Consumer medicine information

Cholfen Eye Drops

Chloramphenicol

BRAND INFORMATION

Brand name

Cholfen Eye Drops

Active ingredient

Chloramphenicol

Schedule

1. WHAT CHOLFEN EYE DROPS IS USED FOR

Cholfen Eye Drops contains chloramphenicol, a synthetic antibiotic, as the active ingredient.

Cholfen Eye Drops is available as eye drops, for external use only.

It is used to treat an eye infection called bacterial conjunctivitis, which is a bacterial infection involving the mucous membrane of the surface of the eye.

The most common symptom is the presence of a sticky yellow-white discharge with mucus and pus (or glued eyes, especially in the morning on waking). Other symptoms include a gritty sensation in the eye, redness, irritation and watering of the eyes. The infection usually starts in one eye and then spreads to the other.

Ask your doctor, pharmacist or optometrist if you have any questions about why Cholfen Eye Drops has been prescribed for you. They may have prescribed it for another purpose.

2. WHEN YOU MUST NOT USE IT

Do not use Cholfen Eye Drops if you are allergic to chloramphenicol or any of the ingredients listed at the end of this leaflet.
Some of the symptoms of an allergic reaction to Cholfen Eye Drops may include irritation, pain and swelling in the eye. Skin rashes, blisters and fever may also occur.
Do not give Cholfen Eye Drops to children under 2 years of age unless your doctor or optometrist tells you.
Do not use Cholfen Eye Drops after the expiry date (EXP.) printed on the pack.
Do not use Cholfen Eye Drops if the packaging is torn, broken or shows signs of tampering.

3. BEFORE YOU START CHOLFEN EYE DROPS

Tell your doctor if the following conditions apply to you:

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 inhibit the healing of the wound.
you wear contact lenses. Contact lenses should not be worn during the course of Cholfen Eye Drops treatment. If you wear hard or 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.
you are pregnant or plan to become pregnant. Your doctor, optometrist or pharmacist will advise you of the risks and benefits of taking Cholfen Eye Drops in pregnancy.
you are breastfeeding or plan to breastfeed.

Your doctor, optometrist or pharmacist will advise you of the risks and benefits of taking Cholfen Eye Drops 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 Cholfen Eye Drops:

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)
your 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 surgery (including dental surgery) using a general anaesthetic
you feel unwell
you have any other medical conditions.

If you have not told your doctor or optometrist about any of the above, tell them before you use Cholfen Eye Drops.

Taking other medicines

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

Some medicines may interfere with Cholfen Eye Drops. These include other eye drops and eye ointments.

These medicines may reduce or increase the effectiveness of Cholfen Eye Drops, reduce its own effectiveness and/or react with Cholfen Eye Drops resulting in untoward or sometimes dangerous side effects.

Your doctor, optometrist or pharmacist has more information on medicines to be careful with or avoid while using this medicine.

4. HOW TO USE IT

Follow all directions given to you by your doctor, optometrist or pharmacist carefully. They may differ from the information contained in this leaflet.

How much to use

The dose of Cholfen Eye Drops may be different for each person and their medical condition. Your doctor, optometrist or pharmacist will recommend the right dose for you.

Do not use in children under 2 years of age except on doctor’s advice.

The usual recommended doses are:

Cholfen Eye Drops:

For adults and children (2 years and over): Instill 1 or 2 drops in the affected eye(s) every two to six hours for 2 to 3 days. The interval between applications may then be increased. Treatment should be continued for at least 48 hours 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.

How to apply Cholfen Eye Drops:

wash hands thoroughly before and after use
open the eye, tilt head back and look upwards
gently pull down the lower lid to form a pouch
approach the eye from the side and hold the bottle dropper near the lid, but do not let the tip of the dropper touch the eye, eyelids or lashes
apply one drop into the pouch
close the eyes (do not rub them) and try not to blink for a short time
apply gentle pressure for about one minute with a finger to the bridge of the nose to prevent the medicine being drained from the eye
blot excess solution around the eye with a tissue
if instilling more than one drop in an eye, separate each installation by several minutes to avoid washing drops out of the eye
To minimise contamination, do not allow the dropper to contact the surface of the eye.

How long to use it

Cholfen Eye Drops should not be used for more than 5 days except on medical advice.

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 next due.

Otherwise, use it as soon as you remember, and then go back to using it as you would normally.

If you are unsure about whether to use your next dose, speak to your doctor, optometrist or pharmacist.

Do not try to make up for missed doses by using more than one dose at a time. This may increase the chance of you getting an unwanted side effect.

If you use too much (overdose):

Accidental ingestion of the drug in adults is unlikely to cause any toxicity due to the low content of antibiotic, but consult your doctor or Poison Information Centre (see below).

If the eye drops are accidentally ingested by infants or young children, immediately telephone your doctor or Poisons Information Centre (telephone 13 11 26) for advice, or go to Accident and Emergency at the nearest hospital. Do this even if there are no signs of discomfort or poisoning.

Urgent medical attention may be needed.

5. WHILE YOU ARE USING IT

Things you must do

Use Cholfen Eye Drops exactly as directed.
Tell all doctors, dentists, optometrists and pharmacists who are treating you that you are using Cholfen Eye Drops.
Tell your doctor immediately if you become pregnant while you are using Cholfen Eye Drops.
Always discuss with your doctor, optometrist or pharmacist any problems or difficulties - during or after using this medicine.
Tell your doctor, optometrist or pharmacist if, for any reason, you have not taken your medicine exactly as prescribed. Otherwise they may think that it was not effective and change your treatment unnecessarily.

Things you must not do

Do not drive or operate machinery until you know how Cholfen Eye Drops affects you. Cholfen Eye Drops may distortyour vision temporarily. Make sure you know how you react to it before you drive a car, operate machinery or do anything else that could be dangerous.
Do not use Cholfen Eye Drops for a longer time than your doctor, optometrist or pharmacist has prescribed.
Do not increase the dose, without first checking with your doctor, optometrist or pharmacist.
Do not use this medicine to treat any other complaints without checking with your doctor, optometrist or pharmacist.
Do not give this medicine to anyone else, even if they have the same condition as you.

6. SIDE EFFECTS

Tell your doctor, optometrist or pharmacist as soon as possible if you do not feel well while you are using Cholfen Eye Drops.

All medicines 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.

Ask your doctor, optometrist or pharmacist if you have any questions.

Tell your doctor, optometrist or pharmacist immediately if you notice any of the following:

eye irritation or swelling that may include itching or burning
skin rashes or blisters
fever.

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.

Tell your doctor, optometrist or pharmacist if you have any other problems while using Cholfen Eye Drops even if you do not think the problems are connected with the medicine or are not listed in this leaflet.

Other side effects may also occur in some people.

7. AFTER USING IT

Storage

Store unopened bottles in a refrigerator, protected from light, where the temperature stays between 2-8°C. Do not freeze. After opening, store at room temperature (below 25°C). Discard 4 weeks after opening. Protect from light.

Do not store Cholfen Eye Drops in a bathroom or near a sink. Do not leave it in the car or on windowsills. Heat and dampness can destroy some medicines.

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

Disposal

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

8. PRODUCT DESCRIPTION

What it looks like

Cholfen Eye Drops are a sterile clear solution of Chloramphenicol. Available in 10 mL plastic container containing 5 mg of Chloramphenicol per mL of eye drops.

Ingredients

Active ingredient: chloramphenicol 5 mg/mL (0.5%)

Other ingredients:

boric acid
borax
hypromellose (Methocel E4M Premium)
water for injection
Phenylmercuric nitrate

SPONSOR

Alphapharm Pty Ltd
Level 1, 30 The Bond
30 – 34 Hickson Road
Millers Point NSW 2000
www.mylan.com.au

Australian Registration Number 349371, Cholfen Eye Drops 10mL

Date of most recent amendment: 4 August 2020

Published by MIMS October 2022

BRAND INFORMATION

Brand name

Cholfen Eye Drops

Active ingredient

Chloramphenicol

Schedule

1 Name of Medicine

Chloramphenicol.

2 Qualitative and Quantitative Composition

Cholfen Eye Drops contains 0.5% w/v chloramphenicol in aqueous base thickened with hypromellose.
Cholfen Eye Ointment contains 1% w/w chloramphenicol in a sterile oculentum base.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Cholfen Eye Drops is a clear to slightly hazy colourless, slightly viscous liquid and odourless.
Cholfen Eye Ointment is a pale yellow opaque ointment.

4 Clinical Particulars

4.1 Therapeutic 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.

4.2 Dose and Method of Administration

Cholfen Eye Drops.

Adults and children 2 years and over: instil 1 or 2 drops in the affected eye(s) every two to six hours for two to three days. The interval between applications may then be increased. Treatment should be continued for at least 48 hours after the eye appears normal. Do not use for more than 5 days in total except on medical advice.
To minimise contamination do not allow the dropper to contact the surface of the eye. Discard solution within one month of opening container.
The systemic absorption of Cholfen Eye Drops can be minimised by applying gentle pressure on the tear-duct for approximately one minute immediately after application.

Cholfen Eye Ointment.

Adults and children 2 years and over: apply 1.5 cm of ointment into the affected eye(s) every 3 hours. If ointment is used together with drops for day and night coverage, 1.5 cm should be applied before bedtime, while using the drops during the day. Continue treatment for at least 48 hours after the eye appears normal. Do not use for more than 5 days in total except on medical advice.
To minimise contamination do not allow the tip to contact the surface of the eye.
Cholfen Eye Drops and Cholfen Eye Ointment are not recommended for children under 2 years except on medical advice.

4.3 Contraindications

Chloramphenicol is contraindicated in individuals with a history of hypersensitivity to any excipients and/or toxic reaction to the drug.

4.4 Special Warnings and Precautions for Use

Identified precautions.

Bone marrow hypoplasia, including aplastic anaemia and death, has been rarely reported following local application of chloramphenicol. 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.
The mechanism for the irreversible aplastic anaemia following ophthalmic use of chloramphenicol has not been established.
Chloramphenicol eye drops and ointment 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.
Contact lens wear.
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.
Patient is a contact lens user.
Patient is using other eye drops or eye ointments 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.
In these cases, referral to a doctor or optometrist is required.

Instructions to patients.

If symptoms worsen at any time or if the eye infection does not improve within 48 hours, seek prompt medical advice.
Patients who wear contact lenses should be advised to seek advice from their doctor or optometrist before using Cholfen Eye Drops and Cholfen Eye Ointment. Contact lenses should not be worn during the course of Cholfen Eye Drops and Cholfen Eye Ointment treatment. If wearing hard or disposable contact lenses, patients can start using their lenses again after successfully completing the course of treatment. If wearing soft contact lenses, patients should wait 24 hours after successfully completing a course of treatment before starting to use their lenses again.

Use in hepatic impairment.

No data available.

Use in renal impairment.

No data available.

Use in the elderly.

No data available.

Paediatric use.

No data available.

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

No data available.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

Cholfen Eye Drops.

Excipients containing boron such as boric acid or borate compounds have been shown to cause reduced fertility and effects on embryofoetal development in animal studies and this appears to be dose related. The relevance of this to humans is uncertain.

Cholfen Eye Ointment.

No data available.
(Category A)
Systemically absorbed/ administered forms of chloramphenicol enter the foetal circulation. If given systemically to the mother shortly before parturition, chloramphenicol may cause bone marrow suppression or "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 recommended dosage is generally not expected to pose a risk to the foetus or neonate.
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 whilst 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 neonate.

4.7 Effects on Ability to Drive and Use Machines

Cholfen Eye Drops and Eye Ointment may distort vision temporarily. It is recommended that patients using Cholfen Eye Drops and Eye Ointment understand how it may affect them before driving a motor vehicle, or operating machinery.

4.8 Adverse Effects (Undesirable Effects)

Blood dyscrasias have been reported in association with the use of chloramphenicol (see Section 4.4 Special Warnings and Precautions for Use). 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. Local irritation with the ophthalmic form may include subjective symptoms of itching or burning. More serious side effects such as angioneurotic oedema; anaphylaxis, urticaria, fever, vesicular and maculopapular dermatitis have been reported in patients sensitive to chloramphenicol and are causes for discontinuing the medication. Similar sensitivity reactions to other materials in topical preparations also may occur.

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

Accidental ingestion of the drug is unlikely to cause any toxicity due to low content of antibiotic.
Cholfen Eye Drops contains 19 mg/mL of borax/boric acid as buffer.
If the eye drops or eye ointment is accidentally ingested by infants or young children, Poisons Information Centre (Telephone 13 11 26 in Australia) should be contacted. The medication should be kept out of reach of children.

Treatment.

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.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

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.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

No data available.

5.3 Preclinical Safety Data

Genotoxicity.

No data available.

Carcinogenicity.

No data available.

6 Pharmaceutical Particulars

6.1 List of Excipients

Cholfen Eye Drops.

Phenylmercuric nitrate, boric acid, borax, hypromellose, water for injection.
Phenylmercuric nitrate (0.002% w/v) is used as a preservative.

Cholfen Eye Ointment.

Liquid paraffin, white soft paraffin, wool fat.
Contains no preservatives.

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

Cholfen Eye Drops.

Store between 2 - 8°C until opened. Refrigerate. Do not freeze. On opening the drops may be stored at room temperature (below 25°C). Discard 4 weeks after opening. Protect from light.

Cholfen Eye Ointment.

Store below 25°C. Discard 4 weeks after opening. Protect from light.

6.5 Nature and Contents of Container

Cholfen Eye Drops.

Plastic dropper bottle contains 10 mL sterile eye drops.

Cholfen Eye Ointment.

5 g tube with an ophthalmic cap.

Australian Register of Therapeutic Goods (ARTG).

AUST R 349371 - Cholfen Eye Drops chloramphenicol 5 mg/mL bottle.
AUST R 380304 - Cholfen Eye Ointment chloramphenicol 10 mg/g eye ointment tube.

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.

Molecular formula is C₁₁H₁₂Cl₂N₂O₅ and a molecular weight of 323.1.

Physical and chemical properties.

Chloramphenicol exists as a white to greyish-white or yellowish white, fine crystalline powder or fine crystals, needles or elongated plates.
Chloramphenicol is slightly soluble in water (1 in 400), chloroform and ether. Freely soluble in ethanol (1 in 2.5), propylene glycol (1 in 7), acetone and ethyl acetate.

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