Pill Identifier App

Neomycin, Polymyxin B, and Gramicidin (Ophthalmic)


VA CLASSIFICATION
Primary: OP201

Commonly used brand name(s): Ak-Spore Ophthalmic Solution; Neocidin Ophthalmic Solution; Neosporin Ophthalmic Solution; Ocu-Spor-G; Ocutricin Ophthalmic Solution; P.N. Ophthalmic; Tri-Ophthalmic; Tribiotic; Triple Antibiotic.

Note: For a listing of dosage forms and brand names by country availability, see Dosage Forms section(s).



Category:


Antibacterial (ophthalmic)—

Indications

Note: Bracketed information in the Indications section refers to uses that are not included in U.S. product labeling.

Accepted

Ocular infections (treatment)—Ophthalmic neomycin, polymyxin B, and gramicidin combination is indicated in the treatment of short-term {06} {07} superficial external ocular infections caused by susceptible organisms. {06} {07}

[Blepharitis, bacterial (treatment)]{01}
[Blepharoconjunctivitis (treatment)] or{01}
[Conjunctivitis, bacterial (treatment)]{01}—Ophthalmic neomycin, polymyxin B, and gramicidin combination is indicated for the treatment of bacterial blepharitis, blepharoconjunctivitis, and bacterial conjunctivitis. {01}

Note: Not all species or strains of a particular organism may be susceptible to neomycin, polymyxin B, and gramicidin combination.



Pharmacology/Pharmacokinetics

Physicochemical characteristics:
Source—
    Neomycin: Derived from Streptomyces fradiae . {02}
    Polymyxin B: Derived from polymyxin B 1 and polymyxin B 2, which are produced by the growth of Bacillus polymyxa . {03}
    Gramicidin: Mixture of three pairs of antibacterial substances (gramicidin A, B, and C), which are produced by the growth of Bacillus brevis . {04}

Chemical group—
    Neomycin: Aminoglycosides.
    Polymyxin B: Polypeptides.
    Gramicidin: Polypeptides. {04}

Mechanism of action/Effect:

Neomycin—See Neomycin (Ophthalmic).

Polymyxin B—See Neomycin, Polymyxin B, and Bacitracin (Ophthalmic).

Gramicidin acts as a cationic detergent by altering the permeability of bacterial cytoplasmic membranes, with resultant changes in the intracellular cation content, especially potassium.

Note: Gramicidin, which has activity against gram-positive cocci and some Neisseria, is considered to be bactericidal, but may be bacteriostatic depending on the susceptibility of the organism. It is inactivated by serum and body fluids and is only effective topically. It should not be used systemically since it is very toxic and is a potent hemolytic.


Absorption:

Neomycin; polymyxin B—May be absorbed following topical application to the eye if tissue damage is present.

Gramicidin—Not significantly absorbed.


Precautions to Consider

Cross-sensitivity and/or related problems

Patients sensitive to one aminoglycoside or polymyxin may be sensitive to other aminoglycosides or polymyxins also. {06} {07}

Pregnancy/Reproduction

Pregnancy—
Problems in humans have not been documented.

Breast-feeding

Problems in humans have not been documented.

Pediatrics

Appropriate studies on the relationship of age to the effects of neomycin, polymyxin B, and gramicidin combination have not been performed in the pediatric population. However, no pediatrics-specific problems have been documented to date.


Geriatrics


Appropriate studies on the relationship of age to the effects of neomycin, polymyxin B, and gramicidin combination 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 neomycin, polymyxin B, or gramicidin{06}{07}


Side/Adverse Effects
For neomycin, dose-related punctate staining of the cornea has occurred. {17}

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 more frequent
    
Hypersensitivity{06}{07} (itching, rash, redness, swelling, or other sign of irritation in or around the eye not present before therapy)



Those indicating need for medical attention only if they continue or are bothersome
Incidence less frequent
    
Burning or stinging of the eye





Patient Consultation
As an aid to patient consultation, refer to Advice for the Patient, Neomycin, Polymyxin B, and Gramicidin (Ophthalmic).

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

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

Proper use of this medication
Proper administration technique for ophthalmic solution

» 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
Checking with physician if no improvement within a few days


Side/adverse effects
Signs of potential side effects, especially hypersensitivity


General Dosing Information
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.


Ophthalmic Dosage Forms

NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN OPHTHALMIC SOLUTION USP

Usual adult and adolescent dose
Antibacterial, ophthalmic
Acute infections: Topical, to the conjunctiva, 1 drop every 15 to 30 minutes initially, the frequency being reduced gradually depending on patient response. {05} {06} {07}

Other infections: Topical, to the conjunctiva, 1 drop two to four times a day, or more frequently, for seven to ten days. {05} {06} {07} {15}


Usual pediatric dose
See Usual adult and adolescent dose.

Strength(s) usually available
U.S.—


1.75 mg of neomycin (base), 10,000 Units of polymyxin B (base), and 25 mcg (0.025 mg) of gramicidin per mL (Rx) [Ak-Spore Ophthalmic Solution{06} (alcohol 0.5%) (thimerosal 0.001%)] [Neocidin Ophthalmic Solution] [Neosporin Ophthalmic Solution{07} (alcohol 0.5%) (thimerosal 0.001%)] [Ocu-Spor-G] [Ocutricin Ophthalmic Solution] [P.N. Ophthalmic] [Tribiotic] [Tri-Ophthalmic] [Triple Antibiotic{16}][Generic]

Canada—


1.75 mg of neomycin (base), 10,000 Units of polymyxin B (base), and 25 mcg (0.025 mg) of gramicidin per mL (Rx) [Neosporin Ophthalmic Solution{15} (alcohol 0.5%, benzalkonium chloride)]

Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer. Store in a tight container. Protect from freezing.

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



Revised: 10/16/1998



References
  1. Per Indications Index review, 1986.
  1. Mycifradin oral-local package insert (Upjohn—US), Rev 11/85.
  1. Neosporin ophthalmic ointment package insert (BW—US), Rev 11/83, Rec 3/22/85.
  1. Neosporin ophthalmic solution (BW). In: PDR Physicians" desk reference. 40th ed. 1986. Oradell, NJ: Medical Economics Company, 1986: 758.
  1. Neosporin ophthalmic solution (BW). In: PDR Physicians" desk reference. 42nd ed. 1988. Oradell, NJ: Medical Economics Company, 1988: 814-5.
  1. AK-Spore ophthalmic solution (Akorn). In: PDR Physicians" desk reference for ophthalmology. 22nd ed. 1994. Montvale, NJ: Medical Economics Data, 1994: 204.
  1. Neosporin ophthalmic solution (BW). In: PDR Physicians" desk reference for ophthalmology. 22nd ed. 1994. Montvale, NJ: Medical Economics Data, 1994: 268.
  1. Not used.
  1. Not used.
  1. Not used.
  1. Not used.
  1. Not used.
  1. Not used.
  1. Not used.
  1. Neosporin ophthalmic solution (BW). In: Krogh CME, editor. CPS Compendium of pharmaceuticals and specialties. 28th ed. Ottawa: Canadian Pharmaceutical Association, 1993: 793.
  1. Triple Antibiotic (H.L. Moore). In: Drug topics red book 1998. Montvale, NJ: Medical Economics Company; 1998. p. 577.
  1. Panelist comment, 7/94.
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