Prednisolone

DRUG INFORMATION

  ADULT
    - This may become important in the treatment of conditions that require tapering
      doses that cannot be adequately accommodated by Orapred ODT, e.g., tapering the
      dose below 10 mg.
      Source: US FDA label for prednisolone (Orapred ODT), section 'dosage and
      administration', retrieved 2026-08-29
    - The initial dose of Orapred ODT may vary from 10 to 60 mg (prednisolone base) per
      day, depending on the specific disease entity being treated.
      Source: US FDA label for prednisolone (Orapred ODT), section 'dosage and
      administration', retrieved 2026-08-29
    - Multiple Sclerosis In the treatment of acute exacerbations of multiple sclerosis,
      daily doses of 200 mg of prednisolone for a week followed by 80 mg every other day
      for one month have been shown to be effective.
      Source: US FDA label for prednisolone (Orapred ODT), section 'dosage and
      administration', retrieved 2026-08-29

  CHILD
    - The efficacy and safety of prednisolone in the pediatric population are based on
      the well-established course of effect of corticosteroids, which is similar in
      pediatric and adult populations. Published studies provide evidence of efficacy
      and safety in pediatric patients for the treatment of nephrotic syndrome (>2 years
      of age), and aggressive lymphomas and leukemias (>1 month of age).
      Source: US FDA label for prednisolone (Orapred ODT), section 'pediatric use',
      retrieved 2026-08-29
    - The range of initial doses is 0.14 to 2 mg/kg/day in three or four divided doses
      (4 to 60 mg/m 2 bsa/day).
      Source: US FDA label for prednisolone (Orapred ODT), section 'dosage and
      administration', retrieved 2026-08-29
    - Nephrotic Syndrome The standard regimen used to treat nephrotic syndrome in
      pediatric patients is 60 mg/m 2 /day given in three divided doses for 4 weeks,
      followed by 4 weeks of single dose alternate-day therapy at 40 mg/m 2 /day.
      Source: US FDA label for prednisolone (Orapred ODT), section 'dosage and
      administration', retrieved 2026-08-29

  RENAL IMPAIRMENT
    - These agents should be used with caution in patients with hypertension, congestive
      heart failure, or renal insufficiency.
      Source: US FDA label for prednisolone (Orapred ODT), section 'warnings and
      cautions', retrieved 2026-08-29

  HEPATIC IMPAIRMENT
    - No liver-impairment dose in this label. Not a statement that none is needed.
      Source: Read and found silent: the US FDA label for prednisolone (Orapred ODT),
      retrieved 2026-08-29

  PREGNANCY
    - Embryo-Fetal Toxicity Prednisolone can cause fetal harm when administered to a
      pregnant woman.
      Source: US FDA label for prednisolone (Orapred ODT), section 'pregnancy',
      retrieved 2026-08-29
    - Human studies suggest a small but inconsistent increased risk of orofacial clefts
      with use of corticosteroids during the first trimester of pregnancy.
      Source: US FDA label for prednisolone (Orapred ODT), section 'pregnancy',
      retrieved 2026-08-29
    - Published animal studies show prednisolone to be teratogenic in rats, rabbits,
      hamsters, and mice with increased incidence of cleft palate in offspring.
      Source: US FDA label for prednisolone (Orapred ODT), section 'pregnancy',
      retrieved 2026-08-29

  BREASTFEEDING
    - Additionally, constriction of the ductus arteriosus was observed in fetuses of
      pregnant rats exposed to prednisolone. 8.2 Lactation Risk Summary Prednisolone is
      present in human milk.
      Source: US FDA label for prednisolone (Orapred ODT), section 'use in specific
      populations', retrieved 2026-08-29
    - No adverse effects in the breastfed infant have been reported following maternal
      administration of prednisolone during breastfeeding.
      Source: US FDA label for prednisolone (Orapred ODT), section 'use in specific
      populations', retrieved 2026-08-29
    - High doses of corticosteroids administered to lactating women for long periods
      could potentially produce problems in the breastfed infant including growth and
      development and interfere with endogenous corticosteroid production (see Clinical
      Considerations) [see Use in Specific Populations ( 8.4 )].
      Source: US FDA label for prednisolone (Orapred ODT), section 'use in specific
      populations', retrieved 2026-08-29