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Gentamicin (ophthalmic): Pediatric drug information

Gentamicin (ophthalmic): Pediatric drug information
(For additional information see "Gentamicin (ophthalmic): Drug information" and see "Gentamicin (ophthalmic): Patient drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • Gentak
Brand Names: Canada
  • Odan-Gentamicin
Therapeutic Category
  • Antibiotic, Aminoglycoside;
  • Antibiotic, Ophthalmic
Dosing: Neonatal

Ophthalmic infections: Limited data available: Ophthalmic:

Ointment: Apply to affected eye(s) 2 to 3 times daily; Note: Use should be reserved for treatment of susceptible infection and not routine prophylaxis for ophthalmia neonatorum.

Solution: Instill 1 to 2 drops into affected eye(s) every 4 hours; up to 2 drops every hour for severe infections

Dosing: Pediatric

Ophthalmic infections: Infants, Children, and Adolescents: Ophthalmic:

Ointment: Instill 1/2 inch (1.25 cm) to affected eye(s) 2 to 3 times daily.

Solution: Instill 1 to 2 drops into affected eye(s) every 4 hours; up to 2 drops every hour for severe infections.

Dosing: Kidney Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling; however, dosage adjustment unlikely necessary due to low systemic absorption.

Dosing: Hepatic Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling; however, dosage adjustment unlikely necessary due to low systemic absorption.

Dosing: Adult

(For additional information see "Gentamicin (ophthalmic): Drug information")

Ophthalmic infections

Ophthalmic infections: Ophthalmic:

Ointment: Instill 1/2" (1.25 cm) 2 to 3 times daily.

Solution: Instill 1 to 2 drops every 4 hours, up to 2 drops every hour for severe infections.

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling. However, dosage adjustment unlikely due to low systemic absorption.

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling. However, dosage adjustment unlikely due to low systemic absorption.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Ointment, Ophthalmic:

Gentak: 0.3% (3.5 g) [contains methylparaben, propylparaben]

Solution, Ophthalmic:

Generic: 0.3% (5 mL)

Generic Equivalent Available: US

May be product dependent

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Ointment, Ophthalmic:

Generic: 0.3% (3.5 g)

Solution, Ophthalmic:

Generic: 0.3% (3.5 mL, 5 mL, 10 mL)

Administration: Pediatric

For topical ophthalmic use only; not for injection into the eye. Avoid contaminating tip of the solution container or ointment tube.

Solution: Gentamicin solution is not for subconjunctival injection. Solution may be instilled into the affected eye. Apply finger pressure to lacrimal sac during and for 1 to 2 minutes after instillation to decrease risk of absorption and systemic effects.

Administration: Adult

For topical ophthalmic use only; not for injection into the eye. Avoid contaminating tip of the solution container or ointment tube.

Storage/Stability

Store at controlled room temperature of 20°C to 25°C (68°F to 77°F).

Use

Topical treatment of ocular bacterial infections, including conjunctivitis, keratitis, keratoconjunctivitis, corneal ulcers, blepharitis, blepharoconjunctivitis, acute meibomianitis, and dacryocystitis caused by Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pyogenes, Streptococcus pneumoniae, Enterobacter aerogenes, Escherichia coli, Haemophilus influenzae, Klebsiella pneumoniae, Neisseria gonorrhoeae, Pseudomonas aeruginosa, and Serratia marcescens (FDA approved in ages ≥1 month and adults)

Medication Safety Issues
Sound-alike/look-alike issues:

Gentamicin may be confused with gentian violet, kanamycin, vancomycin

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]).

Adverse Reactions

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

>1%: Ophthalmic: Burning sensation of eyes, eye irritation

<1%, postmarketing, and/or case reports: Corneal ulcer, hallucination, hypersensitivity reaction, purpura, thrombocytopenia

Contraindications

Hypersensitivity to gentamicin or any component of the formulation

Warnings/Precautions

Concerns related to adverse effects:

• Corneal healing: May delay corneal healing.

• Sensitization: Topical use has been associated with local sensitization (redness, irritation); discontinue if sensitization is noted.

• Superinfection: Prolonged use may result in fungal or bacterial superinfection; if purulent discharge, inflammation, or pain are increased, therapy should be re-evaluated.

Other warnings/precautions:

• Appropriate use: Not for injection into the eye.

• Long-term use: Not intended for long-term therapy.

Warnings: Additional Pediatric Considerations

Ointment should not be used as routine prophylaxis for ophthalmia neonatorum due to reports of severe ocular reactions described as eyelid erythema and swelling, ocular discharge, and periocular blistering, typically reported within 48 hours after administration (Binenbaum 2010; Nathawad 2011).

Metabolism/Transport Effects

None known.

Drug Interactions

There are no known significant interactions.

Pregnancy Considerations

Adverse events were observed following systemic administration of gentamicin in animal reproduction studies. The amount of gentamicin available systemically following application of the ophthalmic drops is below the limit of detection (<0.5 mcg/mL) (Trope 1979). In general, if ophthalmic agents are needed in pregnant women, the minimum effective dose should be used in combination with punctal occlusion to decrease systemic absorption (Samples 1988).

Mechanism of Action

Interferes with bacterial protein synthesis by binding to 30S ribosomal subunit resulting in a defective bacterial cell membrane

Pharmacokinetics (Adult data unless noted)

Absorption: Ophthalmic drops: Systemic absorption: Undetected (<0.5 mcg/mL)

Pricing: US

Ointment (Gentak Ophthalmic)

0.3% (per gram): $11.13

Solution (Gentamicin Sulfate Ophthalmic)

0.3% (per mL): $3.84 - $8.57

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.

Brand Names: International
  • AB-Genta (TZ);
  • Apigen (AE, BH, JO, QA, SA);
  • Apigent (EG);
  • Bactigen (VN);
  • Biogenta Oftalmica (CO);
  • Citol Gentamicina (PY);
  • Garamicina Oftalmica (CO, CR, DO, GT, HN, NI, PA, SV);
  • Garamycin (CH, EG, HK, ID, MY, PH, QA, SA, SG, TW);
  • Garasone (CZ);
  • Garexin (ID);
  • Gemin Eye Drops (TW);
  • Genmycin (IN);
  • Genoptic (AU, NZ, SG);
  • Gent-Ophtal (DE);
  • Genta-590 (PE);
  • Genta-Oph (TH);
  • Gentabrand (EC);
  • Gentacil (LK);
  • Gentacin (BH, QA);
  • Gentadar (AE, BH, JO, QA);
  • Gentagram (BR, PE);
  • Gental (PY, TH);
  • Gentalline (FR);
  • Gentalyn (CL, VE);
  • Gentamytrex (NL);
  • Gentanal (ID);
  • Gentapro (SG);
  • Gentasone (LK);
  • Genticin (CY, DK, GB, TR);
  • Genticyn (IN);
  • Gentocil (ET, PT);
  • Lacromycin (IL);
  • Miragenta (CO);
  • Oftalmolosa Cusi Gentamicin (TW);
  • Ophtagram (CH);
  • Optagen (PK);
  • Opthagen (PH);
  • Opti-Genta (IL);
  • Optigen (SG);
  • Optigent (ET);
  • Provisual (AR);
  • Refobacin (DE);
  • Sagestam (ET);
  • Sagestam Eye Drops (ID);
  • Wei Lun (CN)


For country abbreviations used in Lexicomp (show table)
  1. Binenbaum G, Bruno CJ, Forbes BJ, et al, "Periocular Ulcerative Dermatitis Associated With Gentamicin Ointment Prophylaxis in Newborns," J Pediatr, 2010, 156(2):320-1. [PubMed 20105641]
  2. Bras JF and Coyle-Gilchrist MM, "Genticin in Conjunctivitis and Keratitis," Br J Ophthalmol, 1968, 52(7):560-1. [PubMed 5724444]
  3. Gentak ophthalmic ointment (gentamicin ophthalmic) [prescribing information]. Lake Forest IL; Akorn, Inc; March 2018.
  4. Gentamicin ophthalmic solution [prescribing information]. Irvine, CA: Allergan, Inc; August 2013.
  5. 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]
  6. Nathawad R, Mendez H, Ahmad A, et al, "Severe Ocular Reactions After Neonatal Ocular Prophylaxis With Gentamicin Ophthalmic Ointment," Pediatr Infect Dis J, 2011, 30(2):175-6. [PubMed 20885334]
  7. Samples JR, Meyer SM. Use of ophthalmic medications in pregnant and nursing women. Am J Ophthalmol. 1988;106(5):616-623. [PubMed 2903673]
  8. Trope GE, Lawrence JR, Hind VM, Everden A. Systemic absorption of topical and subconjunctival gentamicin. Br J Ophthalmol. 1979;63(10):692-693.
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