Gentamicin Sulfate eent

Pronunciation

Class: Antibacterials
VA Class: AM300
CAS Number: 1405-41-0
Brands: Gentak, Pred-G

Introduction

Antibacterial; aminoglycoside antibiotic produced by Micromonospora purpurea.a b c d e

Uses for Gentamicin Sulfate

Bacterial Ophthalmic Infections

Treatment of superficial infections of the eye caused by susceptible bacteria.a b c

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Used alone or in fixed combination with a topical corticosteroid (e.g., prednisolone) when such combination therapy is indicated.d e (See Use of Fixed Combinations Containing Corticosteroids under Cautions.)

Gentamicin Sulfate Dosage and Administration

Administration

Ophthalmic Administration

Apply topically to the eye(s) as an ophthalmic solution, suspension, or ointment.a b c d e

Not for injection into the eye; do not inject subconjunctivally or instill directly into the anterior chamber of the eye.a b c d

Avoid contamination of the tip of the container.102 c d e

Shake suspension well prior to use.d

Dosage

Available as gentamicin sulfate and as fixed combinations containing prednisolone acetate; dosage expressed in terms of gentamicin.b c d e

Pediatric Patients

Bacterial Ophthalmic Infections
Gentamicin Sulfate 0.3%
Ophthalmic Solution

Infants and children >1 month of age: 1 or 2 drops into the affected eye(s) every 4 hours.c

Infants and children >1 month of age: For severe infections, instill up to 2 drops into the affected eye(s) every hour.c

Ophthalmic Ointment

Infants and children >1 month of age: Apply a 1.25-cm ribbon to the affected eye(s) 2 or 3 times daily.b

Adults

Bacterial Ophthalmic Infections
Gentamicin Sulfate 0.3%
Ophthalmic Solution

1 or 2 drops into the affected eye(s) every 4 hours.c

Severe infections: Instill up to 2 drops into the affected eye(s) every hour.c

Ophthalmic Ointment

Apply a 1.25-cm ribbon to the affected eye(s) 2 or 3 times daily.b

Gentamicin Sulfate 0.3% and Prednisolone Acetate 0.6%

If improvement does not occur after 2 days, reevaluate the patient.d e

Do not discontinue therapy prematurely.d e

Ophthalmic Solution

Initial 24–48 hours, up to 1 drop into the conjunctival sac of the affected eye(s) every hour; thereafter, 1 drop 2–4 times daily.d

Ophthalmic Ointment

Apply a 1.25-cm ribbon into the conjunctival sac of the affected eye(s) 1–3 times daily.e

Cautions for Gentamicin Sulfate

Contraindications

  • Known hypersensitivity to gentamicin or any ingredient in the formulation.a b c d e

Warnings/Precautions

Sensitivity Reactions

Sensitization may occur.a b c d e Discontinue if hypersensitivity reaction occurs.a b c

Commercially available gentamicin preparations contain other ingredients (e.g., parabens), which may cause allergic contact dermatitis.a (See Preparations.)

Cross-allergenicity

Cross-allergenicity occurs among the aminoglycosides.a

General Precautions

Superinfection

Prolonged use may result in overgrowth of nonsusceptible organisms, including fungi.a b c d e If superinfection occurs, discontinue drug and institute appropriate therapy.a

Use of Fixed Combinations Containing Corticosteroids

Topical corticosteroids may mask clinical signs of bacterial, fungal, or viral infections or may suppress hypersensitivity reactions to gentamicin or other ingredients in the formulation.a

When gentamicin is used in fixed combination with a corticosteroid, consider the cautions, precautions, and contraindications associated with EENT corticosteroids.a d e

Infection Complications

Ophthalmic ointments may delay corneal healing.b

Bacterial and fungal corneal ulcers possible during treatment.b c

Specific Populations

Pregnancy

Category C.b c d e

Lactation

Systemic gentamicin is distributed into breast milk.g Gentamicin in fixed combination with prednisolone acetate (ophthalmic suspension and ophthalmic ointment): Discontinue nursing or the drug.d e

Pediatric Use

Safety and efficacy of gentamicin ophthalmic solution and ophthalmic ointment not established in neonates.b c

Safety and efficacy of gentamicin in fixed combination with prednisolone acetate (ophthalmic suspension and ophthalmic ointment) not established.d e

Geriatric Use

Gentamicin in fixed combination with prednisolone acetate (ophthalmic suspension and ophthalmic ointment): No substantial differences in safety or efficacy relative to younger patients.d e

Common Adverse Effects

Transient irritation, burning, stinging.a b c d

Gentamicin Sulfate Pharmacokinetics

Absorption

Extent

Absorption is greatest when the cornea is abraded.a

Distribution

Extent

Systemic gentamicin crosses the placenta and is distributed into breast milk.g

Stability

Storage

Ophthalmic

Ointment

Gentamicin: 2–30°C.b

Gentamicin in fixed combination with prednisolone acetate: 15–25°C.e

Solution

Gentamicin: 2–30°C; avoid excessive heat.c

Suspension

Gentamicin in fixed combination with prednisolone acetate: 15–25°C.d Do not freeze; avoid excessive heat (≥40°C).d

Actions and Spectrum

  • Usually bactericidal in action.a

  • Mechanism of action not fully elucidated; however, appears to inhibit protein synthesis in susceptible bacteria by irreversibly binding to 30S ribosomal subunits.a

  • Active against many aerobic gram-negative and some aerobic gram-positive bacteria.a b c Inactive against fungi, viruses, and most anaerobic bacteria.a

  • Natural and acquired resistance to gentamicin demonstrated in both gram-negative and gram-positive bacteria.a Resistance to other aminoglycosides and several other anti-infectives (e.g., chloramphenicol, sulfonamides, tetracycline) may be transferred on the same plasmid.a

  • Partial cross-resistance between gentamicin and other aminoglycosides.a

Advice to Patients

  • Importance of removing soft contact lenses prior to administering preparations containing benzalkonium chloride and of delaying reinsertion of the lenses for ≥5 minutes after administration.f

  • Importance of not touching tip of container to the eye, eyelid, fingers, or any other surface to avoid contamination.a b c

  • Importance of discontinuing therapy and contacting clinician if the infection worsens or does not improve, or if any signs of sensitivity occur (discharge, swelling, pain).b c

  • Advise patient not to share the drug with any other person.d

  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs.b c

  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.b c

  • Importance of informing patients of other important precautionary information. (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Gentamicin Sulfate

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Ophthalmic

Ointment

0.3% (of gentamicin)

Gentak (with parabens)

Akorn

Gentamicin Sulfate

Fougera

Solution

0.3% (of gentamicin)*

Gentak (with benzalkonium chloride)

Akorn

Gentamicin Sulfate

Bausch & Lomb, Falcon

Gentamicin Sulfate and Prednisolone Acetate

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Ophthalmic

Ointment

Gentamicin Sulfate 0.3% (of gentamicin) and Prednisolone Acetate 0.6%

Pred-G (with chlorobutanol 0.5%)

Allergan

Suspension

Gentamicin Sulfate 0.3% (of gentamicin) and Prednisolone Acetate 1%

Pred-G (with benzalkonium chloride; viscous)

Allergan

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 02/2014. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Gentamicin Sulfate 0.3% Solution (SANDOZ): 5/$24.99 or 10/$43.97

Pred-G 0.3-1% Suspension (ALLERGAN): 5/$39.99 or 15/$99.97

AHFS DI Essentials. © Copyright, 2004-2014, Selected Revisions August 1, 2008. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

101. Akorn. Gentamicin sulfate ophthalmic solution USP, 0.3% prescribing information. Buffalo Grove, IL; 2002 Jan.

102. Akorn. Gentamicin sulfate ophthalmic ointment USP, 0.3% prescribing information. Somerset, NJ; 1998 Jul.

103. Allergan. Pred-G (gentamicin and prednisolone acetate ophthalmic suspension, USP) 0.3%/1% prescribing information. In: Physicians’ desk reference for ophthalmic medicines. 34th ed. Montevale, NJ: Thomson PDR; 2006: 234-5.

104. American Academy of Ophthalmology. Preferred Practice Pattern: Conjunctivitis. 2003. From the American Academy of Ophthalmology website (http://www.aao.org) Accessed 11 May 2006.

a. AHFS drug information 2008. McEvoy, GK, ed. Gentamicin sulfate (ophthalmic). Bethesda, MD: American Society of Health-System Pharmacists; 2008:2845-6.

b. Akorn, Inc. gentamicin sulfate ophthalmic ointment USP 0.3% prescribing information. Buffalo Grove, IL; 2008 Feb.

c. Akorn, Inc. Gentamicin sulfate ophthalmic solution USP 0.3% prescribing information. Buffalo Grove, IL; 2006 Oct.

d. Allergan, Inc. Pred-G (gentamicin and prednisolone acetate) ophthalmic suspension USP 0.3%/1.0% prescribing information. Irvine, CA; 2005 Dec.

e. Allergan, Inc. Pred-G (gentamicin and prednisolone acetate) ophthalmic ointment USP 0.3%/0.6% prescribing information. Irvine, CA; 2004 Jan.

f. Christensen MT, Barry JR, Turner FD. Five-minute removal of soft lenses prevents most absorption of a topical ophthalmic solution. CLAO J. 1998; 24:227-231. [PubMed 9800062]

g. Briggs GG, Freeman RK, Yaffe SJ. Drugs in Pregnancy and lactation, 7th ed. Lippincott Williams & Wilkins: Philadelphia, PA; 2005:720-22.

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