ORAL SUSPENSION OF DAPSONE 2 MG/ML. EFFICACY, SAFETY AND FORMULATION IN PEDIATRIC PATIENT WITH LINEAR IG A DERMATOSIS: A CASE REPORT

M.D.P. LÓPEZ LÓPEZ1*, J. MORENO BENEGAS1, M.A. TORRECILLA ABRIL1, B. OYA ALVAREZ DE, MORALES1, V. CAO VIÑA1, L. GUTIERREZ LUCENA1, R. CONTRERAS COLLADO1

1HOSPITAL UNIVERSITARIO DE JAÉN, SERVICIO DE FARMACIA, JAÉN, SPAIN.

Received Date: April 01, 2025; Accepted Date: April 07, 2025; Published Date: April 11, 2025;

*Corresponding author: M.D.P. LÓPEZ LÓPEZ, HOSPITAL UNIVERSITARIO DE JAÉN, SERVICIO DE FARMACIA, JAÉN, SPAIN.

Keywords: Dapsone, Dermatosis, igA

Background and importance

Linear Ig A dermatosis of childhood is a rare autoimmune disorder, which manifests with outbreaks of vesicular and bullous lesions. The first-line treatment is dapsone.

Aim and objectives

To evaluate the efficacy and safety of treatment with mastered formula (FM) of dapsone 2 mg/ml oral suspension in a child with linear Ig A dermatosis. Describe the preparation of the FM.

Material and methods

Retrospective observational study of a child with linear Ig A dermatosis treated with dapsone. The variables collected: sex, age, analytical data (blood count, reticulocytes, glucose 6-phosphate dehydrogenase (G6PD) deficiency test, kidney and liver function), previous treatments and data related to treatment with dapsone. (concentration, dose, frequency of administration, duration of treatment, efficacy and safety). The clinical history and FM preparation protocols were reviewed.

Results

23-month-old patient with blistering lesions in different locations. Skin biopsy compatible with linear Ig A dermatosis confirmed with direct immunofluorescence test. Previously treated with oral prednisone. He has normal G6PD activity and a normal blood count, and oral dapsone 1.5mg/kg/day is started. A bibliographic search was carried out, finding an oral suspension preparation from dapsone tablets and SyrSpend® SF PH4, with physicochemical stability of 90 days at room temperature and in the refrigerator. A microbiological risk matrix was applied, assigning a validity period of 90 days in the refrigerator and 30 days at room temperature. From the beginning, a favorable evolution was observed, with rapid resolution of injuries. Five months after starting treatment, he had an outbreak with perioral lesions, increasing the dose of dapsone to 2 mg/kg/day. Two months later, in a control analysis, hemoglobin values of 9.5 g/dl and MCV of 87.9 fL were observed, diagnosing megaloblastic anemia secondary to the medication. Treatment is temporarily suspended, with analytical values normalizing after 40 days. It was decided to treat again with dapsone 0.5 g/kg/day. Currently the patient has no active lesions and no significant analytical abnormalities.

Conclusion and relevance

FM dapsone 2 mg/ml oral suspension was found to be effective for the treatment of linear Ig A dermatosis with excellent short-term response and prolonged remissions. Regarding safety, periodic analytical controls are recommended to avoid the appearance of megaloblastic anemia.


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ISSN: 2641-712X
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Language: English
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