Each 1 ml or 1 g contains: 

Ciprofloxacin (as hydrochloride) ............................. 3 mg

Inactive ingredients: 

CIPROCIN Sterile Eye Drops: 

Benzalkonium chloride, disodium edetate, mannitol, acetic acid glacial, sodium acetate anhydrous, sodium hydroxide or hydrochloric acid, water for injection.

CIPROCIN Sterile Eye Ointment: 

Anhydrous lanolin, chlorobutanol, yellow soft paraffin.

Adults, Newborn infants (0-27 days), Infants and toddlers (28 days to 23 months), Children (2-11 years) and Adolescents (12-16 years): 

CIPROCIN Sterile Eye Drops is indicated for the treatment of corneal ulcers and superficial infections of the eye and adnexa caused by susceptible strains of bacteria.

Adults and Children 1 year and above:

CIPROCIN Sterile Eye Ointment is indicated for the treatment of the following infections when known or suspected to be caused by ciprofloxacin-susceptible bacteria:

Corneal ulcers.

Conjunctivitis.

Blepharitis.

Consideration should be given to official guidance on the appropriate use of antibacterial agents.

CIPROCIN Eye Drops: 

Adults, Newborn infants (0-27 days), Infants and toddlers (28 days to 23 months), Children (2-11 years) and Adolescents (12-16 years): 

Corneal Ulcers: 

CIPROCIN must be administered in the following intervals, even during night time:

On the first day, instill 2 drops into the affected eye(s) every 15 minutes for the first six hours and then 2 drops into the affected eye(s) every 30 minutes for the remainder of the day.

On the second day, instill 2 drops in the affected eye(s) hourly.

On the third through the fourteenth day, place two drops in the affected eye(s) 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 Infections: 

The usual dose is 1 or 2 drops in the affected eye(s) four times a day.

In severe infections, the dosage for the first two days may be 1 or 2 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.

Children: 

Safety and effectiveness of ciprofloxacin eye drops were determined in 230 children between the ages of 0 and 12 years of age. No serious adverse drug reaction was reported in this group of patients.

Use in renal and hepatic impairment: No studies have been performed using ciprofloxacin eye drops in patients with kidney or liver problems.

CIPROCIN Sterile Eye Ointment: 

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: 

1.25 cm 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): 

1.25 cm 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.

Use in elderly: 

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

Use in children: 

Clinical studies have indicated that dosage modifications are not required for children.

There is no experience in children less than 1 year old.

Use in hepatic and renal impairment: 

No studies have been performed in patients with kidney or liver problems.

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

Hypersensitivity to quinolones.

For ocular use only.

The clinical experience in children less than one year old, particularly in neonates is very limited.

The use of CIPROCIN in neonates with ophthalmia neonatorum of gonococcal or chalamydial origin is not recommended as ciprofloxacin has not been evaluated in such patients. Neonates with ophthalmia neonatorum should receive appropriate treatment for their condition.

When using CIPROCIN 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. Only a few patients had a history of hypersensitivity reactions.

Serious acute hypersensitivity reactions to ciprofloxacin may require immediate emergency treatment. Oxygen and airway management should be administered where clinically indicated.

CIPROCIN 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.

Tendon inflammation and rupture may occur with systemic fluoroquinolone therapy including ciprofloxacin, particularly in elderly patients and those treated concurrently with corticosteroids. Therefore treatment with CIPROCIN Sterile Eye Drops/CIPROCIN Sterile Eye Ointment should be discontinued at the first sign of tendon inflammation.

In patients with corneal ulcer and frequent administration of ciprofloxacin eye drops/ointment, white topical ocular precipitates (medication residue) have been observed which resolved after continued application of the eye drops/ointment. The precipitate does not preclude the continued application of CIPROCIN Sterile Eye Drops/CIPROCIN Sterile 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. 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 CIPROCIN Sterile Eye Drops/CIPROCIN Sterile Eye Ointment.

CIPROCIN Sterile 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 CIPROCIN Sterile Eye Drops and wait at least 15 minutes before reinsertion.

Do not touch tip to any surface as this may contaminate the drug.

Do not use the product if the imprinted carton seals have been damaged, or removed.

There is no experience in children less than 1 year old.

Use of CIPROCIN Sterile Eye Ointment in neonates with ophthalmia neonatorum is not recommended as ciprofloxacin has not been evaluated in such patients. Neonates with ophthalmia neonatorum should receive appropriate treatment for their condition.

When using CIPROCIN Sterile 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.

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: 

There are no adequate data from the use of ciprofloxacin in pregnant woman.

Animal studies do not indicate direct harmful effects with respect to reproductive toxicity.

Systemic exposure to ciprofloxacin after topical use is expected to be low.

As a precautionary measure, it is preferable to avoid the use of CIPROCIN during pregnancy, unless the therapeutic benefit is expected to outweigh the potential risk to the fetus.

Lactation: 

Orally administered ciprofloxacin is excreted in the human breast milk. It is unknown whether ciprofloxacin is excreted in human breast milk following topical ocular administration. A risk to the suckling child cannot be excluded. Therefore, caution should be exercised when CIPROCIN is administered to nursing mothers.

The product has no or negligible influence on 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.

The most frequently reported adverse drug reactions were ocular discomfort, dysgeusia and corneal deposits occurring approximately in 6%, 3% and 3% of patients respectively.

The adverse reactions listed below are classified according to the following convention: Very common (≥1/10); Common (≥1/100 to <1/10); Uncommon (≥1/1,000 to <1/100); Rare (≥1/10,000 to <1/1,000); Very rare (<1/10,000); or Not known (cannot be estimated from the available data).

Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.

The following undesirable effects were reported in association with the ophthalmic use of ciprofloxacin: 

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, reduced visual acuity , eyelid oedema, blurred vision, eye pain, dry eye, eye swelling, eye pruritus, increased lacrimation, eye discharge, eyelid margin crusting, eyelid exfoliation, conjunctival oedema, erythema of eyelid.

Rare: Ocular toxicity, keratitis, conjunctivitis, corneal epithelium defect, diplopia, hypoaesthesia 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.

Description of selected adverse events: 

With locally applied fluoroquinolones (generalized) rash, toxic epidermolysis, dermatitis exfoliative, Stevens-Johnson syndrome and urticaria occur very rarely.

Serious and occasionally fatal hypersensitivity (anaphylactic) reactions, some following the first dose, have been reported in patients receiving systemic quinolone therapy.

Some reactions were accompanied by cardiovascular collapse, loss of consciousness, tingling, pharyngeal or facial oedema, dyspnoea, urticaria, and itching.

Ruptures of the shoulder, hand, Achilles, or other tendons that required surgical repair or resulted in prolonged disability have been reported in patients receiving systemic fluoroquinolones. Studies and post-marketing experience with systemic fluoroquinolones indicate that the risk of these ruptures may be increased in patients receiving corticosteroids, especially geriatric patients and in tendons under high stress, including the Achilles tendon.

To date, clinical and post-marketing data have not demonstrated a clear association between ciprofloxacin and musculoskeletal and connective tissue adverse reactions.

In isolated cases blurred vision, decreased visual acuity and medication residue have been observed with ophthalmic ciprofloxacin.

Moderate to severe phototoxicity has been observed in patients treated with systemic quinolones. Nevertheless, phototoxic reactions to ciprofloxacin are uncommon. 

Pediatric population: 

Safety and effectiveness of ciprofloxacin eye drops/ointment were determined in children between the ages of 0 and 12 years of age. No serious adverse drug reaction was reported in this group of patients.

A topical overdose of CIPROCIN may be rinsed out from the eye(s) with warm 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 bottle or one tube.

Pharmacodynamic properties: 

Pharmacotherapeutic Group: Ophtalmogicals, Other Anti-infectives. 

Mechanism of Action: 

CIPROCIN Sterile Eye Drops/Ointment contains the fluoroquinolone ciprofloxacin. The cidal and inhibitory activity of ciprofloxacin against bacteria results from an interference with the DNA gyrase, an enzyme needed by the bacterium for the synthesis of DNA. Thus the vital information from the bacterial chromosomes cannot be transcribed which causes a breakdown of the bacterial metabolism.

Ciprofloxacin has in vitro activity against a wide range of Gram-positive and Gram-negative bacteria.

Mechanism of Resistance: 

Fluoroquinolone resistance, particularly ciprofloxacin, requires significant genetic changes in one or more of five major bacterial mechanisms:

a) enzymes for DNA synthesis, 

b) protecting proteins, 

c) cell permeability, 

d) drug efflux, or 

e) plasmid-mediated aminoglycoside 6'-N-acetyltransferase, AAC (6')-Ib.

Fluoroquinolones, including ciprofloxacin, differ in chemical structure and mode of action from aminoglycosides, beta-lactam antibiotics, macrolides, tetracyclines, sulfonamides, trimethoprim, and chloramphenicol. Therefore, organisms resistant to these drugs may be susceptible to ciprofloxacin.

Pharmacokinetic properties:

Absorption studies in humans with the ointment have not been conducted; however exposure levels would be expected to be less than ciprofloxacin ophthalmic solution. Ciprofloxacin eye drops solution is rapidly absorbed into the eye following topical ocular administration. Systemic levels are low following topical administration.

Plasma levels of ciprofloxacin in human subjects following 2 drops of 0.3% ciprofloxacin solution every 2 hours for two days and then every four hours for 5 days ranged from non-quantifiable (< 1.0 ng/mL) to 4.7 ng/mL . The mean peak ciprofloxacin plasma level obtained in this study is approximately 450-fold less than that seen following a single oral dose of 250 mg ciprofloxacin. The systemic pharmacokinetic properties of ciprofloxacin have been well studied. Ciprofloxacin widely distributes to tissues of the body. The apparent volume of distribution at steady state is 1.7 to 5.0 l/kg. Serum protein binding is 20-40%. The half-life of ciprofloxacin in serum is 3-5 hours. Both ciprofloxacin and its four primary metabolites are excreted in urine and faeces. Renal clearance accounts for approximately two-thirds of the total serum clearance with biliary and faecal routes accounting for the remaining percentages.

In patients with impaired renal function, the elimination half-life of ciprofloxacin is only moderately increased due to extrarenal routes of elimination. Similarly, in patients with severely reduced liver function the elimination half-life is only slightly longer.

There are no pharmacokinetic data available in respect of use in children.

CIPROCIN Sterile Eye Drops:  Store at a temperature not exceeding 30^°C.

Use for 28 days after opening and store at room temperature.

CIPROCIN Sterile Eye Ointment:  Store at a temperature from 15^°C - 30^°C.

CIPROCIN Sterile Eye Drops: 5 ml Plastic dropper bottle. 

CIPROCIN Sterile Eye Ointment: Ophthalmic tube of 5 g.