Prednisolone

Registered South African indications:

• Non-infectious allergic and inflammatory disorders of the lid, conjunctiva, cornea and sclera (including chemical and thermal burns) - mild to moderate (Prednisolone acetate 1.2mg/ml)
• Steroid responsive inflammation of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the eye globe (Prednisolone acetate 10mg/ml)
• Non-infected inflammatory conditions of the outer eye and anterior segment (Prednisolone sodium phosphate 2.5mg/0.5ml)

Contraindications

South African recommendations

Prednisolone acetate (1.2mg/ml & 10mg/ml)

• Hypersensitivity to any components of the formulation
• Acute, untreated purulent ocular infections
• Superficial herpes simplex (dendritic keratitis), vaccinia, varicella and other viral diseases of the cornea and conjunctiva
• Mycobacterial infection of the eye (ocular tuberculosis)
• Fungal diseases of the ocular structures

Prednisolone sodium phosphate (2.5mg/0.5ml)

• Hypersensitivity to prednisolone sodium phosphate or to any of the ingredients in the formulation
• Viral, fungal, tuberculous, and other bacterial infections
• Ulcerated eyes
• Patients with glaucoma as prolonged use can cause intra-ocular pressure to rise

Recommendations in other jurisdictions

Prednisolone acetate 1% w/v

• Hypersensitivity to the active substance or to any of the excipients
• Acute untreated purulent ocular infections
• Acute superficial herpes simplex (dendritic keratitis); vaccinia, varicella and most other viral diseases of the cornea and conjunctiva
• Fungal diseases of the eye
• Mycobacterial infection such as tuberculosis of the eye

Prednisolone sodium phosphate 0.5% w/v

• Hypersensitivity to the active substance or to any of the excipients
• Viral, fungal, tuberculous and other bacterial infections
• Prolonged application to the eye of preparations containing corticosteroids has caused increased intraocular pressure and therefore the drops should not be used in patients with glaucoma
• In children, long-term, continuous topical corticosteroid therapy should be avoided due to possible adrenal suppression

Cautions

• Pregnancy
• Breastfeeding
• Corneal or scleral thinning
• Concomitant use of soft contact lenses
• Undiagnosed red eye
• Repeated or prolonged use without regular review
• Signs of infection
• Significantly damaged corneas
• May impair and ability to drive and operate machinery

Forms avail. in SA and covered in this monograph: opd

Dosages below include:

• South African registered indications and dosages
• Indications and dosages registered in other jurisdictions

South African registered indications and dosages

Non-infectious allergic and inflammatory disorders of the lid, conjunctiva, cornea and sclera (including chemical and thermal burns) - mild to moderate

Prednisolone acetate 1.2mg/ml

• Ophthalmic (opd): Initial (24-48hrs): Instil 2 drops into the conjunctival sac of affected eye(s), 1hrly; Maintenance: 1-2 drops into the conjunctival sac of affected eye(s), 6-12hrly

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Care should be taken not to discontinue therapy prematurely. Shake container well before using

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Steroid responsive inflammation of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the eye globe

Prednisolone acetate 10mg/ml

• Ophthalmic (opd): Initial (24-48hrs): Instil 2 drops into the conjunctival sac of affected eye(s), 1hrly; Maintenance: 1-2 drops into the conjunctival sac of affected eye(s), 6-12hrly; Treatment duration: ≤10 days except under strict ophthalmic supervision with regular checks for intraocular pressure

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Care should be taken not to discontinue therapy prematurely (i.e. not to stop prednisolone 10mg/ml abruptly or taper off too quickly). Shake well before using

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Treatment should not exceed 10 days without reassessment

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To reduce possible systemic absorption, it may be recommended that the lacrimal sac be compressed at the medial canthus (punctal occlusion) for 1 minute. This should be performed immediately following the instillation of each drop

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Non-infected inflammatory conditions of the outer eye and anterior segment

Prednisolone sodium phosphate 2.5mg/0.5ml

• Ophthalmic (opd): Instil 1-2 drops into affected eye(s), as required; Treatment duration: ≤7 days except under strict supervision

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Each unit should be discarded after a single use

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Indications and dosages registered in other jurisdictions

Steroid-responsive inflammatory conditions of the eye, after excluding the presence of viral, fungal and bacterial pathogens
- Short-term treatment

Prednisolone acetate 1% w/v

• Ophthalmic (opd): Initial (24-48hrs): Instil 2 drops into the conjunctival sac, 1hrly; Maintenance: 1-2 drops into the conjunctival sac, 6-12hrly

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Care should be taken not to discontinue therapy prematurely

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Route of administration is by ocular instillation. To reduce possible systemic absorption, it may be recommended that the lacrimal sac be compressed at the medial canthus (punctal occlusion) for 1 minute. This should be performed immediately following the instillation of each drop. Shake well before use

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Non-infected inflammatory conditions of the eye

Prednisolone sodium phosphate 0.5% w/v

• Ophthalmic (opd): Instil 1-2 drops into affected eye(s), as required

Paed. forms avail. in SA and covered in this monograph: opd

Paed. dosages below include:

• South African registered indications and dosages
• Indications and dosages registered in other jurisdictions

South African registered indications and dosages

Non-infected inflammatory conditions of the outer eye and anterior segment

Prednisolone sodium phosphate 2.5mg/0.5ml

• Ophthalmic (opd): Dosages at the discretion of the ophthalmologist

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Each unit should be discarded after single use

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Prednisolone should not be used for more than one week except under strict supervision

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In children, long term continuous use should be avoided due to possible adrenal suppression

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Prednisolone acetate 1.2mg/ml: No dosage information available

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Prednisolone acetate 10mg/ml: Safety and efficacy in paediatric patients have not been established

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Indications and dosages registered in other jurisdictions

Non-infected inflammatory conditions of the eye

Prednisolone sodium phosphate 0.5% w/v

• Ophthalmic (opd): Dosages at the discretion of the medical practitioner

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Contraindication: In children, long-term, continuous topical corticosteroid therapy should be avoided due to possible adrenal suppression

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Prednisolone acetate 1% w/v: The safety and efficacy in paediatric population have not yet been established. No posology can be recommended

Pregnancy

• Caution
• Safety for use in pregnancy has not been established. There is inadequate evidence of safety in human pregnancy. Topical administration of corticosteroids to pregnant animals can cause abnormalities of foetal development including cleft palate and intrauterine growth retardation. There may be a very small risk of such effects in the human foetus

Breastfeeding

• Caution; not recommended
• Safety for use during breastfeeding has not been established. There is insufficient information on the excretion of ophthalmic prednisolone in human milk. A risk to the newborns/infants cannot be excluded

Fertility

• No fertility data is available

Renal Impairment

• No dose adjustment recommended

Hepatic Impairment

• No dose adjustment recommended

Elderly

• No dose adjustment recommended

Porphyria Information

• Not porphyrinogenic (NP)

Drugs in Sport

• Permitted - No warnings

Skin and Subcutaneous Tissue Disorders

• Dermatitis

Immune, Blood and Lymphatic System Disorders 

• Hypersensitivity
  - Irritation
  - Burning
  - Stinging
  - Itching

Sensory Disorders 

• Increased intraocular pressure
• Cataracts
• Eye perforation
• Mydriasis
• Corneal calcification
• Optic nerve damage
• Reduced visual acuity
• Visual field defects
• Chorinoretinopathy
• Ptosis
• Epithelial punctate keratatits
• Corneal or scleral malacia
• Acute anterior uveitis
• Blurred vision

• Anticholinesterases
• Antiviral eye preparations
• Salicylates
• CYP3A inhibitors
• Cobicistat-containing agents
• Barbiturates
• Sedative hypnotics
• Tricyclic antidepressants

None routine. Specific cases may require

• Intraocular pressure

Prednisolone, a glucocorticoid, inhibits phospholipase A2; thus decreases prostaglandin formation. Prednisolone shares the same general properties as other corticosteroids, able to lyse and destroy lymphocytes and affect the activation and migration of leucocytes. The actions of corticosteroids are mediated by the binding of the corticosteroid molecules to receptor molecules located within sensitive cells.

Eye drop (per ml) 1.2mg

• Pred Mild (Allergan) originator

Eye drop (per 0.5ml) 2.5mg

• Minims Prednisolone Sodium Phosphate 0.5% (Soflens) originator

Eye drop (per ml) 10mg

• Pred Forte (Allergan) originator

Also available in the following form: Syrup.