Instructions Norfloxacin eye/ear drops 3 mg/ml bottle 5 ml
Composition
active ingredient: norfloxacin;
1 ml of solution contains norfloxacin 3 mg;
Excipients: decamethoxine, sodium chloride, disodium edetate (Trilon B), buffer solution (pH 4.67), purified water.
Dosage form
Eye and ear drops.
Main physicochemical properties: transparent colorless or with a faint greenish tint liquid.
Pharmacotherapeutic group
Means used in ophthalmology and otology. Antimicrobial agents. ATX code S03A A.
Pharmacological properties
Pharmacodynamics
Norfloxacin is an antimicrobial agent of the fluoroquinolone group; it inhibits the activity of bacterial cell DNA gyrase and bacterial DNA replication. Norfloxacin has a broad spectrum of antimicrobial activity against the vast majority of gram-negative microorganisms. The MIC for Escherichia coli, Klebsiella spp., Proteus spp., Citrobacter spp. is 2 mg/l or less. Acinetobacter spp., Providencia spp., Serratia spp. are less sensitive. The MIC for Pseudomonas aeruginosa is less than 1-2 mg/l, for Haemophilus influenzae, Neisseria gonorrhoeae and Neisseria meningitidis is less than 2 mg/l, for pathogenic strains of Salmonella and Schigella is less than 1 mg/ml, for Campylobacter is less than 4 mg/ml, for staphylococci is 1-4 mg/ml, for streptococci is 2-16 mg/l. Anaerobic bacteria are insensitive to the drug, Enterococcus and Acinetobacter are slightly sensitive.
Pharmacokinetics
Information on the distribution of norfloxacin when used in ophthalmology and otology is not available, but it is known that norfloxacin is distributed in most body fluids and tissues, including the eyes and ears. From 10% to 15% of the drug binds to blood proteins. It begins to act 1 hour after instillation into the eye. The maximum serum concentration for a daily ophthalmic dose is 10.2 ng/ml.
Norfloxacin is broken down into 6 active metabolites, the antibacterial activity of which is lower than that of the parent compound. Norfloxacin is metabolized in the liver and kidneys. Approximately 30% of the active substance is excreted in the urine unchanged. The half-life of the drug is 3-4 hours.
Indication
Superficial eye infections (bacterial conjunctivitis, keratitis, blepharitis), infections of the outer and middle ear (otitis externa, chronic purulent otitis media).
Contraindication
Hypersensitivity to norfloxacin or other fluoroquinolone drugs. Viral and fungal diseases of the eyes and ears.
Interaction with other medicinal products and other types of interactions
Interactions with other drugs with topical use of Norfloxacin have not been described. However, there is evidence that systemic use of some quinolones leads to an increase in theophylline plasma concentrations, affects the metabolism of caffeine and enhances the effect of oral anticoagulants such as warfarin and its derivatives, and is also associated with a temporary increase in serum creatinine levels in patients who have used cyclosporine concomitantly.
Application features
Norfloxacin in the form of drops is prescribed for topical use only. To achieve a better therapeutic effect, drops should be used in combination with systemic antimicrobial therapy (except in mild cases).
Severe and sometimes fatal hypersensitivity reactions (anaphylactic reactions) have been reported in patients receiving systemic quinolones, some of which occurred after the first dose. Some reactions were accompanied by cardiovascular collapse, loss of consciousness, tingling, swelling of the throat or face, dyspnea, urticaria, and pruritus. Only a few patients had a history of hypersensitivity reactions. Severe anaphylactic reactions require immediate emergency treatment with epinephrine and other resuscitative measures (including oxygen therapy), intravenous infusion, intravenous antihistamines, corticosteroids, vasoconstrictor amines, and mechanical ventilation as clinically indicated. Prolonged use of norfloxacin, as with any antibacterial agent, may result in overgrowth of nonsusceptible organisms, including fungi. If superinfection occurs, appropriate treatment is recommended.
Use caution when prescribing Norfloxacin drops to patients with epilepsy, convulsive syndromes of other etiology, severe liver/kidney dysfunction, and cerebral atherosclerosis.
Photophobia may develop; wear light-protective glasses and avoid prolonged exposure to bright light.
Norfloxacin should be discontinued at the first sign of skin rash or other signs of hypersensitivity reaction.
Regardless of the severity of clinical manifestations, treatment of ophthalmological diseases should be carried out after a thorough examination of the eyes using a slit lamp. When using the drug for the treatment of otitis, it is recommended to conduct a medical examination of patients in order to promptly determine the possible need for other therapeutic measures (systemic use of antibiotics, surgical intervention).
Before instilling the drug into the ear, it is necessary to aspirate the pus and wash the external auditory canal with an antiseptic solution.
Use during pregnancy or breastfeeding
Not recommended for use during pregnancy or breastfeeding.
Ability to influence reaction speed when driving vehicles or other mechanisms
For 30 minutes after instilling the drug into the eyes, you should refrain from driving vehicles and engaging in potentially dangerous activities that require increased attention.
Method of administration and doses
Application to the eyes.
Adults and children over 15 years of age with acute infectious eye diseases should be prescribed 1-2 drops every 15-30 minutes, and then reduce the frequency of instillations as the symptoms of the disease decrease.
For moderately severe processes, prescribe 1-2 drops 2-6 times a day.
For acute and chronic trachoma, prescribe 2 drops in each eye 2-4 times a day for 1-2 months.
After the symptoms of the disease disappear, the use of the drug should be continued for the next 48 hours.
Application to the ears.
Adults and children over 15 years of age with ear diseases should be prescribed 5 drops in the ear 3 times a day.
The drops should be at body temperature. Before using the drops, the external auditory canal should be sanitized. The patient should lie on his side or tilt his head to facilitate instillation. After instillation, the head should be kept in this position for about 2 minutes. A cotton swab can be placed in the external auditory canal.
When the symptoms of the disease disappear, the use of the drug should be continued for the next 48 hours.
Children
Do not use in children under 15 years of age.
Overdose
There have been no reports of Norfloxacin overdose in ophthalmology and otology.
Accidental ingestion of drops may cause nausea, vomiting, diarrhea, headache, dizziness, and feelings of anxiety.
Treatment: if necessary, symptomatic therapy should be carried out; it is necessary to ensure sufficient fluid intake and the formation of an acidic urine reaction to prevent crystalluria.
Adverse reactions
On the part of the organs of vision: feeling of discomfort, foreign body sensation, eyelid swelling, conjunctival hyperemia and edema, photophobia.
Allergic reactions, including rash, skin hyperemia, itching, angioedema, dermatitis.
On the part of the organs of hearing: itching in the ear, ringing in the ears.
Other: unpleasant taste in the mouth.
Expiration date
2 years.
The shelf life of the solution after opening the bottle is 10 days.
Storage conditions
Store in the original packaging at a temperature not exceeding 25 °C.
Keep out of reach of children.
Packaging
5 ml in a bottle with a dropper cap in a box.
Vacation category
According to the recipe.
Producer
Limited Liability Company "Research Plant "GNTSLS".
Limited Liability Company "PHARMEX GROUP".
Location of the manufacturer and its business address.
Ukraine, Kharkiv region, Kharkiv city, Vorobyovy street, building 8.
(Limited Liability Company "Research Plant "GNTSLS")
Ukraine, 08300, Kyiv region, Boryspil city, Shevchenko st., building 100.
(Limited Liability Company "PHARMEX GROUP")
