Loteprednol Ophthalmic

Loteprednol (ophthalmic) is a prescription medication used to treat pain and swelling after eye surgery. 

• Loteprednol (ophthalmic) is available under various brand names: Alrex, Eysuvis, Inveltys, Lotemax, Lotemax SM 

Common side effects of Loteprednol (ophthalmic) include:

• minor burning when using the eye drops.
• eye pain, blurred vision.
• dry or watery eyes.
• feeling like something is in the eye.
• your eyes may be more sensitive to light.
• headache; or
• runny nose, sore throat.

Serious side effects of Loteprednol (ophthalmic) include:

• hives. 
• difficult breathing. 
• swelling of the face, lips, tongue, or throat.
• pain when using the eye drops.
• worsening redness or itching.
• eye pain or swelling, trouble closing the eye.
• pain behind the eyes, sudden vision changes.
• tunnel vision, seeing halos around lights; or
• signs of eye infection--redness, severe discomfort, crusting, or drainage.

Rare side effects of Loteprednol (ophthalmic) include:

• none

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors.
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights.
• Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheartedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult and pediatric dosage

Ophthalmic suspension

• 0.2 % (Alrex)
• 0.25 % (Eysuvis)
• 0.5 % (Lotemax)
• 1 % (Inveltys)

Ophthalmic ointment

• 0.5 % (Lotemax)

Ophthalmic gel

• 0.38 % (Lotemax SM)
• 0.5 % (Lotemax)

Dry eye disease: 

Adult dosage

• Ophthalmic: 0.25 % suspension: Instill 1 to 2 drops into each eye 4 times daily for up to 2 weeks.

Ophthalmic inflammatory conditions:

Adult dosage

• Ophthalmic: 0.5 % suspension: Instill 1 to 2 drops into the conjunctival sac of the affected eye(s) 4 times daily. During the initial treatment within the first week, the dosing may be increased up to 1 drop every hour.

Postoperative ophthalmic inflammation/pain: 

Adult dosage

• 0.38 % gel: Apply 1 drop into the conjunctival sac of the affected eye(s) 3 times daily beginning 24 hours after surgery and continuing throughout the first 2 weeks of the postoperative period.
• 0.5 % ointment: Apply approximately 1/2-inch ribbon into the conjunctival sac of the affected eye(s) 4 times daily beginning 24 hours after surgery and continuing throughout the first 2 weeks of the postoperative period.
• 0.5 % gel, 0.5 % suspension: Instill 1 to 2 drops into the conjunctival sac of the affected eye(s) 4 times daily beginning 24 hours after surgery and continuing throughout the first 2 weeks of the postoperative period.
• 1% suspension: Instill 1 to 2 drops into the affected eye(s) twice daily beginning the day after surgery and continuing throughout the first 2 weeks of the postoperative period.

Pediatric dosage

Children: Ophthalmic: 0.5 % gel (Lotemax): 

• Instill 1 to 2 drops into the conjunctival sac of the affected eye(s) 4 times daily beginning postoperative day 1 and continuing throughout the first 2 weeks of the postoperative period; trials in young pediatric patients (mean age: 3 years) were conducted following cataract surgery.

Seasonal allergic conjunctivitis: 

Adult dosage

• 0.2% suspension: Instill 1 drop into affected eye(s) 4 times daily.

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Loteprednol (ophthalmic) has no noted severe interactions with any other drugs.
• Loteprednol (ophthalmic) has no noted serious interactions with any other drugs.
• Loteprednol (ophthalmic) has no noted moderate interactions with any other drugs.
• Loteprednol (ophthalmic) has no noted minor interactions with any other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• hypersensitivity to loteprednol
• glaucoma; or
• cataracts, or cataract surgery
• eye infection

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Loteprednol (ophthalmic)?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Loteprednol (ophthalmic)?”

Cautions

• You should not use this medicine if you have an eye infection (including herpes simplex)
• Do not share this medicine with another person, even if they have the same symptoms you have.
• This medicine may cause blurred vision and may impair your reactions. Avoid driving or hazardous activity until you know how this medicine will affect you.

Pregnancy and Lactation

• Tell your doctor if you are pregnant.

Inveltys

• The drug is not absorbed systemically following topical ophthalmic administration and maternal use is not expected to result in fetal exposure to the drug

Lotemax and Alrex

• There are no adequate and well-controlled studies on pregnant women; use during pregnancy only if the potential benefit justifies the potential risk to the fetus

Lactation

• Tell your doctor if you are breastfeeding.

Inveltys

• The drug is not absorbed systemically by the mother following topical ophthalmic administration, and breastfeeding is not expected to result in the exposure of the child

Lotemax and Alrex

• There are no data on the presence of loteprednol etabonate in human milk, effects on the breastfed infant, or on milk production; developmental and health benefits of breastfeeding should be considered, along with the mother’s clinical need for therapy and any potential adverse effects on the breastfed infant
• It is not known whether topical ophthalmic administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk
• Systemic steroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects