Consumer medicine information

Ciloquin Eye Drops 0.3%

Ciprofloxacin

BRAND INFORMATION

Brand name

Ciloquin

Active ingredient

Ciprofloxacin

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Ciloquin Eye Drops 0.3%.

What is in this leaflet

Please read this leaflet carefully before you use Ciloquin Eye Drops.

This leaflet answers some common questions about Ciloquin Eye Drops. It does not contain all of the available information. It does not take the place of talking to your doctor or pharmacist.

The information in this leaflet was last updated on the date listed on the final page. More recent information on the medicine may be available.

You should ensure that you speak to your pharmacist or doctor to obtain the most up to date information on the medicine.

You can also download the most up to date leaflet from www.novartis.com.au

The updates may contain important information about the medicine and its use of which you should be aware.

All medicines have risks and benefits. Your doctor has weighed the expected benefits of you using Ciloquin Eye Drops against the risks this medicine could have for you.

The information in this leaflet applies to Ciloquin only. This information does not apply to similar products, even if they contain the same ingredients.

If you have any concerns about using this medicine, ask your doctor or pharmacist.

Keep this leaflet with the medicine.

You may need to read it again.

What Ciloquin is used for

Ciloquin Eye Drops are used to treat certain types of eye infections caused by bacteria. Your doctor will usually prescribe this medicine to treat a type of eye infection called bacterial conjunctivitis or an infected ulcer of the cornea.

Ciloquin Eye Drops contain the active ingredient ciprofloxacin hydrochloride. Ciprofloxacin hydrochloride is a "fluoroquinolone" antibiotic. This antibiotic works by killing the bacteria that are causing your infection.

Ciloquin Eye Drops are only available on a doctor's prescription.

Your doctor may have prescribed Ciloquin for another reason.

Ask your doctor if you have any questions about why Ciloquin has been prescribed for you.

Use in children

Do not use Ciloquin Eye Drops in children under 12 months of age. The safety and effectiveness of Ciloquin Eye Drops has not been established in children below the age of 12 months including neonates (the newborn).

Before you use Ciloquin

When you must not use it

Do not use Ciloquin Eye Drops if you have an allergy to:

  • Ciprofloxacin
  • Any other "quinolone" antibiotics e.g. nalidixic acid
  • Any of the other ingredients in Ciloquin Eye Drops that are listed under "Product description".

Some of the symptoms of an allergic reaction may include:

  • shortness of breath
  • wheezing or difficulty breathing
  • swelling of the face, lips, tongue or other parts of the body
  • rash, itching or hives on the skin.

Do not put the eye drops into your eye(s) while you are wearing soft contact lenses. The preservative in Ciloquin Eye Drops, benzalkonium chloride may be deposited in soft contact lenses. Ciloquin Eye Drops may cause irritation or discolour soft contact lenses.

Wearing contact lenses is not recommended while you are using Ciloquin Eye Drops as you are being treated for an eye infection.

Do not use this medicine after the expiry date printed on the pack or bottle or if the seal around the pack is broken or shows signs of tampering. If it is has expired or is damaged, return it to your pharmacist for disposal.

If you use this medicine after the expiry date has passed, it may not work.

If this medicine has expired or is damaged, return it to your pharmacist for disposal.

If you are not sure whether you should start using Ciloquin Eye Drops, talk to your doctor.

Before you start to use it

Tell your doctor if you have had an allergy to any other medicines or any other substances, such as foods, preservatives or dyes.

Tell your doctor if you are pregnant or plan to become pregnant. Your doctor will discuss the possible risks and benefits of using Ciloquin during pregnancy.

Tell your doctor if you are breastfeeding. Your doctor will discuss the possible risks and benefits of using Ciloquin when you are breastfeeding.

If you have not told your doctor about any of the above, tell him/ her before you use Ciloquin Eye Drops.

Taking or using other medicines

Tell your doctor or pharmacist if you are taking or using any other medicines, including other eye drops or ointments, and any other medicines that you buy without a prescription from a pharmacy, supermarket or health food shop.

Some medicines and ciprofloxacin may interfere with each other.

Tell your doctor if you are taking any of the following:

  • medicines to thin your blood e.g. warfarin
  • medicines to prevent tissue rejection e.g. cyclosporin
  • theophylline for asthma or breathing problems
  • caffeine for the treatment of migraines.

Your doctor and pharmacist will have more information on medicines to be careful with or avoid while using this medicine.

How to use Ciloquin

Carefully follow all directions given to you by your doctor and pharmacist. They may differ from the information contained in this leaflet.

If you are being changed from one medicine to another, follow your doctor's instructions carefully as to when to stop the medicine and when to start the new eye drops.

If you do not understand the instructions on the carton / bottle, ask your doctor or pharmacist for help.

How much to use

The usual dose to treat corneal ulcers is:

Day 1

2 drops in the affected eye(s) every 15 minutes for the first 6 hours.

2 drops in the affected eye(s) every 30 minutes for the remainder of the first day.

Day 2

2 drops in the affected eye(s) every 60 minutes.

Days 3 to 14

2 drops in the affected eye(s) every 4 hours.

Your doctor may continue treatment with Ciloquin Eye Drops until the surface of your eye (cornea) is completely healed.

The usual dose to treat bacterial conjunctivitis is:

Days 1 and 2

One drop in the affected eye(s) every 2 hours while you are awake.

Days 3 to 7

1 drop in the affected eye(s) every 4 hours while you are awake.

Your doctor will tell you how many drops you need to use each day.

These dosing instructions will be printed on the label your pharmacist puts on the bottle or carton.

How to use it

It is important to use Ciloquin exactly as your doctor or pharmacist has told you. If you use the drops less often than your doctor has advised, your medicine may not work as well and your eye problem may not improve. If you use the drops more often than your doctor has advised, your eye problem may not improve any faster and this may increase the incidence of side effects.

If you are wearing soft contact lenses, remove them before putting the drops in your eye.

Follow these steps to use the eye drops:

  1. Wash your hands thoroughly with soap and water.
  2. Immediately before using a bottle for the first time, break the safety seal around the neck area and throw the loose plastic ring away.
  3. Shake the bottle.
  4. Remove the cap from the bottle.
  5. Hold the bottle upside down in one hand between your thumb and middle finger (see Diagram1).

  1. While tilting your head back, gently pull down the lower eyelid of your eye to form a pouch/pocket.
  2. Place the tip of the bottle close to your eye. Do not let it touch your eye.
  3. Release one drop into the pouch/pocket formed between your eye and eyelid by gently tapping or pressing the base of the bottle with your forefinger (see Diagram 2 and 3).

  1. Close your eye. Do not blink or rub your eye.
  2. While your eye is closed, place your index finger against the inside corner of your eye and press against your nose for about two minutes. This will help to stop the medicine from draining through the tear duct to the nose and throat, from where it can be absorbed into other parts of your body. This will also reduce the unpleasant taste sensation that some people experience when using these drops.
  3. If necessary, repeat the above steps for the other eye.
  4. Your eyelids can only hold less than one drop at a time, so it is normal for a small amount of the eye drop to spill onto your cheek. You should wipe away any spillage with a tissue.
  5. Replace the cap on the bottle, closing it tightly.
  6. Wash your hands again with soap and water to remove any residue.

You may feel a slight burning sensation in the eye shortly after using Ciloquin Eye Drops. If this persists, or is very uncomfortable, contact your doctor or pharmacist.

Be careful not to touch the dropper tip against your eye, eyelid or anything else. This will help to prevent your eye drops becoming dirty or contaminated.

After using Ciloquin Eye Drops wait at least 5 minutes before putting any other eye drops in your eye(s).

When to use it

Use Ciloquin Eye Drops every day, at about the same times each day unless your doctor tells you otherwise. Using your eye drops at the same times each day will help to treat your eye infection.

It will also help you remember when to use the eye drops.

How long to use it

Continue using your medicine for as long as your doctor tells you.

As Ciloquin Eye Drops start to kill the bacteria that are causing the infection in your eye(s) you will start to feel better. However, it is very important that you continue to use Ciloquin Eye Drops for the full treatment period advised by your doctor to ensure that the infection does not return.

If you are unsure about when to stop using Ciloquin Eye Drops you should talk to your doctor or pharmacist.

If you forget to use it

If you forget to use Ciloquin Eye Drops you should put the drops that you missed in as soon as you remember and then go back to using them as recommended by your doctor.

If it is almost time for your next dose, skip the dose that you have missed and continue to use them as recommended.

Do not use double the amount to make up for the dose that you missed. Using multiple doses may cause unwanted side effects.

If you are not sure whether to skip the dose, talk to your doctor or pharmacist.

If you are having trouble remembering to use the medicine, ask your pharmacist for some hints.

If you use too much (overdose)

If you accidentally put too many drops in your eye(s), immediately rinse your eye(s) with warm water.

If you think that you or anyone else may have swallowed any or all of the contents of a bottle of Ciloquin, immediately telephone your doctor or the Poisons Information Centre on 13 11 26 for advice, or go to Accident and Emergency at your nearest hospital. Do this even if there are no signs of discomfort or poisoning.

While you are using Ciloquin

Things you must do

Tell your doctor if, for any reason, you have not used Ciloquin Eye Drops exactly as prescribed. Otherwise your doctor may think that the eye drops were not effective and change the treatment unnecessarily.

If you become pregnant while you are using this medicine, tell your doctor immediately.

Tell all the doctors, dentists and pharmacists who are treating you that you are using Ciloquin.

If you are about to be started on any new medicine, remind your doctor or pharmacist that you are using Ciloquin Eye Drops.

Things you must not do

Do not use Ciloquin Eye Drops to treat other complaints unless your doctor tells you to.

Do not give this medicine to anyone else, even if they appear to have the same condition as you.

Do not stop using Ciloquin Eye Drops or lower the dose without first asking your doctor.

Do not let children handle Ciloquin Eye Drops.

Things to be careful of

Be careful driving or operating machinery until you know how Ciloquin Eye Drops affect you and your vision. As with any eye medicines, temporary blurred vision or other visual disturbances may affect the ability to drive or use machinery in some people. If blurred vision occurs when you use your drops, wait until your vision is clear before driving or operating machinery.

Side Effects

Tell your doctor as soon as possible if you do not feel well while you are using Ciloquin Eye Drops.

This medicine helps most people with an eye infection but it may have unwanted side effects in a few people. All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.

Do not be alarmed by the following list of possible side effects. You may not experience any of them.

Most side effects from Ciloquin Eye Drops occur in, or around, the eye.

These include:

  • Redness, itching, irritation, pain, swelling or discomfort in or around the eye(s) and/or eyelids
  • A white precipitate in the eye(s) or crusting on the eyelid(s)
  • Excess tear production or discharge from the eye(s)
  • Dry eye(s)
  • Staining, swelling or irregular appearance of the front of the eye(s) (cornea)
  • Flaking skin of the eyelids
  • A numb sensation in or around the eye(s)
  • Tired eyes
  • Allergic reactions
  • A feeling that something is in your eye(s)
  • Decreased or blurred vision
  • Double vision
  • Sensitivity to light.

These are the most common side effects of your medicine. They are usually mild and short lived.

Occasionally some people notice unwanted effects in the rest of their body as a result of using Ciloquin Eye Drops. These effects may include:

  • Bad taste in the mouth following the use of Ciloquin Eye Drops
  • Nausea
  • Diarrhoea or abdominal pain
  • Headache
  • Dizziness
  • Ear pain
  • Increased drainage from the sinuses
  • Skin inflammation.

If you are over 65 years of age and taking inflammatory inhibiting medicines similar to cortisone, you have a higher risk of getting tendon problems during treatment with Ciloquin Eye Drops. If this occurs, stop treatment and immediately consult your doctor.

If any of the following happen, stop using Ciloquin Eye Drops and tell your doctor immediately or go to Accident and Emergency at your nearest hospital:

  • skin rash
  • swelling of face, hands or feet
  • wheezing, difficulty in breathing
  • shortness of breath
  • severe and sudden onset of pinkish, itchy swellings on the skin, also called hives or nettle rash.

These hypersensitivity reactions can be very serious side effects. You may need urgent medical attention or hospitalisation. These side effects are very rare.

Tell your doctor or pharmacist if you notice anything that is making you feel unwell.

Other side effects not listed above may also occur in some people.

After using Ciloquin

Storage

Store Ciloquin Eye Drops in a cool dry place, where the temperature stays below 25°C. Do not refrigerate or freeze. Protect from light.

Do not store Ciloquin Eye Drops or any other medicine in the car, the bathroom or any other warm, damp place. Heat and dampness can destroy some medicines.

Do not leave the top off the bottle for any length of time, to avoid contaminating the eye drops.

Keep it out of the sight and reach of children. A locked cupboard at least one-and-half metres above the ground is a good place to store medicines.

Disposal

Write the date on the bottle when you open the eye drops and throw out any remaining solution after four weeks. Eye drops contain a preservative which helps prevent germs growing in the solution for the first four weeks after opening the bottle. After this time there is a greater risk that the drops may become contaminated and cause an eye infection. A new bottle should then be used.

If your doctor tells you to stop using Ciloquin Eye Drops or they have passed their expiry date, ask your pharmacist what to do with the remaining solution.

Product description

What it looks like

Ciloquin Eye Drops are a sterile liquid supplied in a pack containing one 5mL dropper bottle with screw cap.

Tamper evidence is provided with a safety seal around the neck area of the bottle.

Ingredients

The active ingredient in Ciloquin Eye Drops is ciprofloxacin (base) 3mg in 1 mL.

Ciloquin Eye Drops also contain:

  • Benzalkonium chloride (0.06mg/mL) as a preservative)
  • Sodium acetate
  • Acetic acid
  • Mannitol
  • Disodium edetate
  • Purified water
  • Hydrochloric acid and/or sodium hydroxide to adjust pH.

Supplier

This product is supplied by:

Novartis Pharmaceuticals Australia Pty Limited
ABN 18 004 244 160
54 Waterloo Road
Macquarie Park NSW 2113
Telephone: 1800 671 203
Web Site: www.novartis.com.au

Australian registration number

AUST R No. 66567

Date of preparation

This leaflet was prepared in October 2023.

© Novartis Pharmaceuticals Australia Pty Limited 2021.

® Registered trademark

Internal document code:
(cil_eye261023c) based on PI (cil_eye261023i)

Published by MIMS December 2023

BRAND INFORMATION

Brand name

Ciloquin

Active ingredient

Ciprofloxacin

Schedule

S4

 

1 Name of Medicine

Ciprofloxacin hydrochloride.

2 Qualitative and Quantitative Composition

Ciloquin Eye Drops contain ciprofloxacin hydrochloride (equivalent of 3 mg/mL ciprofloxacin base).
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Ciloquin Eye Drops is a sterile, multiple-dose product, for topical ophthalmic use.

4 Clinical Particulars

4.1 Therapeutic Indications

Treatment of bacterial keratitis (infected corneal ulcers) and severe bacterial conjunctivitis caused by organisms susceptible to ciprofloxacin in adults and children 12 months of age or older.

4.2 Dose and Method of Administration

The recommended dosage regimen for the treatment of corneal ulcers is: two drops into the affected eye every 15 minutes for the first six hours and then two drops into the affected eye every 30 minutes for the remainder of the first day. On the second day, instil two drops in the affected eye hourly. On the third through the fourteenth day, place two drops in the affected eye every four hours. Treatment may be continued after 14 days if corneal re-epithelialization has not occurred.
The recommended dosage regimen for the treatment of bacterial conjunctivitis is: one drop instilled into the conjunctival sac(s) every two hours while awake for two days and one drop every four hours while awake for the next five days.

4.3 Contraindications

A history of hypersensitivity to ciprofloxacin or any other component of the medication is a contraindication to its use. A history of hypersensitivity to other quinolones, including nalidixic acid, may also contraindicate the use of ciprofloxacin.

4.4 Special Warnings and Precautions for Use

For topical use only - not for injection.
For ocular use only.

Identified precautions.

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. Only a few patients had a history of hypersensitivity reactions. Serious anaphylactic reactions require immediate emergency treatment with adrenaline and other resuscitation measures, including oxygen, intravenous fluids, intravenous antihistamines, corticosteroids, pressor amines and airway management, as clinically indicated.
Moderate to severe phototoxicity manifested by an exaggerated sunburn reaction has been observed in some patients who were exposed to direct sunlight while receiving some members of the quinolone class of drugs, including oral ciprofloxacin. Excessive sunlight should be avoided.

General.

As with other antibacterial preparations, prolonged use of ciprofloxacin may result in overgrowth of nonsusceptible organisms, including fungi. If superinfection occurs, appropriate therapy should be initiated. When using Ciloquin Eye Drops one should take into account the risk of a rhinopharyngeal passage which can contribute to the occurrence and the diffusion of bacterial resistance.
Whenever clinical judgment dictates, the patient should be examined with the aid of magnification, such as slit lamp biomicroscopy and, where appropriate, fluorescein staining. Ciprofloxacin should be discontinued at the first appearance of a skin rash or any other sign of hypersensitivity reaction.
Tendon inflammation and rupture may occur with systemic fluoroquinolone therapy including ciprofloxacin, particularly in elderly patients and in those treated concurrently with corticosteroids. Therefore treatment with Ciloquin 0.3% eye drops should be discontinued at the first sign of tendon inflammation.
Ciloquin Eye Drops contains benzalkonium chloride which may cause irritation and is known to discolour soft contact lenses. 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 Ciloquin Eye Drops. In clinical studies of patients with bacterial corneal ulcer a white crystalline precipitate located in the superficial portion of the corneal defect was observed in 35 (16.6%) of 210 patients. The onset of the precipitate was within 24 hours to 7 days after starting therapy. In one patient, the precipitate was immediately irrigated out upon its appearance. In 17 patients, resolution of the precipitate was seen in 1 to 8 days (seven within the first 24-72 hours); in five patients, resolution was noted in 10-13 days. In nine patients, exact resolution days were unavailable, however, at follow up examinations, 18-44 days after onset of the event, complete resolution of the precipitate was noted. In three patients, outcome information was unavailable. The precipitate did not preclude continued use of ciprofloxacin, nor did it adversely affect the clinical course of the ulcer or visual outcome (see Section 4.8 Adverse Effects (Undesirable Effects)).

Use in the elderly.

No data available.

Paediatric use.

Safety and effectiveness in children below the age of 1 year particularly in neonates is very limited and have not been established. Although ciprofloxacin and other quinolones cause arthropathy in immature animals after oral administration, topical ocular administration of ciprofloxacin to immature animals did not cause any arthropathy, and there is no evidence that the ophthalmic dosage form has any effect on the weight bearing joints.
Use of Ciloquin Eye Drops in neonates with ophthalmia neonatorum of gonococcal or chlamydial origin is not recommended as it has not been evaluated in such patients. Neonates with ophthalmia neonatorum should receive appropriate treatment for their condition.

Effects on laboratory tests.

See Section 4.8 Adverse Effects (Undesirable Effects), Postmarketing events, Investigations.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Specific drug interaction studies have not been conducted with ophthalmic ciprofloxacin. However, the systemic administration of some quinolones has been shown to elevate plasma concentrations of theophylline, interfere with the metabolism of caffeine, enhance the effects of the oral anticoagulant warfarin and its derivatives and have been associated with transient elevations in serum creatinine in patients receiving ciclosporin concomitantly.
Given the low systemic concentration of ciprofloxacin following topical ocular administration, drug interactions are unlikely to occur.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

Studies have not been performed in humans to evaluate the effect of topical administration of ciprofloxacin on fertility.
(Category B3)
Reproduction studies have been performed in rats and mice at doses up to six times the usual daily human oral dose and have revealed no evidence of impaired fertility or harm to the fetus due to ciprofloxacin. In rabbits, as with most antimicrobial agents, ciprofloxacin (30 and 100 mg/kg orally) produced gastrointestinal disturbances resulting in maternal weight loss and an increased incidence of abortion. No teratogenicity was observed at either dose. After intravenous administration at doses up to 20 mg/kg, no maternal toxicity was produced and no embryotoxicity or teratogenicity was observed. There are no adequate and well controlled studies in pregnant women. As a precautionary measure, it is preferable to avoid the use of Ciloquin during pregnancy. Ciprofloxacin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
 It is not known whether topically applied ciprofloxacin is excreted in human milk, however, it is known that orally administered ciprofloxacin is excreted in the milk of lactating rats, and oral ciprofloxacin has been reported in human breast milk after a single 500 mg dose. Caution should be exercised when ciprofloxacin is administered to a nursing mother.

4.7 Effects on Ability to Drive and 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.

4.8 Adverse Effects (Undesirable Effects)

The most frequently reported drug related adverse reaction was local burning or discomfort. In corneal ulcer studies with frequent administration of the drug, white crystalline precipitates were seen in approximately 17% of patients (see Section 4.4 Special Warnings and Precautions for Use).
Tabulated adverse reaction data (considered to be related or possibly related to treatment), providing comparisons to placebo and other active comparators (to an incidence of 1% or greater in the ciprofloxacin eye drops 0.3% treatment group), which have been generated from all adult clinical studies with ciprofloxacin eye drops 0.3% are provided in Table 1.
Uncommon ophthalmic events (occurring in less than 1% and greater than 0.1% of patients) included lid margin crusting, crystals/ scales, dryness/ dry eye, discharge, corneal staining, keratopathy/ keratitis, tearing, photophobia, pain, vision decrease, chemosis, corneal infiltrates, inflammation, blurred vision, corneal toxicity, allergy, intolerance, lid oedema, heavy sensation, swelling, conjunctival reaction, numbing sensation, conjunctivitis, punctate epithelial erosion and progression of infiltrate.
Uncommon systemic events (occurring in less than 1% and greater than 0.1% of patients) included nausea and sinus drainage.

Postmarketing events.

The following adverse reactions are classified according to the following convention: very common, common, uncommon, rare, very rare, or not known (cannot be estimated from the available data), according to system organ classes. Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. The adverse reactions have been observed during clinical trials and postmarketing experience.

Infections and infestations.

Rare (> 0.01% to ≤ 0.1%): hordeolum, rhinitis.

Immune system disorders.

Rare (> 0.01% to ≤ 0.1%): hypersensitivity.

Nervous system disorders.

Common (> 1% to < 10%): dysgeusia.
Uncommon (> 0.1% to ≤ 1%): headache.
Rare (> 0.01% to ≤ 0.1%): dizziness.

Eye disorders.

Common (> 1% to < 10%): corneal deposits, ocular discomfort, ocular hyperaemia.
Uncommon (> 0.1% to ≤ 1%): keratopathy, corneal infiltrates, corneal staining, photophobia, visual acuity reduced, eyelid oedema, blurred vision, eye pain, dry eye, eye swelling, eye pruritus, foreign body sensation in eyes, lacrimation increased, eye discharge, eyelid margin crusting, eyelid exfoliation, conjunctival oedema, erythema of eyelid.
Rare (> 0.01% to ≤ 0.1%): ocular toxicity, punctate keratitis, keratitis, conjunctivitis, corneal disorder, corneal epithelium defect, diplopia, hypoaesthesia eye, asthenopia, eye irritation, eye inflammation, conjunctival hyperaemia.

Ear and labyrinth disorders.

Rare (> 0.01% to ≤ 0.1%): ear pain.

Respiratory, thoracic and mediastinal disorders.

Rare (> 0.01% to ≤ 0.1%): paranasal sinus hypersecretion.

Gastrointestinal disorders.

Uncommon (> 0.1% to ≤ 1%): nausea.
Rare (> 0.01% to ≤ 0.1%): diarrhoea, abdominal pain.

Skin and subcutaneous tissue disorders.

Rare (> 0.01% to ≤ 0.1%): dermatitis.

General disorders and administration site conditions.

Rare (> 0.01% to ≤ 0.1%): drug intolerance.

Investigations.

Rare (> 0.01% to ≤ 0.1%): laboratory test abnormal.
Additional adverse reactions identified from postmarketing surveillance include the following.
Frequencies cannot be estimated from the available data.

Musculoskeletal and connective tissue disorders.

Tendon disorder.
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 postmarketing 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 postmarketing data have not demonstrated a clear association between Ciloquin and musculoskeletal and connective tissue adverse reactions.
In patients with corneal ulcer and frequent administration of Ciloquin, white topical ocular precipitates (medication residue) have been observed which resolved after continued application of Ciloquin. The precipitate does not preclude the continued use of Ciloquin, nor does it adversely affect the clinical course of the recovery process.
The incidence of adverse events to marketed drugs such as Ciloquin Eye Drops is difficult to reliably assess due to the nature of spontaneous, voluntary reporting systems and the problems associated with estimating the total exposure to the drug. Postmarketing data must also be evaluated in the knowledge that causality may be difficult or impossible to establish.
The most common adverse events reported in the postmarketing period for ciprofloxacin eye drops 0.3% were precipitate in the eye, eye discomfort, nonspecific ocular irritation and foreign body sensation. No adverse events were reported at an incidence greater than 1:100,000.

Reporting suspected adverse effects.

Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions at www.tga.gov.au/reporting-problems.

4.9 Overdose

A topical overdose of Ciloquin Eye Drops may be flushed from the eye(s) with warm tap water. Accidental oral ingestion of Ciloquin is not likely to be associated with toxicity.
Treatment of any exposure is symptomatic and supportive.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Microbiology. Ciprofloxacin has in vitro activity against a wide range of Gram negative and Gram positive organisms.
The bactericidal action of ciprofloxacin results from interference with the enzyme DNA gyrase which is needed for the synthesis of bacterial DNA.
Ciprofloxacin has been shown to be active against most strains of the following organisms both in vitro and in clinical infections (see Section 4.1 Therapeutic Indications).

Gram positive.

Staphylococcus aureus (including methicillin susceptible and methicillin resistant strains); Staphylococcus epidermidis; Streptococcus pneumoniae; Viridans group of Streptococcus.

Gram negative.

Pseudomonas aeruginosa; Serratia marcescens; Haemophilus influenzae.

Other organisms.

Most strains of Pseudomonas cepacia and some strains of Pseudomonas maltophilia are resistant to ciprofloxacin as are most anaerobic bacteria, including Bacteroides fragilis and Clostridium difficile.
The minimal bactericidal concentration (MBC) generally does not exceed the minimal inhibitory concentration (MIC) by more than a factor of 2. Resistance to ciprofloxacin in vitro usually develops slowly (multiple step mutation).
Ciprofloxacin does not cross react with other antimicrobial agents such as beta-lactams or aminoglycosides, therefore, organisms resistant to these drugs may be susceptible to ciprofloxacin.

Clinical trials.

Following therapy with ciprofloxacin eye drops 76% of the patients with corneal ulcers and positive bacterial cultures were clinically cured and complete re-epithelialization occurred in about 92% of the ulcers. In 3 and 7 day multicentre clinical trials, 52% of the patients with conjunctivitis and positive conjunctival cultures were clinically cured and 70-80% had all causative pathogens eradicated by the end of treatment.

5.2 Pharmacokinetic Properties

Absorption.

A systemic absorption study was performed in which Ciloquin Eye Drops were administered in each eye every two hours while awake for two days followed by every four hours while awake for an additional 5 days. The maximum reported plasma concentration of ciprofloxacin was less than 5 nanogram/mL. The mean concentration was usually less than 2.5 nanogram/mL.

5.3 Preclinical Safety Data

Animal pharmacology.

Ciprofloxacin and related drugs have been shown to cause arthropathy in immature animals of most species tested following oral administration. However, a one month topical ocular study using immature beagle dogs did not demonstrate any articular lesions.

Genotoxicity.

Eight in vitro mutagenicity tests have been conducted with ciprofloxacin and the test results are listed below:
Salmonella microsome test (negative).
E. coli DNA repair assay (negative).
Mouse lymphoma cell forward mutation assay (positive).
Chinese hamster V79 cell HGPRT test (negative).
Syrian hamster embryo cell transformation assay (negative).
Saccharomyces cerevisiae point mutation assay (negative).
Saccharomyces cerevisiae mitotic crossover and gene conversion assay (negative).
Rat hepatocyte DNA repair assay (positive).
Thus, two of the eight tests were positive, but the results of the following three in vivo test systems gave negative results:
Rat hepatocyte DNA repair assay.
Micronucleus test (mice).
Dominant lethal test (mice).

Carcinogenicity.

Carcinogenicity studies in mice (oral doses up to 1090 mg/kg/day and 1455 mg/kg/day in males and females, respectively) and rats (oral doses up to 241 mg/kg/day and 328 mg/kg/day in males and females, respectively) showed no evidence of carcinogenicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

Ciloquin Eye Drops also contain sodium acetate, glacial acetic acid, mannitol, disodium edetate, hydrochloric acid and/or sodium hydroxide (to adjust pH), purified water and benzalkonium chloride (0.06 mg/mL) as preservative.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Store below 25°C. Do not refrigerate or freeze. Protect from light.
Discard container 4 weeks after opening.

6.5 Nature and Contents of Container

As a sterile ophthalmic solution 5 mL in plastic bottle.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of in accordance with local requirements.

6.7 Physicochemical Properties

Ciprofloxacin, a faint to light yellow crystalline powder which is soluble in water, is a fluoroquinolone antibacterial active against a broad spectrum of gram positive and gram negative ocular pathogens.
The pH of Ciloquin Eye Drops is approximately 4.5 and the osmolality is approximately 300 m0sm.

Chemical structure.

The chemical structure of ciprofloxacin hydrochloride is represented as:

Chemical name.

The monohydrochloride monohydrate salt of 1-cyclopropyl-6-fluoro- 1,4-dihydro-4-oxo- 7-piperazin-1-ylquinoline- 3-carboxylic acid.

Empirical formula.

C17H18FN3O3.HCl.H2O.

Molecular weight.

385.8.

CAS number.

86393-32-0.

7 Medicine Schedule (Poisons Standard)

Prescription Only Medicine (Schedule 4).

Summary Table of Changes