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Toxicological information

Direct observations: clinical cases, poisoning incidents and other

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Administrative data

Endpoint:
direct observations: clinical cases, poisoning incidents and other
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
2011
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
A reliable secondary source, summarising ISDN pharmaco-toxicological properties, was used. However, the primary sources were not revisited in order to verify their contents; for this reason reliability score 2 was used. The used secondary source has been updated on January, 2011; therefore it covers the most updated literature on the substance.

Data source

Referenceopen allclose all

Reference Type:
secondary source
Title:
No information
Year:
1999
Bibliographic source:
Physicians' desk reference
Reference Type:
secondary source
Title:
No information
Year:
2011
Bibliographic source:
Drugdex Drug Evaluation: DRUGDEX® System. Thomson Reuters, Greenwood Village, Colorado.

Materials and methods

Study type:
poisoning incident
Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
No detailed information is available.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent

Method

Type of population:
general
Reason of exposure:
other: therapeutic

Results and discussion

Any other information on results incl. tables

The average methemoglobin level measured was 0.2%; these results were comparable to those observed in parallel patients who received placebo.

Applicant's summary and conclusion

Conclusions:
Nitrate ions liberated during metabolism of isosorbide dinitrate can oxidize hemoglobin into methemoglobin. When methemoglobinemia is diagnosed, the treatment of choice is methylene blue, 1 to 2 mg/kg intravenously.