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Gentamicin (Ophthalmic)


VA CLASSIFICATION
Primary: OP201

Commonly used brand name(s): Alcomicin; Garamycin; Genoptic Liquifilm; Genoptic S.O.P.; Gentacidin; Gentafair; Gentak; Ocu-Mycin; Spectro-Genta.

Another commonly used name is
gentamycin .
Note: For a listing of dosage forms and brand names by country availability, see Dosage Forms section(s).



Category:


Antibacterial (ophthalmic)—

Indications

Accepted

Blepharitis, bacterial (treatment)
Blepharoconjunctivitis (treatment)
Conjunctivitis, bacterial (treatment)
Corneal ulcers (treatment)
Dacryocystitis (treatment)
[Episcleritis (treatment)]
Keratitis, bacterial (treatment)
Keratoconjunctivitis, bacterial (treatment) or
Meibomianitis (treatment)—Ophthalmic gentamicin is indicated in the treatment of blepharitis, blepharoconjunctivitis, conjunctivitis, dacryocystitis, keratitis, keratoconjunctivitis, and acute meibomianitis caused by coagulase-negative and coagulase-positive staphylococci, Streptococcus pyogenes, S. pneumoniae, Pseudomonas aeruginosa , indole-positive and indole-negative Proteus species, Escherichia coli , Klebsiella pneumoniae , Hemophilus influenzae , H. aegyptius , Enterobacter aerogenes (Aerobacter aerogenes) , Moraxella lacunata (Morax-Axenfeld bacillus), Serratia marcescensand Neisseria species, including N. gonorrhoeae . {03}{04} {06} {17}

Note: Not all species or strains of a particular organism may be susceptible to gentamicin.



Pharmacology/Pharmacokinetics

Physicochemical characteristics:

Chemical group—
    Aminoglycosides.


pH
    Gentamicin sulfate ophthalmic solution is buffered to pH of approximately 7 {03}.

Mechanism of action/Effect:

Aminoglycoside; actively transported across the bacterial cell membrane, binds to a specific receptor protein on the 30 S subunit of bacterial ribosomes, and interferes with an initiation complex between mRNA (messenger RNA) and the 30 S subunit, inhibiting protein synthesis. DNA may be misread, thus producing nonfunctional proteins; polyribosomes are split apart and are unable to synthesize protein.

Note: Aminoglycosides are bactericidal, while most other antibiotics that interfere with protein synthesis are bacteriostatic.


Absorption:

May be absorbed in minute quantities following topical application to the eye.


Precautions to Consider

Cross-sensitivity and/or related problems

Patients sensitive to one aminoglycoside may be sensitive to other aminoglycosides also.

Pregnancy/Reproduction

Problems in humans have not been documented.

Pregnancy Category C.

Postpartum—
Gentamicin given to pregnant rats in daily doses approximately 500 times the maximum recommended ophthalmic human dose resulted in offspring with decreased body and kidney weights.
{03}{06}
Breast-feeding

Problems in humans have not been documented.
{03}{06}{17}
Pediatrics

Appropriate studies on the relationship of age to the effects of this medicine have not been performed in neonates. Safety and efficacy have not been established.{03}{06}


Geriatrics


Appropriate studies on the relationship of age to the effects of this medicine have not been performed in the geriatric population. However, no geriatrics-specific problems have been documented to date.

Medical considerations/Contraindications
The medical considerations/contraindications included have been selected on the basis of their potential clinical significance (reasons given in parentheses where appropriate)— not necessarily inclusive (» = major clinical significance).


Risk-benefit should be considered when the following medical problem exists
Sensitivity to gentamicin {03}{06}


Side/Adverse Effects
The following side/adverse effects have been selected on the basis of their potential clinical significance (possible signs and symptoms in parentheses where appropriate)—not necessarily inclusive:

Those indicating need for medical attention
Incidence less frequent
    
Allergic reaction or Hypersensitivity {03}{06}(itching, redness, swelling, or other sign of irritation not present before therapy)
    
Conjunctivitis {03} {06} (redness of eye, eyelid, or inner lining of eyelid)

Incidence rare
    
Corneal ulcers, bacterial or fungal{03} {06} (blurred vision, eye pain, sensitivity to light, and/or tearing)
    
Hallucinations{03} {06} (seeing, hearing, or feeling things that are not there)
    
Thrombocytopenia{03} {06} (black, tarry stools; blood in urine or stools; unusual bleeding or bruising)



Those indicating need for medical attention only if they continue or are bothersome
Incidence less frequent
    
Burning or stinging {06}



Those not indicating need for medical attention
For ophthalmic ointment dosage form only
    
Blurred vision





Patient Consultation
As an aid to patient consultation, refer to Advice for the Patient, Gentamicin (Ophthalmic).

In providing consultation, consider emphasizing the following selected information (» = major clinical significance):

Before using this medication
»   Conditions affecting use, especially:
Sensitivity to gentamicin or to any related antibiotic, such as amikacin, kanamycin, neomycin, netilmicin, streptomycin, or tobramycin

Proper use of this medication
Proper administration technique

» Compliance with full course of therapy

» Proper dosing
Missed dose: Applying as soon as possible; not applying if almost time for next dose

» Proper storage

Precautions while using this medication
Check with physician if no improvement within a few days

Avoid wearing contact lenses during treatment


Side/adverse effects
Blurred vision may occur for a few minutes after application of ophthalmic ointments

Signs of potential side effects, especially allergic reaction or hypersensitivity, conjunctivitis, bacterial or fungal corneal ulcers, hallucinations, or thrombocytopenia


General Dosing Information
Gentamicin sulfate ophthalmic solution is not for subconjunctival injection or for direct injection into the anterior chamber of the eye. {03}

Although some manufacturers recommend a dose of 2 drops of an ophthalmic solution at appropriate intervals, the conjunctival sac will usually hold only 1 drop.

At night the ophthalmic ointment may be used as an adjunct to the ophthalmic solution to provide prolonged contact with the medication.

In infections of the tear sacs (dacryocystitis), often occurring in children with nonpatent tear passages, hot compresses and gentle massage of the area over the tear duct may be useful adjuncts to treatment with the ophthalmic solution.


Ophthalmic Dosage Forms

GENTAMICIN SULFATE OPHTHALMIC OINTMENT USP

Usual adult and adolescent dose
Antibacterial (ophthalmic)
Topical, to the conjunctiva, a thin strip (approximately 1 cm) of ointment to the affected eye every eight to twelve hours. {06} {08} {09} {11}


Usual pediatric dose
See Usual adult and adolescent dose.

Neonates—Safety and efficacy have not been established.{06}

Strength(s) usually available
U.S.—


5 mg of gentamicin sulfate, equivalent to 3 mg of gentamicin base, per gram (Rx) [Garamycin (methylparaben) (propylparaben )] [Genoptic S.O.P. (methylparaben) ( propylparaben)] [Gentacidin] [Gentafair ( may contain methylparaben) (may contain propylparaben )] [Gentak ( methylparaben) (propylparaben)] [Ocu-Mycin{14}][Generic](may contain methylparaben)( may contain propylparaben)

Canada—


5 mg of gentamicin sulfate, equivalent to 3 mg of gentamicin base, per gram (Rx) [Garamycin (methylparaben) (propylparaben )]

Packaging and storage:
Store below 30 °C (86 °F){06}. Store in a collapsible ophthalmic ointment tube. Protect from freezing.

Auxiliary labeling:
   • For the eye.
   • Continue medicine for full time of treatment.


GENTAMICIN SULFATE OPHTHALMIC SOLUTION USP

Usual adult and adolescent dose
Antibacterial (ophthalmic)
Mild to moderate infections: Topical, to the conjunctiva, 1 to 2 drops into the affected eye every four hours. {03} {07} {09} {11}

Severe infections: Topical, to the conjunctiva, 1 to 2 drops into the affected eye as often as once every hour. {03} {07} {09} {11}


Usual pediatric dose
See Usual adult and adolescent dose.

Neonates—Safety and efficacy have not been established.{03}

Strength(s) usually available
U.S.—


5 mg of gentamicin sulfate, equivalent to 3 mg of gentamicin base, per mL (Rx) [Garamycin (benzalkonium chloride)] [Genoptic Liquifilm (polyvinyl alcohol 1.4%) ( benzalkonium chloride)] [Gentacidin (benzalkonium chloride)] [Gentafair{10} (may contain benzalkonium chloride)] [Gentak (benzalkonium chloride 0.01%)] [Ocu-Mycin{14}] [Spectro-Genta{15}][Generic](may contain benzalkonium chloride)

Canada—


5 mg of gentamicin sulfate, equivalent to 3 mg of gentamicin base, per mL (Rx) [Alcomicin{16} (benzalkonium chloride 0.01%)] [Garamycin ( benzalkonium chloride)]

Packaging and storage:
Store below 30 °C (86 °F){03}. Store in a tight container. Protect from freezing.

Auxiliary labeling:
   • For the eye.
   • Continue medicine for full time of treatment.

Note: Dispense in original unopened container.




Revised: 07/18/2000



References
  1. Open.
  1. Open.
  1. Product Information: Garamycin™ Opthalmic Solution, gentamicin. Schering, Kenilworth, N.J. (PI revised 9/1997) reviewed 7/2000.
  1. Panel comments, Gentamicin (Ophthalmic-Otic), 11/27/86.
  1. Open.
  1. Product Information: Garamycin™ Opthalmic Ointment, gentamicin. Schering, Kenilworth, N.J. (PI revised 9/1997) reviewed 7/2000.
  1. Genoptic Liquifilm solution, Allergan.

    PDR-ophth-91, p 242.
  1. Genoptic S.O.P. ointment, Allergan. PDR-ophth-91, p 243.
  1. Gentacidin ointment and solution, Iolab. PDR-ophth-91, p 268.
  1. Gentafair solution & ointment, Adco, Best generics, Dixon-Shane, Gen-King, Glenlawn, Qualitest. Redbook-92.
  1. Gentak ointment and solution, Akorn. PDR-ophth-91, p 208.


  1. Not used
  1. Open.
  1. Ocu-Mycin ointment and solution, Ocumed. PDR-ophth-91, p 288.
  1. Spectro-Genta solution, Spectrum. Redbook-92.
  1. Alcomicin solution, Alcon. CPS-91, p 28.
  1. Product Information: Garamcyin™, gentamicin. Schering Canada. In: Compendium of Pharmaceuticals and Specialties on CD-ROM, 34th ed. Canadian Pharmaceutical Association, Ottawa, Ontario, Canada, 1999.
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