Consumer medicine information

Chloromycetin Eye Drops

Chloramphenicol

BRAND INFORMATION

Brand name

Chloromycetin Eye Drops

Active ingredient

Chloramphenicol

Schedule

S3

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Chloromycetin Eye Drops.

What is in this leaflet

This leaflet answers some common questions about Chloromycetin Eye Drops and Eye Ointment. 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 or pharmacist has weighed the risks of you using Chloromycetin 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 Chloromycetin is used for

Chloromycetin Eye Drops and Ointment are topical antibiotic preparations for the treatment of bacterial conjunctivitis. Bacterial conjunctivitis is a highly contagious bacterial infection involving the mucous membrane of the surface of the eye. The common symptoms are the presence of a sticky yellow-white discharge with mucous and pus, a gritty sensation in the eye, irritation and redness of the eye and watery eyes. The infection usually starts in one eye and then spreads to the other. Chloromycetin belongs to a group of medicines called antibiotics.

It works by stopping the growth of the bacteria causing your infection.

Ask your doctor or pharmacist if you have any questions about why this medicine has been prescribed for you.

Your doctor or pharmacist may have prescribed it for another reason.

Chloromycetin is not addictive.

Before you use it

When you must not use it

Do not use Chloromycetin if you have an allergy to:

  • chloramphenicol
  • any of the ingredients listed at the end of this leaflet
  • any other similar medicines.

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 use Chloromycetin if you wear contact lenses except on medical advice.

Do not give Chloromycetin to children under 2 years of age, unless on medical advice.

Do not use Chloromycetin after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering.

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

If you are not sure whether you should start using this medicine, talk to your doctor or pharmacist.

Before you start to use it

Tell your doctor, optometrist or pharmacist if the following conditions apply to you:

  • you have allergies to any other medicines, foods preservatives or dyes.
  • you or your family have blood disorders (e.g. anaemia) or problems with bone marrow.
  • you have an injury to the cornea .
    Eye preparations may stop the healing of the wound.
  • you wear contact lenses.
    Contact lenses should not be worn during the course of Chloromycetin treatment. If you wear hard or soft disposable contact lenses, you can start using them again after completing the course of treatment. If wearing soft contact lenses, you should wait 24 hours after completing a course of treatment before starting to use them again.

Tell your doctor, optometrist or pharmacist if you are pregnant or plan to become pregnant, or are breastfeeding or plan to breastfeed.

Your doctor, optometrist or pharmacist will advise you of the risks and benefits of using Chloromycetin in pregnancy or while breastfeeding.

If you have bought this medicine without a prescription and without prior consultation from a doctor or optometrist, it is important to check the following list. Speak to your doctor or optometrist if any apply before you start to use Chloromycetin:

  • you are allergic to any other antibiotic eye drops or ointments.
  • you are using other eye drops or eye ointments.
  • you have pain within your eye (rather than just feeling sore or gritty).
  • swelling around the eye.
  • blurred vision or sensitivity to light.
  • limited eye movement.
  • abnormal pupil (the black circle in the centre of the eye looks cloudy).
  • there is copious yellow-green purulent discharge that accumulates after being wiped away.
  • you have injured your eye or there is a foreign body in the eye.
  • you have been welding without eye protection immediately before your eye symptoms appeared.
  • you have glaucoma.
  • you have dry eye syndrome.
  • you have had similar symptoms in the past.
  • you have had eye surgery or laser treatment in the past six months.
  • you have recently travelled overseas.
  • you are allergic to any other medicines or any foods, dyes or preservatives.
  • you have had surgery (including dental surgery) using a general anaesthetic.
  • you feel unwell.
  • you have any other medical condition.

If you have not told your doctor or optometrist about any of the above, tell him/her before you start using Chloromycetin.

Taking or using other medicines

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

Chloromycetin Eye Drops or Ointment and some other medicines may interfere with each other. These include other eye drops and ointments.

These medicines may be affected by Chloromycetin or may affect how well it works. You may need different amounts of your medicines, or you may need to use different medicines.

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

How to use Chloromycetin

Follow all directions given to you by your doctor or pharmacist carefully.

They may differ from the information contained in this leaflet.

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

Do not give Chloromycetin to children under 2 years of age, unless on medical advice.

How much to use

The dose of Chloromycetin may be different for different people. Your doctor or pharmacist will tell you the right amount to use.

Chloromycetin Eye Drops
Place one or two drops in the affected eye(s) every 2 to 6 hours for 2 to 3 days. The interval between doses may then be increased.

Chloromycetin Eye Ointment
Apply 1.5 cm of ointment every 3 hours.

How to use them

Wash your hands. Tilt your head back and pull the lower lid away from your eye to make a space. For the Eye Drops, drop the medicine into this space. For the Eye Ointment, squeeze the ointment into this space. Let go of your eyelid and gently close your eyes. Try not to blink. Keep your eyes closed for 1 or 2 minutes to allow the medicine to come into contact with the infection.

When using the Eye Drops, apply gentle pressure to the inner corner of the eye (the tear duct) for approximately 1 minute immediately after placing the drops in the eye. This will reduce the amount of medicine absorbed into the blood stream or other parts of the body.

To keep the medicine as germ free as possible, do not touch the tip of the bottle or tube to any surface including the eye. After using Chloromycetin Eye Ointment wipe the tip of the tube with a clean tissue.

When to use them

If the Eye Drops and Ointment are used together for day and night treatment, use the drops during the day and the ointment at night before bed.

Use Chloromycetin Eye Drops or Ointment at about the same time each day.

Using it at the same time each day will help you remember when to use it.

It does not matter if you use this medicine before or after food.

How long to use them

Normally treatment is continued for at least 2 days after the eye appears normal. Do not use for more than 5 days in total except on medical advice.

If the condition worsens or does not get better after 2 days, seek immediate medical advice.

If you forget to use them

If it is almost time for your next dose, skip the dose you missed and instil your next dose when you are meant to.

Otherwise, instil a dose as soon as you remember, and then go back to using your medicine as you would normally.

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

This may increase the chance of you getting an unwanted side effect.

If you are not sure what to do, ask your doctor or pharmacist.

If you have trouble remembering to use your medicine, ask your pharmacist for some hints.

If you take too much (overdose)

Rinse your eye with large amounts of water for at least 15 minutes if pain, swelling, excessive tears or an uncomfortable sensitivity to the light is experienced after application of Chloromycetin Eye Drops or Ointment. Contact your doctor or pharmacist if symptoms are still present after thoroughly rinsing your eye.

Immediately telephone your doctor or the Poisons Information Centre (telephone 13 11 26) or go to Accident and Emergency at the nearest hospital if you think an infant or young child may have accidentally swallowed Chloromycetin Eye Drops or Ointment.

Do this even if there are no signs of discomfort or poisoning. The child may need urgent medical attention.

Contact your doctor or the Poisons Information Centre (telephone 13 11 26) if you or another adult accidentally swallows Chloromycetin Eye Drops or Ointment. It is a good idea to do this even if there are no signs of discomfort or poisoning.

While you are using Chloromycetin

Things you must do

Use Chloromycetin Eye Drops or Ointment exactly as your doctor or pharmacist has prescribed.

If the symptoms of your infection do not improve within a few days, or if they become worse, tell your doctor or pharmacist.

Stop using Chloromycetin and tell your doctor or pharmacist if irritation occurs or you experience an allergic reaction.

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

Tell any other doctors, dentists, and pharmacists who treat you that you are using Chloromycetin.

Things you must not do

Do not use Chloromycetin for longer than your doctor or pharmacist has prescribed.

Do not use Chloromycetin Eye Drops or Ointment to treat any other complaints unless your doctor or pharmacist tells you to.

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

Do not stop using your medicine or lower the dosage without checking with your doctor or pharmacist.

If you do not complete the full course prescribed by your doctor or pharmacist, the infection may not be completely cured. The bacteria may grow again and your symptoms may return.

Things to be careful of

Be careful driving or operating machinery until you know how Chloromycetin affects you.

This medicine generally does not cause any problems with your ability to drive a car or operate machinery. However, as with many other medicines, Chloromycetin may cause tiredness in some people. If you are affected, do not drive, operate machinery or do anything else that could be dangerous.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well during or after using Chloromycetin Eye Drops or Ointment.

Chloromycetin helps most people with eye infections 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 attention if you get some of the side effects.

Ask your doctor or pharmacist to answer any questions you may have.

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

Tell your doctor or pharmacist if you notice any of the following and it worries you:

  • temporary itching, burning or stinging eyes

The above side effects are usually mild and short-lived.

Tell your doctor or pharmacist as soon as possible if you notice any of the following:

  • eye soreness, redness or swelling that was not present before treatment or that worsens after treatment
  • skin rash, itching or swelling
  • fever
  • unusual tiredness, weakness, bleeding or bruising more easily than normal

The above list includes very serious side effects, which may require medical attention. Serious side effects are rare.

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

  • allergic reactions including fever, rash, swelling of the face, lips, mouth or sore throat that may cause difficulty in swallowing or breathing, shortness of breath, swelling of the hands, feet or ankles.

The above list includes serious side effects. You may need urgent medical attention or hospitalisation.

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

Tell your doctor or pharmacist if you notice anything that is making you feel unwell during or after treatment with Chloromycetin.

After using Chloromycetin

Storage

Keep your Eye Drops and Ointment in the bottle or tube until it is time to use them. If you take the Eye Drops or Ointment out of the bottle or tube they may not keep well.

Eye Drops
Keep unopened bottles in the refrigerator, where the temperature stays between 2°C and 8°C. After opening, keep Chloromycetin Eye Drops in a cool dry place where the temperature stays below 25°C. Protect from light.

Eye Ointment
Keep Chloromycetin Eye Ointment in a cool dry place where the temperature stays below 25°C. Protect from light.

Discard unused Eye Drops or Ointment within one month.

Do not store Chloromycetin or any other medicine in the bathroom or near a sink. Do not leave it on a windowsill or in the car. Heat and dampness can destroy some medicines.

Keep Chloromycetin where children cannot reach it.

A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

Disposal

If your doctor tells you to stop using Chloromycetin or the expiry date has passed, ask your pharmacist what to do with any medicine that is left over.

Chloromycetin Eye Drops and Ointment should be discarded within one month after opening.

Product Description

What it looks like

Chloromycetin Eye Drops are in a 10 mL plastic dropper bottle with a tamper-evident seal.

Chloromycetin Eye Ointment is in a 4 g tube with a tamper-evident seal.

Ingredients

Eye drops
Each 1 mL contains 5 milligrams of chloramphenicol as the active ingredient. It also contains:

  • phenylmercuric nitrate
  • boric acid
  • borax
  • purifed water.

Eye Ointment
Each 1 gram contains 10 milligrams of chloramphenicol as the active ingredient. It also contains:

  • plastibase 50W
  • liquid paraffin.

Chloromycetin does not contain lactose, sucrose, gluten, tartrazine or any other azo dyes.

Supplier

Chloromycetin Eye Drops and Ointment are supplied by:
Pfizer Australia Pty Limited
ABN 50 008422 348
38-42 Wharf Road
West Ryde NSW 2114
Australia
Toll Free Number: 1800 675 229

Australian Registration Numbers:

  • Eye Drops: AUST R 57090
  • Eye Ointment: AUST R 56589

This leaflet was revised in January 2013.

® Registered trademark

© Pfizer Australia Pty Ltd

BRAND INFORMATION

Brand name

Chloromycetin Eye Drops

Active ingredient

Chloramphenicol

Schedule

S3

 

Name of the medicine

Chloramphenicol.

Excipients.

Purified water, boric acid, borax and phenylmercuric nitrate as the preservative.

Description

Chemical name: 2,2-dichloro-N- [(αR,βR)-β-hydroxy -α-hydroxymethyl-4- nitrophenethyl] acetamide. Molecular formula: C11H12Cl2N2O5. MW: 323.1. Chloramphenicol is a white to greyish white or yellowish white, fine crystalline powder or fine crystals, needles or elongated plates. Soluble 1:400 of water, 1:2.5 of alcohol, and 1:7 of propylene glycol; freely soluble in acetone and ethyl acetate; slightly soluble in ether. A 2.5% suspension in water has a pH of 4.5 to 7.5.

Pharmacology

Pharmacodynamics.

Chloramphenicol is a broad spectrum antibiotic originally isolated from Streptomyces venezuelae. It is primarily bacteriostatic and acts by inhibition of protein synthesis by interfering with the transfer of activated amino acids from soluble RNA to ribosomes.

Pharmacokinetics.

Chloramphenicol is found in measurable amounts in the aqueous humour following local application to the eye.
Chloramphenicol is rapidly absorbed from the gastrointestinal tract when given by mouth and widely distributed throughout most body tissues and fluids. It is inactivated primarily in the liver by glucuronyl transferase and excreted mainly in the urine.

Indications

For the treatment of bacterial conjunctivitis. For use under medical supervision only in the treatment of other superficial ocular infections caused by chloramphenicol sensitive organisms.

Contraindications

Chloromycetin eye drops are contraindicated in individuals with a history of hypersensitivity and/or toxic reaction to chloramphenicol or any other component of the medication.

Precautions

Discontinue promptly if sensitisation or irritation occurs.
Bone marrow hypoplasia, including aplastic anaemia and death, has been rarely reported following local application of chloramphenicol. Chloramphenicol should be used with caution in patients who have been identified as having an individual or family history of blood disorders. Chloramphenicol should not be used when less potentially dangerous agents would be expected to provide effective treatment.
Ophthalmic agents may retard corneal wound healing.
The use of this antibiotic, as with other antibiotics, may result in the overgrowth of nonsusceptible organisms, including fungi. If infections caused by nonsusceptible organisms appear during therapy, its use should be discontinued and appropriate measures should be taken. In all serious infections, the topical use of chloramphenicol should be supplemented by appropriate systemic medication.
Chloramphenicol eye preparations should not be recommended for OTC use under the following circumstances: photophobia; severe pain in the eye or pain and swelling around the eye; loss of, reduced or blurred vision; restriction of eye movement; cloudy cornea; copious yellow green purulent discharge that accumulates after being wiped away; abnormal pupils; injury to the eye or suspicion of a foreign body in the eye; history of welding without eye protection immediately prior to onset of symptoms; glaucoma; dry eye syndrome; individuals who wear contact lenses except on medical advice; patient is using other eye preparations at the time of presentation; patient has had eye surgery or laser treatment in the past six months; individual or family history of bone marrow problems; recent overseas travel; patient has had similar symptoms in the past; patient feels unwell; children under the age of 2 years except on medical advice; use for longer than 5 days unless on medical advice.
In these cases, referral to a doctor or optometrist is required.

Use in pregnancy.

(Category A)
There are no studies to establish the safety of this drug in pregnancy.
Systemically absorbed/ administered forms of chloramphenicol enter the foetal circulation and are distributed into breast milk. If given systemically to the mother shortly before parturition or while breastfeeding, chloramphenicol may cause bone marrow suppression of the neonate or the grey baby syndrome, characterised by cyanosis and hypothermia, owing to the limited glucuronidating capacity of the neonate's liver. However, limited absorption following ophthalmic use at the recommended dosage is generally not expected to pose a risk to the foetus or neonate.

Use in lactation.

See Use in pregnancy, above.

Interactions

Systemically absorbed/ administered forms of chloramphenicol have been known to interact with certain drugs.

Adverse Effects

Chloramphenicol is absorbed systemically from the eye and toxicity has been reported following chronic exposure. Dose related toxicity following a single ocular exposure is unlikely. The following clinical adverse experiences have been observed with the use of chloramphenicol. More serious side effects (indicated by *) have been reported in patients sensitive to chloramphenicol and are causes for discontinuing the medication. The adverse reactions are listed by system organ class and frequency (common: ≥ 1% and < 10%, uncommon: ≥ 0.1% and < 1%, not known: cannot be estimated from available data).

Blood and lymphatic system disorders.

Not known: blood disorder (see Precautions).

Immune system disorders.

Uncommon: hypersensitivity. Not known: anaphylactic reaction*, reaction to drug excipients.

Nervous system disorders.

Uncommon: burning sensation.

Eye disorders.

Common: eye swelling, ocular hyperaemia.

Skin and subcutaneous tissue disorders.

Not known: angioedema*, rash vesicular*, urticaria*, rash maculopapular*, pruritus.

General disorders and administration site conditions.

Not known: pyrexia*.

Dosage and Administration

Instil one or two drops in the affected eye(s) two to six hourly for two to three days. The interval between applications may then be increased. Discard the solution within one month of opening the container.
Blinking following eye drop instillation discourages the intraocular penetration of a drug which minimises therapeutic effect and maximises systemic toxicity. Nasolacrimal occlusion (NLO) and eyelids closure (ELC) improves intraocular penetration and decreases systemic absorption.

Instructions to patients.

If symptoms worsen at any time or if the eye infection does not improve within 48 hours, seek prompt medical advice.
Do not use in children under 2 years of age except on medical advice.
Patients who wear contact lenses should be advised to seek medical advice from their doctor or optometrist before using Chloromycetin. Contact lenses should not be worn during the course of Chloromycetin treatment. If wearing hard or disposable contact lenses, patients can start using their contact lenses again after successfully completing the course of treatment. If wearing soft contact lenses, patients should wait 24 hours after successfully completing the course of treatment before starting to use their lenses again.
Treatment should be continued for at least 2 days after the eye appears normal but do not use for longer than 5 days except on medical advice.

Overdosage

Accidental ingestion of chloramphenicol eye drops is unlikely to cause any toxicity due to the low content of antibiotic. Each mL of Chloromycetin Eye Drops contains 19 mg of borax/ boric acid as buffer. It is advisable to keep medication out of reach of children. If accidentally ingested by infants or young children, a local Poisons Information Centre should be contacted. As there is individual variability in the pharmacokinetics of chloramphenicol in infants and children, monitor plasma levels. Levels exceeding 25 microgram/mL are frequently considered toxic.
If irritation, pain, swelling, lacrimation or photophobia occur after undesired eye contact, the exposed eye(s) should be irrigated with copious amounts of room temperature water for at least 15 minutes. If symptoms persist after 15 minutes of irrigation, an ophthalmological examination should be considered.
Contact the Poisons Information Centre on 131 126 for advice on the management of an overdose.

Presentation

Eye drops, 5 mg/mL: 10 mL (plastic dropper bottle with tamper seals).

Storage

Storage conditions.

Store between 2°C and 8°C.
After dispensing, the drops may be stored below 25°C for up to 1 month and should then be discarded.
Protect from light.

Poison Schedule

S3.