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Lotemax Ophthalmic Ointment

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Lotemax Ophthalmic Ointment

Lotemax Ophthalmic Ointment Side Effects Center

Medical Editor: Charles Patrick Davis, MD, PhD

Lotemax (loteprednol etabonate) is a corticosteroid indicated for the treatment of post-operative inflammation and pain following ocular surgery. This drug is available as a generic named loteprednol etabonate eye drops. Adverse reactions associated with ophthalmic steroids include elevated intraocular pressure, which may be associated with optic nerve damage, cataract formation, and herpes simplex.

Lotemax (loteprednol etabonate) is supplied as a 3.5 gram tube filled with loteprednol etabonate ophthalmic ointment (0.5% strength of Lotemax). Lotemax is dosed in approximately ½ inch ribbons into the conjunctival sac(s) four times daily beginning 24 hours after surgery and continuing throughout the first two weeks of the post-operative period. Lotemax should be used during pregnancy only if the potential benefit justifies the potential risk to the embryo or fetus. It is not known whether topical ophthalmic administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Caution should be exercised when Lotemax ointment is administered to a nursing woman. Serious side effects are eye infections, glaucoma and thinning of eye tissue. The safety and efficacy of this drug is not available for pediatric patients.

Our Lotemax Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Lotemax Ophthalmic Ointment in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using loteprednol and call your doctor at once if you have:

  • signs of a new eye infection such as swelling, redness, irritation, or drainage;
  • blurred vision, eye pain, or seeing halos around lights;
  • problems with your vision; or
  • severe pain, burning or stinging when using the eye drops.

Common side effects may include:

  • minor burning when using the eye drops;
  • dry, red, itchy, or watery eyes;
  • feeling that something is in your eye;
  • being more sensitive to light;
  • headache; or
  • runny nose, sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Lotemax Ophthalmic Ointment (loteprednol etabonate) »

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Lotemax Ophthalmic Ointment FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Adverse reactions associated with ophthalmic steroids include elevated intraocular pressure, which may be associated with optic nerve damage, visual acuity and field defects, posterior subcapsular cataract formation, secondary ocular infection from pathogens including herpes simplex, and perforation of the globe where there is thinning of the cornea or sclera.

The most common ocular adverse event reported at approximately 25% in subjects in clinical studies with Lotemax ointment was anterior chamber inflammation. Other common adverse events, with an incidence of 4-5%, were conjunctival hyperemia, corneal edema, and eye pain. Many of these events may have been the consequence of the surgical procedure. The only non-ocular adverse event occurring at ≥ 1% was headache (1.5%).

Read the entire FDA prescribing information for Lotemax Ophthalmic Ointment (loteprednol etabonate) »

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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