Dancil® Eye -Ear Drops

Composition:

Each ml contains: Active substance Ofloxacin – 3,0 mg Auxiliary substances Benzalkonium Chloride, Sodium Chloride, Edetate Disodium, Hypromellose, Sodium Hydroxide, Hydrochloric Acid, Water for injection.

Trade Name:

Dancil® eye – ear drops

Composition :

Each ml contains :
Active substance:

  • Ofloxacin – 3,0 mg
  • Auxiliary substances
  • Benzalkonium Chloride, Sodium Chloride, Edetate Disodium, Hypromellose, Sodium Hydroxide, Hydrochloric Acid, Water for injection.

Pharmacotherapeutic Group:

Antimicrobial agent – fluoroquinolone

Indications:

  • Infectious diseases of eye adnexa and anterior segment of the eye caused by microorganisms sensitive to ofloxacin in adults and children aged 1 year and older
  • Prevention of infection in eye surgery.

Ear infections

Ofloxacin is indicated for the treatment of the following conditions in adults and children in the age of 15 years and older:

  • Otitis externa caused by Escherichia coli, Pseudomonas aeruginosa, Staphylococcus aureus.
  • Chronic purulent otitis media, including with perforation of the tympanic membrane caused by Proteus mirabilis, Pseudomonas aeruginosa, or Staphylococcus aureus.
  • Acute otitis media with inserted tympanostomy tube, caused by Haemophilus influenzae, Moraxella catarrhalis, Pseudomonas aeruginosa, Staphylococcus aureus and Streptococcus pneumoniae.

Dosage and Administration:

Infectious diseases of the eyes:

  • For treatment of bacterial corneal ulcer recommended dose of ofloxacin for adults and children aged 1 year and older – 1-2 drops of 0.3 % solution in affected eye (or both eyes) every 30 minutes during waking hours, and then – through 4 and 6 hours after falling asleep, during 2 days. Starting from 3 days of treatment and during the next 4-6 days solution can be instilled by 1-2 drops every hour during waking hours, and then – 1-2 drops 4 times a day for another 3 days or until a clinical cure.
  • For treatment of conjunctivitis, blepharitis, keratoconjunctivitis, keratitis, meibomitis, dacrocystitis and prevention of infections in ophthalmic after eye injury and surgery ofloxacin in the form of eye drops normally used only during wakefulness. For adults and children aged 1 year and older the recommended dose of ofloxacin – 1-2 drops of 0.3% solution in affected eye (or both eyes) every 2-4 hours (while awake) for 2 days, then – 1-2 drops 4 times a day for no more than 5 days. Ear infections

Children 15 years and older and adults:

  • Otitis externa: 10 drops into affected ear, 1 time a day for 7 days.
  • Acute otitis media with inserted tympanostomy tube: 5 drops into affected ear 2 times a day for 10 days.
  • Chronic purulent otitis media with perforation of the tympanic membrane: 10 drops into affected ear 2 times a day for 14 days.

Before instillation, to avoid the development of vertigo (possible when using a cold solution) warm the bottle in hands for 1-2 minutes. Instillation produced in the position of the patient lying on his side. After instillation patient must maintain this position for 5 minutes to facilitate the passage of solution through the external auditory canal. If necessary instillation in the other ear, make the same actions.

Contraindications:

Hypersensitivity (including to other quinolones), nonbacterial eye adnexa disease and anterior segment eye nonbacterial otitis media, pregnancy, lactation period, the age under 1 year for use in ophthalmology, under 15 years – for otolaryngology.

Warning and precautions:

As during treatment with other antibiotics, prolonged use may result in overgrowth of non-susceptible organisms. If worsening infection occurs, or if clinical improvement is not noted within a reasonable period, discontinue use and institute alternative therapy.

Soft contact lenses should not be worn during the treatment. Rigid contact lenses are to be removed before instillation and set again in 20 minutes after instillation. Preparation should not be injected subconjunctival or into anterior chamber eye. Patient should wear sunglasses (due to possible development of photophobia) and avoid prolonged exposure to bright light.

Adverse Effects:

After instillation into eye may cause transient stinging or discomfort, conjunctival hyperemia, contact conjunctivitis, keratitis, foreign body sensation in the eye, blurred vision, swelling of the face or periorbital area, pain in the eye, photophobia, itching, lacrimation and a sense of dry eyes

Rarely catatony, dizziness, nausea and headache occur. Also described rare cases of hemorrhagic conjunctivitis with edema of eyelid

Local reactions (allergic reactions, mild pain and hyperemia of the tympanic membrane) in the application of ofloxacin in the form of ear drops at otitis externa develop in 16.8 % of patients.

1% of patients reported of pain in the ear, a sense of ringing in the ears, transient hearing loss, external appearance and otitis media.

Drug Interaction:

No information available related to interaction with medicinal products.

Over Dosage:

In case of topical application of excessive doze of Dancil® eyes should be washed out with pure water of a room temperature. There is no data of systemic signs of overdose.

Packaging:

Eye drops 0.3 %. 5 ml into dropper-vial with screw-on cap. Each vial packed in unit carton along with Instructions for Use.

Storage Conditions:

  • Store at a temperature of up to 25 ºC in a place, protected from light. Do not freeze.
  • Keep away from reach of children.

Shelf-Life:

  • 2 years from the date of manufacturing
  • 30 days after opening the vial
  • Do not use after expiration date, specified on package.