Consumer medicine information

Ciproxin HC

Ciprofloxacin; Hydrocortisone

BRAND INFORMATION

Brand name

Ciproxin HC Ear Drops

Active ingredient

Ciprofloxacin; Hydrocortisone

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Ciproxin HC.

SUMMARY CMI

Ciproxin® HC Ear Drops

Consumer Medicine Information (CMI) summary

The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist.

1. Why am I using Ciproxin HC Ear Drops?

Ciproxin HC Ear Drops contains the active ingredients ciprofloxacin hydrochloride and hydrocortisone. Ciproxin HC Ear Drops are used to treat acute bacterial otitis externa (acute infection of the outer ear caused by bacteria) in adults and children aged 2 years and older.

For more information, see Section 1. Why am I using Ciproxin HC Ear Drops? in the full CMI.

2. What should I know before I use Ciproxin HC Ear Drops?

Do not use if you have ever had an allergic reaction to Ciproxin HC Ear Drops or any of the ingredients listed at the end of the CMI.

Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.

For more information, see Section 2. What should I know before I use Ciproxin HC Ear Drops? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with Ciproxin HC Ear Drops and affect how it works.

A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I use Ciproxin HC Ear Drops?

  • Put three drops in the affected ear(s) twice daily for seven days.
  • Follow the instructions provided by your doctor and use Ciproxin HC Ear Drops carefully.

More instructions can be found in Section 4. How do I use Ciproxin HC Ear Drops? in the full CMI.

5. What should I know while using Ciproxin HC Ear Drops?

Things you should do
  • Remind any doctor, dentist or pharmacist or specialist you visit that you are using Ciproxin HC Ear Drops.
  • Tell your doctor immediately if you develop any signs of an allergic reaction.
  • Avoid direct exposure to sunlight during treatment with Ciproxin HC Ear Drops.
Things you should not do
  • Do not stop using this medicine suddenly.
  • Do not use it in children less than 2 years of age.
  • Do not give Ciproxin HC Ear Drops to anyone else, even if they seem to have the same condition as you.
Driving or using machines
  • Be careful before you drive or use any machines or tools until you know how Ciproxin HC Ear Drops affect you.
Looking after your medicine
  • Store below 25°C. Do not refrigerate or freeze.
  • Do not leave the top off the bottle for any length of time. Put the top back on the bottle immediately after use to avoid any contamination.

For more information, see Section 5. What should I know while using Ciproxin HC Ear Drops? in the full CMI.

6. Are there any side effects?

Common side effects include ear pain, itching in ear, uncomfortable feeling in ear, fever, dizziness, buzzing, hissing, whistling, ringing or other persistent noise in the ear, headache.

For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.



FULL CMI

Ciproxin® HC Ear Drops

Active ingredient(s): ciprofloxacin hydrochloride and hydrocortisone

Consumer Medicine Information (CMI)

This leaflet provides important information about using Ciproxin HC Ear Drops. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using Ciproxin HC Ear Drops.

Where to find information in this leaflet:

1. Why am I using Ciproxin HC Ear Drops?
2. What should I know before I use Ciproxin HC Ear Drops?
3. What if I am taking other medicines?
4. How do I use Ciproxin HC Ear Drops?
5. What should I know while using Ciproxin HC Ear Drops?
6. Are there any side effects?
7. Product details

1. Why am I using Ciproxin HC Ear Drops?

Ciproxin HC Ear Drops contain the active ingredients ciprofloxacin hydrochloride and hydrocortisone. Ciprofloxacin hydrochloride belongs to class of medicines called fluoroquinolone which are used to treat different types of infections caused by bacteria. Hydrocortisone is a steroid which helps to reduce swelling, pain and redness.

Ciproxin HC Ear Drops are used to treat acute bacterial otitis externa in adults and children aged 2 years and older. It is the acute infection of the outer ear caused by bacteria. Symptoms include ear pain and swelling. Ciproxin HC Ear Drops help to kill the bacteria that causes infection and decrease the symptoms of otitis externa. Ciproxin HC Ear Drops do not work against infections caused by viruses or fungus.

2. What should I know before I use Ciproxin HC Ear Drops?

Warnings

Do not use Ciproxin HC Ear Drops:

  • If you are allergic to ciprofloxacin hydrochloride and hydrocortisone, or any of the ingredients listed at the end of this leaflet.
    Always check the ingredients to make sure you can use this medicine.
  • If you are allergic to other quinolone antibiotics e.g. nalidixic acid, Levaquin.
    Symptoms of allergic reaction may include: shortness of breath, difficulty breathing, swelling of the face, lips, tongue or other parts of the body, rash, hives.
  • If you have any ear problems such as ear drum rupture (symptoms such as ear pain, dizziness, hearing loss).
  • If you have been treated for a condition called Necrotising malignant otitis externa (severe ear infection).
  • If you suffer from any viral or fungal ear infection.

Check with your doctor if you:

  • have any other medical conditions such as diabetes
  • take any medicines for any other condition
  • are allergic to natural rubber (latex) since the dropper cap contains it.
  • have any eye problems such as blurred vision.

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.

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

Check with your doctor if you are pregnant or intend to become pregnant.

Your doctor will advise you regarding the possible risks and benefits of using Ciproxin HC Ear Drops during pregnancy.

Talk to your doctor if you are breastfeeding or intend to breastfeed.

Your doctor will advise you regarding the possible risks and benefits of using Ciproxin HC Ear Drops during breast feeding.

3. What if I am taking other medicines?

Tell your doctor or pharmacist if you are taking any other medicines, including any other ear drops, medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.

Some medicines may interfere with Ciproxin HC Ear Drops and affect how it works.

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect Ciproxin HC Ear Drops.

4. How do I use Ciproxin HC Ear Drops?

How much to use

For children (age 2 and above) and adults:

  • Put three drops in the affected ear(s) twice daily for seven days.
  • Follow the instructions provided when Ciproxin HC Ear Drops were prescribed, including the number of days it should be taken.
  • Ask your doctor or pharmacist if you do not understand your dose.

When to use Ciproxin HC Ear Drops

  • Ciproxin HC Ear Drops should be used at the same time every day unless your doctor tells you otherwise.

How to use Ciproxin HC Ear Drops

  • Follow the instructions provided by your doctor and use Ciproxin HC Ear Drops carefully.

Below are steps to use Ciproxin HC Ear Drops:

  • Wash your hands thoroughly.
  • To open a new bottle of Ciproxin HC Ear Drops, remove the cap and replace it with the dropper cap supplied in the carton. Your pharmacist may have already done this for you.
  • Do not touch the dropper tip with your fingers or to your ear or any other surface. This will help prevent the ear drops getting contaminated.
  • Shake the bottle well prior to use.
  • Put Ciproxin HC Ear Drops in a sitting or lying down position with the affected ear turned upwards (see Diagram 1).

  • Gently squeeze the bulb on the dropper cap to draw up the liquid into the dropper.
  • Put the tip of the dropper close to the ear and gently squeeze three drops into the ear (see Diagram 2).

  • Hold the head in the same position for about 30-60 seconds. This will help the drops to reach deeper into the ear (see Diagram 3).

  • Repeat the above steps for the other ear if necessary.
  • There might be a slightly unpleasant feeling since the drops flow all the way into the ear. If it persists, or is very uncomfortable, contact your doctor or pharmacist immediately.

If you forget to use Ciproxin HC Ear Drops

Ciproxin HC Ear Drops should be used regularly at the same time each day. If you miss your dose at the usual time, put the drops that you missed in the ear(s) 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 you missed and take your next dose when you are meant to.

Do not take a double dose to make up for the dose you missed.

If you use too much Ciproxin HC Ear Drops

If you think that you have used too much Ciproxin HC Ear Drops, you may need urgent medical attention.

You should immediately:

  • phone the Poisons Information Centre
    (by calling 13 11 26), or
  • contact your doctor, or
  • go to the Emergency Department at your nearest hospital.

You should do this even if there are no signs of discomfort or poisoning.

5. What should I know while using Ciproxin HC Ear Drops?

Things you should do

Avoid direct exposure to sunlight as it may cause moderate to severe phototoxicity (increased sensitivity of the skin to sun having symptoms such as redness, itching, swelling)

Call your doctor straight away if you:

  • develop any signs of allergic reaction.
  • become pregnant or if you are breast feeding while using Ciproxin HC Ear Drops.
  • have any ear problems e.g. ear drum rupture (having symptoms such as ear pain, dizziness, hearing loss).
  • suffer from any eye problems such as blurred vision.
  • are taking any other medicines for any other medical conditions.

Remind any doctor, dentist, pharmacist or specialist you visit that you are using Ciproxin HC Ear Drops.

Things you should not do

  • Do not stop using this medicine suddenly.
  • Do not use it in children less than 2 years of age.
  • Do not give Ciproxin HC Ear Drops to anyone else, even if they seem to have the same condition as you.
  • Do not use it in your eyes. Ciproxin HC Ear Drops are only for ear use.
  • Do not use Ciproxin HC Ear Drops just before having a bath, shower or going swimming.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how Ciproxin HC Ear Drops affect you.

Looking after your medicine

Follow the instructions in the carton on how to take care of your medicine properly.

Store below 25°C.

Do not refrigerate or freeze.

Do not leave the top off the bottle at any time, to avoid contaminating the ear drops.

Store it in a cool dry place away from moisture, heat or sunlight; for example, do not store it:

  • in the bathroom or near a sink, or
  • in the car or on window sills.

Keep it where young children cannot reach it.

When to discard your medicine

Discard any remaining Ciproxin HC Ear Drops solution after 14 days after opening it.

Getting rid of any unwanted medicine

If you no longer need to use this medicine or it is out of date, take it to any pharmacy for safe disposal.

Do not use this medicine after the expiry date.

6. Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.

Less serious side effects

Less serious side effectsWhat to do
General problems
  • Rash
  • Feeling of tingling or numbness
  • Itching
  • Hives
  • Headache
  • Fever
  • Feeling sick
  • Dizziness
  • Blurred vision or other eye problems
  • Fungal nail infection
Ear problems:
  • Ear pain
  • Uncomfortable feeling in ear
  • Sensation of fullness of the ear
  • Itching in ear
Speak to your doctor if you have any of these less serious side effects and they worry you.

Serious side effects

Serious side effectsWhat to do
Ear problems:
  • Partial loss of hearing
  • Buzzing, hissing, whistling, ringing or other persistent noise in the ear
  • Medication residue (white material remaining in the ear while using Ciproxin HC Ear Drops without or with symptoms such as uncomfortable feeling in ear, hearing disorders, ear pain)
  • Infection of the outer ear (otitis externa) of the non-treated ear
  • Infection of the middle ear (symptoms: temporary hearing loss and pain, earache)
Call your doctor straight away, or go straight to the Emergency Department at your nearest hospital if you notice any of these serious side effects.

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.

Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.

7. Product details

This medicine is only available with a doctor's prescription.

What Ciproxin HC Ear Drops contains

Active ingredients
(main ingredients)		Ciprofloxacin hydrochloride and Hydrocortisone.
Other ingredients
(inactive ingredients)		polysorbate 20, sodium acetate, acetic acid-glacial, sodium chloride, hydrogenated soy phosphatidylcholine, polyvinyl alcohol, water-purified, soya bean products
Potential allergensbenzyl alcohol and, soya bean products

Do not take this medicine if you are allergic to any of these ingredients.

What Ciproxin HC Ear Drops looks like

Ciproxin HC Ear Drops are supplied as a non-sterile, slightly viscous white to off-white opaque suspension in a 10 mL bottle with a separately wrapped non-sterile dropper assembly.

Who distributes Ciproxin HC Ear Drops

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. 136662

This leaflet was prepared in April 2025.

Internal document code:
(cip130619c_v2) based on PI (cip130619i)

Published by MIMS July 2025

BRAND INFORMATION

Brand name

Ciproxin HC Ear Drops

Active ingredient

Ciprofloxacin; Hydrocortisone

Schedule

S4

 

1 Name of Medicine

Ciprofloxacin hydrochloride and hydrocortisone.

2 Qualitative and Quantitative Composition

Ciproxin HC Ear Drops contains 2.33 mg/mL ciprofloxacin hydrochloride (corresponding to 2.0 mg/mL ciprofloxacin), 10 mg/mL hydrocortisone and 9.0 mg/mL benzyl alcohol as preservative.
Ciproxin HC Ear Drops contain benzyl alcohol as a preservative. Other excipients are: polysorbate 20, sodium acetate, acetic acid-glacial, sodium chloride, hydrogenated soy phosphatidylcholine, polyvinyl alcohol, water-purified. Ciproxin HC Ear Drops contain soya bean products.

3 Pharmaceutical Form

Ciproxin HC Ear Drops is supplied as a non-sterile, slightly viscous white to off-white opaque suspension in a 10 mL bottle with acetous odour with a separately wrapped non-sterile dropper assembly.

4 Clinical Particulars

4.1 Therapeutic Indications

Ciproxin HC Ear Drops are indicated for the treatment of acute bacterial otitis externa, caused by organisms susceptible to ciprofloxacin (see Section 5 Pharmacological Properties), in adults and children aged 2 years and older.

4.2 Dose and Method of Administration

For children (age 2 and older) and adults.

Three drops of the suspension (equivalent to about 0.09 mL Ciproxin HC Ear Drops containing 0.18 mg ciprofloxacin and 0.9 mg hydrocortisone) should be instilled into the affected ear twice daily for seven days. The bottle should be shaken well, immediately before use.
The patient should be either sitting or lying down with the affected ear turned upwards and then the drops should be instilled. This position should be maintained for 30-60 seconds to facilitate penetration of the drops into the external ear canal. Repeat if necessary for the opposite ear.

Use in the elderly.

No specific limitation.

Use in children.

For children less than 2 years of age, there is insufficient data available.

Use in hepatic impairment.

No specific limitation.

Use in renal impairment.

No specific limitation.

4.3 Contraindications

The safety and efficacy of Ciproxin HC Ear Drops have not been studied in the presence of a perforated tympanic membrane. Ciproxin HC Ear Drops are, therefore, contraindicated in patients with known or suspected perforation, or where there is a risk of perforation of the tympanic membrane.
Ciproxin HC Ear Drops are also contraindicated in patients being treated for necrotising "malignant" otitis externa. This condition, which is particularly common in diabetes, should be treated with systemic anti-pseudomonal agents.
Ciproxin HC Ear Drops should not be used to treat viral or fungal infections of the external ear canal unless it is suspected that there is a secondary bacterial infection present which will respond to topical ciprofloxacin.
Known hypersensitivity to benzyl alcohol, hydrocortisone, ciprofloxacin or other quinolone antimicrobial agents, or any of the excipients.

4.4 Special Warnings and Precautions for Use

Serious and occasionally fatal hypersensitivity (anaphylactic) reactions, some following the first dose, have been reported in patients receiving systemic quinolones.
Ciproxin HC Ear Drops should be discontinued at the first appearance of any sign of local or general hypersensitivity.
Ciproxin HC Ear Drops are not for ophthalmic use.
As with other antibiotic preparations, prolonged use may result in overgrowth of nonsusceptible organisms, including fungi. If superinfection occurs, appropriate therapy should be initiated. If an infection is not improved after one week, cultures and susceptibility tests should be performed to verify the identity of the organism and to determine what alternative therapy should be initiated.
Moderate to severe phototoxicity has been observed in some patients exposed to direct sunlight while receiving some members of the quinolone class of drugs, including ciprofloxacin.
The dropper cap contains natural rubber (latex) which may cause severe allergic reactions.

Visual disturbance.

Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.

Carcinogenicity, mutagenicity, impairment of fertility.

Long-term carcinogenicity studies in mice and rats have been completed for ciprofloxacin. After daily oral doses of 1090 (male mice), 1455 (female mice), 241 (male rats) and 328 mg/kg (female rats) were administered for up to 2 years, there was no evidence that ciprofloxacin had any carcinogenic effects in these species. No long-term studies of Ciproxin HC Ear Drops have been performed to evaluate carcinogenic potential.
Ciprofloxacin was mutagenic in the mouse lymphoma assay and showed DNA damage in a DNA repair assay in vitro but not in an in vivo repair assay. Ciprofloxacin was negative in assays for chromosomal damage and cell transformation.
Studies performed in rats at oral doses of ciprofloxacin up to 100 mg/kg/day revealed no evidence of impairment of fertility.
Long term studies have not been performed to evaluate the carcinogenic potential of the effect on fertility of topical hydrocortisone. Mutagenicity studies with hydrocortisone were negative.

Use in the elderly.

See Section 4.2 Dose and Method of Administration.

Paediatric use.

See Section 4.2 Dose and Method of Administration.

Effects on laboratory tests.

Specific laboratory test interaction studies have not been conducted with Ciproxin HC Ear Drops, however such effects are not expected with the use of Ciproxin HC Ear Drops.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Specific drug interaction studies have not been conducted with Ciproxin HC Ear Drops. No additions to the formulation are recommended. Ciproxin HC Ear Drops should be administered separately, because the compatibility of other drugs with this formulation is unknown. Specific systemic drug interactions are not expected to occur with Ciproxin HC Ear Drops, because they are minimally absorbed.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

Studies performed in rats at oral doses of ciprofloxacin up to 100 mg/kg/day revealed no evidence of impairment of fertility.
Long term studies have not been performed to evaluate the carcinogenic potential of the effect on fertility of topical hydrocortisone.
(Category B3)
Reproduction studies have been performed in rats and mice using oral doses of up to 100 mg/kg and IV doses up to 30 mg/kg and have revealed no evidence of harm to the fetus as a result of ciprofloxacin. In rabbits, ciprofloxacin (30 and 100 mg/kg orally) produced gastrointestinal disturbances resulting in maternal weight loss and an increased incidence of abortion, but no teratogenicity was observed at either dose. After intravenous administration of doses up to 20 mg/kg, no maternal toxicity was produced in the rabbit and no embryo-toxicity or teratogenicity was observed.
Corticosteroids are generally teratogenic in laboratory animals when administered systemically at relatively low dosage levels. The more potent corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. Studies in animals with hydrocortisone have shown reproductive toxicity.
Animal reproduction studies have not been conducted with Ciproxin HC Ear Drops. No adequate and well controlled studies have been performed in pregnant women. Caution should be exercised when Ciproxin HC Ear Drops are used by a pregnant woman.
 Ciprofloxacin/ metabolites are excreted in human milk with systemic use. It is not known whether ciprofloxacin or hydrocortisone/ metabolites are excreted in human milk following topical otic administration. Because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Caution should be exercised with the use of Ciproxin HC Ear Drops since there is no experience of the drug's safety in nursing mothers.

4.7 Effects on Ability to Drive and Use Machines

The effects of this medicine on a person's ability to drive and use machines were not assessed as part of its registration.

4.8 Adverse Effects (Undesirable Effects)

Clinical trials.

There are no placebo controlled studies of the efficacy and safety of Ciproxin HC Ear Drops. In clinical trials against the active control (polymixin B (10,000 IU), neomycin (3.5 mg/mL) and hydrocortisone (10 mg/mL)), the adverse events in Table 1 were recorded in more than 1% of patients.
During clinical trials, adverse events considered to be at least possibly related to treatment occurred in 3.9% of patients using Ciproxin HC Ear Drops. Drug related events reported with an incidence of between 0.1 and 1% were hypoaesthesia, paraesthesia, pruritus, rash, urticaria, ear pain, ear disorder and a sensation of fullness of the ear. Headache (1.2%) has also been reported.

Postmarketing experience.

The following adverse reactions have been reported during clinical studies with Ciproxin HC Ear Drops and are classified according to the subsequent 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) and very rare (< 1/10,000). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.

Ear and labyrinth disorders.

Common (≥ 1% to < 10%): ear pruritus.
Uncommon (≥ 0.1% to < 1%): ear pain, ear congestion, ear discomfort, ear canal erythema.

Infections and infestations.

Uncommon (≥ 0.1% to < 1%): fungal skin infection.

Nervous system disorders.

Uncommon (≥ 0.1% to < 1%): dizziness, headache.

Gastrointestinal disorders.

Uncommon (≥ 0.1% to < 1%): nausea.

Skin and subcutaneous tissue disorders.

Uncommon (≥ 0.1% to < 1%): skin exfoliation, urticaria, rash, pruritus.

General disorders and administration site conditions.

Uncommon (≥ 0.1% to < 1%): medication residue.
Additional adverse reactions identified from postmarketing surveillance include the following. Frequencies cannot be estimated from the available data.

Ear and labyrinth disorders.

Not known: hypoacusis, tinnitus.
Very rare cases of product residue in the ear canal with or without symptoms such as ear discomfort, hearing disorders, ear pain have been reported during postmarketing experience.

Eye disorders.

Vision blurred (see Section 4.4 Special Warnings and Precautions for Use).

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

There are no human data on overdosage with Ciproxin HC Ear Drops.
No significant toxic effects are to be expected in an acute otic overdose, nor in the event of accidental ingestion of Ciproxin HC Ear Drops.
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.

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. Hydrocortisone is a corticosteroid hormone with known and well characterised anti-inflammatory properties.

Clinical trials.

Two pivotal efficacy studies have been conducted with 1,697 patients, of which 1,410 were evaluable for efficacy. Following therapy with Ciproxin HC Ear Drops for seven days, 85% of the patients were clinically cured (resolution vs failure), with a bacterial response rate (eradication + presumed eradication versus persistence) of 93% at the end of therapy (EOT). At follow-up (11 - 31 days after EOT), 94% of patients remained clinically cured. The predominant causative organisms isolated were Pseudomonas aeruginosa and Staphylococcus aureus. The bacteriological response by causative organism at the end of therapy is shown in Table 2.

5.2 Pharmacokinetic Properties

Clinical pharmacokinetic studies have not been performed with Ciproxin HC Ear Drops since the predicted ciprofloxacin serum concentrations after ototopic administration of a 0.2% suspension (total dose per ear per application approximately 180 microgram) would be below the existing assay detection limits (limit of quantification 0.5 microgram/L). Even if full absorption of the topical dose were seen, peak ciprofloxacin concentrations of only approximately 3 microgram/L would be expected at steady state, based on data for oral administration.
Absorption of hydrocortisone after topical administration is generally low, and varies greatly with the site of administration. It would be impossible by serum assay to distinguish the very small contribution due to the exogenous hydrocortisone (total dose per ear per application 0.9 mg) from that due to endogenous cortisol production. Measurements after ototopical administration are not known to have been performed.

5.3 Preclinical Safety Data

Genotoxicity.

See Section 4.4 Special Warnings and Precautions for Use.

Carcinogenicity.

See Section 4.4 Special Warnings and Precautions for Use.

6 Pharmaceutical Particulars

6.1 List of Excipients

See Section 2 Qualitative and Quantitative Composition.

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

Shelf life after opening.

14 days.

6.5 Nature and Contents of Container

Ciproxin HC Ear Drops is supplied as a non-sterile, slightly viscous white to off-white opaque suspension in a 10 mL bottle with a separately wrapped non-sterile dropper assembly.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.

6.7 Physicochemical Properties

Ciprofloxacin hydrochloride.

A synthetic carboxyquinolone derivative with broad spectrum antimicrobial activity. It is the monohydrochloride monohydrate salt of 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid. It is a faintly yellowish to yellow crystalline substance with a molecular weight of 385.8. Its empirical formula is C17H18FN3O3.HCl.H2O.

Hydrocortisone.

A white to off-white crystalline powder, practically insoluble in water, sparingly soluble in acetone and in alcohol, soluble in chloroform with a molecular weight of 362.47. It is an anti-inflammatory corticosteroid, with a chemical name of 11β, 17, 21-trihydroxypregn-4-ene-3,20-dione, and its empirical formula is C21H30O5.

Chemical structure.

Its chemical structure is as follows:

CAS number.

Ciprofloxacin hydrochloride (CAS 86393-32-0).
Hydrocortisone (CAS 50-23-7).

7 Medicine Schedule (Poisons Standard)

S4.

Summary Table of Changes