Consumer Information for: LOTEMAX

Consumer Information

Information about the product including what the product is used for, dosage, warnings, proper use and side effects. This summary will not tell you everything about the product. Contact your healthcare professional if you have any questions about the product.


What the medication is used for

Lotemax™ is used for the treatment of post-operative inflammation of the eye following cataract surgery

What it does

Loteprednol etabonate is a corticosteriod. It acts by reducing inflammation and eases the symptoms.

When it should not be used

Do not use Lotemax™:

  • If you are allergic to loteprednol or any ingredients contained in Lotemax™ (see What the nonmedicinal ingredients are), or if you are allergic to any other corticosteroid.
  • If you have eye diseases caused by viruses such as herpes simplex, vaccinia, and varicella) or caused by bacteria or a fungus, or if you think you have any other eye infection.
  • If you are pregnant, breastfeeding, under 18 years of age or have had glaucoma or increased pressure in the eye, see Warnings and Precautions.
What the medicinal ingredient is

The medicinal ingredient is loteprednol etabonate. Each mL contains 5 mg (0.5% w/v) loteprednol etabonate

What the non-medicinal ingredients are

Benzalkonium Chloride (0.01% w/v) as preservative

Edetate Disodium, Glycerin, Povidone, Purified Water and Tyloxapol. Hydrochloric Acid and/or Sodium Hydroxide may be added to adjust the pH.

What dosage form it comes in

Sterile ophthalmic suspension (eye drops) 0.5% w/v

BEFORE you use Lotemax™ talk to your doctor or pharmacist if:

  • Lotemax™ should not be used if you are pregnant, breastfeeding or under 18 years of age.
  • If you are pregnant or intend to become pregnant, or if you are breast feeding as there might be a risk of harm to the embryo/foetus or nursing baby.
  • If you have an eye disease/infection caused by viruses (such as herpes simplex, vaccinia, and varicella), or by bacteria or a fungus, or if you think you have any other eye infection.
  • If you have glaucoma or have been told that you have increased pressure in the eye as Lotemax™ might increase the pressure in the eye. Glaucoma which occurs when the pressure in the eye increases for a period of time, can cause damage to the optic nerve, vision problems, and sometimes a loss of vision. Your doctor may monitor your intraocular pressure.
  • If signs and symptoms fail to improve after two days of using Lotemax™, consult your doctor.

Consult your doctor if the following occurs while taking Lotemax™:

  • If you develop an eye infection or other new or worsening symptoms

The preservative in Lotemax™, benzalkonium chloride, may be absorbed by soft contact lenses. After instilling Lotemax™, you must wait at least 10 to 15 minutes before inserting your contact lenses. Do not wear a contact lens if your eye is red. Lotemax™ should not be used to treat contact lens irritation.

Warnings and precautions
Interactions with this medication

Drugs that may interact with Lotemax™ include: medicines taken to control the ocular pressure. Please inform your doctor or pharmacist if you are taking or have taken recently any other medicines, even those not prescribed.

Proper use of this medication

This product is sterile when packaged For ophthalmic use only.

Usual Dose

For Adults only
Do not use in children, or if you are pregnant or breastfeeding.

  • Shake Lotemax™ eye drops vigorously before using.
  • Apply one drop of Lotemax™ eye drops into the gap between your eyeball and eyelid, four times a day or as directed.
  • If applying more than one drop, wait 30 seconds before the second drop is applied to the eye.
  • Do not allow the tip of the dropper to touch any surface because this may contaminate the medicine.
  • If you wear soft contact lenses you must wait at least 10 to 15 minutes after instilling Lotemax™ before inserting your contact lenses.
  • Your doctor will tell you how long your treatment with Lotemax™ eye drops will last.
  • If redness or itching become aggravated consult a physician.
  • If you are using another medicine in the eye, wait at least 10 minutes before applying.
  • Lotemax™ should be stored upright between 15°–25°C for up to 28 days after first opening.

Overdose

If you use more Lotemax™ than you should, or there is accidental oral ingestion, you should immediately contact your doctor, or regional poison control centre.

Missed Dose

If you forget to use Lotemax™ eye drops, wait until the next dose and then continue as before. Do not double doses.

Side effects and what to do about them

Eye drops can cause your vision to be blurred. This usually passes quickly. Do not drive or use machines until your vision is clear. Like all medicines, Lotemax™ can have unwanted effects. The most common side effects in patients treated with Lotemax™ are:

  • Increased pressure within the eye
  • Blurred or abnormal vision
  • Burning when putting drops in the eye or at any time while on the medication
  • Swelling or discharge from the eyes
  • Painful, dry or sticky eyes
  • Tearing
  • Sensation of having an object in your eye
  • Itching in the eye or on the eyelid
  • Redness in the eye or on the eyelid
  • Photophobia (discomfort on exposure to light)

Other unwanted effects might include:

  • Headache or migraine, cough or sore throat, runny nose, fatigue, nervousness, facial swelling, general pain, or rash.

If you notice these or any other effects, tell your doctor or a pharmacist.

This is not a complete list of side effects. For any unexpected effects while taking Lotemax™, contact your doctor or pharmacist.

How to store

Store upright between 15°–25°C (59°–77°F). DO NOT FREEZE.

Keep out of reach of children

Reporting side effects

You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following three ways:

  • Report online at www.healthcanada.gc.ca/medeffect
  • Call toll-free at 1-866-234-2345
  • Complete a Canada Vigilance Reporting Form and:
    • Fax toll-free to 1-866-678-6789, or
    • Mail to:
      Canada Vigilance Program
      Health Canada
      Postal Locator 0701E
      Ottawa ON K1A 0K9

Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffectTM Canada Web site at www.healthcanada.gc.ca/medeffect.

NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.

More information

This document plus the full product monograph, prepared for health professionals can be found at: http://www.bausch.ca or by contacting the sponsor, Bausch & Lomb Incorporated, at: 1-888-459-5000

This leaflet was prepared by Bausch & Lomb Incorporated.

Last revised: January 12, 2009

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