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Toxicological information

Additional toxicological data

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Administrative data

Endpoint:
additional toxicological information
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
1993
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: IPCS publication , reviewed

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1993
Report Date:
1993

Materials and methods

Type of study / information:
review
Test guideline
Guideline:
other: none
Principles of method if other than guideline:
review
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Pharmaceutical grade Dapsone
CAS number : 80-08-0
Other numbers :
1358F
NCI-CO1718
NSC 6091D
RTECS: BY892500
WR 488

Results and discussion

Any other information on results incl. tables

Main risks and target organs :

Methaemoglobinaemia and haemolysis are the main risks of acute intoxication. Haemolytic anaemia, agranulocytosis, aplastic anaemia and other blood dyscrasias may occur in chronic poisoning. Main risks and target organs Methaemoglobinaemia and haemolysis are the main risks of acute intoxication. Haemolytic anaemia, agranulocytosis, aplastic anaemia and other blood dyscrasias may occur in chronic poisoning. Target organs are central and peripheral nervous systems, blood, liver and skin.

Therapeutic dosage :

Adults Leprosy: 50 to 100 mg per day (6 to 10 mg/kg per week). Treatment may be continued for several years. Dermatitis multiformis: 100 to 300 mg per day.

Children Leprosy: 6 to 10 mg/kg per week. Methaemoglobinaemia may last for up to 10 days. Haemolysis is usually delayed but it may persist for 14 days, returning to normal within 3 to 4 weeks.

Contraindications :

Hypersensitivity reactions may be observed. They include: exfoliative dermatitis, toxic erythema, erythema multiforme, urticaria, erythema nodosum.

Dapsone levels are influenced by acetylation rates. Patients with genetically determined slow acetylation rates, or who are receiving treatment affecting acetylation, may require an adjustment in dosage.

Applicant's summary and conclusion

Conclusions:
ICPS review summarizes the toxic properties as well as the pharmacology and metabolism of Dapsone.
Executive summary:

ICPS review summarizes the toxic properties as well as the pharmacology and metabolism of Dapsone.