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Prednisolone and Gentamicin

Pronunciation

(pred NIS oh lone & jen ta MYE sin)

Index Terms

  • Gentamicin and Prednisolone

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)

Suspension, ophthalmic:

Pred-G: Prednisolone acetate 1% and gentamicin sulfate 0.3% (5 mL) [contains benzalkonium chloride]

Brand Names: U.S.

  • Pred-G

Pharmacologic Category

  • Antibiotic/Corticosteroid, Ophthalmic

Pharmacology

Gentamicin: Interferes with bacterial protein synthesis by binding to 30S and 50S ribosomal subunits resulting in a defective bacterial cell membrane

Prednisolone: Reduces inflammation by inhibiting edema, leukocyte migration, fibrin deposition, capillary proliferation and dilation, collagen deposition and scar formation.

Use: Labeled Indications

Inflammatory ocular conditions and superficial ocular infections: 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; viral disease of the cornea and conjunctiva (including epithelial herpes simplex keratitis [dendritic keratitis], vaccinia, varicella); mycobacterial or fungal infection of the eye

Dosing: Adult

Inflammatory conditions and superficial ocular infections: Ophthalmic:

Ointment: Apply 1/2 inch ribbon into the conjunctival sac of the affected eye(s) 1 to 3 times per day

Suspension: Instill 1 drop into the conjunctival sac of the affected eye(s) 2 to 4 times per day; during the initial 24 to 48 hours, the dosing frequency may be increased if necessary up to 1 drop every hour

Note: If signs and symptoms do not improve after 2 days of treatment, the patient should be re-evaluated.

Dosing: Geriatric

Refer to adult dosing.

Dosing: Renal Impairment

There are no dosage adjustments provided in the manufacturer's labeling

Dosing: Hepatic Impairment

There are no dosage adjustments provided in the manufacturer's labeling

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

Ceritinib: Corticosteroids may enhance the hyperglycemic effect of Ceritinib. Monitor therapy

NSAID (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

Adverse Reactions

Frequency not defined.

Central nervous system: Local discomfort

Infection: Secondary infection

Local: Local irritation

Ophthalmic: Glaucoma, increased intraocular pressure, optic nerve damage (infrequent), subcapsular posterior cataract, superficial punctate keratitis

Miscellaneous: Wound healing impairment

Warnings/Precautions

Concerns related to adverse effects:

• Infection: Steroids may mask infection or enhance existing ocular infection (including herpes simplex); prolonged use may result in secondary bacterial or fungal superinfection due to immunosuppression.

• Ocular effects: Ocular irritation and punctate keratitis have occurred. Prolonged use of corticosteroids may result in glaucoma; damage to the optic nerve, defects in visual acuity and fields of vision, corneal and scleral thinning (leading to perforation), and posterior subcapsular cataract formation may occur.

Disease-related concerns:

• Glaucoma: Use with caution; monitor intraocular pressure frequently.

• Ocular herpes simplex: Use with extreme caution; frequent slit lamp microscopy is recommended.

Special populations:

• Cataract surgery patients: Use following cataract surgery may delay healing or increase the incidence of bleb formation.

• 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.

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 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 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.

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