Consumer medicine information

Ocuflox Eye Drops

Ofloxacin

BRAND INFORMATION

Brand name

Ocuflox

Active ingredient

Ofloxacin

Schedule

What is in this leaflet

This leaflet answers some common questions about OCUFLOX® eye drops. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you using OCUFLOX® eye drops against the benefits they expect it will have for you.

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 OCUFLOX® eye drops are used for

OCUFLOX® eye drops contain the drug ofloxacin and are used to treat certain eye infections.

OCUFLOX® eye drops act by killing a wide range of bacteria that cause certain eye infections such as conjunctivitis (inflamed eyes) and corneal ulcers (infection on the surface of the eye).

Ask your doctor if you have any questions about why OCUFLOX® eye drops have been prescribed for you.

Before you use OCUFLOX® eye drops

When you must not use it

Do not use OCUFLOX® eye drops if:

you have an allergy to ofloxacin or any of the ingredients listed
when wearing soft contact lenses
the packaging shows any signs of tampering
4 weeks after opening them
the expiry date on the carton and bottle has passed
if you use this medicine after the expiry date has passed, it may not work effectively
the seal around the cap is broken.

These drops are for topical use only.

Before you start to use it

Tell your doctor if:

you have had an allergy to any medicines or any other substances, such as foods, preservatives or dyes
you are pregnant or intend to become pregnant
you are breast-feeding or intend to breast-feed
you have an allergy to antibiotics
you wear contact lenses
you are taking other medicines, including any you have bought at you pharmacy, supermarket or health food shop.

Do not put OCUFLOX® eye drops into your eye(s) while you are wearing soft contact lenses. The preservative in OCUFLOX® eye drops (benzalkonium chloride) may be deposited in soft contact lenses. You can put your soft contact lenses back into your eyes 15 minutes after you have used OCUFLOX® eye drops.

Avoid allowing the tip of the dispensing container to contact the eye or surrounding structures to avoid eye injury and contamination of eye drops.

Taking other medicines

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

It is not expected that OCUFLOX® will interact with other medicines, however you should always ask your optical practitioner, doctor or pharmacist if you have any concerns about using OCUFLOX® eye drops as well as other medications.

How to use OCUFLOX® eye drops

How much to use

Your doctor will tell you how many drops you need to use each day. Use OCUFLOX® eye drops only as prescribed by your doctor.

Conjunctivitis:
The usual dosage of eye drops is one drop in the eye(s) every four hours for the first two days, then one drop every six hours for up to eight days. Do not stop using OCUFLOX® eye drops even if you feel well unless instructed by your doctor. You should not normally use these drops for this complaint for more than 10 days without checking with your doctor.

Corneal Ulcer:
The usual dosage of eye drops is one drop in the eye(s) every 30 minutes (while awake) for the first two days, then one drop every hour for the next four days. Then put one drop in the eye(s) four times daily until your doctor tells you to stop. Your eye(s) will usually be completely healed within 21 days. Do not stop using OCUFLOX® eye drops even if you feel well unless instructed by your doctor.

How to use it

Open the eye(s) needing the drops, tilt your head back and look upward
Gently pull down the lower eyelid
Bring the eye drops near the eye and squeeze one drop into the eye
Avoid touching the eye, eyelids or lashes with the dropper
Close your eyes and blink; this helps distribute the drops in the eye chamber
While your eyes are closed, gently press your fingers on the inner corner(s) of your eye(s)
Wipe any excess away with a clean tissue
Replace cap on the dropper bottle.

How long to use it

Continue using OCUFLOX® eye drops for as long as your doctor prescribes.

If you forget to use it

If it is almost time for your next dose, skip the dose you missed and use your next dose when you are meant to. Otherwise, use the drops as soon as you remember, and then go back to using them as you would normally.

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

Do not use double the amount to make up for the dose that you missed.

If you use too much (overdose)

If you accidentally put several 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 OCUFLOX® eye drops, immediately telephone your doctor or Poisons Information Centre 24 hours on 13 11 26 (Australia) for advice, or go to casualty at your nearest hospital. Do this even if there are no signs of discomfort or poisoning.

If you have used too many OCUFLOX® eye drops you may have burning, stinging, tearing, itching and pain of the eye(s) (see below ‘Side effects’). The eye(s) should be flushed with water or saline solution. If you have questions or concerns, or are not sure about something, please consult your doctor or pharmacist.

While you are using OCUFLOX® eye drops

Things you must do

If you develop an eye infection, receive an eye injury, or have eye surgery tell your doctor.

If you become pregnant while using OCUFLOX® eye drops tell your doctor immediately.

If you wear soft contact lenses, remove them before using OCUFLOX® eye drops. Leave your lenses out for at least 15 minutes after putting in the eye drops.

Tell your doctor if your condition gets worse or does not get better while using OCUFLOX® eye drops.

If you are about to start any new medicine tell your doctor and pharmacist that you are using OCUFLOX® eye drops.

Things you must not do

Do not give OCUFLOX® eye drops to anyone else, even if they have the same condition as you.

Do not stop using OCUFLOX® eye drops without first talking to your doctor.

Things to be careful of

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are using OCUFLOX® eye drops.

Keep enough eye drops to last weekends and holidays.

Be careful driving or operating machinery until you know how OCUFLOX® eye drops affect you.

When using OCUFLOX® eye drops avoid direct exposure to sunlight or artificial ultraviolet light.

OCUFLOX® eye drops should not be recommended for use in children under the age of 12 years.

Side effects

All medicines can have side effects. Sometimes they are serious, most of the time they are not. Some patients may experience unwanted effects during OCUFLOX® treatment. You may need medical treatment if you get some of the side effects. Ask your doctor or pharmacist to answer any questions you may have.

If while undergoing treatment with OCUFLOX® eye drops you experience any side-effects or symptoms which may be due to this medication (whether or not it is mentioned below) please inform your Doctor or Pharmacist as early as possible.

Things which may occur:
Burning, stinging, tearing and itching of the eyes, feeling something in the eye, inability to tolerate bright light, blurred vision, red and inflamed eyes, swelling around the eyes, mouth, pharynx, under the skin, watery eye, itchy eye/eyelid, skin rash or hives, dry eyes, pain in the eye, shortness of breath or dizziness.

After using OCUFLOX® eye drops

Storage

Keep your OCUFLOX® eye drops in a cool place where the temperature stays below 25°C.

Keep the medicine where children cannot reach it.

OCUFLOX® eye drops should be protected from light and excess heat.

Do not put the eye drops in the freezer.

Any open unused OCUFLOX® eye drops should be thrown out after 4 weeks of use or returned to your pharmacist.

Disposal

If your doctor tells you to stop using the eye drops or they have passed their expiry date, ask your pharmacist what to do with any remaining bottles.

Product description

What OCUFLOX® eye drops look like:

Clear, pale to light yellowish sterile solution in a white LDPE bottle.

Ingredients

Active ingredient:
ofloxacin 3 mg per mL

Inactive ingredients:
benzalkonium chloride
sodium chloride
citric acid monohydrate
sodium hydroxide and/or hydrochloric acid may be added to adjust pH
purified water

Manufacturer/Supplier

AbbVie Pty Ltd
241 O’Riordan Street
Mascot NSW 2020
AUSTRALIA
Ph: 1800 043 460
www.abbvie.com.au

OCUFLOX® eye drops can be identified by registration number: AUST R 47485

OCUFLOX and its design are trademarks of Allergan, Inc., an AbbVie company.

Date of preparation: May 2023

Published by MIMS October 2023

BRAND INFORMATION

Brand name

Ocuflox

Active ingredient

Ofloxacin

Schedule

1 Name of Medicine

Ofloxacin.

2 Qualitative and Quantitative Composition

Ocuflox eye drops contain 3 mg/mL ofloxacin.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Eye drops, solution.

4 Clinical Particulars

4.1 Therapeutic Indications

Ocuflox eye drops are indicated for the treatment of corneal ulcers (bacterial keratitis) and severe bacterial conjunctivitis caused by ofloxacin sensitive organisms in adults.

4.2 Dose and Method of Administration

Corneal ulcers (bacterial keratitis).

Days 1 and 2.

Instill one to two drops into the affected eye(s) every 30 minutes while awake. Instill a further one to two drops into the affected eye(s) during the night, four hours after retiring, and again two hours after this.

Days 3 to 7.

Instill one to two drops into the affected eye(s) every hour while awake.

Days 7 to completion of treatment (usually within 21 days).

Instill one to two drops into the affected eye(s) four times daily until the ulcer is completely healed (complete epithelialisation and no progression of infiltrate).

Bacterial conjunctivitis.

The dosage recommendation is one drop every four hours for the first two days, and then one drop every six hours into the affected eye(s) for up to eight days. Dosage should not normally be continued for more than 10 days without an ophthalmic review (see Section 4.4 Special Warnings and Precautions for Use).
In order to minimise systemic absorption of Ocuflox eye drops, apply pressure to the tear duct immediately following administration of the drug.
Ocuflox eye drops have been assessed in clinical studies for up to 23 days treatment; safety has not been adequately demonstrated for longer periods of use.

4.3 Contraindications

Ocuflox eye drops are contraindicated in patients sensitive to ofloxacin or any other component of the solution. A history of hypersensitivity to other quinolone anti-infectives, including nalidixic acid, may also contraindicate the use of Ocuflox eye drops.

4.4 Special Warnings and Precautions for Use

Identified precautions.

The preservative in Ocuflox eye drops, benzalkonium chloride, may be absorbed by and cause discoloration of soft contact lenses. Ocuflox eye drops should not be administered while wearing soft contact lenses. Patients should be instructed to remove contact lenses prior to the administration of Ocuflox and wait at least 15 minutes following administration before reinserting soft contact lenses.
Patients should be instructed to avoid allowing the tip of the dispensing container to contact the eye or surrounding structures to avoid eye injury and contamination of eye drops.
Ocuflox eye drops are not for injection.
Serious and occasionally fatal hypersensitivity (anaphylactic/ anaphylactoid) reactions, some following the first dose, have been reported in patients receiving systemic quinolones, including ofloxacin. Some reactions were accompanied by cardiovascular collapse, loss of consciousness, angioedema (including laryngeal, pharyngeal or facial edema), airway obstruction, dyspnea, urticaria, and itching. Serious, acute hypersensitivity reactions may require immediate emergency treatment. Oxygen and airway management should be administered as clinically indicated.
There have been rare reports of Stevens-Johnson syndrome and toxic epidermal necrolysis reported in association with topical ophthalmic ofloxacin.
Hypersensitivity reactions including angioedema, dyspnea, anaphylactic reaction/ shock, oropharyngeal swelling, and tongue swollen have been reported with Ocuflox eye drops (see Section 4.8 Adverse Effects (Undesirable Effects), Postmarketing experience).
If an allergic reaction to ofloxacin occurs, discontinue the drug. Use Ocuflox eye drops with caution in patients who have exhibited sensitivities to other quinolone antibacterial agents.
As with other anti-infectives, prolonged use may result in overgrowth of non-susceptible organisms. If superinfection occurs, or if clinical improvement is not noted within a reasonable period, discontinue use and institute appropriate therapy.
Corneal precipitates, and corneal perforation in patients with pre-existing corneal epithelial defect/ corneal ulcers, have been reported during treatment with topical ophthalmic ofloxacin. However, a causal relationship has not been established.
Quinolones induce phototoxicity in a number of in vitro and in vivo animal models. Quinolones have the potential to produce phototoxic reactions in sensitive individuals following systemic administration. Patients taking ofloxacin should avoid direct exposure to sunlight or artificial ultraviolet light. Therapy should be discontinued if photosensitivity occurs.
While systemic concentrations of ofloxacin are low following topical dosing, neurological adverse reactions (including convulsions, increased intra-cranial pressure and toxic psychosis) have been associated with oral administration.
Long-term, high dose use of other fluoroquinolones in experimental animals has caused lenticular opacities. However, this effect has not been reported in human patients, nor has it been noted following topical ophthalmic treatment with ofloxacin for up to six months in animal studies including studies in monkeys.

Use in the elderly.

No comparative data are available with topical dosing in elderly versus other age groups.

Paediatric use.

Adequate clinical studies of the safety of topical ophthalmic treatment with ofloxacin in children have not been conducted. Ocuflox eye drops should be avoided in children who have not attained joint maturity. The oral administration of quinolones (including norfloxacin, ciprofloxacin, ofloxacin, nalidixic acid and cinoxacin) has led to lesions or erosions of the cartilage in weight-bearing joints and other signs of arthropathy in immature animals of various species.

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

It has been shown that the systemic administration of some quinolones inhibits the metabolic clearance of caffeine and theophylline. Drug interaction studies conducted with systemic ofloxacin have demonstrated that metabolic clearance of caffeine and theophylline are not significantly affected by ofloxacin.
Although there have been reports of an increased prevalence of CNS toxicity with systemic dosing of fluoroquinolones when used concomitantly with systemic nonsteroidal anti-inflammatory drugs (NSAIDs), this has not been reported with the concomitant systemic use of NSAIDs and ofloxacin.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

No data available.
(Category B3)
There were no adequate and well-controlled studies performed in pregnant women. Since systemic quinolones have been shown to cause arthropathy in immature animals, it is recommended that Ocuflox eye drops not be used in pregnant women.
Ofloxacin has not been shown to have any teratogenic effects at oral dose up to 810 mg/kg/day and 160 mg/kg/day when administered to pregnant rats and rabbits, respectively. Additional studies in rats with oral doses up to 360 mg/kg/day demonstrated no adverse effects on late foetal development, labour, delivery, lactation, neonatal viability or growth of the newborn. Doses of 810 mg/kg/day and 160 mg/kg/day resulted in decreased fetal bodyweight and increased fetal mortality in rats and rabbits, respectively. Minor fetal skeletal variations were reported in rats receiving doses of 810 mg/kg/day.
Because ofloxacin and other quinolones taken systemically are excreted in breast milk and there is potential for harm to nursing infants, a decision should be made whether to temporarily discontinue nursing or not to administer the drug, taking into account the importance of the drug to the mother.

4.7 Effects on Ability to Drive and Use Machines

As with any ocular medication, if transient blurred vision occurs at instillation, the patient should wait until the vision clears before driving or using machinery.

4.8 Adverse Effects (Undesirable Effects)

The following adverse reactions have been reported in association with use of ofloxacin.
Transient side effects reported with Ocuflox eye drops include burning/ stinging (10-14% of treated eyes), tearing (6-11% of treated eyes), itching, foreign body sensation, photophobia, blurred vision, hyperemia, conjunctivitis, chemical conjunctivitis/ keratitis, periocular/ facial oedema, eye oedema, eye pruritus, eyelid pruritus, dry eyes, eye pain (1-5% of treated eyes) and dizziness. These symptoms led to cessation of treatment in 1.6% of patients.
Adverse events such as burning and stinging, tearing, photophobia and foreign body sensation occur more frequently in patients treated for corneal ulcer. The incidence of discomfort is likely to be a result of the underlying condition.
Gastrointestinal disorders reported include nausea.
Since a small amount of ofloxacin is systemically absorbed after topical administration, side effects reported with systemic use could possibly occur.

Postmarketing experience.

The following adverse reactions have been identified during post-marketing use of Ocuflox eye drops in clinical practice. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made.

Eye disorders.

Hypersensitivity, lacrimation increased, eyelid oedema and ocular hyperemia.

Immune system disorders.

Hypersensitivity (including angioedema, dyspnea, anaphylactic reaction/ shock, oropharyngeal swelling and tongue swollen) and allergic dermatitis.

Nervous system disorders.

Dizziness.

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

The acute oral LD₅₀ values in male/ female mice and male/ female rats exceed 5 g/kg and 3 g/kg respectively. In monkeys, the acute oral LD₅₀ value is greater than 0.5 g/kg. Acute overdosage information for humans is not available.
Signs of toxicity after oral or subcutaneous administration included hypoactivity, ptosis, hypopnoea, convulsion and tremor in rats, mice, dogs and monkeys. In addition, emesis was observed in dogs and monkeys.
In the event of accidental ingestion of 5 mL of Ocuflox eye drops, 15 mg of ofloxacin would be ingested. This amount does not appear to be clinically significant in terms of overdosage. However, there would be an increased potential for systemic reactions (see Section 4.8 Adverse Effects (Undesirable Effects)).
In the event of a topical overdosage, flush eye with a sterile topical ocular irrigant.
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.

Ofloxacin is a third generation fluorinated 4-quinolone having broad spectrum in vitro bactericidal activity against certain aerobic Gram-positive, Gram-negative and some anaerobic bacteria.
Ofloxacin appears to have more than one mechanism contributing to its bactericidal action. The primary mechanism of action is believed to be the inhibition of bacterial DNA gyrase, the enzyme responsible for inserting negative supercoils into bacterial DNA. Apparently, this enzyme inhibition leads to bacterial death through a complex process in which DNA synthesis is arrested and regulation of normal gene expression is disrupted. Ofloxacin, unlike most of the other quinolones, possesses an additional bactericidal mechanism which is not dependent on protein or RNA synthesis. It is bactericidal in both the replicating and nonreplicating stages of bacterial growth.
Ofloxacin, in vitro maintains an inhibitory effect on cell growth of susceptible bacteria for 6-8 hours after drug removal.
Ofloxacin is not subject to degradation by beta-lactamase enzymes nor is it modified by enzymes such as aminoglycoside adenylases or phosphorylases, or chloramphenicol acetyltransferase. Spontaneous resistance is rare and occurs in only 1 in 10¹⁰ to 10¹¹ sensitive bacteria under routine laboratory conditions. Development of resistance to greater than 8 microgram/mL of ofloxacin typically requires two independent genetic mutations under aerobic conditions. The viability and pathogenicity of most resistant mutants are reduced. Resistant mutants are typically unstable and most readily revert to full sensitivity to ofloxacin when cultured without quinolones.

Clinical trials.

Corneal ulcer.

In a randomised, double-blind, parallel group trial of 134 patients with positive bacterial cultures, Ocuflox treated patients had an overall clinical success rate of 86%. The median time to clinical success was 11 days of treatment (range 8-14 days).

5.2 Pharmacokinetic Properties

Absorption.

Tear film ofloxacin concentrations ranged from 5.67 to 31.0 microgram/g during the 40-minute period following the last dose in the 11-day study. In 5 subjects mean tear film levels measured four hours after topical dosing (9.16 ± 8.24 microgram/g) were higher than the 2 microgram/mL minimum concentration of ofloxacin necessary to inhibit 90% of most bacterial strains (MIC₉₀) in vitro.

Distribution.

In rabbits, an eye-drop instillation produced therapeutically effective concentrations of ofloxacin in tears (i.e. above MIC₉₀ for most ocular pathogens) for four to six hours.

Metabolism.

Serum, urine and tear film concentrations of ofloxacin were measured in 30 healthy women at various time points during a ten-day course of treatment with 3 mg/mL ofloxacin eye drops. The mean serum ofloxacin concentration ranged from 0.4 nanogram/mL to 1.9 nanogram/mL. Maximum ofloxacin concentration increased from 1.1 nanogram/mL on day one to 1.9 nanogram/mL on day 11 after QID dosing for 10 to 12 days. Maximum serum ofloxacin concentrations (1.89 ± 1.13 nanogram/mL) after ten days of topical dosing were more than 1000 times lower than those reported after standard oral doses of ofloxacin.

Excretion.

Topical ofloxacin was excreted in the urine primarily in unmodified form.

5.3 Preclinical Safety Data

Genotoxicity.

Ofloxacin shows high selectivity for the bacterial DNA gyrase enzyme while showing little activity against mammalian topoisomerase (counterpart mammalian target) enzyme.
Cross-resistance has been observed between ofloxacin and other fluoroquinolones. Ofloxacin has shown in vitro efficacy against certain organisms resistant to other types of antimicrobials, including aminoglycosides, chloramphenicol, macrolides (erythromycin), sulfacetamide, penicillins and tetracycline.

Carcinogenicity.

Long term studies to determine the carcinogenic potential of ofloxacin have not been conducted.

6 Pharmaceutical Particulars

6.1 List of Excipients

Ocuflox eye drops contain 3 mg/mL ofloxacin and are formulated as an isotonic solution using 9 mg/mL sodium chloride preserved with 0.05 mg/mL benzalkonium chloride. The pH of Ocuflox eye drops range from 6.0 - 7.0.

6.2 Incompatibilities

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

6.3 Shelf Life

2 years.

6.4 Special Precautions for Storage

Store below 25°C. Protect from light and excessive heat.
To avoid contamination of the solution, keep container tightly closed.
Do not touch dropper tip to any surface.
Discard contents 4 weeks after opening the bottle. Contents are sterile if seal is intact.

6.5 Nature and Contents of Container

Eye drops: 5 mL (dropper bottle). AUST R 47485.

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

Chemical structure.

Description: Ofloxacin is a white to yellow crystalline powder which is soluble in glacial acetic acid, sparingly soluble in chloroform and slightly soluble in water, methanol, ethanol or acetone. Its melting point is 260°C - 270°C with decomposition.
Chemical name: (±)-9-Fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido [1, 2, 3-de]-1, 4 benzoxazine-6-carboxylic acid.

CAS number.

82419-36-1.

7 Medicine Schedule (Poisons Standard)

S4 - Prescription Only Medicine.

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