- ANTI-INFECTIVE AGENTS
- OPHTHALMOLOGICAL DRUGS
- Pharmaceutical Form : Eye Drops
- Composition : Each 1 mL contains: Ciprofloxacin Hcl 3.5 mg equivalent to Ciprofloxacin 3 mg
- Active Substance : Ciprofloxacin
Adults, newborn infants (0-27 days), infants and toddlers (28 days to 23 months), children (2-11 years) and adolescents (12 – 16 years) :
Ciprofloxacin is indicated for the treatment of corneal ulcers and superficial infections of the eye and adnexa caused by susceptible strains of bacteria.
- Hypersensitivity to the active substance or to any of the excipients.
- Hypersensitivity to quinolones.
For ocular use only.
The use of ciprofloxacin eye drops in neonates with ophthalmia neonatorum of gonococcal or chalamydial origin is not recommended as it has not been evaluated in such patients.
When using ciprofloxacin eye drops one should take into account the risk of rhinopharyngeal passage which can contribute to the occurrence and the diffusion of bacterial resistance.
Serious and occasionally fatal hypersensitivity (anaphylactic) reactions, some following the first dose, were observed in patients receiving treatment based on systematically administered quinolones.
Some reactions were accompanied by cardiovascular collapse, loss of consciousness, tingling, pharyngeal or facial oedema, dyspnoea, urticaria and itching.
Serious acute hypersensitivity reactions to ciprofloxacin may require immediate emergency treatment.
Ciprofloxacin should be discontinued at the first appearance of skin rash or any other sign of hypersensitivity.
As with all antibacterial preparations prolonged use may lead to overgrowth of non-susceptible bacterial strains or fungi.
If superinfection occurs, appropriate therapy should be initiated.
Treatment with ciprofloxacin 0.3 % Eye Drops should be discontinued at the first sign of tendon inflammation.
In patients with corneal ulcer and frequent administration of ciprofloxacin Eye Drops, white topical ocular precipitates (medication residue) have been observed which resolved after continued application of ciprofloxacin Eye Drops.
The precipitate does not preclude the continued application of ciprofloxacin Eye Drops nor does it adversely affect the clinical course of the recovery process. The onset of the precipitate was within 24 hours to 7 days after starting therapy. Resolution of the precipitate varied from immediately to 13 days after therapy commencing.
Contact lens wear is not recommended during treatment of an ocular infection. Therefore, patients should be advised not to wear contact lenses during treatment with ciprofloxacin eye drops.
Ciprofloxacin Eye Drops contains benzalkonium chloride which may cause irritation and is known to discolour soft contact lenses.
Avoid contact with soft contact lenses. In case patients are allowed to wear contact lenses they should be instructed to remove them prior to application of ciprofloxacin Eye Drops and wait at least 15 minutes before reinsertion.
If more than one topical ophthalmic medicinal product is being used, the medicines must be administered at least 5 minutes apart. Eye ointments should be administered last.
It is preferable to avoid the use of ciprofloxacin during pregnancy, unless the therapeutic benefit is expected to outweigh the potential risk to the fetus.
Caution should be exercised when ciprofloxacin is administered to nursing women.
Effects on ability to drive and use machines:
This product has no or negligible influence on the ability to drive or use machines.
Temporarily blurred vision or other visual disturbances may affect the ability to drive or use machines. If transient blurred vision occurs upon instillation, the patient must wait until the vision clears before driving or using machinery
– Immune system disorders:
– Nervous system disorders:
– Eye disorders:
Common: corneal deposits, ocular discomfort, ocular hyperaemia
Uncommon: keratopathy, punctate keratitis, corneal infiltrates, photophobia, visual acuity reduced, eyelid oedema, blurred vision, eye pain, dry eye, eye swelling, eye pruritus, lacrimation increased, eye discharge, eyelid margin crusting, eyelid exfoliation, conjunctivaloedema, erythema of eyelid
Rare: ocular toxicity, keratitis, conjunctivitis, corneal epithelium defect, diplopia, hypoesthesia eye, asthenopia, eye irritation, eye inflammation, hordeolum
– Ear and labyrinth disorders:
Rare: ear pain.
– Respiratory, thoracic and mediastinal disorders:
Rare: paranasal sinus hypersecretion, rhinitis
– Gastrointestinal disorders:
Rare: diarrhea, abdominal pain.
– Skin and subcutaneous tissue disorders:
– Musculoskeletal and connective tissue disorders:
Not known: tendon disorder.
DOSAGE AND ADMINISTRATON:
Adults, newborn infants (0-27 days), infants and toddlers (28 days to 23 months), children (2-11 years) and adolescents (12 – 16 years)
Ciprofloxacin 0.3 % must be administered in the following intervals, even during night time:
On the first day, instil 2 drops into the affected eye every 15 minutes for the first six hours and then 2 drops into the affected eye every 30 minutes for the remainder of the day.
On the second day, instil 2 drops in the affected eye hourly.
On the third through the fourteenth day, place two drops in the affected eye every 4 hours. If the patient needs to be treated longer than 14 days, the dosing regimen is at the discretion of the attending physician.
Superficial Ocular Infection:
The usual dose is one or two drops in the affected eye(s) four times a day. In severe infections, the dosage for the first two days may be one or two drops every two hours during waking hours.
For either indication a maximum duration of therapy of 21 days is recommended.
The dosage in children above the age of 1 year is the same as for adults.
Use in children:
No serious adverse drug reaction was reported in this group of patients.
STORAGE CONDITIONS: Do not store above 25°C.
Do not refrigerate or freeze.
PACKAGING: Bottle of 5 – 10 m