Lotemax: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

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 important nonmedicinal 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 forms it comes in:

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

WARNINGS AND PRECAUTIONS

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.

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.

IMPORTANT: PLEASE READ

Lotemax® Product Monograph Page 29 of 29

• 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 IT

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

Keep out of reach of children.

REPORTING SUSPECTED SIDE EFFECTS

To monitor drug safety, Health Canada through the Canada Vigilance Program collects information on serious and unexpected effects of drugs . If you suspect you have had a serious or unexpected reaction to this drug you may notify Canada Vigilance:

toll-free telephone: 866-234-2345 toll-free fax 866-678-6789

Online: www.healthcanada.gc.ca/medeffect By email: CanadaVigilance@hc-sc.gc.ca

By regular mail:

Canada Vigilance National Office

Marketed Health Products Safety and Effectiveness Information Bureau

Marketed Health Products Directorate

Health Products and Food Branch

Tunney’s Pasture, AL 0701C

Ottawa ON K1A 0K9

NOTE: Should you require information related to the management of the side effect, please contact your health care provider before notifying Canada Vigilance. 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

Last revised: January 12, 2009