Neomycin + Dexamethasone Eye, Ear and Nose Drops (5 ml)

Compound

1 ml of the drug contains active substances: Neomycin sulfate 5.0 mg, Dexamethasone sodium phosphate 1.0 mg,
Excipients: sodium chloride, sodium dihydrogen phosphate dihydrate, disodium phosphate dodecahydrate, water for injection.

Indications for use

• short-term treatment of eye diseases accompanied by a superficial bacterial infection amenable to corticosteroid treatment (excluding viral and fungal diseases: blepharitis, conjunctivitis, keratitis, iridocyclitis, iritis)


• prevention and treatment of inflammatory processes of the eye in the postoperative period


• treatment of ear diseases: acute and chronic otitis externa and otitis media (without damage to the tympanic membrane), infectious-allergic diseases of the outer ear


• treatment of diseases of the nose: rhinitis, sinusitis, sinusitis

 

Method of administration and dosage

For eyes

Adults: instill the drug into the conjunctival sac, 1-2 drops every 4-6 hours, with a gradual decrease in the frequency of use as the symptoms of inflammation decrease.

For ears

Adults: drops of Dexamethasone with neomycin are instilled for infections of the external ear canal, 2-3 drops in each ear 3-4 times a day, or put a cotton swab moistened with the drug in the ear.

Before using the ear drops, it is recommended to warm the bottle by holding it in your hand to avoid the discomfort associated with the ingress of cold liquid into the ear.

For nose

Adults: 2-3 drops in each nasal passage 3-4 times a day.

The course of treatment is no more than 5-6 days.

It is not recommended to use the drug for longer than the prescribed period, without consulting your doctor.

 

Side effects

Rarely (with prolonged use):

- an increase in intraocular pressure with the possible subsequent development of glaucoma and, in isolated cases, with damage to the optic nerve and visual fields, deterioration of visual acuity
- subcapsular cataract
- skin reactions (short-term burning sensation, lacrimation, conjunctival hyperemia)
- allergic reactions (itching and swelling of the eyelids, redness of the conjunctiva)
- accession of a secondary (fungal) infection
- in case of violation of the integrity of the tympanic membrane - the risk of toxic effects on the hearing and vestibular apparatus

 

Contraindications

• hypersensitivity to the drug


• keratitis caused by the Herpex simplex or Varicellazoster virus (treelike keratitis)


• chicken pox


• advanced purulent infectious diseases


• violation of the integrity of the corneal epithelium and thinning of the sclera


• viral and fungal infections of the eyes and ears


• infectious or traumatic injury (perforation) of the tympanic membrane


• auditory neuritis


• pregnancy and lactation


• children and adolescents up to 18 years old

 

Drug interactions

Incompatible with monomycin, streptomycin, gentamicin, amikacin, netilmicin.

If you are allergic to neomycin, cross-allergy to other aminoglycosides is possible.

Concomitant and / or sequential use of an aminoglycoside (neomycin) and other systemic, oral or topical drugs with neurotoxic, ototoxic or nephrotoxic effects can lead to additive toxicity and, if possible, should be excluded.

 

Special instructions

The simultaneous use of other aminoglycosides is not allowed.

Corticosteroids can reduce resistance to and develop bacterial, viral, or fungal infections; can mask clinical signs of infection, making it difficult to timely detect the ineffectiveness of the antibiotic or suppress hypersensitivity reactions to the components of the drug. In patients with persistent corneal ulceration who have taken or are taking corticosteroids, the possibility of a fungal infection is possible. If a fungal infection is confirmed, corticosteroid treatment should be discontinued.

With topical application of corticosteroids for diseases that cause thinning of the cornea or sclera, their perforation is possible.

Topical corticosteroids in the eye can slow the healing of corneal wounds.

To avoid the risk of developing corneal herpes simplex, frequent assessment of the patient using slit lamp biomicroscopy is necessary.

Prolonged use can lead to an increase in intraocular pressure with subsequent damage to the optic nerve, a decrease in visual acuity and fields, as well as the formation of a posterior subcapsular cataract. When using the drug for more than 10 days, it is necessary to control the intraocular pressure.

For acute purulent eye infections, corticosteroids may worsen or mask symptoms.

During the period of treatment with the drug Dexamethasone with neomycin, it is prohibited to wear soft contact lenses. When using rigid lenses, remove them before instillation and put them back on 15-20 minutes after instillation of the drug.

Pregnancy and lactation

The safety and effectiveness of this drug during pregnancy has not been established.

The drug is not recommended for use during pregnancy.

There is no reliable evidence do the active components of the drug penetrate into breast milk after topical application?

Since systemic corticosteroids and aminoglycosides pass into breast milk, the risk to the nursing infant cannot be excluded.

When prescribing the drug, it is necessary to make an informed decision about interrupting breastfeeding or stopping it (abstaining from drug treatment, taking into account the benefits / risks of breastfeeding for the child and the benefits of treatment for the woman).

Use in pediatrics

There are no data on the effectiveness and safety of the drug in children and adolescents.

Influence on the ability to drive vehicles and control mechanisms

If the patient, after using the drug, temporarily decreases the clarity of vision, then it is not recommended to drive a car and engage in other activities that require a high concentration of attention and speed of psychomotor reactions until it is restored.

Pharmacological properties

Pharmacokinetics

Neomycin practically does not undergo systemic absorption; it is found in therapeutic concentration in the corneal stroma, moisture of the anterior chamber and vitreous body within 6 hours.

Dexamethasone is absorbed into the aqueous humor, cornea, iris, choroid, ciliary body and retina. Systemic absorption can only occur with high doses or with prolonged treatment. The maximum concentration in aqueous humor, approximately 30 ng / ml, is reached within two hours, which subsequently decreases within half an hour to 3 hours.

When using the drug Dexamethasone with neomycin in the ear, systemic absorption is absent with the integrity of the tympanic membrane.

Pharmacodynamics

Dexamethasone with neomycin is a combined preparation for topical use in ophthalmology and otorhinolaryngology, which has antimicrobial and anti-inflammatory effects. This is due to the presence of a broad-spectrum antibiotic from the aminoglycoside group - neomycin sulfate and glucocorticoid hormone - dexamethasone sodium phosphate.

Neomycin has a bactericidal effect. The mechanism of action is associated with a direct effect on ribosomes and inhibition of bacterial cell protein synthesis. It is active against many gram-negative and gram-positive microorganisms, incl. in relation to Staphylococcus aureus, Streptococcus pneumoniae, Escherichia coli, Proteus, Shigella. It is not very effective against streptococci and Pseudomonas aeruginosa. Not effective against pathogenic fungi, viruses, anaerobic bacteria. Resistance of microorganisms to neomycin develops slowly and to a small extent.

Dexamethasone is a glucocorticoid. It has anti-inflammatory, anti-allergic and desensitizing effects. Dexamethasone stabilizes cell membranes, reduces capillary permeability, has an antiexudative effect by stabilizing the lysosomal membranes.

The combination of dexamethasone with an antibacterial component can reduce the development of the infectious process.

 

Storage conditions

Store in a dark place at a temperature not exceeding 25 ºС.
Keep out of the reach of children!

Shelf life - 1.5 years
The period of use after opening the bottle is no more than 4 weeks.
Do not use after the expiration date.