Dapsone (Oral)

Dapsone, a sulfone, is part of the group of medicines known as anti-infectives.

Dapsone is used to treat leprosy (Hansen's disease) and to help manage dermatitis herpetiformis, a skin condition. When treating leprosy, dapsone may be prescribed along with one or more other medicines. Dapsone may also be used for other conditions as decided by your doctor.

Dapsone is available only with your doctor's prescription.

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, contact your doctor.

In deciding to use a medicine, you and your doctor need to weigh the risks against the benefits. Here are some important things to consider for this medicine:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, let your healthcare professional know if you have any other allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

There is no specific information comparing the use of dapsone in children to its use in other age groups, but this medicine is not expected to cause different side effects or problems in children compared to adults.

Geriatric

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

Breast Feeding

There are no adequate studies in women to determine the risk to an infant when using this medication while breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should never be used together, while in other cases, two different medicines may be used together even if an interaction might happen. In these situations, your doctor may want to adjust the dose, or other precautions may be needed. When taking this medicine, it is especially important that your healthcare professional knows if you are taking any of the medicines listed below. The following interactions have been chosen based on 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 necessary in some cases. If both medicines are prescribed together, your doctor may adjust the dose or how often you take one or both of the medicines.

• Methotrexate
• Warfarin
• Zidovudine

Using this medicine with any of the following medicines may increase the risk of certain side effects, but taking both may be the best treatment for you. If both medicines are prescribed together, your doctor may adjust the dose or how often you take one or both of the medicines.

• Amprenavir
• Atazanavir
• Fosamprenavir
• Rifabutin
• Rifapentine

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used around the time of eating food or certain types of food due to possible interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical problems may affect the use of this medicine. Make sure to inform your doctor if you have any other medical conditions, especially:

• Anemia (severe) or
• Glucose-6-phosphate dehydrogenase (G6PD) deficiency or
• Methemoglobin reductase deficiency—There is a higher risk of severe blood disorders and reduced survival of red blood cells

• Liver disease—Dapsone may, on rare occasions, cause liver damage.

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

Check with your doctor right away 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 lessen 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 happen 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.

Available Dosage Forms:

• Tablet

Therapeutic Class: Leprostatic

Chemical Class: Sulfone

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 teenagers—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. Children—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 teenagers—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. Children—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.