Prednisolone sodium phosphate auricular and ocular
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Drops containing prednisolone sodium phosphate.
Drugs List
Therapeutic Indications
Uses
Eye - non-infected inflammatory conditions
Non-infected inflammatory conditions of the ear
Dosage
The frequency of dosing depends on the clinical response and the lowest effective dose should be used for the shortest possible time.
Discontinue the drops if no response within 7 days.
After prolonged treatment of 6 to 8 weeks, withdraw drops slowly to avoid relapse.
Adults
Eyes
Instil 1 to 2 drops in to the eye every one or two hours until control is achieved. The frequency may then be reduced.
Ears
Instil 2 to 3 drops into the ear every two or three hours until control is achieved. The frequency may then be reduced.
Children
Eyes
Instil 1 to 2 drops in to the eye every one or two hours until control is achieved. The frequency may then be reduced.
Ears
Instil 2 to 3 drops into the ear every two or three hours until control is achieved. The frequency may then be reduced.
Contraindications
Soft contact lenses
Ear infection
Glaucoma
Herpetic keratitis
Ocular infection
Perforated tympanic membrane
Undiagnosed red eye
Precautions and Warnings
Infants
Breastfeeding
Pregnancy
May mask symptoms or signs of infections
Advise patient blurred vision may affect ability to drive/operate machinery
Exclude raised intraocular pressure, cataracts & infection before repeating
Treat and control infections prior to commencing therapy
Contains benzalkonium chloride. Not to be used with soft contact lenses
In combined therapy, administer eye products at least five minutes apart
To reduce systemic absorption compress lacrimal sac during administration
Check ocular lens frequently - risk of cataract formation
Monitor intraocular pressure frequently - risk of steroid glaucoma
Perform eye tests in any patient with vision change/ophthalmologic symptoms
Prolonged or high dose may lead to adrenal suppression
Contains phosphate: Risk of calcification in existing notable cornea damage
May cause perforation of eye in disorders that thin the sclera or cornea
Prolonged use may result in ocular infections
Systemic side effects may occur
Withdraw gradually after long-term use
Discontinue if no improvement occurs within 7 days
Maintain treatment at the lowest effective dose
Avoid long term use
There is an increased risk of adrenal suppression in infants, particularly after prolonged use. In addition, systemic effects may include growth retardation, psychological and behavioural effects in children and adolescents.
Pregnancy and Lactation
Pregnancy
Use prednisolone sodium phosphate auricular and ocular drops with caution during pregnancy.
The manufacturer advises that safety for use during pregnancy has not been established. Animals studies show that topical administration of corticosteroids can cause abnormalities of foetal development, including cleft palate and intrauterine growth retardation. At the time of writing there is limited human data available. There may be a small risk of similar effects in the human foetus.
Lactation
Use prednisolone sodium phosphate auricular and ocular drops with caution during breastfeeding.
The manufacturer notes that there is insufficient information on the excretion of prednisolone sodium phosphate and its metabolites in human milk. Effects on exposed infants are unknown.
Side Effects
Acute anterior uveitis
Adrenal suppression
Anxiety
Blurred vision (transient)
Burning sensation (local)
Cataracts
Chorioretinopathy
Corneal deposits
Corneal or scleral malacia
Corneal thinning
Cushing's syndrome
Cushingoid facies
Dermatitis
Epithelial punctate keratitis
Glaucoma
Hypersensitivity reactions
Increased intra-ocular pressure
Irritation (localised)
Itching sensation (local)
Mydriasis
Optic nerve damage
Perforation of the ocular globe
Posterior subcapsular cataracts
Psychomotor hyperactivity
Ptosis
Reduced visual acuity
Scleral thinning
Sleep disturbances
Stinging
Thinning of the ocular globe
Visual field defects
Overdosage
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Further Information
Last Full Review Date: October 2019
Reference Sources
Summary of Product Characteristics: Prednisolone Sodium Phosphate 0.5% w/v Eye and Ear Drops, Solution. RPH Pharmaceuticals AB. Revised November 2018.
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
FDB Disclaimer : FDB Multilex is intended for the use of healthcare professionals and is provided on the basis that the healthcare professionals will retain FULL and SOLE responsibility for deciding what treatment to prescribe or dispense for any particular patient or circumstance.