Pronunciation:

DAP-sone

Classifications:

Chemical—

Sulfone

Uses of This Medicine:

Dapsone belongs to the family of medicines called antibiotics. 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.

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:

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.

Children—

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.

Older adults—

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—

	Pregnancy Category	Explanation
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.

Breast-feeding—

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.

Other medicines—

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

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 deficiency—May increase chance of severe blood disorder.

Proper Use of This Medicine:

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 teenagers—Apply a thin layer to the affected area(s) of the skin twice daily, morning and evening.
    • Children—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 While Using This Medicine:

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 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 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.