Pseudoephedrine hydrochloride

Sensitisation data (human)

Administrative data

Endpoint:

sensitisation data (humans)

Type of information:

other: Case report

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Human case study. Limitations in design and/or reporting but otherwise adequate for assessment.

Data source

Reference

Reference Type:

publication

Title:

Short Communication: Contact sensitivity and systemic reaction to pseudoephedrine and lignocaine

Author:

Downs; A.M.R.

Year:

1998

Bibliographic source:

Contact Dermatitis, 1998, 39, 33

Materials and methods

Type of sensitisation studied:

skin

Study type:

case report

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

A case report of a 35-year-old atopic woman after possible sensitization to prilocaine and lignocaine leading to the sensitization to pseudoephedrine due to cross-sensitization.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Pseudoephedrine hydrochloride

EC Number:

206-462-1

EC Name:

Pseudoephedrine hydrochloride

Cas Number:

345-78-8

Molecular formula:

C10H15NO.ClH

IUPAC Name:

2-(methylamino)-1-phenylpropan-1-ol hydrochloride

Details on test material:

- Name of test material (as cited in study report): pseudoephedrine

Method

Type of population:

general

Ethical approval:

not applicable

Subjects:

- Number of subjects exposed: 1
- Sex: Female
- Age: 35

Clinical history:

A 35-year-old atopic woman applied Emla cream (lignocaine 2.5%, prilocaine 2.5%) to inflamed skin after a sunburn. Within a few days, she developed blistering of the skin. Several months later, she took a tablet of Nurofen Cold and Flu Remedy (200 mg ibuprofen, 30 mg pseudoephedrine HCl), which after several hours induced palpitations and a generalised red itchy eruption. Prednisolone 30 mg oral daily controlled the cutaneous reaction within a week. She re-challenged herself with oral Nurofen without incident, but Nurofen Cold and Flu Remedy produced the same symptoms, which again settled with a short course of oral prednisolone. Several weeks later, she was given a 2% plain lignocaine intrabuccal injection. Within minutes, she developed swollen hands, tachycardia and a red itchy eruption over her trunk and limbs. To her knowledge, she had never had a previous local anaesthetic administered. She was taking no other medication.

Route of administration:

dermal

Details on study design:

Patch testing with: pseudoephedrine (1% pet.), lignocaine (1% pet.), prilocaine (1% pet.) procaine, amylocaine and the European standard series.

Results and discussion

Results of examinations:

Patch testing showed positive reactions (++) to pseudoephedrine 1% pet. and lignocaine 1% pet. at 2 and 4 days, a positive reaction (+) to prilocaine 1% pet. at D4, but negative reactions to procaine, amylocaine and the European standard series. Sensitization to prilocaine and lignocaine may have occurred in this patient following the topical application of Emla cream to an already inflamed skin site. The presence of a benzene ring and a distally-placed nitrogen molecule, surrounded by methyl groups, in lignocaine, prilocaine and pseudoephedrine, suggests some sharing of epitopes between all 3 chemicals. Therefore, sensitization to pseudoephedrine may be due to crosssensitization.

Applicant's summary and conclusion

Conclusions:

Sensitization to pseudoephedrine may be due to crosssensitization after possible sensitization to prilocaine and/or lignocaine following the topical application of these substances in Emla cream.

Executive summary:

In a case report sensitization to prilocaine and lignocaine may have occurred in a patient following the topical application of Emla cream to an already inflamed skin site. Several months later application of pseudoephidrine resulted in palpitations and a generalised red itchy eruption. Patch testing showed positive reactions to pseudoephedrine, lignocaine and prilocaine. The presence of a benzene ring and a distally-placed nitrogen molecule, surrounded by methyl groups, in lignocaine, prilocaine and pseudoephedrine, suggests some sharing of epitopes between all 3 chemicals. Therefore, sensitization to pseudoephedrine may be due to crosssensitization.