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Details for: LOTEMAX OINTMENT

Company: BAUSCH & LOMB INC

DIN DIN name Active Ingredient(s) Strength Dosage Form Route of Administration
02421941LOTEMAX OINTMENTLOTEPREDNOL ETABONATE0.5 % / W/WOINTMENTOPHTHALMIC
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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

Lotemax® Ointment is used for the treatment of post-operative inflammation and pain following eye surgery.

What it does

Lotemax® Ointment is a corticosteroid and is believed to act by reducing the production of substances associated with inflammation, including prostaglandins and leukotrienes. By reducing these substances inflammation and pain are reduced..

When it should not be used

Do not use Lotemax® Ointment:

  • If you are allergic to loteprednol or any of the ingredients contained in Lotemax® Ointment (see What the important nonmedicinal ingredients are) or if you are allergic to any other corticosteroid.
  • If you have eye infections 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.
What the medicinal ingredient is

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

What the non-medicinal ingredients are

Mineral Oil, White Petrolatum.

What dosage form it comes in

Sterile ophthalmic ointment 0.5% w/w.

Warnings and precautions

BEFORE you use Lotemax® Ointment talk to your doctor or pharmacist:

  • If you have an eye disease/infection 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 had or have glaucoma or increased pressure in the eye as Lotemax ® Ointment 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® Ointment, consult your doctor
  • If you are pregnant or planning to become pregnant. Lotemax® Ointment should not be used in pregnant women unless the doctor determines this is appropriate for you as there might be a risk of harm to the embryo or fetus.
  • If you are breastfeeding or planning to breastfeed. Lotemax® Ointment should not be used in breastfeeding women unless the doctor determines that this is appropriate for the infant as there might be a risk of harm to the nursing baby.
  • If you are under 18 years of age.

Consult your doctor if the following occurs while taking Lotemax® Ointment:

  • If you develop an eye infection or other new or worsening symptoms
  • If you develop a blister on the eye (a bleb).
Interactions with this medication

Drug interaction studies have not been done for Lotemax® Ointment.

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

Usual Dose

For adults only.
Apply a small amount (about½ inch ribbon) into the conjunctival sac(s) (see pictogram) four times daily beginning 24 hours after surgery and continuing throughout the first 2 weeks of the postoperative period.

  • Do not touch the eyelid or surrounding areas with the tip of the tube. The cap should remain on the tube when not in use
  • Wash hands prior to using Lotemax® Ointment
  • Do not wear contact lenses during the course of therapy.
  • Do not use if tamper evident skirt is visible on bottom of cap.
  • If pain, redness, itching or inflammation becomes aggravated, consult your doctor
  • If you are using another medication in the eye, wait at least 15 minutes before applying.

Overdose

In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

Missed Dose

If you miss a dose, take the next dose as scheduled then continue as before. Do not double doses.

Side effects and what to do about them

Eye ointment 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® Ointment can have unwanted effects. The most common side effects in patients treated with Lotemax® Ointment are:

  • Increased pressure within the eye
  • Blurred or abnormal vision
  • 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)

Another unwanted effect might include headache, cold, cough, runny nose, or drug sensitivity.

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

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

How to store

Store between 15-25ºC (59-77ºF) for up to 14 days after first opening, then discard the tube.

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: March 14, 2014.

Date modified: