Consumer medicine information

Minims Chloramphenicol

Chloramphenicol

BRAND INFORMATION

Brand name

Minims Chloramphenicol 0.5% Eye Drops

Active ingredient

Chloramphenicol

Schedule

S3

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Minims Chloramphenicol.

What is in this leaflet

This leaflet answers some common questions about Minims Chloramphenicol, including how to use the 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 benefits and risks. Your pharmacist, doctor or optometrist has weighed the risks of you using Minims Chloramphenicol 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 Minims Chloramphenicol is used for

Minims Chloramphenicol is a broad-spectrum antibiotic solution that 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 this medicine has been prescribed for you. They may have prescribed it for another reason.

Before you use Minims Chloramphenicol

When you must not use it

Do not use Minims Chloramphenicol if you have an allergy to:

  • Any medicine containing chloramphenicol
  • Any of the ingredients listed at the end of this leaflet.

Some of the symptoms of an allergic reaction may include:

  • Shortness of breath
  • Wheezing or difficulty breathing
  • Swelling of the face, lips, tongue or other parts of the body
  • Rash, itching or hives on the skin.

Do not use Minims Chloramphenicol on children under 2 years of age unless your doctor tells you.

Do not use this medicine 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.

Before you start to use it

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

  • if you have had an allergy to any other medicines, foods, preservatives or dyes.
  • if you have any blood disorder such as reduced blood cells, or lack of white blood cells or low blood platelet count.
    Your pharmacist, doctor or optometrist may wish to use an alternative treatment since chloramphenicol has been associated with depression of the bone marrow, which is a serious complaint.
  • if you are to have or have had eye surgery.
    Your pharmacist, doctor or optometrist may wish to use an alternative treatment since chloramphenicol may slow corneal wound healing.
  • if you are pregnant or plan to become pregnant.
    Your doctor will advise you of the risks and benefits involved.
  • if you are breast-feeding or intend to breast-feed.
    Your doctor will discuss the risks and benefits involved.
  • if you wear contact lenses.
    Contact lenses should not be worn during the course of Minims Chloramphenicol treatment. If you wear hard or disposable contact lenses, you can start using them again after successfully completing the course of treatment. If wearing soft contact lenses, you should wait 24 hours after successfully completing a course of treatment before starting to use them again.

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

If you have bought this medicine without a prescription and without prior consultation from a pharmacist, doctor or optometrist, it is important to check the following list. Speak to your pharmacist, doctor or optometrist if any of the following applies to you before you start using Minims Chloramphenicol:

  • you are allergic to any other antibiotic eye drops
  • you are using other eye drops or 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 may be torn, not round, very big or does not change size in the light)
  • 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 have surgery (including dental surgery) using a general anaesthetic
  • you feel unwell
  • you have any other medical conditions

If you have not told your pharmacist, doctor or optometrist about any of the above, tell them before you use Minims Chloramphenicol.

Taking other medicines

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

Some medicines and Minims Chloramphenicol may interfere with each other. These include medicines containing:

  • chymotrypsin.
    It is not recommended to use these eye drops at the same time as any medicine containing chymotrypsin.

These medicines may be affected by Minims Chloramphenicol 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 will have more information on medicines to be careful with or avoid while using this medicine.

How to use Minims Chloramphenicol

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.

How much to use

Use Minims Chloramphenicol only when prescribed by your pharmacist, doctor or optometrist. The dose of the eye drops may be different for each person and their medical condition. Your pharmacist, doctor or optometrist will tell you how often to use the eye drops and how many drops to use each time.

The usual dose of Minims Chloramphenicol in adults and children 2 years and over is one or two drops instilled into each affected eye every two to six hours for two to three days. The interval between applications may then be increased. Severe infections may require one or two drops every fifteen to twenty minutes to begin with then gradually reducing the frequency of application as the infection is controlled. 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. If the condition becomes worse or does not get better after 2 days, seek medical advice.

Do not use in children under 2 years of age except on Doctor's advice.

How to use it

You may find it easier to put drops in your eye while you are sitting or lying down.

Follow these steps to use the eye drops.

  1. Wash your hands well with soap and water.
  2. Shake the container.
  3. Break the seal.
  4. Hold the container upside down in one hand between your thumb and forefinger.
  5. Using your other hand, gently pull down your lower eyelid to form a pouch/pocket.
  6. Tilt your head back and look up.
  7. Put the tip of the container close to your lower eyelid. Do not let it touch your eye.
  8. Release one or two drops into the pouch/pocket formed between your eye and eyelid by gently squeezing the container.
  9. Close your eye. Do not blink or rub your eye.
  10. While your eye is closed, place your index finger against the inside corner of your eye and press against your nose for about two minutes.

This is very important when administering to children. This will help to stop the medicine from draining through the tear duct to the nose and throat, from where it can be absorbed into other parts of your body.

Repeat steps 4-10 for the other eye if needed.

Throw away any eye drops left in the container.

How long to use it

Minims Chloramphenicol 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 dose when you are meant to.

Otherwise, use it 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 using your medicine, ask your pharmacist for some hints.

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

If you use too much (overdose)

Accidental swallowing of the solution is unlikely to cause any bad side effects due to the low content of Chloramphenicol. If you think that an infant or young child may have swallowed any or all of the contents of the container of Minims Chloramphenicol, immediately telephone your doctor or Poisons Information Centre (Australia 13 11 26, New Zealand 0800 964 766) for advice.

Urgent medical attention may be needed.

While you are using Minims Chloramphenicol

Things you must do

Use exactly as directed.

Tell your doctor if you are to have or have had eye surgery.

Your doctor may advise you to stop using Minims Chloramphenicol as they may slow corneal wound healing.

If you have any irritation, pain, swelling, excessive tear production or light-sensitivity occur while using the eye drops, flush the treated eye(s) with lots of water (room temperature) for at least 15 minutes.

Stop using the eye drops and contact your doctor if these symptoms persist.

If you wear contact lenses, stop wearing them while you are using Minims Chloramphenicol.

If you are about to be started on any new medicine, remind your doctor and pharmacist that you are using Minims Chloramphenicol.

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

Things you must not do

Do not stop using Minims Chloramphenicol without first checking with your pharmacist, doctor or optometrist unless you are experiencing painful sensitivity reactions such as irritation, burning, stinging or itching.

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

If you need to stop because of sensitisation, irritation or lack of effect, contact your pharmacist, doctor or optometrist immediately.

Do not use this medicine to treat any other complaints unless your doctor tells you to.

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

Do not increase the dose without first checking with your Doctor, optometrist or pharmacist.

Things to be careful of

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

This medicine generally does not cause any problems with your ability to drive a car or operate machinery. However, it may temporarily blur your vision at the time of application. Make sure you know how you react to this medicine and allow enough time to regain clear vision before you drive a car or operate machinery.

Side effects

Tell your doctor or pharmacist if you do not feel well while you are using Minims Chloramphenicol.

This medicine helps most people with infections of the eye, but it may have unwanted 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.

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 they worry you:

  • Blurred vision and/or problems seeing clearly
  • Local eye irritation or feeling of having something in the eye
  • Skin rash

The above list includes the more common side effects of your medicine. They are usually mild and short lived.

Tell your doctor immediately or visit Accident and Emergency at your nearest hospital if you notice any of the following:

  • Swelling of the face, lips, mouth, tongue or throat or other parts of the body
  • Shortness of breath, wheezing or trouble breathing
  • Rash, itching or hives
  • Bruising or bleeding more easily than usual
  • Fever
  • Blistering skin

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

Other side effects not listed above may also occur in some patients. Tell your doctor if you notice any other effects.

After using Minims Chloramphenicol

Storage

Keep the unopened eye drops in a refrigerator (2-8°C) where children cannot reach them. Do not freeze the eye drops or expose them to strong light.

Discard each single dose unit and any remaining solution in it immediately after use. Do not save unused contents.

Disposal

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

Product description

What it looks like

Minims Chloramphenicol comes in single dose units containing 0.5mL of a clear, colourless solution.

Each carton contains 20 single dose units.

Ingredients

Minims Chloramphenicol contains 0.5%w/v of chloramphenicol as the active ingredient.

It also contains:

  • Water - Purified
  • Borax
  • Boric acid

The eye drops do not contain any preservatives.

Manufacturer/Supplier

In Australia Minims Chloramphenicol is supplied by:

iNova Pharmaceuticals (Australia) Pty Ltd
Level 10, 12 Help Street
Chatswood, NSW 2067
Phone: (02) 8918 6322

Minims Chloramphenicol 0.5%
AUST R 32263

In New Zealand Minims Chloramphenicol is supplied by:

Bausch & Lomb (NZ) Ltd
c/- Bell Gully
Auckland Vero Centre
48 Shortland Street
Auckland 1140
New Zealand

Toll free number: 0508375394

Date of preparation

This leaflet was prepared in September 2015.

BRAND INFORMATION

Brand name

Minims Chloramphenicol 0.5% Eye Drops

Active ingredient

Chloramphenicol

Schedule

S3

 

1 Name of Medicine

Chloramphenicol.

6.7 Physicochemical Properties

Chemical structure.


CAS number.

56-75-7.
Chemical name: 2,2-dichloro-N-[(α-R, β-R) -β-hydroxy-α-hydroxymethyl-4-nitrophenethylene]-acetamide.
Molecular formula: C11H12Cl2N2O5.
Molecular weight: 323.1.
Chloramphenicol is a white to greyish white or yellowish white, fine crystalline powder or fine crystals, needles or elongated plates.

2 Qualitative and Quantitative Composition

Minims Chloramphenicol Eye Drops contain chloramphenicol 0.5% (5 mg/mL). No preservatives are included in the formulation.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

A single-use eye drops, solution.
Minims Chloramphenicol Eye Drops are single-use, clear, colourless sterile eye drops. No preservatives are included in the formulation.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Chloramphenicol is a broad spectrum antibiotic which is effective against both Gram positive and Gram negative organisms. Chloramphenicol is bacteriostatic and acts by inhibition of protein synthesis. Chloramphenicol is an antimicrobial substance produced by the growth of certain strains of Streptomyces venezuelae.

Clinical trials.

This information is not available.

5.2 Pharmacokinetic Properties

Chloramphenicol is rapidly absorbed after oral administration. In the liver, chloramphenicol is inactivated by conjugation with glucuronic acid or by reduction to inactive aryl amines. Excretion is mainly renal, though some bile excretion occurs following oral administration.

5.3 Preclinical Safety Data

Genotoxicity.

No data available.

Carcinogenicity.

No data available.

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.

4.3 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

This product 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 wearer; 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 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.
In severe infections topical use of chloramphenicol should be supplemented with appropriate systemic treatment.
The use of this antibiotic, as with other antibiotics, may result in the overgrowth of non-susceptible organisms, including fungi. If infections caused by non-susceptible organism appear during therapy, its use should be discontinued and appropriate measures taken.

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 this product. Contact lenses should not be worn during the course of treatment with this product. 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.

Local effects.

Sensitivity reactions such as transient irritation, burning, stinging, itching and dermatitis may occur.
Discontinue promptly if sensitisation or irritation occurs.

Systemic effects.

The mechanism for irreversible aplastic anaemia following ophthalmic use of chloramphenicol has not been established.
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 chloramphenicol may retard corneal wound healing.

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

Chymotrypsin (an eye drop used during cataract surgery) may not work properly if it is given at the same time as Minims Chloramphenicol.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

No data available.
(Category A)
Drugs which have been taken by a large number of pregnant women and women of childbearing age without any proven increase in the frequency of malformations or other direct or indirect harmful effects on the foetus having been observed.
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 foetus or neonate.
There are no studies on use in lactation.

4.8 Adverse Effects (Undesirable Effects)

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.
Blood dyscrasias have been reported in association with 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 singular ocular exposure is unlikely.
Signs of local irritation with subjective symptoms of itching or burning. More serious side effects include 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 material in topical preparations may also occur.

4.2 Dose and Method of Administration

Systemic absorption may be reduced by compressing the lacrimal sac at the medial canthus for a minute during and following the instillation of drops. This blocks the passage of the drops via the nasolacrimal duct to wide absorptive area of the nasal and pharyngeal mucosa. It is especially advisable in children.

Adults and children 2 years of age and over.

One to two drops applied to each affected eye every two to six hours for two to three days. The interval between applications may then be increased. Severe infections may require one to two drops every fifteen to twenty minutes initially, reducing the frequency of instillation gradually as the infection is controlled.
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.
Each Minims unit should be discarded after a single dose.
The product is not recommended for children under 2 years of age except on medical advice.

4.7 Effects on Ability to Drive and Use Machines

May cause transient blurring of vision on instillation. Warn patients not to drive or operate hazardous machinery unless vision is clear.

4.9 Overdose

Accidental ingestion of the drug is unlikely to cause any toxicity due to the low content of antibiotic. Minims Chloramphenicol contain borax and boric acid as a buffer and if ingestion by infants or young children occurs, the Poisons Information Centre should be contacted. It is advisable to keep medication out of the reach of children.

Treatment.

If irritation, pain, lacrimation or photophobia occurs 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 ophthalmic examination should be considered.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

7 Medicine Schedule (Poisons Standard)

S3.

6 Pharmaceutical Particulars

6.1 List of Excipients

Borax, boric acid and purified water.

6.2 Incompatibilities

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

6.3 Shelf Life

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

6.4 Special Precautions for Storage

Store at 2°C to 8°C. Refrigerate. Do not freeze. Do not expose to strong light.

6.5 Nature and Contents of Container

Minims Chloramphenicol Eye Drops are supplied as a clear colourless sterile eye drops in a single use polypropylene tube (unit) overwrapped in a polyester sachet. The sachets are packed in cartons of 20 units. Each unit containing approximately 0.5 mL solution.

6.6 Special Precautions for Disposal

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

Summary Table of Changes