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Notes

Details

How Supplied
Sterile aqueous drops (10ml) in plastic bottle.
Dosing
ECP/HCP to advise. "Eyes: Instill 1-2 drops into the affected eye up to six times a day, or more frequently if required. (severe infections may require 1 or 2 drops every fifteen to twenty minutes initially, reducing the frequency of instillation gradually as the infection is controlled)."

"Ears: The area should be cleansed and 2-3 drops instilled in the affected ear 3-4 times a day and at night or more frequently if required". Always read SmPC via link in Notes below.
Formulation
Sterile Aqueous Solution containing:, Gentamicin sulphate equivalent to 30mg gentamicin base in 10ml of solution, Excipient(s) with known effect: Benzalkonium chloride 0.10mg/ml, Sodium Chloride, Disodium Edetate, Sodium Metabisulphite, Borax, Benzalkonium Chloride solution, Water for Injection, Sodium Hydroxide solution (pH adjuster), Hydrochloric acid (pH adjuster). Always read SmPC via link in Notes below.
Contact Lens Use
No, see Contra-Indications/Cautions
Indications
"Treatment of infections of the external structures of the eye and its adnexa caused by susceptible bacteria. Such infections include conjunctivitis, keratitis, kerato-conjunctivitis, corneal ulcers, blepharitis and blepharo-conjunctivitis, acute meibomianitis, episcleritis and dacryocystitis. It may be used for the prevention of ocular infection after: removal of a foreign body, burns or lacerations of the conjunctiva; damage from chemical or physical agents and after ocular surgery".

Also indicated for the treatment of otitis externa. Always read SmPC via link in Notes below.
Contra-Indications/Cautions
Due to the potentially wide range and seriousness of the Contra-indications/Cautions relating to this product the prescriber of this medicine should fully aware of original documentation, Patient Information Leaflet etc. All pts should be instructed to read the Patient Information Leaflet before using product. Attention is drawn to this products POM classification. Soft CLs should not be worn for 24 hours after completing Tx. Pt not to use product concurrently with other eye drops or ointment. Store below 25C. Protect from light. Discard 28 days after first opening. "This formulation of Gentamicin Eye/Ear Drops contains benzalkonium chloride as a preservative which may be deposited in soft contact lenses. Hence, Gentamicin should not be used while wearing these lenses. The lenses should be removed before instillation of the drops and not reinserted earlier than 15 minutes after use. "Benzalkonium chloride has been reported to cause eye irritation, symptoms of dry eyes and may affect the tear film and corneal surface. Should be used with caution in dry eye patients and in patients where the cornea may be compromised. Patients should be monitored in case of prolonged use." If symptoms become worse - pt to seek medical advice immediately. Pregnancy/lactation - EDDB. Advise pt to read and understand all accompanying product information before first use - EDDB. Always read SmPC via link in Notes below.
Adverse Reactions
Due to the potentially wide range and seriousness of the Adverse Reactions relating to this product the prescriber of this medicine should fully aware of original documentation, including SPC and PIL - see Notes. All pts should be instructed to read the Patient Information Leaflet before using product. If irritation occurs, persists or increases, pt to discontinue use and consult ECP/HCP - EDDB. If vision changes or irritation occurs, persists or increases, pt to discontinue use and consult ECP/HCP. Always read SmPC via link in Notes below.
Legal Category
POM.
Notes

1. SmPC: https://www.medicines.org.uk/emc/product/4218/smpc

2. PIL: https://www.medicines.org.uk/emc/product/4218/pil

3. ON NO ACCOUNT SHOULD THE DATA CONTAINED ON THIS PAGE BE USED AS A BASIS FOR CLINICAL DECISION MAKING/PX ADVICE  - THIS SHOULD ONLY BE DONE BY REFERENCE TO THE ORIGINAL PRESCRIBER AND/OR PRODUCT DOCUMENTATION.

4. Because products are regularly improved and change, product data and advice may occasionally change. As a result, EDDB recommends that you and your patient always read the product label and Patient Information Leaflet carefully before using any products. Please do not solely rely on the information provided on this website. Because of this, EDDB is unable to accept liability for any inaccuracies or incorrect information contained on this site.

5. Pt MUST BE INSTRUCTED TO READ ACCOMPANYING PATIENT INFORMATION LEAFLET BEFORE USE.

6. Attention is drawn to this product's POM/P category and the full relevant legal restrictions therof.

7. Attention is drawn to specific warnings in Contra-Indications/Cautions and Adverse Reactions on this page and the full text of the SPC and PIL, all of which should be read and understood.

8.REMINDER: TERMS OF USE. By using this website I agree I am an Eye Care/Health Care Professional and have read, understood and accepted all the terms of use as outlined in the Disclaimer and the Privacy Policy.

Product information

Not every product may be listed, or have full data. Every effort is being made to fill in the gaps as soon as possible. It will continue to grow in breadth and depth as data arrives and products are released, almost on a daily basis. Endeavours will be made to include information on 'retailers' drops such as Sainsbury's, Superdrug etc, so you can have data available when your patient tells you they are using Tesco Allergy Drops (Sodium Cromoglicate) and asks "can I use it with my contact lenses?". If you would like to propose products for the database, have any ideas, suggestions, would like to provide missing data or see any factual inaccuracies please email adpconsultancy@gmail.com