Sandoz Opticort: Uses, Side Effects and Dosage

What is Sandoz Opticort used for?

It is used in the eye(s) to treat:

• Inflammation due to infection (redness, itching, swelling, burning) in the front parts of the eye:

  • White of the eye (scleritis)
  • Clear layer on top of the white part of the eye (episcleritis)
  • Coloured part of the eye (iridocycitis)
  • Muscles and tissue involved in focusing the eye
• Inflammation due to infection (redness, swelling, burning) of the eyelid (blepharitis)
• Infected itchy, red rash of the eyelid
• Allergic and contagious eye infections
• Face skin reddening leading to red and yellow bumps (rosacea keratitis)

It is used in the ear(s) for:

• Redness and swelling of the ear canal (otitis externa)
• Red, scaly, greasy, itchy and inflamed skin of the outer ear

Sandoz Opticort contains antibacterial ingredients called framycetin and gramicidin, and it should be used exactly as directed by your healthcare professional.

How does Sandoz Opticort work?

Sandoz Opticort is a combination product that contains:

• 2 antibiotics (framycetin and gramicidin) that kill the bacteria that are causing the infection.
• 1 steroid (dexamethasone) that lowers inflammation

What are the ingredients in Sandoz Opticort?

Medicinal ingredients: dexamethasone sodium metasulfobenzoate, framycetin sulphate, gramicidin

Non-medicinal ingredients: phenylethyl alcohol 0.5% as preservative, sodium citrate, citric acid, polysorbate 80, ethyl alcohol, sodium chloride, sodium hydroxide and/or hydrochloric acid to adjust pH and water.

Sandoz Opticort comes in the following dosage forms:

Each milliliter of solution contains 5 mg framycetin sulphate; 0.05 mg gramicidin and 0.5 mg dexamethasone (as dexamethasone sodium metasulfobenzoate).

Sandoz Opticort is available in amber glass ophthalmic bottles of 8 mL (8 mL fill).

Do not use Sandoz Opticort if:

Eye:

• You are allergic to any of the ingredients in Sandoz Opticort;
• You have herpetic eye disease or other viral diseases of the cornea and conjunctiva;
• You have tuberculosis and fungal diseases of the eye;
• You have trachoma;
• You have untreated eye infections with thick discharges.

Ear:

• You are allergic to any of the ingredients in Sandoz Opticort;
• You have viral or fungal infections;
• You have untreated ear infections of the ear discharges;
• Your eardrum is punctured.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take Sandoz Opticort. Talk about any health conditions or problems you may have, including if you:

• Used corticostroids before.
• Have open wounds or damaged skin since deafness might happen if Sandoz Opticort is used directly on them.

Experience Allergies

• New itching, rash, redness or irritation that happens after using Sandoz Opticort.

Experience Eye Problems

• Blurred vision or other changes in vision (cataracts)
• Increased eye pressure
• If you take Sandoz Opticort for a long period of time, you should have your eye pressure checked regularly
• Perforation of the cornea due to thinning of the cornea

Get Pregnant

• If you become pregnant while taking Sandoz Opticort, talk to your healthcare professional right away.
• Sandoz Opticort should not be used for a long period of time during pregnancy unless the benefits outweigh the risks.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

How to take Sandoz Opticort:

Use in the Eye(s):

• Wash your hands.
• Remove the cap on the bottle.
• Tilt your head back. Pull down the lower lid of your eye.
• Squeeze 1 drop at a time into the pocket made by the lower lid.
• To avoid possibility of reinfection later, do not touch eye with dropper.
• Close your eye.
• Wipe away any excess drops with a clean tissue.
• Always put the cap back on the bottle as soon as you have used it.

Use in the Ear(s):

• Wash your hands.
• Remove the cap on the bottle.
• Tilt your head on one side.
• Squeeze 2 or 3 drops into your ear. Squeeze the dropper carefully.
• Lie your head with your affected ear facing upwards for a few minutes.
• To avoid possibility of reinfection later, do not touch ear with dropper. Alternatively, a saturated gauze wick may be inserted by the physician into the external ear canal.
• Wipe away any excess drops with a clean tissue.
• Always put the cap back on the bottle as soon as you have used it.

Misuse or overuse of Sandoz Opticort could lead to the growth of bacteria that will not be killed by framycetin or gramicidin. This means that Sandoz Opticort or other medicines that contain framycetin or gramicidin may not work for you in the future.

Do not share your medicine.

Usual dose:

In the eye(s)

• 1 or 2 drops every 1 to 2 hours (generally for 2 or 3 days).
• Afterwards, 1 or 2 drops 3 or 4 times daily.

In the ear(s)

• 2 or 3 drops in the ear canal 3 or 4 times daily.

Overdose:

If you think you have taken too much Sandoz Opticort, contact your healthcare professional, hospital emergency department or regional poison control centre immediately, even if there are no symptoms.

Missed Dose:

It is important to take this medication exactly as prescribed by your doctor. If you miss a dose, administer it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not administer a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

What are possible side effects from using Sandoz Opticort?

These are not all the possible side effects you may feel when taking Sandoz Opticort. If you experience any side effects not listed here, contact your healthcare professional.

Eye disorders

• Increased eye pressure (glaucoma);
• Perforation of the cornea (the transparent layer forming the front of the eye);
• Eye allergies;
• Burning or stinging of the eye;
• Cloudy vision;
• Blurred or distorted vision (chorioretinopathy).

Serious side effects and what to do about them

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.

Reporting Side Effects

Storage:

Store between 15 and 25 °C. Protect from light. Discard 28 days after initial use.

Keep out of reach and sight of children.

If you want more information about Sandoz Opticort:

• Talk to your healthcare professional
• Find the full product monograph that is prepared for healthcare professionals and includes this Consumer Information by visiting the Health Canada website (https://health-products.canada.ca/dpd-bdpp/index-eng.jsp); the manufacturer’s website http://www.sandoz.ca ,or by calling 1-800-361-3062.

Last Revised June 5, 2019