Prednisolone Acetate Ophthalmic Suspension is an adrenocortical steroid prepared as sterile ophthalmic suspension for using in eye problems. The active ingredient is represented with the chemical name given here below
What is the Chemical name and composition of Prednisolone eye drops? What are prednisolone eye drops?
Pregna-1, 4-diene-3,20- dione, (acetyloxy)-11,17-dihydroxy-,(118)-.
Prednisolone Eye drops Composition:
Active: Prednisolone Acetate IP 1% w/v
Preservative: Benzalkonium Chloride Solution (as Preservative) IP 0.02% v/v
Vehicle: Aqueous one and carbomer for uniformity in Suspension.
Inactives: Sterile Aqueous Base q.8.
Why is this eye drops medication prescribed?
Ophthalmic prednisolone is a steroid medication prescribed for the treatment of eye inflammation.
It is typically prescribed for conditions such as blepharitis, allergic conjunctivitis, vernal keratoconjunctivitis, and dry eye syndrome. It can also be used before or after certain surgeries and after eye trauma.
It helps reduce irritation, redness, burning, and swelling caused by various conditions such as chemical exposure, heat radiation, infection, allergy, or foreign bodies.
Additionally, it may be used after eye surgery as a preventative measure against swelling and redness.
Prednisolone changes how the immune system works to reduce inflammation. It does this by preventing certain cells from releasing substances that cause inflammation and improving circulation in the eye. It also affects cell processes related to inflammation, like causing white blood cells to produce fewer inflammatory chemicals. Ophthalmic prednisolone effectively treats symptoms of eye inflammation and is well-tolerated when used as directed.
CLINICAL PHARMACOLOGY:
Corticosteroids are capable of suppressing the inflammatory response caused by various agents, which may potentially delay or slow down the healing process. They have the ability to inhibit multiple aspects of inflammation, including edema, fibrin deposition, capillary dilation, leukocyte migration, capillary proliferation, fibroblast proliferation, collagen deposition, and scar formation.
Ophthalmic prednisolone reduces the irritation, redness, burning, and swelling of eye inflammation caused by chemicals, heat, radiation, infection, allergy, or foreign bodies in the eye. It sometimes is used after eye surgery. Prednisolone is in a class of medications called steroids. It prevents swelling and redness by changing the way the immune system works.
Ophthalmic prednisolone reduces the irritation, redness, burning, and swelling of eye inflammation caused by chemicals, heat, radiation, infection, allergy, or foreign bodies in the eye. It sometimes is used after eye surgery. Prednisolone is in a class of medications called steroids. It prevents swelling and redness by changing the way the immune system works.
Source: medlineplus.gov
Mechanism of Action 🎬 How Prednisolone Drops Work
The mechanism of action of ocular corticosteroids is not yet fully understood, although it is believed that they work by inducing proteins that inhibit phospholipase A2, collectively known as lipocortins. These proteins are thought to regulate the production of inflammatory mediators such as prostaglandins and leukotrienes by inhibiting the release of their common precursor, arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A2. Corticosteroids are known to rise Intraocular pressure (IOP).
Uses of Prednisolone Eye drops
Steroid responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe such as allergic conjunctivitis, acne rosacea, superficial punctate keratitis, herpes zoster keratitis, Iritis, cyclitis, selected infective conjunctivitis, when the inherent hazard of steroid use is accepted to obtain an advisable diminution in oedema and inflammation; corneal Injury from chemical, radiation, or thermal bums, or penetration of foreign bodies.
CONTRAINDICATIONS:
Prednisolone Acetate Ophthalmic Suspension should not be used in cases of viral diseases of the Cornea and conjunctiva, including epithelial herpes simplex keratitis (also known as dendritic keratitis), vaccinia, and varicella.
It is also not recommended for use in cases of mycobacterial infection of the eye or fungal diseases of ocular structures. Additionally, Prednisolone Acetate Ophthalmic Suspension should not be used by individuals who have a known or suspected hypersensitivity reaction towards other corticosteroids.
WARNINGS:
FOR TOPICAL OPHTHALMIC USE ONLY. NOT FOR INJECTION.
Extended usage of corticosteroids can lead to glaucoma, which may cause harm to the optic nerve, impair visual acuity and field of vision, as well as contribute to the development of posterior subcapsular cataracts. Additionally, prolonged use can suppress the body’s immune response, thereby increasing the risk of secondary ocular infections. Various ocular diseases and long-term use of topical corticosteroids have been known to cause corneal and scleral thinning. Use of topical corticosteroids in the presence of thin corneal or scleral tissue may lead to perforation.
Acute purulent infections of the eye may be masked or activity enhanced by the presence of corticosteroid medication. It this product is used for 10 days or longer, intraocular pressure should be routinely monitored even though it may be difficult in children and uncooperative patients. Steroids should be used with caution in the presence of glaucoma. Intraocular pressure should be checked frequently. The use of steroids after cataract surgery may delay healing and increase the incidence of bleb formation. Use of ocular steroids may prolong the course and may exacerbate the severity of many viral infections of the eye (including herpes simplex). Employment of a corticosteroid medication in the treatment of patients with a history of herpes simplex requires great caution; frequent slit lamp microscopy is recommended. Corticosteroids are not effective in mustard gas keratitis and Sjogren’s keratoconjunctivitis.
PRECAUTIONS:
General: The initial prescription and renewal of the medication order should be made by a physician only after examination of the patient with the aid of magnification, such as slit lamp blo microscopy and, where appropriate, fluorescein staining. If signs and symptoms fail to improve after two days, the patient should be re-evaluated. As fungal infections of the cornea are particularly prone to develop coincidentally with long-term local corticosteroid applications, fungal Invasion should be suspected in any persistent corneal ulceration where a corticosteroid has been used or is in use. Fungal cultures should be taken when appropriate. If this product is used for 10 days or longer, intraocular pressure should be monitored (SEE WARNINGS).
Information & Note for Patients:
If inflammation or pain persists longer than 48 hours or becomes aggravated, the patient should be advised to discontinue use of the medication and consult a physician. This product is sterile when packaged. To prevent contamination care should be taken to avoid touching the bottle tip to eyelids or to any other surface. The use of this bottle by more than one person may spread infection. Keep the bottle tightly closed when not in use. Keep out of the reach of children. Use the suspension within one month after opening the bottle.
Can Prednisolone drops can be used in Pregnancy?
PREGNANCY: NO
Teratogenic effects Pregnancy Category C: Prednisolone has been shown to be teratogenic . Prednisolone Acetate Ophthalmic Suspension should be used during pregnancy only if the potential benefit justifies the potential risk to the foetus.
Nursing Mothers:
It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Corticosteroids administered systemically can be found in human milk and may have negative effects on growth, interfere with natural corticosteroid production, or cause other unwanted effects. It is important to consider the potential serious adverse reactions in nursing infants from prednisone acetate and make a decision on whether to stop nursing or discontinue the drug, considering the drug’s importance to the mother.
Paediatric Use: Safety and effectiveness in paediatric patients have not been established
ADVERSE REACTIONS: (side effects)
Adverse reactions include, in decreasing order of frequency, elevation of intraocular pressure (IOP) with possible development of glaucoma and infrequent optic nerve damage, posterior subcapsular cataract formation, and delayed wound healing.
While systemic effects are rare, there have been reported instances of systemic hypercorticoidism following the use of topical steroids. Corticosteroid-containing preparations have also been associated with acute anterior uveitis and globe perforation. Keratitis, conjunctivitis, corneal ulcers, mydriasis, conjunctival hyperaemia, loss of accommodation and have occasionally been reported following local use of corticosteroids. Continuous use of steroid might lead to Fungal and viral infections of the cornea. The possibility of fungal invasion should be considered in any persistent corneal ulceration where steroid treatment has been used (SEE WARNINGS).
DOSAGE AND ADMINISTRATION: How to use?
SHAKE WELL BEFORE USING
Two drops topically in the eye(s) four times daily. In cases of bacterial infections, concomitant use of anti-infective agents is a must. Care should be taken not to discontinue therapy prematurely. If you dont observe any improvement in signs and symptoms of the patient, after two days he or she must be re-evaluated. The dosing of prednisolone acetate ophthalmic suspension may be reduced, but care should be taken not to discontinue therapy prematurely. Withdrawal of treatment after continuous use for long time should not be sudden and should be carried out by gradually decreasing the frequency of applications.
HOW SUPPLIED:
Prednisolone is a sterile ophthalmic suspension that comes in a 10 ml sale pack and a 10 ml sample pack. It is supplied in a lyondellbasel Purell low-density polyethylene dispensing system for versatile use. The package is tamper-evident. A shrink band around the closure and neck area can be observed for this purpose.
How Prednisolone eye drops is Stored?
STORAGE:
store below 30°C. Protect from light & moisture. Do not freeze. Preserve closed vial in a carton till in use.
What are the substitutes for Prednisolone acetate ophthalmic suspension USP ?
In cases where Prednisolone acetate ophthalmic suspension USP is not available, there are substitutes that can be used for its intended purpose. These include Predmet 1% Eye Drop (Sun Pharmaceutical Industries Ltd.), Renisol 1% Eye Drop (Intas Pharmaceuticals Ltd.), and Predace 1% Eye Drop (Micro Labs Ltd.).
These medications have the same composition, strength and form as Prednisolone acetate ophthalmic suspension USP and are equally effective in treating the same condition. However, they should be taken only after consulting with a physician as their use may come with certain side effects. Also, one must make sure that they read all instructions carefully before using them. The dosage should be strictly followed to ensure maximum effectiveness and safety of the person using these medicines.
Prednisolone acetate ophthalmic suspension USP is a type of corticosteroid used in the treatment of various eye problems such as allergic reactions or inflammations. As it is a prescription-based medication, one needs to consult a doctor before taking it. In cases where Prednisolone acetate ophthalmic suspension USP is not available, there are substitutes that can be used for its intended purpose. These include Predmet 1% Eye Drop (Sun Pharmaceutical Industries Ltd.), Renisol 1% Eye Drop (Intas Pharmaceuticals Ltd.), and Predace 1% Eye Drop (Micro Labs Ltd.).
They should be taken only after consulting with a physician as their use may come with certain side effects. Also, one must make sure that they read all instructions carefully before using them