (0.6 mg per pound) of body weight once a day. Dapsone should be taken with other medicines to treat Hansen`s disease.
    
    
    • Childrena€”Dose is based on body weight . The usual dose is 1.4 mg per kg (0.6 mg per pound) of body weight once a day. Dapsone should be taken with other medicines to treat Hansen`s disease.
    
    
    
    
  
  
  • For dermatitis herpetiformis:
    
    
    
    • Adults and teenagersa€”50 mg once a day to start . Your doctor will increase your dose, up to 300 mg once a day, until your symptoms are controlled. Then your dose will be decreased to the lowest dose that will still control your symptoms .
    
    
    • Childrena€”Dose is based on body weight . The usual dose is 2 mg per kg (0.9 mg per pound) of body weight once a day to start . Your doctor will increase your dose until your symptoms are controlled. Then your dose will be decreased to the lowest dose that will still control your symptoms .
    
    
    
    
  
  
  
  

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.

You may skip a missed dose if it does not make your symptoms come back or get worse. If your symptoms do come back or get worse, take the missed dose as soon as possible.

Storage

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

It is very important that your doctor check your progress at regular visits.

If your symptoms do not improve within 2 to 3 months (for leprosy), or within a few days (for dermatitis herpetiformis), or if they become worse, check with your doctor .

Side Effects

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

• Back, leg, or stomach pains


• Bluish fingernails, lips, or skin


• Difficult breathing


• Fever


• Loss of appetite


• Pale skin


• Skin rash


• Unusual tiredness or weakness

Rare

• Itching, dryness, redness, scaling, or peeling of the skin, or loss of hair


• Mood or other mental changes


• Numbness, tingling, pain, burning, or weakness in hands or feet


• Sore throat


• Unusual bleeding or bruising


• Yellow eyes or skin

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:

Rare

• Headache


• Loss of appetite


• Nausea or vomiting


• Nervousness


• Trouble in sleeping

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.