NEOMIN [neomycin, polymyxin-B, gramicidin] 1.75 mg + 5000 IU + 0.025 mg Eye and ear drops
instructions for the medical use of
the medicinal product
NEOMIN
Tradename:
Neomin, Неомин
International
non-proprietary name or generic name: neomycin, polymyxin-B, gramicidin, неомицин, полимиксин-В, грамицидин
Dosage form: eye
and ear drops.
1 ml of the preparation contains:
active substances: neomycin sulfate 1.75 mg, polymyxin-B sulfate 5000
IU, gramicidin 0.025 mg;
excipients: Benzalkonium
chloride, propylene glycol, poloxamer 407, sodium chloride, polysorbate 80,
hydrochloric acid, sodium hydroxide, water for injection.
Pharmacotherapeutic
group: combinations of different antibiotics.
Pharmacological
properties
A combination drug with antibacterial effect.
Neomycin is an
aminoglycoside antibiotic active against gram-negative and gram-positive
pathogens. It acts primarily on bacterial cells by inhibiting protein
synthesis, irreversibly binding to the 30S ribosome subunit, blocking the
incorporation of new amino acids, or causing disruptions in the reading of the
genetic code.
Polymyxin B is a polypeptide antibiotic active against gram-negative pathogens. It
acts by increasing the permeability of the bacterial cell membrane by
interacting with its phospholipid components.
Gramicidin is a
polypeptide antibiotic active against gram-positive pathogens. It acts by
increasing the permeability of the bacterial cell membrane to inorganic
cations, forming a network of channels in the normal lipid bilayer of the
membrane. Resistance Mechanism
Aminoglycoside resistance can arise through various mechanisms: changes
in the ribosomal subunit in the bacterial cell; impaired transport into the
cell; and inactivation of several enzymes capable of phosphorylation,
adenylation, and acetylation.
Aminoglycoside resistance mediated by modifying enzymes can be
plasmid-mediated or chromosomal. These enzymes can act on one or more
aminoglycosides, leading to cross-resistance. Cross-resistance between
aminoglycosides is due to sensitivity to the same class of modifying enzymes:
adenylate transferase (ANT) and acetyl transferase (ACC). Aminoglycosides can
also be sensitive to another class of modifying enzymes. Resistance to
beta-lactams is not associated with resistance to aminoglycosides. However,
many methicillin-resistant staphylococci have been found to be resistant to
some aminoglycoside antibiotics. Resistance to polypeptide antibiotics can
arise due to impaired binding of the antibiotic to membrane binding sites.
Acquired resistance to polymyxin B is rare, although adaptive resistance can
develop in enterobacteria when exposed to sublethal concentrations. Complete
cross-resistance exists between polymyxin B and colistin.
Indications for use
Treatment of the following bacterial
infections: purulent bacterial conjunctivitis, keratitis, corneal ulcers, and
chronic dacryocystitis.
Pre- and postoperative
ophthalmological prophylaxis, including surgical interventions and removal of
foreign bodies from the eye.
Inflammatory diseases of the ears.
Contraindications
• Individual
hypersensitivity to any of the drug's components;
• Allergy to
other related antibiotics, such as framycetin, kanamycin, or gentamicin;
• Pregnancy;
• Lactation;
• Children
and adolescents under 18 years of age.
Method
of administration and dosage
Topical.
Ophthalmology,
recommended dose:
Purulent
bacterial conjunctivitis, keratitis, corneal ulcers, and chronic dacryocystitis
For the first two
days, instill one or two drops into the affected eye(s) every 2-4 hours
throughout the day.
Thereafter,
instill one or two drops every 4-6 hours until the infection resolves.
Surgical
prophylaxis
The dosage and
schedule are determined by your doctor, and you should follow these
instructions several days before, during, and for several days after the
procedure.
Treatment should
be continued for at least two days after the infection resolves, but not for
more than seven days without medical supervision.
Otology,
recommended dose:
Instill one or
two drops into the affected ear every 4 hours until the infection resolves.
The dosage
regimen and duration of treatment will be adjusted based on your doctor's
opinion.
Instructions
for ophthalmic use:
Wash your hands thoroughly
before using the medication.
Avoid contact of
the tip of the opened bottle with the eye or your hands.
Tilt your head
back, place the tip of the bottle over your eye, and pull down your lower
eyelid with the index finger of your other hand. Apply gentle pressure to the
bottle and instill the required amount of medication into the conjunctival sac.
After
instillation, close your eyes and do not blink or open them for approximately 2
minutes to ensure optimal contact between the mucous membrane and the
medication.
Close the bottle
tightly after each use.
Special instructions and precautions
Consult a physician before using this medication.
Wearing contact lenses is not recommended while
treating eye inflammation. If necessary, soft contact lenses should be removed
before using this medication and reinserted no sooner than 15 minutes after
instillation.
This medication contains benzalkonium chloride,
which may cause eye irritation and is known to discolor soft contact lenses.
Avoid contact with soft contact lenses.
If multiple topical ophthalmic medications are used
concurrently, allow at least 15 minutes between applications. Eye ointments
should be applied last.
To avoid possible contamination of the dropper tip
and solution, do not touch the bottle tip to your eyelids, surrounding areas,
or other surfaces. Keep the bottle tightly closed when not in use.
Long-term use of Neomin may cause overgrowth of
non-susceptible microorganisms, including fungi, so discontinue use and
initiate appropriate therapy. The drug is used to treat bacterial infections
and is ineffective against viral infections.
Caution should be exercised when using Neomin
concomitantly with other aminoglycosides or other systemic polypeptide
antibiotics.
Influence on the ability to drive vehicles and
mechanisms
Blurred vision may occur after using the eye drops.
Therefore, driving or engaging in activities requiring increased alertness and
rapid psychomotor reactions is not recommended immediately after instillation.
Side effect
The following local side effects are
possible: itching, swelling, burning, irritation, dryness, and folliculitis.
These symptoms resolve after discontinuing
use.
Patients with hypersensitivity to
benzalkonium chloride may develop allergic blepharitis or conjunctivitis.
If any of the side effects listed in the
instructions worsen, or you notice any other side effects not listed in the
instructions, notify your doctor.
Interaction
with other medicinal products
With significant systemic absorption, both neomycin
sulfate and polymyxin B sulfate may potentiate and prolong the respiratory
depressant effects of muscle relaxants.
There
are no data on drug overdose.
Storage conditions
Store at temperatures
below 30°C.
Keep out of reach of
children!
Shelf
life
2 years. Do not use
after the expiration date printed on the package.
Vacation
conditions
By prescription.
Release form
10 ml of the product
in LDPE dropper bottles with a screw-on protective cap.
1 bottle with instructions for use in a cardboard box.