NORMAX

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT NORMAX (NORMAX)

Composition:

Active substance: norfloxacin.

1 ml of solution contains norfloxacin 3 mg (0.003 g);

Excipients: edetate disodium, sodium chloride, benzalkonium chloride solution, water for injections.

Pharmaceutical form. Eye and ear drops.

Main physicochemical properties: clear, colorless to pale yellow solution, free from mechanical particles.

Pharmacotherapeutic group.

Medicinal products used in ophthalmology. Antimicrobial agents. Norfloxacin.

ATC code S03AA09

Pharmacological properties.

Pharmacodynamics.

Norfloxacin is an antimicrobial agent of the fluoroquinolone group; it inhibits bacterial cell DNA gyrase activity and bacterial DNA replication. Norfloxacin has a broad spectrum of antimicrobial activity against the majority of Gram-negative microorganisms. The MIC for Escherichia coli, Klebsiella spp., Proteus spp., Citrobacter spp. is 2 mg/L or less. Less susceptible are Acinetobacter spp., Providencia spp., Serratia spp. The MIC for Pseudomonas aeruginosa is less than 1–2 mg/L, for Haemophilus influenzae, Neisseria gonorrhoeae, and Neisseria meningitidis – less than 2 mg/L, for pathogenic strains of Salmonella and Shigella – less than 1 mg/mL, for Campylobacter – less than 4 mg/mL, for staphylococci – 1–4 mg/mL, for streptococci – 2–16 mg/L. Anaerobic bacteria are resistant to the drug, while Enterococcus and Acinetobacter are poorly susceptible.

Pharmacokinetics.

There is no available information on the distribution of norfloxacin when used in ophthalmology; however, it is known that norfloxacin distributes into most body fluids and tissues, including the eyes and ears. Protein binding ranges from 10 to 15%. It begins to act within 1 hour after instillation into the eye. The maximum plasma concentration following the daily ophthalmological dose is 10.2 ng/mL.

Norfloxacin is metabolized into 6 active metabolites, each having lower antibacterial activity compared to the parent compound. Norfloxacin is metabolized in the liver and kidneys. Approximately 30% of the active substance is excreted unchanged in urine. The elimination half-life of the drug is 3–4 hours.

Clinical characteristics.

Indications.

Superficial eye infections (bacterial conjunctivitis, keratitis, blepharitis), infections of the external and middle ear (external otitis, chronic suppurative otitis media).

Contraindications.

Hypersensitivity to norfloxacin or to other drugs of the fluoroquinolone class. Viral and fungal diseases of the eyes and ears.

Interaction with other medicinal products and other forms of interaction.

Interactions with other medicinal products have not been described with topical administration of norfloxacin. However, there are reports that systemic administration of certain quinolones leads to increased plasma theophylline concentrations, affects caffeine metabolism, enhances the effect of oral anticoagulants such as warfarin and its derivatives, and is associated with transient elevation of serum creatinine levels in patients receiving concomitant cyclosporine.

Special precautions for use.

Norfloxacin eye drops are intended for topical use only. To achieve optimal therapeutic effect, the 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, including cases after the first dose. Some of these reactions were accompanied by cardiovascular collapse, loss of consciousness, paresthesia, throat and facial swelling, dyspnea, urticaria, and pruritus. Only a few of these patients had a history of hypersensitivity reactions. Severe anaphylactic reactions require immediate emergency treatment, including epinephrine and other resuscitation measures (including oxygen therapy), intravenous fluid administration, intravenous antihistamines, corticosteroids, vasoconstrictor amines, and mechanical ventilation as clinically indicated. Prolonged use of norfloxacin, as with other antibacterial agents, may result in overgrowth of microorganisms not susceptible to the drug, including fungi. If superinfection occurs, appropriate therapy should be initiated. Norfloxacin eye drops should be administered with caution in patients with epilepsy, seizure disorders of other etiologies, significant hepatic or renal impairment, and cerebral atherosclerosis.

Photosensitivity may occur; patients should wear photoprotective sunglasses and avoid prolonged exposure to bright light.

The use of Norfloxacin should be discontinued at the first sign of skin rash or other signs of hypersensitivity.

Regardless of the severity of clinical symptoms, ophthalmic conditions should be managed only after thorough eye examination using a slit lamp. When the drug is used to treat otitis, patients should undergo regular medical monitoring to promptly identify any need for additional therapeutic interventions (such as systemic antibiotic therapy or surgical procedures).

Prior to instillation of the drug into the ear, pus should be aspirated and the external auditory canal should be irrigated with an antiseptic solution.

Use during pregnancy or breastfeeding.

Norfloxacin is not recommended during pregnancy or breastfeeding.

Ability to affect reaction speed when driving or operating machinery.

For 30 minutes after instilling the drops into the eyes, patients should refrain from driving or engaging in activities requiring heightened attention and alertness.

Method of Administration and Dosage.

Ocular Use.

For adults and children aged 15 years and older: in acute infectious eye diseases, administer 1–2 drops every 15–30 minutes, then gradually reduce the instillation frequency according to the decrease in disease symptoms.

In cases of moderate severity, administer 1–2 drops 2–6 times daily.

For acute and chronic trachoma, administer 2 drops into each eye 2–4 times daily for 1–2 months.

After symptoms disappear, continue using the drug for an additional 48 hours.

Otic Use.

For adults and children aged 15 years and older: in ear disorders, administer 5 drops into the affected ear 3 times daily. The drops should be at body temperature. Prior to instillation, the external auditory canal should be cleaned. The patient should lie on their side or tilt their head to facilitate instillation. After instillation, the head should be kept in this position for approximately 2 minutes. A cotton wick may be placed in the external auditory canal.

After symptoms resolve, continue treatment for an additional 48 hours.

Children.

Do not use in children under 15 years of age.

Overdose.

There have been no reports of norfloxacin overdose in ophthalmology or otology.

Following accidental oral ingestion of the drops, symptoms such as nausea, vomiting, diarrhea, headache, dizziness, and anxiety may occur.

Treatment: if necessary, symptomatic therapy should be administered; ensure adequate fluid intake and promote acidic urine reaction to prevent crystalluria.

Adverse reactions.

Eye disorders: discomfort, foreign body sensation, eyelid edema, conjunctival hyperemia and edema, photophobia.

Allergic reactions: including rash, skin hyperemia, pruritus, Quincke's edema, dermatitis.

Aural and labyrinthine disorders: ear pruritus, tinnitus.

Other: unpleasant taste in the mouth.

Shelf life. 2 years.

Do not use after the expiry date stated on the packaging.

The shelf life of the solution after opening the bottle is 10 days.

Storage conditions. Store in the original packaging, out of the reach of children, at a temperature between 15 °C and 25 °C.

Packaging.

5 ml in a plastic dropper bottle or a glass bottle with dropper. One bottle per cardboard box.

Prescription status. Prescription only.

Manufacturer.

Alcon Parenterals (I) Limited

Manufacturer's address and place of business.

SP-918, Phase-III, Industrial Area, Bhiwadi 301019, Alwar District, Rajasthan, India