Dosage Forms
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Ointment, ophthalmic:
Pred-G: Prednisolone acetate 0.6% and gentamicin sulfate 0.3% (3.5 g) [contains edetate disodium, polysorbate 80]
Suspension, ophthalmic:
Pred-G: Prednisolone acetate 1% and gentamicin sulfate 0.3% (5 mL) [contains benzalkonium chloride]
Pharmacology
Mechanism of Action
Gentamicin: Interferes with bacterial protein synthesis by binding to 30S ribosomal subunits resulting in a defective bacterial cell membrane. Gentamicin is active against common staphylococci (coagulase positive and coagulase negative) and streptococci, Diplococcus pneumonia, Haemophillus influenza, and gram-negative species, including Pseudomonas aeruginosa. Additionally, gentamicin has been found to be effective against Escherichia coli, Klebsiella-Enterobactor-Serratia species, and Citrobacter species.
Prednisolone: Reduces inflammation by inhibiting edema, leukocyte migration, fibrin deposition, capillary proliferation and dilation, collagen deposition, and scar formation.
Pharmacokinetics/Pharmacodynamics
Absorption
Topical application of gentamicin/prednisolone combination drops results in small amounts of the drugs being absorbed systemically.
Use: Labeled Indications
Superficial bacterial ocular infections with associated inflammation: Treatment of steroid responsive inflammatory ocular conditions where either a superficial bacterial ocular infection or the risk of bacterial ocular infection exists.
Contraindications
Hypersensitivity to gentamicin, prednisolone, other corticosteroids, or any component of the formulation; untreated ocular infection (bacterial, viral, varicella, fungal, mycobacteria).
Dosage and Administration
Dosing: Adult
Superficial bacterial ocular infections with associated inflammation: Ophthalmic:
Ointment: Apply 1/2 inch ribbon into the conjunctival sac of the affected eye(s) 1 to 3 times daily.
Suspension: Instill 1 drop into the conjunctival sac of the affected eye(s) 2 to 4 times daily.
Note: If signs and symptoms do not improve or worsen after 2 days of treatment, the patient should be re-evaluated.
Dosing: Geriatric
Refer to adult dosing.
Administration
Ophthalmic: Note: Contact lenses should not be worn during therapy. Do not touch the bottle or tube tip to eyelid(s) or any other surface.
Ointment: Apply into pocket between eyeball and lower lid; patient should look downward before closing eye.
Suspension: Shake well before using. Tilt head back, instill into the conjunctival sac and close eye(s). Apply light finger pressure on lacrimal sac for 1 minute following instillation.
Storage
Ointment: Store at 15°C to 25°C (59°F to 77°F).
Suspension: Store at 15°C to 25°C (59°F to 77°F). Avoid excessive heat (≥40°C [104°F]). Do not freeze.
Drug Interactions
Nonsteroidal Anti-Inflammatory Agents (Ophthalmic): May enhance the adverse/toxic effect of Corticosteroids (Ophthalmic). Healing of ophthalmic tissue during concomitant administration of ophthalmic products may be delayed. Monitor therapy
Ritodrine: Corticosteroids may enhance the adverse/toxic effect of Ritodrine. Monitor therapy
Adverse Reactions
Frequency not defined.
Dermatologic: Contact dermatitis, skin rash
Gastrointestinal: Dysgeusia
Hypersensitivity: Angioedema, hypersensitivity reaction
Ophthalmic: Allergic conjunctivitis, blurred vision, burning sensation of eyes, eye discharge, eye irritation, eye pain, foreign body sensation of eye, increased lacrimation, ocular edema, ocular hyperemia, stinging of eyes, superficial punctate keratitis, visual impairment
Warnings/Precautions
Concerns related to adverse effects:
- Cataracts: Prolonged use of corticosteroids may result in posterior subcapsular cataract formation. Use following cataract surgery may delay healing or increase the incidence of bleb formation.
- Corneal thinning: Various ophthalmic disorders, as well as prolonged use of corticosteroids, may result in corneal and scleral thinning. Continued use in a patient with thinning may result in perforation.
- Glaucoma: Prolonged use of corticosteroids may result in elevated intraocular pressure (IOP) and/or glaucoma, damage to the optic nerve, and defects in visual acuity and fields of vision. Use with caution in patients with glaucoma; monitor IOP in any patient receiving treatment for ≥10 days.
- Immunosuppression: Prolonged use of corticosteroids may increase the incidence of secondary infection, mask acute infection (including fungal infections), or prolong or exacerbate viral infections. Corticosteroids should not be used to treat ocular herpes simplex. Use extreme caution in patients with a history of ocular herpes simplex; frequent slit lamp microscopy examinations are recommended. Fungal infection should be suspected in any patient with persistent corneal ulceration who has received corticosteroids.
- Systemic absorption: Studies have demonstrated topical ophthalmic corticosteroids are absorbed systemically and may cause endogenous corticosteroid production reduction. Caution is advised with prolonged use of topical ophthalmic corticosteroids in terms of systemic immunosuppression and additional systemic hazard of corticosteroid exposure (Burch 1968).
Special populations:
- Contact lens wearers: Some products contain benzalkonium chloride which may be absorbed by soft contact lenses; contact lenses should not be worn during treatment of ophthalmologic infections.
Dosage form specific issues:
- Polysorbate 80: Some dosage forms may contain polysorbate 80 (also known as Tweens). Hypersensitivity reactions, usually a delayed reaction, have been reported following exposure to pharmaceutical products containing polysorbate 80 in certain individuals (Isaksson,2002; Lucente 2000; Shelley 1995). Thrombocytopenia, ascites, pulmonary deterioration, and renal and hepatic failure have been reported in premature neonates after receiving parenteral products containing polysorbate 80 (Alade 1986; CDC 1984). See manufacturer’s labeling.
Other warnings/precautions:
- Appropriate use: For ophthalmic use only. Do not inject subconjunctivally or introduce into the anterior chamber of the eye. A maximum of 20 mL of suspension or a maximum of 8 g of ointment should be prescribed initially; patients should be re-evaluated (eg, intraocular pressure and exams using magnification and fluorescein staining, where appropriate) prior to additional refills. Use >10 days should include routine monitoring of intraocular pressure.
Pregnancy
Pregnancy Risk Factor
C
Pregnancy Considerations
Animal reproduction studies have not been conducted with this combination. See individual agents.
Patient Education
- Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)
- Patient may experience watery eyes, blurred vision, foreign body sensation in eye, change in taste, burning, or stinging. Have patient report immediately to prescriber vision changes, eye pain, or severe eye irritation (HCAHPS).
- Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.
Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.
