Prednisolone acetate 1 %
QUALITATIVE AND QUANTITATIVE COMPOSITION :
Active : Prednisolone acetate 10 mg/ml
Excipients : Contains BenzaIkonium chlorid 0.1 mg/ml, Hydroxypropyl methylcellulose, Polysorbate 80 , Glycerin , Dibasic sodium phosphate anhydrous, EDTA, Citric acid, N20H, and Water for injection.
PHARMACEUTICAL FORM :
3.1. Therapeutic indications:
For short-teem treatment of steroid-responsive inflamnutory conditions of the eye, after excluding the presence of viral, fungal and bacterial pathogens in adults.
3.2. Method of administration:
– Route of administration is l:!Y ocular instillation.
– Adults: One to two drops instilled into the coojuncriv2l sac two to four times daily. During the initial 24 to 48 boon the dosing & quency may he safely increased to 2 drops every hour Care should be taken not to discontinue therapy prematurely. – Shake the bottle well before use,
– Safety and effectiveness in paediatric patients have not been established.
– No overall differences in safety or effr.ctiveness 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 he performed immediately following the instillation of each mop.
3.3. Contraindications :
Acute untreated purulent ocular infections. Acute super6cial herpes simpla (dendritic keratiris)vaccinia , varicella and most other viral diseases of the cornea and
conjunctiva Fungal diseases of the eye and ocular tuberculosis or sensitivity to any component of the formulation.
3.4. Special warnings and precautions for use:
Acute purulent infections of the eye nu.y be masked or enhanced by the use of topical steroids. Otchapred auspension 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, Orchapred suspension 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 keratitis should treated with caution. The use of steroid medication in the ~ce of stromal herpes simplex
caution and should be followed by frequent, mandatory; slit-lamp microscopy.
Use of topical corticostercids 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 frequendy during treatment with Orchaprcd auapension.
Eye drops containing corticosteroids should not be used for more than 10 days except under strict ophthalmic supervision with regular checks for inrraocular pressure, Posterior subcapsular cataract fonnation has hem 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 3.2).
The possibility of adrenal suppression should be considered with prolonged. frequent, use of high dose topical steroids, particularly in infants and children.
3.5. Interaction with other medicinal products and other forms of interaction :
3.6. Pregnancy and lactation:
There is inadequate: evidence of safety in human pregnancy. Adminismtion of conicosteroids to pregnant a.n.i.mal.s can cause abnormalities of foetal devdopment including cleft palate and inrra-utenne growth ret:m:htion. 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 beaefie outweighs the potential risk to the foetus. It is not known whether topical administration of Orchapred euepenelcn could result in sufficient systemic absorption to produce detectable quantities in breast milk. Therefore. use is not recommended in women breast feeding infants.
3.7. Effects on ability to drive and use machines:
Orchapred stnpenaion Ill2J 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.
3.8. Undesirable effects :
The following undesirable effects have been repotted following use of Orchapred suapcnaion.
Frequency categories: very common (1/10); common (1/100 to <1/10); uncommon (1/1.000 to <1/100); rare (1/10.000 to <1 / 1.000); very nee «1 / 10,000), not known (cannot be estimated from available data).
Immune system disorders:
Not known: Hypersensitivity, Urticaria.
Nervous system disorders!
Not knowre Headache.
Not known: Intraocular pressure Increased, Cataract (including subcapsular)*. Eye penetration (scleral or corneal perforstioo)”, Eye fungal infection*.
Not known : Dysgeusia
Skin and subcutaneous tissue disorders:
Not known: Pruritus, Rash
Systemic extensive: topical use of corticosterOids may lead to systemic side effects* .
• See Section 3.4 for further information.
3.9. Overdose :
There is 00 clinical experience of overdosage. Acute overdosage is unlikely to occur via the ophthalmic route.
4.1. Pharmacodynamic properties:
Prednisolone acetate is a synthetic adreoocorticoid with the general properties of prednisolooc. Adrenoconicoids diffuse: across cell membnnc:s to complex with cytoplasmic recepton and subsequently stimulate synthesis of enzymes with anti-inflammatory effects.
Glucocotticoids inhibit the cedens, 6brin deposition. capilbry dilation and ph2gocytic 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 compared to that of hydrocortisone.
4.2. Pharmacokinetic properties:
Prednisolone acetate ius been shown to penetrate mpidly the cornea after topical application of a suspension preparation. Aqueous humour T mu occurs between 30 and 4S minutes after installation. The half lifc of predclsolone acetate in human aqueous humour is approximately .30 minutes.
4.3. Preclinical safety data:
Non-clinical data reveal no special hazard of prednisolone acetate for humans based on conventional studies 00 the acute toxic potential of Orchaprcd suspension.
PHARMACEUTICAL PARTICULARS :
5.1. Incompatibilities :
5.2. Shelf life:
24 months unopened &.30 days after first opening.
5.3. Special precautions for storage:
Store at temperature not exceeding 300 C.
5.4. Nature and contents of container:
Carton box containing white polyethylene plastic bottle of 5 ml/l0 ml with dropper and inner leaflet,
5.5. Special precautions for disposal and other handling!
No special requirements.
Manufactured by :
Orchidia Pharmaceutical lndustries
industrial zone • Al-Obour City, Egypt