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Prednisolone and gentamicin: Drug information

Prednisolone and gentamicin: Drug information
(For additional information see "Prednisolone and gentamicin: Patient drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • Pred-G S.O.P.;
  • Pred-G [DSC]
Pharmacologic Category
  • Antibiotic/Corticosteroid, Ophthalmic
Dosing: Adult
Superficial bacterial ocular infections with associated inflammation

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: Kidney Impairment: Adult

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

Dosing: Hepatic Impairment: Adult

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

Dosing: Older Adult

Refer to adult dosing.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. 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

Contraindications

Hypersensitivity to gentamicin, prednisolone, other corticosteroids, or any component of the formulation; untreated ocular infection (bacterial, viral, varicella, fungal, mycobacteria).

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.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Ointment, ophthalmic:

Pred-G S.O.P.: 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 [DSC]) [contains benzalkonium chloride]

Generic Equivalent Available: US

No

Pricing: US

Ointment (Pred-G S.O.P. Ophthalmic)

0.3-0.6% (per gram): $54.99

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Administration: Adult

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.

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.

Medication Safety Issues
Pediatric patients: High-risk medication:

KIDs List: Gentamicin ophthalmic ointment, when used in neonates, is identified on the Key Potentially Inappropriate Drugs in Pediatrics (KIDs) list and should be avoided due to risk of severe ocular reactions (strong recommendation; high quality of evidence)(PPA [Meyers 2020]).

Metabolism/Transport Effects

Refer to individual components.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.

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. Risk C: Monitor therapy

Pregnancy Considerations

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

Breastfeeding Considerations

It is unknown if topical use results in sufficient absorption to produce detectable quantities in breast milk. Due to the potential for serious adverse reactions in the nursing infant, the manufacturer recommends a decision be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of treatment to the mother. See individual agents.

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 (Adult Data Unless Noted)

Absorption: Topical application of gentamicin/prednisolone combination drops results in small amounts of the drugs being absorbed systemically.

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AE) United Arab Emirates: Pred G;
  • (EG) Egypt: Apigent P;
  • (IL) Israel: Aflumycin;
  • (PK) Pakistan: Gentapred;
  • (PR) Puerto Rico: Pred G | Pred g s.o.p.;
  • (TH) Thailand: Pred Oph
  1. Alade SL, Brown RE, Paquet A Jr. Polysorbate 80 and E-Ferol toxicity. Pediatrics. 1986;77(4):593-597. [PubMed 3960626]
  2. Burch PG, Migeon CJ. Systemic absorption of topical steroids. Arch Ophthalmol. 1968;79(2):174-176. doi: 10.1001/archopht.1968.03850040176013. [PubMed 5635343]
  3. Centers for Disease Control (CDC). Unusual syndrome with fatalities among premature infants: association with a new intravenous vitamin E product. MMWR Morb Mortal Wkly Rep. 1984;33(14):198-199. http://www.cdc.gov/mmwr/preview/mmwrhtml/00000319.htm. [PubMed 6423951]
  4. Pred-G Ointment (prednisolone/gentamicin) [prescribing information]. Irvine, CA: Allergan; January 2004.
  5. Pred-G Suspension (prednisolone/gentamicin) [prescribing information]. Madison, NJ: Allergan; July 2018.
  6. Isaksson M, Jansson L. Contact allergy to Tween 80 in an inhalation suspension. Contact Dermatitis. 2002;47(5):312-313. [PubMed 12534540]
  7. Lucente P, Iorizzo M, Pazzaglia M. Contact sensitivity to Tween 80 in a child. Contact Dermatitis. 2000;43(3):172. [PubMed 10985636]
  8. Meyers RS, Thackray J, Matson KL, et al. Key Potentially Inappropriate Drugs in Pediatrics: The KIDs List. J Pediatr Pharmacol Ther. 2020;25(3):175-191. [PubMed 32265601]
  9. Samples JR and Meyer SM, “Use of Ophthalmic Medications in Pregnant and Nursing Women,” Am J Ophthalmol, 1988, 106(5):616-23. [PubMed 2903673]
  10. Shelley WB, Talanin N, Shelley ED. Polysorbate 80 hypersensitivity. Lancet. 1995;345(8980):1312-1313. [PubMed 7746084]
  11. Trope GE, Lawrence JR, Hind VM, et al, "Systemic Absorption of Topical and Subconjunctival Gentamicin," Br J Ophthalmol, 1979, 63(10):692-3. [PubMed 508681]
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