Chloramphenicol belongs to a group of medicines called antibiotics. Chloramphenicol Eye Drops are
used for the treatment of bacterial conjunctivitis (infection of the eye). The infected eye will probably
be red, gritty or itchy. In the morning there will be a sticky discharge which may make it difficult to
open the eye. When put in the eye, Chloramphenicol works by helping kill the bacteria (germs) and
allow the body to overcome the infection.

Always use Chloramphenicol exactly as your doctor or pharmacist has told you. You should check
with your doctor or pharmacist if you are not sure.
Adults, children and infants:
The recommended dosage is two drops to be applied to the affected eye every 3 hours or more
frequently if required. Continue treatment at least 48 hours after the eye appears normal.
 Instructions for using eye drops
 Unscrew the cap from the bottle, check the dropper is clean.
 Pull your lower eyelid gently down, and then carefully instil two drops inside the lower
eyelid, in the corner closest to the nose.

 Release the lower eyelid, and blink a few times to make sure the eye is covered by the liquid.
 If you use drops in both eyes, repeat the steps for your other eye.
 Put the bottle cap back on firmly immediately after use.

Do not wear contact lenses during treatment. Wait until 24 hours after the end of the treatment before you wear your contact lenses. You can wear glasses during treatment. DO NOT use Chloramphenicol Eye Drops if the answer to the following questions is yes:  Have you ever had an allergic reaction to Chloramphenicol or to any of the other ingredients listed in this leaflet.  Have you or someone in your family ever had a blood disorder or bone marrow disease including anemia (decrease in the number of red blood cells). Signs of this include tiredness, unusual bruising or increase in the number of infections that you get.

If any new infection appears during treatment, you should stop taking the drops and speak to your
doctor.
If you use Chloramphenicol Eye Drops for a long time, your doctor may do some blood tests to check
for any Problems.
Take special care with Chloramphenicol Eye Drops and talk with your doctor or pharmacist before
taking your medicine if:
 You have visual disturbances.
 You have severe pain in the eye.
 You are sensitive to light.
 Your eye is inflamed and you have a rash on the scalp or face.
 Your eye looks cloudy.
 The black or coloured part of the eye looks unusual.
 You have a foreign body in the eye.
 You have an eye infection that keeps coming back.
 You have glaucoma (raised pressure in the eye).
 You have dry eyes.
 You have eye injury or eye surgery.
 You are currently using any other eye drops or eye ointment.

Please tell your doctor or pharmacist if you are taking or having recently taken any other medicines,
including medicines obtained without a prescription. They may be affected by Chloramphenicol or
affect how well the drops work.
In particular, tell your doctor if you are taking any of the following:
 Medicines for cancer such as methotrexate.
 Medicines for the immune system such as azathioprine

The drops should not be used in pregnancy unless your doctor feels that it is clearly needed, as the
effects are unknown. The drops should not be used whilst breast feeding. Tell your doctor if you are
planning to become pregnant, or are breast feeding so that a different medicine can be considered

If the drop blurs your vision, do not drive or operate machines until you can clearly see again.

Along with the relief of symptoms a medicine may produce side effects. Most people taking this
medicine find it causes no problems. A few people can be allergic to Chloramphenicol Eye Drops.
• You may notice that your eyes burn or sting for a short while after using the drops. If prolonged
irritation, swelling, watery eyes or sensitivity to light occurs, then the exposed eye should be washed
with water for 15 minutes. If the symptoms continue after this, an eye examination may be required.
Stop taking your medicine and tell your doctor or pharmacist immediately if you experience the
following side effects:
• Wheeziness (shortness of breath), fever, swelling of your face, lips or tongue, itching, rash with
swelling of the skin (the rash could be puffy (swollen) or blotchy, or look like little blisters.
• A sore throat, bruising or being unable to overcome an infection. On very rare occasions, patients
using chloramphenicol have had changes in their blood cells causing severe tiredness or easy
bruising.

Tell your doctor or pharmacist if:
• Any of the effects gets serious.
• You notice any side effects not listed in this leaflet.
To report any side effect(s):
Saudi Arabia:
The National Pharmacovigilance and Drug Safety Centre (NPC)
Fax: +966-11-205-7662.
Call NPC at +966-11-2038222,
Exts: 2317-2356-2353-2354-2334-2340.
Toll free phone: 8002490000
E-mail: npc.drug@sfda.gov.sa
Website: www.sfda.gov.sa/npc
Other GCC States:
Please contact the relevant competent authority

Accidental ingestion of the drops is unlikely to cause systemic toxicity due to the low content of the
antibiotic in the product. If irritation, pain, swelling, lacrimation or photophobia occur after undesired
eye contact, the exposed eye(s) should be irrigated for at least 15 minutes. If symptoms persist after
this, an ophthalmological examination should be considered.

Pharmacotherapeutic group: Antibiotics
ATC code: S01AA01
Chloramphenicol is a broad spectrum antibiotic with bacteriostatic activity and is effective against a
wide range of gram-negative and gram-positive organisms including Haemophilus influenzae,
Streptococcus pneumoniae, Staphylococcus aureus, Streptococcus viridans, Moraxella species and
Enterobacteriaceae, the main pathogens responsible for acute bacterial conjunctivitis.

Chloramphenicol exerts its antibacterial effect by reversibly binding to bacterial ribosomes thereby
inhibiting bacterial protein synthesis.

Evidence suggests that chloramphenicol is absorbed systemically via topical ocular administration.
Any chloramphenicol that is absorbed will be widely distributed in the body tissues and fluids. It is
found in cerebrospinal fluid, is secreted in saliva, with the highest concentrations occurring in the
kidneys and liver.
Chloramphenicol also diffuses across the placenta into the foetal circulation and into breast milk.
Chloramphenicol is excreted chiefly in the urine as the glucuronide with small amounts being
excreted via the bile and faeces. It has a reported half-life of 1.5 to 5 hours which is increased in
patients with liver impairment and neonates to between 24 and 28 hours in the latter.

No additional data of relevance to the prescriber.

 Borax
 Boric acid
 Chlorobutanol
 Hydrochloric acid 1N OR sodium hydroxide 1N (for pH adjustment),
 Hydroxypropyl Methylcellulose
 Water for injection

Not Applicable.

Unopening: 2 Years After First opening: Discard after 30 days of opening.

Store in a refrigerator (2oC to 8oC).
Keep out of the reach and sight of children.
Protect from light by storing in the original packaging.

Optichlor Ophthalmic Solution, 10 ml filled in LDPE bottle with LDPE Nozzle & HDPE Cap. and
packed in carton with PIL.

No special requirements.