DAPSONE SUMMARY
Dapsone-USP, 4,4'-diaminodiphenylsulfone (DDS) is a primary treatment for Dermatitis herpetiformis. It is an antibacterial drug for susceptible cases of leprosy. It is a white, odorless crystalline powder, practically insoluble in water and insoluble in fixed and vegetable oils.
Dapsone is used to control the dermatologic symptoms of Dermatitis herpetiformis. Dapsone is used alone or in combination with other anti-leprosy drugs for leprosy.
SAFETY INFORMATION
Dapsone is contraindicated in patients with Dapsone hypersensitivity. Complete blood counts and laboratory monitoring should be done frequently. See labeling.
PRODUCT INFORMATION
[
dap 'soce
]
INDICATIONS AND USAGE
Dermatitis herpetiformis: (D.H.)
Leprosy: All forms of leprosy except for cases of proven Dapsone resistance.
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NEWS HIGHLIGHTS
Published Studies Related to Dapsone
Measurement of adherence, drug concentrations and the effectiveness of artemether-lumefantrine, chlorproguanil-dapsone or sulphadoxine-pyrimethamine in the treatment of uncomplicated malaria in Malawi. [2009.08.26]
BACKGROUND: Sulphadoxine-pyrimethamine (SP) is the only single dose therapy for uncomplicated malaria, but there is widespread resistance. At the time of this study, artemether-lumefantrine (AL) and chlorproguanil-dapsone (CPD), both multi-dose regimes, were considered possible alternatives to SP in Malawi. The aim of this study was to investigate the impact of poor adherence on the effectiveness of AL and CPD... CONCLUSION: This study provides reassurance of the effectiveness of AL, even with unsupervised dosing, as it is rolled out across sub-Saharan Africa. Self-reported adherence appears to be an unreliable measure of adherence in this population.
Short report: comparison of chlorproguanil-dapsone with a combination of sulfadoxine-pyrimethamine and chloroquine in children with malaria in northcentral Nigeria. [2009.02]
Effective and affordable treatment of malaria is critical in the face of resistance of Plasmodium falciparum to chloroquine (CQ) and sulfadoxine-pyrimethamine (SP). We conducted a randomized controlled trial comparing the efficacy of chlorproguanil-dapsone (CD) with a combination SP plus CQ in children in Nigeria less than five years of age with malaria...
Efficacy of dapsone in the treatment of pemphigus and pemphigoid: analysis of current data. [2009]
Dapsone is a chemotherapeutic agent primarily used in treating leprosy, Pneumocystis jiroveci (previously carinii) pneumonia, and malaria...
Randomized trial of artesunate+amodiaquine, sulfadoxine-pyrimethamine+amodiaquine, chlorproguanal-dapsone and SP for malaria in pregnancy in Tanzania. [2009]
BACKGROUND: Malaria in pregnancy is serious, and drug resistance in Africa is spreading. Drugs have greater risks in pregnancy and determining the safety and efficacy of drugs in pregnancy is therefore a priority. This study set out to determine the efficacy and safety of several antimalarial drugs and combinations in pregnant women with uncomplicated malaria... CONCLUSIONS: Failure rates with monotherapy were unacceptably high. The two combinations tested were efficacious and appeared safe. It should not be assumed that efficacy in pregnancy is the same as in children. TRIAL REGISTRATION: ClinicalTrials.gov NCT00146731.
Hematologic safety of dapsone gel, 5%, for topical treatment of acne vulgaris. [2008.12]
OBJECTIVE: To evaluate the risk of hemolysis in subjects with glucose-6-phosphate dehydrogenase (G6PD) deficiency who were treated for acne vulgaris with either dapsone gel, 5% (dapsone gel), or vehicle gel... CONCLUSIONS: After treatment with dapsone gel, 5%, no clinical or laboratory evidence of drug-induced hemolytic anemia was noted in G6PD-deficient subjects with acne vulgaris. Trial Registration clinicaltrials.gov Identifier: NCT00243542.
Clinical Trials Related to Dapsone
A Phase II, Randomized Study of ACZONEâ„¢ (Dapsone) Gel, 5% for Papulopustular Rosacea. [Completed]
The purpose of this study is to evaluate the safety and effectiveness of ACZONEâ„¢ gel compared
to placebo (inactive substance), MetroGel® and a combination of ACZONE™ gel and MetroGel® for
the treatment of rosacea.
ACZONEâ„¢ gel, 5% is a topical (applied to the skin) medication that is approved by the United
States Food and Drug Administration (FDA) for the treatment of acne vulgaris in people 12
years and older. The use of ACZONEâ„¢ for the treatment of rosacea is investigational. An
investigational use is one that is not approved by the FDA.
Subjects will apply the study treatment for 12 weeks. Efficacy assessments will be performed
at baseline and Weeks 2, 4, 8, and 12. Laboratory assessments will be conducted at baseline
and Week, 2, 4 and 12.
Chlorproguanil-Dapsone-Artesunate (CDA) Versus Chlorproguanil-Dapsone (LAPDAP) For Uncomplicated Malaria [Completed]
CDA is a combination of chlorproguanil, dapsone and artesunate, being developed in a
public-private partnership with the Medicines for Malaria Venture (MMV), World Health
Organisation (WHO-TDR) and academic partners from the London School of Hygiene and Tropical
Medicine, University of Liverpool and the Liverpool School of Tropical Medicine as a
treatment for acute uncomplicated P. falciparum malaria.
The combination of chlorproguanil HCl (CPG) and dapsone (DDS) as chlorproguanil-dapsone has
already been shown to be efficacious against P. falciparum in adults and children in
Sub-Sahara Africa. The addition of artesunate to LAPDAP has been demonstrated to increase
the parasite kill rate as demonstrated in the phase II study, and reduce the chance of any
parasites escaping treatment over the 3-day course. The addition of artesunate is also
anticipated to have the population benefit of protection against the development of resistant
strains of P. falciparum, although it will not be possible to demonstrate this in a clinical
trial. One further population benefit of the artemisinin drugs are their ability to suppress
the sexual forms of the parasite (gametocytes), which should reduce infectivity after
antimalarial treatment and potentially lower transmission rates with widespread use,
including the spread of any parasites resistant to the partner drug.
The aims of this phase III study are to compare the efficacy of a fixed ratio combination
tablet of CDA to chlorproguanil-dapsone, and collect supporting safety data. This will be a
multi-centre, double-blind, double-dummy, randomised trial, in children, adolescents and
adults, with chlorproguanil-dapsone as a comparator.
A Phase II Study of ACZONEâ„¢ (Dapsone) Gel, 5% As a Treatment For Tarceva® (Erlotinib)Related Rash [Terminated]
The purpose of this study is to evaluate the safety and preliminary efficacy of ACZONE in
subjects treated with the HER1/EGFR inhibitor Tarceva (erlotinib) who develop a rash on the
face
A Phase 3 Study to Compare the Safety and Efficacy of 5% Dapsone Topical Gel, (DTG) Twice Daily in Combination With Once Daily Vehicle Control, Adapalene Gel 0.1% or Benzoyl Peroxide Gel 4%. [Completed]
The purpose of this study is to compare the safety and efficacy of 5% Dapsone Topical Gel,
(DTG) twice daily in combination with once daily vehicle control, adapalene gel 0. 1% or
benzoyl peroxide gel 4%. The second objective of the study is to determine dapsone exposure
after co-administration of DTG 5% with vehicle control, adapalene or benzoyl peroxide gel.
Comparison of Two Dosage Regimens of Oral Dapsone for Prophylaxis of Pneumocystis Carinii Pneumonia in Pediatric HIV Infection [Completed]
Primary: To compare the toxicity of daily versus weekly dapsone in HIV-infected infants and
children; to study the pharmacokinetics of orally administered dapsone in HIV-infected
infants and children.
Secondary: To obtain information on the rate of Pneumocystis carinii pneumonia ( PCP )
breakthrough in children receiving two different dose regimens of dapsone.
Prophylaxis for Pneumocystis carinii pneumonia ( PCP ) is recommended for all HIV-infected
children considered to be at high risk. Approximately 15 percent of children are intolerant
to trimethoprim / sulfamethoxazole, the first choice drug for PCP prophylaxis. Since many
children are also unable to take or tolerate aerosolized pentamidine, dapsone is a second
choice for PCP prophylaxis. The most favorable dose regimen for dapsone has not been
established.
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PATIENT REVIEWS / RATINGS / COMMENTSBased on a total of 1 ratings/reviews, Dapsone has an overall score of 8. The effectiveness score is 10 and the side effect score is 6. The scores are on ten point scale: 10 - best, 1 - worst.
| | Dapsone review by 50 year old female patient | | | Rating |
| Overall rating: | |   |
| Effectiveness: | | Highly Effective |
| Side effects: | | Moderate Side Effects | | |
Treatment Info |
| Condition / reason: | | dermatitis herpetiformis |
| Dosage & duration: | | 200mg taken once a day for the period of 1 year and continuing |
| Other conditions: | | celiac |
| Other drugs taken: | | nil | | |
Reported Results |
| Benefits: | | Dapsone treated the intensly itchy skin condition quickly and efficiently. A gluten free diet alone did not relieve this condition. |
| Side effects: | | The side effects after one year have been a slight decrease in red blood count. There has also been an onset of shakyness which I believe has been a side effect. |
| Comments: | | 2-100mg tablets are taken at bedtime. The dosage is self medicating, which means that if the condition is under control I can lower the doseage to see if the contrlo can be maintained at a lower dose. So far, after one year, I have been unable to do so. |
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Page last updated: 2009-10-20
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