Composition:

Each 1g contains Ciprofloxacin Hcl Monohydrate 3.5mg equivalent to Ciprofloxacin 3mg.

Indications:

Adults and children 1 year and above:

For the treatment of the following infections when known or suspected to be caused by ciprofloxacin-susceptible bacteria, corneal ulcers, conjunctivitis, blepharitis.

Contraindications:

• Hypersensitivity to the active substance or to any of the excipients.

• Hypersensitivity to quinolones.

Dosage and Administration:

Adults and children 1 year and above:

The recommended dosage regimens for adults (including the elderly) and children over the age of one year of age are as follows:

• Corneal ulcers: 1.25cm ointment ribbon applied into the conjunctival sac every 1-2 hours around the clock for two days, then every 4 hours for a further 12 days. The dosing may be extended at the discretion of the physician.
• Bacterial conjunctivitis (and blepharitis): 1.25cm ointment ribbon applied into the conjunctival sac (or on the lid margin, respectively) three times daily for two days, then twice daily for a further five days. The dosing may be extended at the discretion of the physician.
• Do not touch tube tip to any surface, as this may contaminate the contents.

Use in elderly:

Clinical studies have indicated dosage modifications are not required for the elderly.

Use in children:

Safety and effectiveness of Ciprofloxacin eye Ointment was determined in 192 children between the ages of one to 12 years. No serious adverse event was reported in these patients.

Use in hepatic and renal impairment:

No studies have been performed using Ciprofloxacin eye Ointment in patients with kidney or liver problems.

 

Warnings:

• For ocular use only.
• In patients with corneal ulcer and frequent administration of Ciprofloxacin Eye Ointment, white topical ocular precipitates (medication residue) have been observed which resolved after continued application of Ciprofloxacin Eye Ointment. The precipitate does not preclude the continued application of Ciprofloxacin Eye Ointment 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.
• There is no experience in children less than 1 year old.
• Use of Ciprofloxacin eye ointment in neonates with ophthalmia neonatorum is not recommended as it has not been evaluated in such patients.
• When using Ciprofloxacin eye ointment one should take into account the risk of a 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.
• 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 eye Ointment should be discontinued at the first sign of tendon inflammation.
• Ciprofloxacin should be discontinued at the first appearance of skin rash or any other sign of hypersensitivity.
• 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 ointment.

Undesirable effects

• Immune system disorders: Rare: hypersensitivity.
• Nervous system disorders: Uncommon: headache. Rare: dizziness.
• 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: Common: dysgeusia. Uncommon: nausea. Rare: diarrhoea, abdominal pain.
• Skin and subcutaneous tissue disorders: Rare: dermatitis.
• Musculoskeletal and connective tissue disorders: Not known: tendon disorder.

Interactions:

Specific drug interaction studies have not been conducted with ophthalmic Ciprofloxacin.

Given the low systemic concentration of ciprofloxacin following topical ocular administration of the product, drug interactions are unlikely to occur.

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.

Pregnancy:

No clinical data from well-controlled studies in pregnant women are available.

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.

Breastfeeding:

Orally administered ciprofloxacin has been found in human breast milk. It is unknown whether ciprofloxacin is excreted to human milk following topical ocular administration. A risk to the suckling child cannot be excluded. Therefore, caution should be exercised when Ciprofloxacin Eye Ointment is administered to a nursing woman.

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.

Overdose:

A topical ocular overdose of Ciprofloxacin eye Ointment may be rinsed from the eye(s) with lukewarm tap water.

Due to the characteristics of this preparation no toxic effects are to be expected with an ocular overdose of this product, or in the event of accidental ingestion of the contents of one tube.