1. Name Of The Medicinal Product
Pred Forte 1% w/v, Eye Drops Suspension
2. Qualitative And Quantitative Composition
1% w/v prednisolone acetate
Excipients: Contains 0.006% w/v Benzalkonium chloride.
For a full list of excipients, see section 6.1
3. Pharmaceutical Form
Eye drops, suspension
A dense white sterile microfine eye drops suspension.
4. Clinical Particulars
4.1 Therapeutic Indications
For short-term treatment of steroid-responsive inflammatory conditions of the eye, after excluding the presence of viral, fungal and bacterial pathogens in adults.
4.2 Posology And Method Of Administration
Route of administration is by ocular instillation.
Adults: One to two drops instilled into the conjunctival sac two to four times daily. During the initial 24 to 48 hours the dosing frequency may be safely increased to 2 drops every hour. Care should be taken not to discontinue therapy prematurely.
Shake well before use
Safety and effectiveness in paediatric patients have not been established.
No posology can be recommended.
No overall differences in safety or effectiveness have been observed between elderly and younger patients.
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.
4.3 Contraindications
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. Ocular tuberculosis.
Sensitivity to any component of the formulation.
4.4 Special Warnings And Precautions For Use
Acute purulent infections of the eye may be masked or enhanced by the use of topical steroids. Pred Forte contains no antimicrobial agent. If infection is present, appropriate measures must be taken to counteract the infective organisms.
Fungal infections of the cornea have been reported coincidentally with long-term steroid application and fungal invasion may be suspected in any persistent corneal ulceration where a steroid has been used, or is in use.
Various ocular diseases and long-term use of topical corticosteroids have been known to cause corneal or scleral thinning. Use of topical corticosteroids in the presence of thin corneal or scleral tissue may lead to perforation.
Pred Forte contains benzalkonium chloride as a preservative and should not be used in patients continuing to wear soft (hydrophilic) contact lenses.
Patients with a history of herpes simplex keratitis should be treated with caution. Use of steroid medication in the presence of stromal herpes simplex requires caution and should be followed by frequent, mandatory, slit-lamp microscopy.
Use of topical corticosteroids may cause an increase in intraocular pressure in certain individuals. This may result in damage to the optic nerve with resultant defects in visual fields. It is advisable that intraocular pressure be checked frequently during treatment with Pred Forte.
Eye drops containing corticosteroids should not be used for more than 10 days except under strict ophthalmic supervision with regular checks for intraocular pressure.
Posterior subcapsular cataract formation has been reported after heavy or protracted use of topical ophthalmic corticosteroids.
The use of steroids after cataract surgery may delay healing and increase the incidence of bleb formation.
Systemic adverse events may occur with extensive use of topical steroids; punctal occlusion may be recommended (see Section 4.2).
The possibility of adrenal suppression should be considered with prolonged, frequent, use of high dose topical steroids, particularly in infants and children.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
None known
4.6 Pregnancy And Lactation
There is inadequate evidence of safety in human pregnancy. Administration of corticosteroids to pregnant animals can cause abnormalities of foetal development including cleft palate and intra-uterine growth retardation. There may therefore be a very small risk of such defects in the human foetus. Therefore this product should be used with caution during pregnancy only if the potential benefit outweighs the potential risk to the foetus.
It is not known whether topical administration of Pred Forte could result in sufficient systemic absorption to produce detectable quantities in breast milk. Therefore, use is not recommended in women breast feeding infants.
4.7 Effects On Ability To Drive And Use Machines
Pred Forte may cause short-lasting blurring of vision upon instillation. If affected, the patient should not use machinery/electric tools or drive until vision has returned to normal.
4.8 Undesirable Effects
The following undesirable effects have been reported following use of Pred Forte.
Frequency categories: very common (
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4.9 Overdose
There is no clinical experience of overdosage. Acute overdosage is unlikely to occur via the ophthalmic route.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
Pharmacotherapeutic group: corticosteroids, ATC code: S01BA04
Prednisolone acetate is a synthetic adrenocorticoid with the general properties of prednisolone. Adrenocorticoids diffuse across cell membranes to complex with cytoplasmic receptors and subsequently stimulate synthesis of enzymes with anti-inflammatory effects. Glucocorticoids inhibit the oedema, fibrin deposition, capillary dilation and phagocytic migration of the acute inflammatory response as well as capillary proliferation, deposition of collagen and scar formation.
Prednisolone acetate has, on a weight to weight basis, a potency three to five times that of hydrocortisone.
5.2 Pharmacokinetic Properties
Prednisolone acetate has been shown to penetrate rapidly the cornea after topical application of a suspension preparation. Aqueous humour Tmax occurs between 30 and 45 minutes after installation. The half life of prednisolone acetate in human aqueous humour is approximately 30 minutes
5.3 Preclinical Safety Data
Non-clinical data reveal no special hazard of Pred Forte for humans based on conventional studies on the acute toxic potential of Pred Forte.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Benzalkonium chloride
Polysorbate 80
Boric acid
Sodium citrate
Sodium chloride
Disodium edentate
Hydroxypropylmethylcellulose
Purified water
6.2 Incompatibilities
None known
6.3 Shelf Life
24 months unopened.
28 days after first opening
6.4 Special Precautions For Storage
Do not store above 25 C. Do not freeze
6.5 Nature And Contents Of Container
5 ml and 10 ml bottles and dropper tips composed of low density polyethylene. Screw caps are medium impact polystyrene
6.6 Special Precautions For Disposal And Other Handling
No special requirements
7. Marketing Authorisation Holder
Allergan Ltd
Marlow International
The Parkway
Marlow
Bucks
SL7 1YL
UK
8. Marketing Authorisation Number(S)
PL 00426/0051
9. Date Of First Authorisation/Renewal Of The Authorisation
3rd March 1988 / 18th March 2003
10. Date Of Revision Of The Text
4th May 2010
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