Eton Pharmaceuticals Announces Availability of Orphan Drug ALKINDI SPRINKLE (hydrocortisone) in the United States - Seite 3

Infections: Excessive doses may increase the risks of new infections or exacerbation of latent infections with any pathogen, including viral, bacterial, fungal, protozoan, or helminthic. Monitor patients for signs and symptoms of infections. Treat all infections seriously and initiate stress-dosing of corticosteroids early.

Growth Retardation: Long-term use in excessive doses may cause growth retardation. Use the minimum dosage of ALKINDI SPRINKLE to achieve the desired clinical response and monitor the patient’s growth.

Cushing Syndrome Due to Use of Excessive Doses of Corticosteroids: Prolonged use with supraphysiologic doses may cause Cushing syndrome. Monitor patients for signs and symptoms of Cushing syndrome every 6 months; pediatric patients under one year of age may require more frequent monitoring.

Decrease in Bone Mineral Density: Corticosteroids decrease bone formation and increase bone resorption which may lead to inhibition of bone growth and development of osteoporosis. Use the minimum dosage of ALKINDI SPRINKLE to achieve desired clinical response.

Psychiatric Adverse Reactions: Use may be associated with severe psychiatric adverse reactions such as euphoria, mania, psychosis with hallucinations, and delirium or depression. Symptoms typically emerge within a few days or weeks of starting the treatment. Most reactions resolve after either dose reduction or withdrawal, although specific treatment may be necessary. Monitor patients for behavioral and mood disturbances during treatment. Instruct caregivers and/or patients to seek medical advice if psychiatric symptoms develop.

Ophthalmic Adverse Reactions: Cataracts, glaucoma, and central serous chorioretinopathy have been reported with prolonged use of high doses. Monitor patients for blurred vision or other visual disturbances and, if they occur, refer them to an ophthalmologist.

Gastrointestinal Adverse Reactions: Increased risk in patients with certain gastrointestinal disorders. Signs and symptoms may be masked.

Adverse Reactions

The most common adverse reactions from corticosteroids include fluid retention, alteration in glucose tolerance, elevation in blood pressure, behavioral and mood changes, and increased appetite and weight gain.

About Eton Pharmaceuticals
Eton Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on developing and commercializing innovative treatments for rare pediatric diseases. Eton is primarily focused on hospital injectable and pediatric rare disease products. The company currently owns or receives royalties from three FDA-approved approved products, including ALKINDI SPRINKLE, Biorphen, and Alaway Preservative Free, and has six additional products that have been submitted to the FDA.