Diagnosis and Management of Infantile Hemangioma

Fixed eruption --- --- --- 1 (4%) 0 0 --- --- ---
Catheter site pain --- --- --- --- --- --- 1 (4%) 0 0
Catheter site
reaction
--- --- --- --- --- --- 1 (4%) 0 0
Shivering --- --- --- --- --- --- 1 (4%) 0 0
Blood potassium --- --- --- --- --- --- 1 (4%)
1
(4%)
Hypoaesthesia --- --- --- --- --- --- 0
1
(4%)
0
Bioavailability studies were also conducted for Orapred ODT® in 24 health patients each
receiving Orapred ODT® 30mg tablet, Pediapred® oral solution 30mg and Orapred® oral
solution 30mg. Adverse events reported in patients taking Oprapred ODT® included: face
edema/swelling face, pharyngolaryngeal pain, blood in stool, eye irritation, and eyelid edema.
A search of the literature for adverse events associated with prednisolone was conducted by
Taro Pharmaceuticals and reported in the FDA review package. 21 The most common adverse
events reported in 4 pediatric studies (mean age 2% of
patients participating in phase 3 clinical studies. 23 These patients were treated with prednisone
extended release (XL) (n=375) and prednisone immediate release tablets (IR) (n=144). Adverse
events included: abdominal pain upper: XL=6 (