Version May 2024
Acne vulgaris:
Note: Reserve for patients with insufficient response to first-line agents (Ref). Avoid simultaneous use with benzoyl peroxide due to temporary yellow-orange discoloration of the skin and facial hair.
Topical:
Gel 5%: Apply pea-sized amount in a thin layer to affected areas twice daily.
Gel 7.5%: Apply pea-sized amount in a thin layer to entire face once daily; may also apply a thin layer to other affected areas of the body once daily.
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
There are no dosage adjustments provided in the manufacturer's labeling.
There are no dosage adjustments provided in the manufacturer's labeling.
Refer to adult dosing.
(For additional information see "Dapsone (topical): Pediatric drug information")
Acne vulgaris:
Gel 7.5%: Children ≥9 years and Adolescents: Topical: Apply a pea-sized amount of gel to entire face once daily; may also apply a thin layer to other affected areas of the body once daily; reevaluate patient if no improvement after 12 weeks of therapy.
Gel 5%: Children ≥12 years and Adolescents: Topical: Apply a pea-sized amount of gel to the acne-affected areas twice daily; reevaluate patient if no improvement after 12 weeks of therapy.
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
There are no dosage adjustments provided in the manufacturer's labeling.
There are no dosage adjustments provided in the manufacturer's labeling.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Adverse reactions reported in adolescents and adults.
1% to 10%: Respiratory: Sinusitis (2%)
<1%:
Dermatologic: Erythema of skin
Hypersensitivity: Facial edema (including lip edema and periorbital swelling)
Nervous system: Depression, psychosis
Frequency not defined:
Gastrointestinal: Abdominal pain, pancreatitis, severe vomiting
Local: Application site reaction (application-site burning, application-site erythema, application-site pruritus, application-site rash, local dryness of skin, local skin exfoliation, oily skin)
Nervous system: Suicidal tendencies, tonic-clonic movements
Respiratory: Pharyngitis
Postmarketing:
Dermatologic: Skin rash (including erythematous rash)
Hematologic & oncologic: Methemoglobinemia (Swartzentruber 2015)
There are no contraindications listed in the manufacturer's labeling.
Canadian labeling: Hypersensitivity to dapsone or any component of the formulation or container.
Concerns related to adverse effects:
• Dermatologic: Localized discoloration (yellow or orange) of the skin or facial hair may occur if benzoyl peroxide is used subsequent to dapsone gel; typically resolves in ~1 to 8 weeks. Skin reactions (eg, bullous and exfoliative dermatitis, erythema multiforme, erythema nodosum, morbilliform and scarlatiniform reactions, toxic epidermal necrolysis, urticaria) have been reported with oral dapsone; similar events were not observed during clinical trials with topical dapsone.
• Hematologic effects: Changes suggestive of hemolysis have been observed in some patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency and using twice-daily dapsone 5% gel. Discontinue use of dapsone with signs/symptoms of hemolytic anemia. Do not use concomitantly with oral dapsone or other antimalarial agents due to increased risk of hemolytic reactions.
• Methemoglobinemia: Cases of methemoglobinemia, resulting in hospitalization, have been reported with twice-daily dapsone 5% gel. Patients with glucose-6-phosphate dehydrogenase deficiency or congenital or idiopathic methemoglobinemia are at increased risk; avoid use in patients with congenital or idiopathic methemoglobinemia. Dapsone may increase methemoglobin levels, especially in combination with methemoglobin-inducing agents. Signs and symptoms of methemoglobinemia (eg, slate grey cyanosis in buccal mucous membranes, lips, and nail beds) may be delayed hours after exposure; discontinue dapsone treatment promptly and seek immediate medical attention in the event of cyanosis.
• Peripheral neuropathy: Has been reported with oral dapsone; similar events were not observed during clinical trials with topical dapsone.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Gel, External:
Aczone: 5% (60 g, 90 g) [contains methylparaben]
Aczone: 7.5% (60 g, 90 g) [contains methylparaben, polysorbate 80]
Generic: 5% (60 g, 90 g); 7.5% (60 g, 90 g)
Yes
Gel (Aczone External)
5% (per gram): $15.76
7.5% (per gram): $15.76
Gel (Dapsone External)
5% (per gram): $9.76 - $10.05
7.5% (per gram): $11.24 - $13.86
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Gel, External:
Aczone: 5% (3 g, 30 g, 60 g) [contains methylparaben]
Topical: Clean and dry skin before applying. Rub in gently and completely. Wash hands after applying. Gel may be gritty. For external use only; avoid applying to inside nose, mouth, eyes, vagina, and mucous membranes
Topical: Wash skin and pat dry; rub in thin layer of gel gently and completely. Wash hands after application. Gel may be gritty. For external use only; avoid applying to inside nose, mouth, eyes, vagina, and mucous membranes.
Acne vulgaris: Topical treatment of acne vulgaris in patients ≥9 years of age (7.5% gel) or patients ≥12 years of age (5% gel).
Dapsone may be confused with Diprosone
Substrate of CYP2C19 (minor), CYP2C8 (minor), CYP2C9 (minor), CYP2E1 (minor), CYP3A4 (minor); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Antimalarial Agents: May enhance the adverse/toxic effect of Dapsone (Topical). Specifically, the risk of hemolytic reactions may be increased. Management: Consider avoidance of this combination when possible. If combined, closely monitor for signs/symptoms of hemolytic reactions. Patients with glucose-6-phosphate dehydrogenase deficiency may be at particularly high risk for adverse hematologic effects. Risk D: Consider therapy modification
Benzoyl Peroxide: May enhance the adverse/toxic effect of Dapsone (Topical). Specifically, the use of these agents in combination may cause skin and facial hair to temporarily turn a tan or yellow/orange color. Risk C: Monitor therapy
Local Anesthetics: Methemoglobinemia Associated Agents may enhance the adverse/toxic effect of Local Anesthetics. Specifically, the risk for methemoglobinemia may be increased. Risk C: Monitor therapy
Methemoglobinemia Associated Agents: Dapsone (Topical) may enhance the adverse/toxic effect of Methemoglobinemia Associated Agents. Risk C: Monitor therapy
Nitric Oxide: May enhance the adverse/toxic effect of Methemoglobinemia Associated Agents. Combinations of these agents may increase the likelihood of significant methemoglobinemia. Risk C: Monitor therapy
Prilocaine: Methemoglobinemia Associated Agents may enhance the adverse/toxic effect of Prilocaine. Combinations of these agents may increase the likelihood of significant methemoglobinemia. Management: Monitor patients for signs of methemoglobinemia (e.g., hypoxia, cyanosis) when prilocaine is used in combination with other agents associated with development of methemoglobinemia. Avoid lidocaine/prilocaine in infants receiving such agents. Risk C: Monitor therapy
Sodium Nitrite: Methemoglobinemia Associated Agents may enhance the adverse/toxic effect of Sodium Nitrite. Combinations of these agents may increase the likelihood of significant methemoglobinemia. Risk C: Monitor therapy
The amount of topical dapsone available systemically is minimal compared to oral administration.
Topical products are recommended as initial therapy for the treatment of acne vulgaris in pregnant females; however, information specific to dapsone is lacking (Kong 2013). Agents other than topical dapsone are preferred (Chien 2016).
It is not known if dapsone is present in breast milk following topical application.
Following oral administration, dapsone is present in breast milk. The amount of topical dapsone available systemically is minimal compared to oral administration. According to the manufacturer, the decision to continue or discontinue breastfeeding during therapy should take into account the risk of infant exposure, the benefits of breastfeeding to the infant, and benefits of treatment to the mother.
For patients at risk of anemia, monitor CBC and reticulocyte counts at baseline and routinely thereafter.
Absorption: ~1% of the absorption of 100 mg tablet
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