Dapsone (Topical Route)

Topical dapsone preparations are used on the skin to help control acne . They may be used alone or with one or more other medicines that are applied to the skin or taken by mouth for acne . They may also be used for other problems, such as skin infections, as determined by your doctor .

This medicine is available only with your doctor`s prescription.

This product is available in the following dosage forms:

• Gel/Jelly

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

Studies on this medicine have been done only in adult and teenager patients, and there is no specific information comparing use of topical dapsone in children less than 12 years of age with use in other age groups.

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 topical 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 (history of) or


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


• Hemoglobin M or


• Methemoglobin reductase deficiencya€”May increase chance of severe blood disorder .

Proper Use

Proper laboratory evaluation prior to starting dapsone treatment .

Not using for any other disorder other than that for which it was prescribed.

Gently washing the affected area with warm water and patting dry before applying this medicine.

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 gel dosage form:
  
  
  
  • For acne
    
    
    
    • Adults and teenagersa€”Apply a thin layer to the affected area(s) of the skin twice daily, morning and evening.
    
    
    • Childrena€”Use and dose must be determined by your 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

Keep out of the reach of children.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Do not keep outdated medicine or medicine no longer needed.

Precautions

Report any side effects to your physician for any blood problems that may be caused by this medicine.

Tell your doctor if you have history of anemia or an enzyme deficiency (such as G6PD).

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 as soon as possible if any of the following side effects occur:

Incidence not known

• Attempts at killing oneself


• Bloating


• Body aches or pain


• Chills


• Congestion


• Constipation


• Cough


• Darkened urine


• Dryness or soreness of throat


• Fast heartbeat


• Fever


• Hoarseness


• Indigestion


• Loss of appetite


• Nausea


• Pains in stomach, side, or abdomen, possibly radiating to the back


• Runny nose


• Stomach pain


• Tender, swollen glands in neck


• Tonic and clonic muscle movements


• Trouble swallowing


• Voice changes


• Vomiting, severe

Reported in clinical trials

• Discouragement


• Feeling sad or empty


• Feeling that others are watching you or controlling your behavior


• Feeling that others can hear your thoughts


• Feeling, seeing, or hearing things that are not there


• Irritability


• Loss of interest or pleasure


• Severe mood or mental changes


• Tiredness


• Trouble concentrating


• Unusual behavior

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:

More common

• Dryness


• Flushing, redness of skin


• Oiliness/peeling


• Unusually warm skin

Less common

• Burning


• Diarrhea


• Difficulty breathing


• Ear congestion


• Headache


• Itching skin


• General feeling of discomfort or illness


• Headache


• Joint pain


• Joint sprain


• Muscle aches and pains


• Pain or tenderness around eyes and cheekbones


• Shivering


• Shortness of breath or trouble breathing


• Sneezing


• Sore throat


• Stuffy nose


• Sweating


• Tightness of chest or wheezing


• Trouble sleeping


• Unusual tiredness or weakness

Incidence not known

• Facial swelling

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.