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Prednisolone and Gentamicin

Medically reviewed by Drugs.com. Last updated on Aug 21, 2020.

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) [contains edetate disodium, polysorbate 80]

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 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.

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).

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

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 Risk Factor

C

Pregnancy Considerations

Animal reproduction studies have not been conducted with this combination. See individual agents.

Patient Education

What is this drug used for?

• It is used to treat or prevent eye infections.

• It is used to treat eye swelling.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Watery eyes

• Blurred vision

• Foreign body sensation in eye

• Change in taste

• Burning

• Stinging

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Vision changes

• Eye pain

• Severe eye irritation

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.

Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.

Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a limited summary of general information about the medicine's uses from the patient education leaflet and is not intended to be comprehensive. This limited summary does NOT include all information available about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not intended to provide medical advice, diagnosis or treatment and does not replace information you receive from the healthcare provider. For a more detailed summary of information about the risks and benefits of using this medicine, please speak with your healthcare provider and review the entire patient education leaflet.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.