Details for: MAXIDEX
Company: NOVARTIS PHARMACEUTICALS CANADA INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 00042560 | MAXIDEX | DEXAMETHASONE | 0.1 % / W/V | SUSPENSION | OPHTHALMIC |
| 00042579 | MAXIDEX | DEXAMETHASONE | 0.1 % / W/W | OINTMENT | OPHTHALMIC |
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
MAXIDEX* - Ointment
MAXIDEX* is used to treat eye inflammation and eye injuries
MAXIDEX* - Suspension
MAXIDEX* is used to treat eye inflammation and eye injuries.
What it does
MAXIDEX* - Ointment
MAXIDEX* contains the steroid dexamethasone, which helps to reduce inflammation.
MAXIDEX* - Suspension
MAXIDEX* contains the steroid dexamethasone, which helps to reduce inflammation.
When it should not be used
MAXIDEX* - Ointment
Do not use MAXIDEX* if you:
- Are allergic (hypersensitive) to dexamethasone or any of the other ingredients in MAXIDEX* (see What the important non-medicinal ingredients are).
- Have herpes simplex keratitis (inflamed cornea of the eye caused by herpes simplex), smallpox, chickenpox or any other viral infection of the eye.
- Have a fungal infection of the eye.
- Have a mycobacterial infection of the eye, including tuberculosis.
- Have an untreated bacterial eye infection.
MAXIDEX* - Suspension
Do not use MAXIDEX* if you:
- Are allergic (hypersensitive) to dexamethasone or any of the other ingredients in MAXIDEX* (see What the important non-medicinal ingredients are).
- Have herpes simplex keratitis (inflamed cornea of the eye caused by herpes simplex), smallpox, chickenpox or any other viral infection of the eye.
- Have a fungal infection of the eye.
- Have a mycobacterial infection of the eye, including tuberculosis.
- Have an untreated bacterial eye infection.
What the medicinal ingredient is
MAXIDEX* - Ointment
Dexamethasone, 0.1% w/w
MAXIDEX* - Suspension
Dexamethasone, 0.1% w/v
What the non-medicinal ingredients are
MAXIDEX* - Ointment
Preservatives: methylparaben, propylparaben
Others: lanolin oil, white petrolatum
MAXIDEX* - Suspension
Preservative: benzalkonium chloride
Others: citric acid and/or sodium hydroxide (to adjust pH), dibasic sodium phosphate, edetate disodium, hydroxypropyl methylcellulose, polysorbate 80, sodium chloride and purified water.
What dosage form it comes in
MAXIDEX* - Ointment
Eye ointment in 3.5 g tube
MAXIDEX* - Suspension
Eye drop suspension in 5 mL bottle
Warnings and precautions
MAXIDEX* - Ointment
BEFORE you use MAXIDEX*, talk to your doctor or pharmacist if you:
- Have diabetes. You may be at a higher risk of developing high pressure in the eyes (intraocular pressure) or cataracts (clouding of the lens).
- Have or have had high pressure in the eye(s), such as glaucoma or ocular hypertension. Your doctor needs to monitor the pressure in your eyes.
- Have a disease that causes thinning of the eye. Small tears (perforations) have occurred.
- Are taking a class of drugs known as nonsteroidal anti-inflammatory drugs (NSAIDs). Taking MAXIDEX* with NSAIDs may slow healing of the eye.
- Are pregnant, might be pregnant or planning to be become pregnant.
- Are breastfeeding or planning to breast-feed.
STOP taking MAXIDEX* if you develop an eye infection.
While taking MAXIDEX*
If you take MAXIDEX* for a long time, your doctor should check your eye pressure regularly. This is especially important for children and predisposed individuals, such as those with diabetes. Taking MAXIDEX* for an extended time increases the risk of increased eye pressure, glaucoma, vision problems and cataract development.
Taking MAXIDEX* for a long time may also put you at risk of developing an eye infection.
Pregnancy and Breastfeeding
If you are pregnant or planning to become pregnant, talk to your doctor or pharmacist before using MAXIDEX*. If you use MAXIDEX* while pregnant, your infant should be observed for signs of hypoadrenalism (underactive adrenal gland), such as weakness, fatigue and weight loss.
It is not known if MAXIDEX* is present in breastmilk. Talk to your doctor or pharmacist if you are breastfeeding or planning to breast-feed.
Driving and Using Machinery
Your vision may become temporarily blurry after taking MAXIDEX*. If this occurs, wait until your vision clears before driving or using machinery.
MAXIDEX* - Suspension
BEFORE you use MAXIDEX*, talk to your doctor or pharmacist if you:
- Have diabetes. You may be at a higher risk of developing high pressure in the eyes (intraocular pressure) or cataracts (clouding of the lens).
- Have or have had high pressure in the eye(s), such as glaucoma or ocular hypertension. Your doctor needs to monitor the pressure in your eyes.
- Have a disease that causes thinning of the eye. Small tears (perforations) have occurred.
- Are taking a class of drugs known as nonsteroidal anti-inflammatory drugs (NSAIDs). Taking MAXIDEX* with NSAIDs may slow healing of the eye.
- Are pregnant, might be pregnant or planning to be become pregnant.
- Are breastfeeding or planning to breast-feed.
STOP taking MAXIDEX* if you develop an eye infection.
While taking MAXIDEX*
If you take MAXIDEX* for a long time, your doctor should check your eye pressure regularly. This is especially important for children and predisposed individuals, such as those with diabetes. Taking MAXIDEX* for an extended time increases the risk of increased eye pressure, glaucoma, vision problems and cataract development.
Taking MAXIDEX* for a long time may also put you at risk of developing an eye infection.
Contact Lens Wearers
You should not wear contact lenses while using MAXIDEX* suspension. MAXIDEX* suspension contains the preservative benzalkonium chloride, which is known to affect soft contact lenses. Avoid contact with soft contact lenses. If you must wear contact lenses, remove your contact lenses before applying MAXIDEX* suspension and wait at least 15 minutes before putting your lenses back in.
Pregnancy and Breastfeeding
If you are pregnant or planning to become pregnant, talk to your doctor or pharmacist before using MAXIDEX*. If you use MAXIDEX* while pregnant, your infant should be observed for signs of hypoadrenalism (underactive adrenal gland), such as weakness, fatigue and weight loss.
It is not known if MAXIDEX* is present in breastmilk. Talk to your doctor or pharmacist if you are breastfeeding or planning to breast-feed.
Driving and Using Machinery
Your vision may become temporarily blurry after taking MAXIDEX*. If this occurs, wait until your vision clears before driving or using machinery.
Interactions with this medication
MAXIDEX* - Ointment
Tell your doctor or pharmacist about all the medicines you are taking, recently took or are planning to take, including those obtained without a prescription.
Taking MAXIDEX* with NSAIDs may slow healing of the eye.
MAXIDEX* - Suspension
Tell your doctor or pharmacist about all the medicines you are taking, recently took or are planning to take, including those obtained without a prescription.
Taking MAXIDEX* with NSAIDs may slow healing of the eye.
Proper use of this medication
MAXIDEX* - Ointment
Adult dose
Apply a thin coating to the affected eye(s) three to four times a day. As your eye gets better, you may only need to apply a thin coating once a day for several days.
How to use
- Tilt your head back.
- Place a finger on your cheek just under your eye and gently pull down until a “v” pocket is formed between your eyeball and lower eyelid.
- Place a small amount of MAXIDEX* in the “v” pocket. Do not let the tip of the tube touch your eye, to avoid contaminating the ointment.
- Look down before closing your eye.
- Replace the cap of the tube.
Overdose
If you use more MAXIDEX* than you should, rinse it out with lukewarm water. Do not apply more MAXIDEX* until it is time for your next regular dose.
MAXIDEX* - Suspension
SHAKE WELL BEFORE USE. After removing the cap: if the security snap collar is loose, remove the snap collar before using MAXIDEX* suspension.
Adult dose
Mild disease: Apply one to two drops in the affected eye(s) 4-6 times daily.
Severe disease: Apply one to two drops in the affected eye(s) every hour. You may reduce the number of drops per day as your eye(s) gets better.
How to use
- Get the MAXIDEX* suspension bottle and a mirror.
- Shake well before use.
- Hold the bottle, pointing down, between your thumb and fingers.
- Tilt your head back.
- Pull down your lower eyelid with a clean finger until there is a “v” pocket between your eyelid and your eye. The drop will go in here (picture 1).
- Bring the bottle tip close to the eye. Do this in front of a mirror if it helps.
- Do not touch your eye, eyelid, surrounding areas or other surfaces with the dropper, to avoid contaminating the suspension.
- Gently press on the base of the bottle to release one drop at a time. Do not squeeze the bottle. It is designed so that a gentle press on the bottom is all that it needs (picture 2).
- If you miss, try again.
- Close the bottle immediately after use.
Overdose
If you use more MAXIDEX* than you should, rinse it out with lukewarm water. Do not apply more MAXIDEX* until it is time for your next regular dose.
Side effects and what to do about them
MAXIDEX* - Ointment
Like all medicines, MAXIDEX* can cause side effects, although
not everybody gets them.
A common side effect (seen in 1/10 to 1/100 patients) observed
with MAXIDEX* is eye discomfort.
Uncommon eye side effects (seen in 1/100 to 1/1000 patients) seen
with MAXIDEX* include: abnormal or foreign sensation in the
eye; eye surface inflammation; dry eye; staining of the eye;
sensitivity to light; blurred vision; increased tearing; eyelid
crusting; itchy eye; eye irritation; and eye redness.
Uncommon side effects in other parts of the body seen with
MAXIDEX* include: bad taste in the mouth.
Other side effects seen with MAXIDEX* include increased eye
pressure, reduced vision, eye injury, eyelid drooping, eye pain,
increased pupil size, dizziness and headache.
| Symptom / effect | Talk with your doctor or pharmacist Only if severe | Talk with your doctor or pharmacist In all cases | Stop taking drug and talk with your doctor or pharmacist |
|---|---|---|---|
| Uncommon | |||
| Allergic reaction (itching, redness or swelling of the eye) | ✔ | ||
| Cushing’s syndrome (hormone problems: growth of extra body hair (particularly in women), muscle weakness and wasting, purple stretch marks on body skin, increased blood pressure, irregular or missing periods, changes in the levels of protein and calcium in your body, stunted growth in children and teenagers and swelling and weight gain of the body and face.) | ✔ | ||
| Unknown | |||
| Infection | ✔ | ||
This is not a complete list of side effects. For any unexpected effects while taking MAXIDEX*, contact your doctor or pharmacist.
MAXIDEX* - Suspension
Like all medicines, MAXIDEX* can cause side effects, although not everybody gets them.
A common side effect (seen in 1/10 to 1/100 patients) observed with MAXIDEX* is eye discomfort.
Uncommon eye side effects (seen in 1/100 to 1/1000 patients) seen with MAXIDEX* include: abnormal or foreign sensation in the eye; eye surface inflammation; dry eye; staining of the eye; sensitivity to light; blurred vision; increased tearing; eyelid crusting; itchy eye; eye irritation; and eye redness.
Uncommon side effects in other parts of the body seen with MAXIDEX* include: bad taste in the mouth.
Other side effects seen with MAXIDEX* include increased eye pressure, reduced vision, eye injury, eyelid drooping, eye pain, increased pupil size, dizziness and headache.
| Symptom / effect | Talk with your doctor or pharmacist Only if severe | Talk with your doctor or pharmacist In all cases | Stop taking drug and talk with your doctor or pharmacist |
|---|---|---|---|
| Uncommon | |||
| Allergic reaction (itching, redness or swelling of the eye) | ✔ | ||
| Cushing’s syndrome (hormone problems: growth of extra body hair (particularly in women), muscle weakness and wasting, purple stretch marks on body skin, increased blood pressure, irregular or missing periods, changes in the levels of protein and calcium in your body, stunted growth in children and teenagers and swelling and weight gain of the body and face.) | ✔ | ||
| Unknown | |||
| Infection | ✔ | ||
This is not a complete list of side effects. For any unexpected effects while taking MAXIDEX*, contact your doctor or pharmacist.
How to store
MAXIDEX* - Ointment
Store at room temperature. Keep out of the reach and sight of children.
MAXIDEX* - Suspension
Store at room temperature. Keep out of the reach and sight of children.
Reporting side effects
You can help improve the safe use of health products for
Canadians by reporting serious and unexpected side effects
to Health Canada. Your report may help to identify new
side effects and change the product safety information.
3 ways to report:
- Online at MedEffect;
- By calling 1-866-234-2345 (toll-free);
- By completing a Consumer Side Effect Reporting Form
and sending it by:
- Fax to 1-866-678-6789 (toll-free), or
- Mail to: Canada Vigilance Program
Health Canada, Postal Locator 1908C
Ottawa, ON
K1A 0K9
Postage paid labels and the Consumer Side Effect Reporting Form are available at MedEffect.
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
More information
MAXIDEX* - Ointment
This document plus the full Prescribing Information, prepared for health professionals can be found at:
http://www.alcon.ca
or by contacting the sponsor, Alcon Canada Inc., at:
1-800-613-2245
This leaflet was prepared by Alcon Canada Inc.
Last revised: July 13, 2018
MAXIDEX is a registered trademark.
MAXIDEX* - Suspension
This document plus the full Prescribing Information, prepared for health professionals can be found at:
http://www.alcon.ca
or by contacting the sponsor, Alcon Canada Inc., at:
1-800-613-2245
This leaflet was prepared by Alcon Canada Inc.
Last revised: July 13, 2018
MAXIDEX is a registered trademark.