Generic Name: Gentamicin Sulfate eent
Class: Antibacterials
VA Class: AM300
CAS Number: 1405-41-0
Introduction
Antibacterial; aminoglycoside antibiotic produced by Micromonospora purpurea.a b c d e
Uses for Gentak
Bacterial Ophthalmic Infections
Treatment of superficial infections of the eye caused by susceptible bacteria.a b c
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.)
Gentak 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 Gentak
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
Gentak 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 SpectrumActions
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
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 |
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 03/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.
Gentak 0.3% Ointment (AKORN): 3/$21.99 or 7/$35.98
Gentamicin Sulfate 0.3% Solution (FALCON PHARMACEUTICALS): 5/$25.99 or 10/$45.98
Pred-G 0.3-1% Suspension (ALLERGAN): 5/$39.35 or 15/$101.19
Disclaimer
This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.
The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.
AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions August 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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