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Drug overview for ACZONE (dapsone):
Generic name: dapsone (DAP-sone)
Drug class: Acne Antibiotics
Therapeutic class: Dermatological
Dapsone is a synthetic sulfone with anti-infective and anti-inflammatory effects.
No enhanced Uses information available for this drug.
Generic name: dapsone (DAP-sone)
Drug class: Acne Antibiotics
Therapeutic class: Dermatological
Dapsone is a synthetic sulfone with anti-infective and anti-inflammatory effects.
No enhanced Uses information available for this drug.
DRUG IMAGES
ACZONE 7.5% GEL PUMP
The following indications for ACZONE (dapsone) have been approved by the FDA:
Indications:
Acne vulgaris
Professional Synonyms:
Acne simplex
Common acne
Simple acne
Indications:
Acne vulgaris
Professional Synonyms:
Acne simplex
Common acne
Simple acne
The following dosing information is available for ACZONE (dapsone):
No enhanced Dosing information available for this drug.
Dapsone is applied topically to the skin as a 5% gel. Dapsone topical gel is for external use only. The gel should not be used orally or intravaginally and contact with the mouth and eyes should be avoided.
The acne affected area should be gently cleansed and dried prior to application of dapsone 5% gel. A pea-sized amount of the gel should be applied in a thin layer and rubbed in gently and completely. Dapsone 5% gel is gritty with visible drug substance particles.
Hands should be washed after applying the gel. Dapsone 5% gel should be stored at 20-25degreesC, but may be exposed to temperatures ranging from 15-30degreesC. The gel should not be frozen.
The acne affected area should be gently cleansed and dried prior to application of dapsone 5% gel. A pea-sized amount of the gel should be applied in a thin layer and rubbed in gently and completely. Dapsone 5% gel is gritty with visible drug substance particles.
Hands should be washed after applying the gel. Dapsone 5% gel should be stored at 20-25degreesC, but may be exposed to temperatures ranging from 15-30degreesC. The gel should not be frozen.
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| ACZONE 7.5% GEL PUMP | Maintenance | Adults apply a pea-sized amount by topical route once daily to cover areas of face with thin layer ; rub in gently and completely |
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| DAPSONE 7.5% GEL PUMP | Maintenance | Adults apply a pea-sized amount by topical route once daily to cover areas of face with thin layer ; rub in gently and completely |
The following drug interaction information is available for ACZONE (dapsone):
There are 0 contraindications.
There are 0 severe interactions.
There are 0 moderate interactions.
The following contraindication information is available for ACZONE (dapsone):
Drug contraindication overview.
Manufacturer states none known.
Manufacturer states none known.
There are 2 contraindications.
Absolute contraindication.
| Contraindication List |
|---|
| Hemolytic anemia from pyruvate kinase and g6PD deficiencies |
| Methemoglobinemia |
There are 1 severe contraindications.
Adequate patient monitoring is recommended for safer drug use.
| Severe List |
|---|
| Glucose-6-phosphate dehydrogenase (g6Pd) deficiency |
There are 0 moderate contraindications.
The following adverse reaction information is available for ACZONE (dapsone):
Adverse reaction overview.
Adverse effects reported in 10% or more of patients receiving topical dapsone 5% gel are oiliness/peeling, dryness, and erythema at the application site.
Adverse effects reported in 10% or more of patients receiving topical dapsone 5% gel are oiliness/peeling, dryness, and erythema at the application site.
There are 9 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
| None. | None. |
| Rare/Very Rare |
|---|
|
Depression Drug-induced psychosis Hemolysis Methemoglobinemia Pancreatitis Pharyngitis Severe vomiting Suicidal Tonic clonic seizure |
There are 13 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Abnormal desquamation Dry skin Erythema Oily skin Pruritus of skin |
Fever Sinusitis Skin irritation |
| Rare/Very Rare |
|---|
|
Acute abdominal pain Cough Facial edema Headache disorder Skin rash |
The following precautions are available for ACZONE (dapsone):
Safety and efficacy of topical dapsone 5% gel have not been established in children younger than 12 years of age.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
Category C. (See Users Guide) Oral dapsone has been associated with embryocidal effects in rats and rabbits when used in dosages approximately 800 and 500 times, respectively, the systemic exposure (based on AUC) observed in human females receiving the maximum recommended dosage of topical dapsone 5% gel. These effects were probably secondary to maternal toxicity. Topical dapsone 5% gel should be used during pregnancy only if potential benefits outweigh potential risks to the fetus.
Dapsone is distributed into milk following oral administration. Systemic absorption is low following topical application of dapsone 5% gel; however, because of the potential to cause adverse reactions in nursing infants, discontinue nursing or discontinue topical dapsone therapy.
There is insufficient experience with topical dapsone 5% gel in geriatric patients 65 years of age or older to determine whether such individuals respond differently than younger individuals.
The following prioritized warning is available for ACZONE (dapsone):
No warning message for this drug.
No warning message for this drug.
The following icd codes are available for ACZONE (dapsone)'s list of indications:
| Acne vulgaris | |
| L70.0 | Acne vulgaris |
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