Dosing & Uses
Dosage Forms & Strengths
prednisolone/gentamicin
ophthalmic suspension
- 1%/0.3%
ophthalmic ointment
- 0.6%/0.3%
Ocular Anti-inflammatory/Anti-infective
Ophthalmic ointment
- Apply to conjunctival sac of affected eye qDay to q8hr
- Re-evaluate patient if no improvement after 2 days of therapy
Ophthalmic suspension
- 1 gtt q6-12hr (up to q1hr during initial 24-48 hr of treatment); may increase dosing frequency to q1hr if necessary
- Re-evaluate patient if no improvement after 2 days of therapy
Safety & efficacy not established
Adverse Effects
Frequency Not Defined
Ocular discomfort
Irritation upon instillation
Punctate keratitis
Elevation of IOP with possible development of glaucoma
Optic nerve damage
Posterior subcapsular cataract formation
Delayed wound healing
Secondary infection
Fungal infections of the cornea
Allergic sensitizations
Rash
Superinfection (herpes)
Postmarketing Reports
Eye burning
Eye stinging
Ocular hyperemia
Eye pain
Eye discharge
Lacrimation increased
Eye edema
Visual impairment
Foreign body sensation in eyes
Dysgeusia
Blurry vision
Hypersensitivity including signs and symptoms related to ocular allergy (e.g. conjunctivitis), angioedema (e.g. tongue edema) and allergic skin reactions (e.g. rash and contact allergy)
Warnings
Contraindications
Hypersensivity to any component
Glaucoma, viral diseases of cornea & conjunctiva (epithelial herpes simplex keratitis, vaccinia, varicella), mycobacterial eye infection & fungal diseases of ocular structures
Cautions
Bacterial keratitis reported from inadvertent contamination of multiple dose ophthalmic solution Immunosuppression resulting from prolonged use of steroid use may result in secondary bacterial and fungal infections; steroids may also mask symptoms of infections and enhance existing ocular infections
Ocular hypertension and/or glaucoma reported with prolonged corticosteroid use
Corticosteroid and gentamicin use following cataract surgery may delay healing
Discontinue use if sensitivity reaction to gentamicin develops
Prolonged gentmicin use may result in fungal or bacterial superinfection
Pregnancy & Lactation
Pregnancy: C
Lactation: Unknown whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk; systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause untoward effects
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Prednisolone prevents/reduces irritation & swelling by suppressing normal immune response, decreasing inflammatory mediators and reverses capillary permeability
Gentamicin alters bacterial cell membrane integrity by binding to 30S and 50S ribosomal subunits, which in turn interferes with bacterial protein synthesis
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Formulary
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