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Dapsone (Topical route)

Pronunciation:

DAP-sone

Brand Names:

  • Aczone

Dosage Forms:

  • Gel/Jelly

Classifications:

Therapeutic—

Antiacne

Chemical—

Sulfone

Uses of This Medicine:

Dapsone topical is used to treat acne. It works by killing the bacteria that cause acne and by keeping the skin pores clean.

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—

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of dapsone topical in children 12 years and older. However, dapsone topical is not recommended for children younger than 12 years.

Older adults—

Although appropriate studies on the relationship of age to the effects of dapsone topical have not been performed in the geriatric population, geriatric-specific problems are not expected to limit the usefulness of dapsone topical in the elderly.

Pregnancy—

Pregnancy CategoryExplanation
All TrimestersCAnimal 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—

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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

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:

  • Glucose-6-phosphate dehydrogenase (G6PD) deficiency or
  • Methemoglobinemia—May increase risk for serious side effects.

Proper Use of This Medicine:

Use this medicine exactly as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. To do so may increase the chance for unwanted effects.

This medicine comes with a patient information leaflet. Read and follow the instructions carefully. Ask your doctor if you have any questions.

This medicine is for use only on the skin. Do not put it in your eyes, nose, mouth, or vagina. Rinse it off right away if it does get on these areas.

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 topical dosage form (gel):
    • For acne:
      • Adults and children 12 years and older—Apply a thin layer on the acne area once a day (7.5% gel) or 2 times per day (5% gel).
      • Children younger than 12 years—Use is not recommended.

Missed dose—

If you miss a dose of this medicine, apply 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.

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.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

It is important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to use it.

Check with your doctor right away if you have bluish-colored lips, fingernails, or palms, dark urine, trouble breathing, dizziness or lightheadedness, a headache, pale skin, unusual bleeding or bruising, or unusual tiredness or weakness. These may be symptoms of a serious blood disorder.

Hemolytic anemia may occur while using this medicine. Tell your doctor right away if you have back, leg, or stomach pain, bleeding gums, chills, dark urine, nosebleeds, nausea or vomiting, or yellow eyes or skin.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

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 immediately if any of the following side effects occur:

Incidence not known
Bluish-colored lips, fingernails, or palms
dark urine
difficult breathing
dizziness or lightheadedness
fever
headache
pale skin
rapid heart rate
sore throat
unusual bleeding or bruising
unusual tiredness or weakness

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, redness, oiliness, or peeling at the application site

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: 9/4/2017
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