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  • CLASSES

    Ophthalmological Anti-infectives

    DEA CLASS

    Rx

    DESCRIPTION

    Aminoglycoside neomycin with polymyxin B and gramicidins A, B and C
    Ophthalmic preparation; used for ophthalmic bacterial infections
    Combination provides overlapping coverage against a wide range of gram-positive and gram-negative bacteria, including streptococci

    COMMON BRAND NAMES

    AK-Spore, AK-Spore Ophthalmic, Neocidin, Neosporin, Ocu-Spore-G, Polymycin

    HOW SUPPLIED

    AK-Spore/AK-Spore Ophthalmic/Gramicidin, Neomycin, Polymyxin B/Neocidin/Neosporin/Ocu-Spore-G/Polymycin Ophthalmic Sol: 1mL, 0.025-1.75-10000U

    DOSAGE & INDICATIONS

    For the treatment of superficial ophthalmic infection of the external eye and its adnexa including bacterial conjunctivitis, keratitis, keratoconjunctivitis, blepharitis, and blepharoconjunctivitis.
    Ophthalmic dosage
    Adults

    Instill 1 or 2 drops into the affected eye(s) every 4 hours for 7 to 10 days. Severe infections may require as much as 2 drops every hour.

    For ophthalmic surgical infection prophylaxis†.
    Ophthalmic dosage
    Adults

    1 drop to the affected eye(s) every 5 to 15 minutes for 5 doses within 1 hour before the start of the procedure. Perioperative antisepsis with povidone-iodine is recommended. Subconjunctival or intracameral antibiotics at the end of the procedure is optional. The necessity of continuing topical antimicrobials postoperatively has not been established.

    †Indicates off-label use

    MAXIMUM DOSAGE

    Adults

    Maximum dosage information not available.

    Geriatric

    Maximum dosage information not available.

    Adolescents

    Maximum dosage information not available.

    Children

    Maximum dosage information not available; safety and efficacy have not been established.

    Infants

    Maximum dosage information not available; safety and efficacy have not been established.

    DOSING CONSIDERATIONS

    Hepatic Impairment

    No dosage adjustment is needed.

    Renal Impairment

    No dosage adjustment is needed.

    ADMINISTRATION

    Ophthalmic Administration

    For ophthalmic use only. Do not give by injection or orally.
    Instruct patient on proper instillation of eye solution.
    Wash hands before and after use. Tilt the head back slightly and pull the lower eyelid down with the index finger. Squeeze one drop into the conjunctival sac and gently apply pressure to the inside corner of your eye for 1 minute; this helps stop the liquid from draining down your tear duct. If you are prescribed more than 1 drop in the same eye, wait about 5 minutes between each drop.
    Avoid contamination. Do not touch the tip of the dropper to the eye, fingertips, or other surface.
    Patients should wait at least fifteen (15) minutes after instilling the eye solution before inserting contact lenses.
    Do not share drops between patients.

    STORAGE

    AK-Spore:
    - Protect from light
    - Store at controlled room temperature (between 68 and 77 degrees F)
    AK-Spore Ophthalmic:
    - Protect from light
    - Store at controlled room temperature (between 68 and 77 degrees F)
    Neocidin :
    - Protect from light
    - Store at controlled room temperature (between 68 and 77 degrees F)
    Neosporin:
    - Protect from light
    - Store at controlled room temperature (between 68 and 77 degrees F)
    Ocu-Spore-G:
    - Protect from light
    - Store at controlled room temperature (between 68 and 77 degrees F)
    Polymycin:
    - Protect from light
    - Store at controlled room temperature (between 68 and 77 degrees F)

    CONTRAINDICATIONS / PRECAUTIONS

    Aminoglycoside hypersensitivity, neomycin hypersensitivity, polymyxin hypersensitivity

    Neomycin; polymyxin B; gramicidin is contraindicated in patients who are allergic to any of the components, including patients with aminoglycoside hypersensitivity, neomycin hypersensitivity, polymyxin hypersensitivity, or gramicidin hypersensitivity. Signs and symptoms of sensitization to topical antibiotics are usually itching, reddening, and edema of the conjunctiva and eyelid. However, sensitization may manifest as failure to heal. Patients should be monitored for the development of hypersensitivity, and the patient should discontinue treatment if signs or symptoms are observed. Long-term use may place the patient at risk to develop hypersensitivity. Patients should avoid products containing these antibiotics after the development of a hypersensitivity reaction. Cross-reaction may occur with such antibiotics as kanamycin, paromomycin, streptomycin, and possibly gentamicin.

    Contact lenses

    Patients who wear contact lenses generally should avoid wearing them while being treated with neomycin; polymyxin B; gramicidin for an ocular infection. If contact lenses must be worn, insert contact lenses at least fifteen (15) minutes after instilling this product.

    Pregnancy

    No well-controlled studies of neomycin; polymyxin B; gramicidin have been conducted in pregnant women. The risk of fetal harm is considered unlikely because systemic absorption of these antibiotics is poor. However, health care providers should be aware that aminoglycosides, such as neomycin, cross the placenta and can cause fetal nephrotoxicity and permanent ototoxicity in infants whose mothers received them during pregnancy. It is not known whether gramicidin or polymyxin B can cause fetal harm during pregnancy. Use during pregnancy only if clearly needed.

    Breast-feeding

    Data are limited regarding use of neomycin; polymyxin B; gramicidin during breast-feeding. It should be noted that other aminoglycoside antibiotics have been found in breast milk. While systemic absorption is not significant with the ophthalmic product, the amount of drug that reaches systemic circulation and breast milk may be minimized by applying pressure over the tear duct by the corner of the eye for 1 minute after ophthalmic administration. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to a maternally administered drug, health care providers are encouraged to report the adverse effect to the FDA.

    Children

    The safe and effective use of neomycin; polymyxin B; gramicidin in children has not been established.

    ADVERSE REACTIONS

    Severe

    anaphylactoid reactions / Rapid / 0-1.0

    Moderate

    erythema / Early / 1.0-10.0
    blurred vision / Early / 1.0-10.0
    superinfection / Delayed / Incidence not known

    Mild

    ocular irritation / Rapid / 1.0-10.0
    ocular pruritus / Rapid / 1.0-10.0

    DRUG INTERACTIONS

    There are no drug interactions associated with Neomycin; Polymyxin B; Gramicidin products.

    PREGNANCY AND LACTATION

    Pregnancy

    No well-controlled studies of neomycin; polymyxin B; gramicidin have been conducted in pregnant women. The risk of fetal harm is considered unlikely because systemic absorption of these antibiotics is poor. However, health care providers should be aware that aminoglycosides, such as neomycin, cross the placenta and can cause fetal nephrotoxicity and permanent ototoxicity in infants whose mothers received them during pregnancy. It is not known whether gramicidin or polymyxin B can cause fetal harm during pregnancy. Use during pregnancy only if clearly needed.

    Data are limited regarding use of neomycin; polymyxin B; gramicidin during breast-feeding. It should be noted that other aminoglycoside antibiotics have been found in breast milk. While systemic absorption is not significant with the ophthalmic product, the amount of drug that reaches systemic circulation and breast milk may be minimized by applying pressure over the tear duct by the corner of the eye for 1 minute after ophthalmic administration. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to a maternally administered drug, health care providers are encouraged to report the adverse effect to the FDA.

    MECHANISM OF ACTION

    Neomycin; polymyxin B; gramicidin is an ophthalmic solution for treating superficial infections of the external eye. The combined action of neomycin; polymyxin B; gramicidin is bactericidal.
    Neomycin sulfate: Neomycin inhibits bacterial protein synthesis through irreversible binding to the 30 S ribosomal subunit of susceptible bacteria. Neomycin is actively transported into the bacterial cell where it binds to receptors present on the 30 S ribosomal subunit. This binding interferes with the initiation complex between the messenger RNA and the subunit. As a result, abnormal, nonfunctional proteins are formed due to misreading of the bacterial DNA. Eventually, susceptible bacteria die because of the lack of functional proteins.
    Polymyxin B sulfate: Polymyxin B binds to gram-negative bacterial cell membrane phospholipids. This binding destroys bacterial membranes with a surface detergent-like mechanism and increases the permeability of the cell membrane, which results in loss of metabolites essential to bacterial existence. Polymyxin B has no in vitro activity against gram-positive organisms or fungi. The in vivo activity of polymyxin B against Pseudomonas aeruginosa is decreased by the presence of divalent cations such as calcium, which is believed to interfere with the binding of the drug to the cell membrane.
    Gramicidin: Gramicidin is bactericidal against a variety of gram-positive bacteria. It increases the permeability of the bacterial cell membrane to inorganic cations. Gramicidin binds to bacterial cell membranes and forms a network of channels through the normal lipid bilayer.

    PHARMACOKINETICS

    Neomycin; polymyxin B; gramicidin combination products are applied topically to the eye.

    Other Route(s)

    Ophthalmic Route
    Animal data suggest neomycin is absorbed into the aqueous humor, especially if the cornea is abraded. It is not known whether gramicidin or polymyxin B are absorbed into aqueous humor. Systemic absorption of these antibiotics after topical application to the eye is not likely to be significant.