ARSETAM

INSTRUCTIONS for medical use of the medicinal product FLOXIMED (FLOXIMED)

Composition

active substance: ciprofloxacin; 1 ml of solution contains ciprofloxacin (in the form of hydrochloride) 3 mg; excipients: sodium acetate, trihydrate; mannitol (E 421); disodium edetate; benzalkonium chloride; glacial acetic acid; purified water.

Pharmaceutical form

Eye and ear drops, solution.

Main physical and chemical properties

Transparent solution from colorless to greenish-yellow.

Pharmacotherapeutic group

Agents for use in ophthalmology and otology. Antimicrobial agents. ATC code S03A A07.

Pharmacological properties

Pharmacodynamics

Mechanism of action

The medicinal product contains ciprofloxacin from the class of quinolones. The bactericidal action of quinolones, which mainly affects the synthesis of bacterial DNA, is expressed by inhibiting DNA gyrase.

Ciprofloxacin has high activity in vitro against most gram-negative microorganisms, including Pseudomonas aeruginosa. It is also effective against aerobic gram-positive microorganisms, such as staphylococci and streptococci.

Susceptibility to microorganisms

Use in ophthalmology

Both in vitro and in clinical use in eye infections, it has been proven that ciprofloxacin is active against most strains of the following organisms.

Use in otology

Ciprofloxacin has high activity in vitro against most aerobic gram-negative microorganisms, including Pseudomonas aeruginosa. It is also effective against aerobic gram-positive microorganisms, such as staphylococci and streptococci.

Limit values of microbial growth inhibition zones

Use in ophthalmology

Ciprofloxacin has been shown to be active in vitro against most strains of the following microorganisms; however, the clinical significance of these data in ophthalmic infections is unknown.

Insensitive species

Some strains of Burkholderia cepacia and Stenotrophomonas maltophilia are resistant to ciprofloxacin, as well as some anaerobic bacteria, especially Bacteroides fragilis.

Preclinical safety data

Ciprofloxacin and other quinolones cause the development of arthropathy in young animals of most species studied after oral administration.

Clinical characteristics

Indications

Corneal ulcers and superficial eye infections (eyes) and their appendages, caused by bacterial strains sensitive to ciprofloxacin.

Acute otitis externa, as well as acute otitis media with drainage through a tympanostomy tube, caused by bacterial strains sensitive to ciprofloxacin.

Contraindications

Increased sensitivity to ciprofloxacin, other quinolones, and/or excipients of the medicinal product.

Interaction with other medicinal products and other types of interactions

No interaction studies were conducted.

Special warnings and precautions for use

General

The medicinal product is intended for local use (in the conjunctival sac or in the external auditory canal).

For eye drops

Clinical experience with ciprofloxacin eye drops in children under 1 year of age, especially newborns, is quite limited.

For ear drops

The efficacy and safety of ciprofloxacin ear drops in children under 1 year of age have not been evaluated.

Use during pregnancy or breastfeeding

Pregnancy

There are no adequate data on the local use of ciprofloxacin in pregnant women.

Breastfeeding

When administered orally, ciprofloxacin was found in breast milk.

Ability to affect reaction rate when driving vehicles or operating machinery

Ciprofloxacin for local use does not have or has a negligible effect on the ability to drive vehicles or operate machinery.

Method of administration and dosage

Use in ophthalmology

Dosage

Adolescents and adults, including elderly patients.

Corneal ulcers. The medicinal product should be used at the following intervals, including at night:

· on the 1st day, instill 2 drops into the conjunctival sac(s) of the affected eye(s) every 15 minutes for the first 6 hours, then 2 drops every 30 minutes during the first day;

· on the 2nd day, instill 2 drops into the conjunctival sac(s) of the affected eye(s) every hour;

· from the 3rd to the 14th day, instill 2 drops into the conjunctival sac(s) of the affected eye(s) every 4 hours.

Method of administration

To prevent contamination of the dropper tip and solution, care should be taken not to touch the eyelids, adjacent areas, or other surfaces with the edge of the dropper bottle.

Use in otology

Dosage

Adults, including elderly patients.

The medicinal product is used in a dose of 4 drops into the ear canal 2 times a day.

Method of administration

The external auditory canal should be carefully cleaned.

Overdose

Symptoms. Given the characteristics of this medicinal product, intended for local use, no toxic effect is expected when used in ophthalmology/otology in the recommended doses, as well as in the event of accidental ingestion of the contents of 1 bottle.

Adverse reactions

Adverse effects observed after application of ciprofloxacin to the eye

Adverse reactions observed after application of ciprofloxacin to the ear

Shelf life

3 years.

Storage conditions

Store at a temperature not exceeding 25 °C in the original packaging and out of reach of children.

Packaging

5 ml of solution in a dropper bottle; 1 dropper bottle in a cardboard box.

Release category

By prescription.

Manufacturer

S.C. Rompharm Company S.R.L., Romania / K.O. Rompharm Comp ani S.R.L., Romania.

Location of the manufacturer and address of the place of business

Otopeni city, Eroilor str. № 1A, 075100, Ilfov county / м. Отопень, вул. Ероілор № 1А, 075100, округ Ілфов.

Applicant

WORLD MEDICINE, LLC, Ukraine / ТОВ «УОРЛД МЕДИЦИН», Україна.