Prednisolone, ocular application

Generic name
Prednisolone, ocular application
Brand name
ATC Code
S01BA04
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Prednisolone, ocular application

Dosages
Side effects in children
Warnings & precautions in children
Contra-indications in children

Interactions
PK
Renal impairment
References

Pharmacokinetics in children

No studies have been carried out on pharmacokinetic parameters of prednisolone in children after ocular application.

dose recommendation of formulary compared to licensed use (on-label versus off-label)

No information is present at this moment.

Available formulations

No information is present at this moment.

Dosages

Inflammatory, non-infectious conditions of the conjunctiva, uveitis and post-operative
  • Ocular
    • 1 month up to 18 years
      [1] [2] [3] [4] [5] [6] [11]

      • Prednisolone drops 0.5% : 1 drop 4-6 times daily.
        Prednisolone drops  1%: 1 drop 4 times daily

        In very severe uveitis, consider: Start of treatment, days 1-3: 1% solution 1 drop every hour, then every 2 hours for 4 days, then 1 drop 5x daily. Maintenance: max 3 drops per day

        Prednisolone ointment 0.5%: Apply an amount of ointment of 1 cm in the lower eyelid 3-4 times daily.

        Prednisolon ointment 0,25%: Apply an amount of ointment of 1 cm in the lower eyelid 3-6 times a day.

      • In cases of uveitis, apply ointment before going to bed. Phase out depending on the clinical picture.

    • Term neonate
      [1] [2] [3] [4] [5] [6] [11]

      • Prednisolone drops 0.5% : 1 drop 4-6 times daily.
        Prednisolone drops  1%: 1 drop 4 times daily

        In very severe uveitis, consider: Start of treatment, days 1-3: 1% solution 1 drop every hour, then every 2 hours for 4 days, then 1 drop 5x daily. Maintenance: max 3 drops per day.

        Prednisolon ointment 0,5%: Apply an amount of ointment of 1 cm in the lower eyelid 3-4 times a day.

        Prednisolon ointment 0,25%: Apply an amount of ointment of 1 cm in the lower eyelid 3-6 times daily.

      • In cases of uveitis, apply ointment before going to bed. Phase out depending on the clinical picture.

Renal impaiment in children > 3 months

GFR ≥10 ml/min/1.73m2: Dose adjustment not required.

GFR <10 ml/min/1.73m2: A general recommendation on dose adjustment cannot be provided.

The complete list of all undesirable drug reactions can be found in the national Summary of Product Characteristics (SmPC) – click here

Side effects in children

Increased ocular pressure (cataract and glaucoma)

Infections, perforation of the cornea [SmPC Prednisolon-Augensalbe Jenapharm]

In longterm use: suppression of the adrenal cortex function.

The complete list of all contra-indications can be found in the national Summary of Product Characteristics (SmPC) – click here

Contra-indications

No information available on specific contra indications in children.

The complete list of all warnings and precautions can be found in the national Summary of Product Characteristics (SmPC) – click here

Warnings & precautions in children

Application of corticosteroids to the eye should be done under the supervision of an ophthalmologist.
If there is insufficient control of the inflammation, switch to another form of treatment because of risk of cataracts, glaucoma and blindness. There is an elevated risk of viral keratitis in prolonged use.

With long-term, high-dose application of topical steroids, the possibility of adrenal suppression should be considered, especially in children. [SmPC Inflanefron forte]

Interactions

The complete list of all interactions can be found in the national Summary of Product Characteristics (SmPC) – click here

ANTIINFLAMMATORY AGENTS

This pages provides a list of drugs from the same ATC class for comparison. This does not necessarily mean that these drugs are interchangeable.

References

  1. Simonini G, et al, Current therapeutic approaches to autoimmune chronic uveitis in children, Autoimmun Rev, 2010, Aug;9(10), 674-83. Epub 2010 May 26
  2. Thorne JE, et al, Risk of cataract development amongchildren with juvenile idiopathic arthritis-related uveitis treated with topical corticosteroids, Ophthalmology, 2010 , Jul;117(7), 1436-41. Epub 2010 Apr 3.
  3. Zierhut M, et al, Therapy of uveitis in children, Int Ophthalmol Clin, 2008, Summer;48(3), 131-52
  4. Wright T, et al, Pediatric rheumatology for the adult rheumatologist II: uveitis in juvenile idiopathic arthritis, J Clin Rheumatol, 2007 , Aug;13(4), 205-10
  5. Thadani SM, et al, Treatment of ocular inflammation in children, Paediatr Drugs, 2004, 6(5), 289-301
  6. NHG , Standaard Het Rode oog (M57), Feb 2006
  7. Allergan Pharmaceuticals Ireland, SmPC, Inflanefran forte 10 mg/ml Augentropfensuspension (6514644.01.00), 12/17
  8. Dr. Gerhard Mann chem.-pharm. Fabrik GmbH, SmPC, Predni-Ophtal® Gel 10 mg/g Augengel (36312.00.00), 11/18
  9. Ursapharm, SmPC, Predni-POS 0,5/1 % Augentropfensuspension (6403399.00.00/57937.00.00), 08/17
  10. mibe GmbH Arzneimittel, SmPC, Prednifluid® 10 mg/ml Augentropfensuspension (89383.00.00), 11/18
  11. mibe GmbH Arzneimittel, SmPC, Prednisolon-Augensalbe JENAPHARM® 2,5 mg/g (3000274.00.00), 05/17
  12. Agepha Pharma s.r.o., SmPC, Ultracortenol® 5 mg/ml Augentropfensuspension (6336697.00.00), 10/15
  13. Agepha Pharma s.r.o., SmPC, Ultracortenol® 5 mg/g Augencreme (6336711.00.00), 10/16

Changes

Therapeutic Drug Monitoring


Overdose