Dapsone topical

Synthetic sulfone1 2 3 5 18 with anti-infective and anti-inflammatory effects.2 3 5 18

Absorption

Bioavailability

Absorbed systemically following topical application to skin.1 5

In patients with acne vulgaris skin lesions, plasma concentrations of dapsone are detectable within 2 hours after the first dose of topical dapsone 5% gel.5

After topical application of dapsone 5% gel to acne vulgaris skin lesions on the face, upper back, shoulders, and/or upper chest (up to approximately 22.5% of total body surface area) twice daily for 14 days, mean peak plasma concentrations of the drug were 19.4 ng/mL and the median time to peak concentrations after a dose was 9 hours.5

In a long-term safety study of dapsone 5% gel, there was no evidence that systemic exposure increases over time.1

Systemic exposure (AUC) following a 14-day regimen of dapsone 5% gel is 126 times lower than systemic exposure (AUC) following a single 100-mg dose of oral dapsone.5

Special Populations

Systemic dapsone exposure following topical application of dapsone 5% gel in children 12–15 years of age is similar to that reported in those ≥16 years of age.1

• Importance of using as directed by the clinician and only for condition prescribed.1

• Advise patient that topical dapsone is for external use only and should not be used orally or intravaginally; importance of avoiding contact with the mouth and eyes.1

• Importance of storing at room temperature and protecting the drug from freezing.1

• Importance of informing clinician of glucose-6-phosphate dehydrogenase (G6PD) deficiency.1

• Importance of reporting any signs of adverse reactions to a clinician.1

• Importance of informing clinician of existing or contemplated concomitant therapy, including prescription and OTC drugs, especially topical agents applied to the skin (e.g., preparations containing benzoyl peroxide).1

• Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1

• Importance of informing patients of other important precautionary information.1 (See Cautions.)

• Store at room temperature. Do not freeze.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about dapsone, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about dapsone. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using dapsone (topical).

Review Date: October 4, 2017

• Diaminodiphenylsulfone

There are no dosage adjustments provided in the manufacturer’s labeling.

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience skin irritation, dry skin, redness, peeling, or oily skin. Have patient report immediately to prescriber signs of pancreatitis (severe abdominal pain, severe back pain, severe nausea, or vomiting), signs of methemoglobinemia (blue or gray color of the lips, nails, or skin; abnormal heartbeat; seizures; severe dizziness or passing out; severe headache; fatigue; loss of strength and energy; or shortness of breath), shortness of breath, loss of strength and energy, suicidal ideation, severe pharyngitis, dark urine, back pain, jaundice, abdominal pain, severe nausea, severe vomiting, or abnormal movements (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Dapsone topical may cause methemoglobinemia (met-HEEM-oh glo-bin-EE-mee-a), a serious condition in which the amount of oxygen in your blood stream becomes dangerously low. Stop using this medicine and call your doctor at once if you notice a blue or gray appearance of your lips, fingernails, or the inside of your mouth.

Call your doctor at once if you have:

• severe sore throat;

• unusual thoughts or behavior;

• a red blood cell disorder--back pain, pale or yellowed skin, dark colored urine, fever, confusion or weakness;

• pancreas problems--severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate; or

• severe skin reaction--fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Common side effects may include:

• dry or peeling skin;

• oily skin; or

• redness where the medicine was applied.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

This medication is used to treat acne. It helps decrease the number and severity of acne pimples and helps pimples that do develop to heal more quickly. Dapsone is an antibiotic. It is not known how dapsone works to treat acne.

How to use Dapsone Gel

Read the Patient Information Leaflet if available from your pharmacist before you start using dapsone and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Wash your hands before and after applying this medication. Gently clean the affected skin with a mild/soapless cleanser and pat dry. Apply a small amount of medication (about the size of a pea) in a thin layer to the affected areas of skin as directed by your doctor. Depending on your brand, this medication is usually used once or twice a day. Rub in gently. Be careful to avoid the eyes and lip area.

Use this medication on the skin only. Do not apply to the inside of the mouth/nose or in or around the groin/vaginal area.

Avoid getting this medication in your eyes. If this occurs, flush with large amounts of water. Call your doctor if eye irritation develops. Wash your hands after using the medication to avoid accidentally getting it in your eyes.

Use this product regularly to get the most benefit from it. To help you remember, use it at the same time(s) each day. Do not use a larger amount or use it more often than directed. Your skin will not improve any faster and you may have a greater risk of side effects.

Tell your doctor if your condition does not get better or if it gets worse after 12 weeks.

No data available