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USP DI Vol. II - DAPSONE (Topical)

DAPSONE (Topical)?


Some commonly used brand names are:

In the U.S.?

  • Aczone

? Not commercially available in Canada.


Category

  • Antiacne agent

Description

Dapsone (DAP-sone) belongs to the family of medicines called antibiotics.Topical dapsone preparations are used on the skin to help control acne. Theymay be used alone or with one or more other medicines that are applied tothe 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, in thefollowing dosage forms:

    Topical
  • Gel (U.S.)


Before Using This Medicine

In deciding to use a medicine,the risks of using the medicine must be weighed against the good it will do.This is a decision you and your doctor will make. For topical dapsone, thefollowing should be considered:

Allergies?Tell your doctor if you have ever had any unusualor allergic reaction to this or to any other dapsone products. Also tell yourdoctor and pharmacist if you are allergic to any other substances, such asfoods, preservatives, or dyes.

Pregnancy?Topical dapsone has not been studied in pregnantwomen. However, this medication has not been shown to cause birth defectsor other problems in animal studies.

Breast-feeding?Topical dapsone passes into breast milk, andmay cause unwanted effects in nursing babies. It may be necessary for youto use another medicine or to stop breast feeding during treatment. Be sureyou have discussed the risks and benefits of the medicine with your doctor.

Children?Studies on this medicine have been done only inadult and teenager patients, and there is no specific information comparinguse of topical dapsone in children less than 12 years of age with use in otherage groups.

Older adults?Many medicines have not been studied specificallyin older people. Therefore, it may not be known whether they work exactlythe same way they do in younger adults or if they cause different side effectsor problems in older people. There is no specific information comparing useof topical dapsone in the elderly with use in other age groups.

Other medicines?Although certain medicines should not be usedtogether at all, in other cases two different medicines may be used togethereven if an interaction might occur. In these cases, your doctor may want tochange the dose, or other precautions may be necessary. Tell your doctor andpharmacist if you are using any other topical prescription or nonprescription(over-the-counter [OTC]) medicine that is to be applied to the same area ofthe skin.

Other medical problems?The presence of other medicalproblems may affect the use of topical dapsone. Make sure you tell your doctorif 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 severeblood disorder.

Proper Use of This Medicine

Dosing?Proper laboratory evaluation priorto starting dapsone treatment.

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

Gently washing the affected area with warm water andpatting dry before applying this 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, apply itas soon as possible. However, if it is almost time for your next dose, skipthe missed dose and go back to your regular dosing schedule.

Storage?To store this medicine:

  • Keep out of the reach of children.
  • Store away from heat and direct light.
  • Keep the medicine from freezing.
  • Do not keep outdated medicine or medicine no longer needed. Ask yourhealth care professional how you should dispose of any medicine you do notuse. Be sure that any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

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

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


Side Effects of This Medicine

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

    Check with your doctorimmediately if any of the following side effects occur:

      Frequency unknown

        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; tonicand clonic muscle movements; trouble in swallowing; voice changes; vomiting,severe; yellow eyes or skin

      Reported in clinical trials

        Discouragement; feeling sad or empty; feeling that others are watching you or controllingyour behavior; feeling that others can hear yourthoughts; feeling, seeing, or hearing things thatare not there; irritability; loss of interest or pleasure; severe mood or mentalchanges; tiredness; troubleconcentrating; unusual behavior

    Other side effects mayoccur that usually do not need medical attention. These side effects may goaway during treatment as your body adjusts to the medicine. However, checkwith your doctor if any of the following side effects continue or are bothersome.

      More Common

        Dryness; flushing, redness of skin; oiliness/peeling; unusually warm skin

      Less common

        Burning; diarrhea; difficulty in breathing; ear congestion; headache; itching skin; general feeling of discomfort or illness; headache; joint pain; jointsprain; muscle aches and pains; pain or tenderness around eyes and cheekbones; shivering; shortness of breath or troubled breathing; sneezing; sore throat; stuffy nose; sweating; tightness of chest or wheezing; troublesleeping; unusual tiredness or weakness

    Frequency unknown

      Facial swelling

Other side effects not listed above may also occur in some patients. Ifyou notice any other effects, check with your doctor.


Developed: 09/13/2005