loteprednol ophthalmic (Rx)

Brand and Other Names:Alrex, Lotemax, more...Inveltys, Lotemax SM, Eysuvis
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

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)

Postoperative Inflammation

Indicated for treatment of postoperative inflammation and pain following ocular surgery

Inveltys

  • Instill 1-2 drops into affected eye(s) BID beginning the day after surgery and continuing throughout the first 2 weeks postoperatively

Lotemax

  • Gel or suspension: Apply 1-2 drops into conjunctival sac of affected eye(s) QID beginning the day after surgery and continuing throughout the first 2 weeks postoperatively
  • Ointment: Apply ~0.5 inch ribbon into conjunctival sac(s) QID beginning the day after surgery and continuing throughout the first 2 weeks postoperatively

Lotemax SM

  • Apply 1 drop of gel into conjunctival sac of affected eye(s) TID beginning the day after surgery and continuing throughout the first 2 weeks postoperatively

Seasonal Allergic Conjunctivitis

Indicated for temporary relief of signs and symptoms of seasonal allergic conjunctivitis

Alrex

  • Instill 1 drop into affected eye(s) QID

Steroid Responsive Inflammatory Conditions

Indicated for steroid responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe (eg, allergic conjunctivitis, acne rosacea, superficial punctate keratitis, herpes zoster keratitis, iritis, cyclitis, selected infective conjunctivitides) when steroid use is accepted to obtain an advisable diminution in edema and inflammation

Lotemax

  • Suspension only
  • Apply 1-2 drops into the conjunctival sac of affected eye(s) QID
  • During initial treatment within the first week, may increase dose up to 1 drop q1hr, if necessary
  • Do not to discontinue therapy prematurely; if signs and symptoms fail to improve after 2 days, re-evaluate patient

Dry Eye Disease

Indicated for short-term treatment of signs and symptoms of dry eye disease

Eysuvis

  • Instill 1-2 gtt in each eye QID for up to 2 weeks
  • Renew prescription only after eye examination under magnification (eg, slit lamp) and IOP evaluation

Dosage Forms & Strengths

ophthalmic suspension

  • 0.5% (Lotemax)

ophthalmic ointment

  • 0.5% (Lotemax)

ophthalmic gel

  • 0.5% (Lotemax)

Postoperative Inflammation

Indicated for treatment of postoperative inflammation and pain following ocular surgery

Lotemax

  • Gel or suspension: Apply 1-2 drops into conjunctival sac of affected eye(s) QID beginning the day after surgery and continuing throughout the first 2 weeks postoperatively
  • Ointment: Apply ~0.5 inch ribbon into conjunctival sac(s) QID beginning the day after surgery and continuing throughout the first 2 weeks postoperatively

Steroid Responsive Inflammatory Conditions

Indicated for steroid responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe (eg, allergic conjunctivitis, acne rosacea, superficial punctate keratitis, herpes zoster keratitis, iritis, cyclitis, selected infective conjunctivitides) when steroid use is accepted to obtain an advisable diminution in edema and inflammation

Lotemax

  • Suspension only
  • Apply 1-2 drops into the conjunctival sac of affected eye(s) QID
  • During initial treatment within the first week, may increase dose up to 1 drop q1hr, if necessary
  • Do not to discontinue therapy prematurely; if signs and symptoms fail to improve after 2 days, re-evaluate patient
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Adverse Effects

>10%

Lotemax ointment only

  • Anterior chamber inflammation (~25%)

5-15%

Lotemax suspension only

  • Abnormal vision/blurring
  • Burning on instillation
  • Chemosis
  • Discharge
  • Dry eyes
  • Epiphora
  • Foreign body sensation
  • Itching
  • Photophobia

<5%

Lotemax gel

  • Anterior chamber inflammation (5%)
  • Eye pain (2%)
  • Foreign body sensation (2%)

Lotemax suspension only

  • Conjunctivitis
  • Corneal abnormalities
  • Eyelid erythema
  • Keratoconjunctivitis
  • Ocular irritation/pain/discomfort
  • Papillae
  • Uveitis

Lotemax ointment

  • Conjunctival hyperemia (4-5%)
  • Corneal edema (4-5%)
  • Eye pain (4-5%)
  • Headache (1.5%)

Frequency Not Defined

Inveltys only

  • Infrequent optic nerve damage
  • Visual acuity and field defects
  • Posterior subcapsular cataract formation
  • Delayed wound healing
  • Secondary ocular infection from pathogens (eg, herpes simplex)
  • Perforation of the globe where there is thinning of the cornea or sclera
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Warnings

Contraindications

Hypersensitivity to any component of the formulation

Most viral diseases of the cornea and conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, and also in mycobacterial infection of the eye and fungal diseases of ocular structures

Cautions

Prolonged use of corticosteroids may result in glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision; use with caution in the presence of glaucoma; if product is used for ≥10 days, monitor intraocular pressure (IOP)

Use of corticosteroids may result in posterior subcapsular cataract formation

Steroid use after cataract surgery may delay healing and increase the incidence of bleb formation; diseases causing thinning of the cornea or sclera, perforations have been known to occur with the use of topical steroids; examine patient prior to initiating or renewing treatment

Prolonged use of corticosteroids may suppress the host response and thus increase the risk of secondary ocular infections; steroids may mask infection or enhance existing infection

Exercise caution with steroid use in patients with a history of herpes; use of ocular steroids may prolong the course and may exacerbate the severity of many viral infections of the eye (eg, herpes simplex)

Fungal infections of the cornea are particularly prone to develop coincidentally with long-term local steroid application; consider fungus invasion in any persistent corneal ulceration where a steroid has been used or is in use; take fungal cultures when appropriate

Do not allow dropper tip to touch any surface, as this may contaminate the suspension

Do not wear contact lenses during therapy

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Pregnancy & Lactation

Pregnancy

Inveltys

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

Lotemax and Alrex

  • There are no adequate and well controlled studies in pregnant women; use during pregnancy only if the potential benefit justifies the potential risk to the fetus
  • Animal data
    • Drug shown to be embryotoxic (delayed ossification) and teratogenic (increased incidence of meningocele, abnormal left common carotid artery, and limb flexures) when administered orally to rabbits during organogenesis at a dose of 3 mg/kg/day (35 times the maximum daily clinical dose), a dose which caused no maternal toxicity; no-observed-effect-level (NOEL) for these effects was 0.5 mg/kg/day (6 times the maximum daily clinical dose)
    • Oral treatment of rats during organogenesis resulted in teratogenicity (absent innominate artery at ≥5 mg/kg/day doses, and cleft palate and umbilical hernia at ≥50 mg/kg/day) and embryotoxicity (increased post-implantation losses at 100 mg/kg/day and decreased fetal body weight and skeletal ossification with ≥50 mg/kg/day)
    • Treatment of rats with 0.5 mg/kg/day (6 times the maximum clinical dose) during organogenesis did not result in any reproductive toxicity; loteprednol etabonate was maternally toxic (significantly reduced body weight gain during treatment) when administered to pregnant rats during organogenesis at doses of ≥5 mg/kg/day
    • Oral exposure of female rats to 50 mg/kg/day of loteprednol etabonate from the start of the fetal period through the end of lactation, a maternally toxic treatment regimen (significantly decreased body weight gain), gave rise to decreased growth and survival, and retarded development in the offspring during lactation; NOEL for these effects was 5 mg/kg/day; no effect on the duration of gestation or parturition when administered orally to pregnant rats at doses up to 50 mg/kg/day during the fetal period

Lactation

Inveltys

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

Lotemax and Alrex

  • There are no data on presence of loteprednol etabonate in human milk, effects on breastfed infant, or on milk production; developmental and health benefits of breastfeeding should be considered, along with mother’s clinical need for therapy and any potential adverse effects on 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

Pregnancy Categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

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Pharmacology

Mechanism of Action

There is no generally accepted explanation for the mechanism of action of ocular corticosteroids

However, corticosteroids are thought to act by the induction of phospholipase A2 inhibitory proteins, collectively called lipocortins

It is believed that these proteins control the biosynthesis of potent mediators of inflammation (eg, prostaglandins, leukotrienes) by inhibiting the release of arachidonic acid

Arachidonic acid is released from membrane phospholipids by phospholipase A2

Corticosteroids are capable of producing a rise in IOP

Absorption

Following topical instillation into the conjunctival sac, absorbed into the aqueous humor and minimal systemic absorption occurs

Submicron particles (Lotemax SM) have faster dissolution in tears and twice the penetration into aqueous humor compared with original Lotemax formulation

Metabolism

Based upon in vivo and in vitro preclinical metabolism studies, loteprednol etabonate undergoes extensive metabolism to inactive carboxylic acid metabolites, PJ-91 and PJ-90

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Administration

Ophthalmic Administration

Remove contact lenses

Do not to touch the eyelid or surrounding areas with the tip of the bottle/tube

Keep cap on bottle/tube when not in use

Wash hands prior to administering; do not use if tamper evident container compromised

If using other eye drops, advise patient to wait at least 5 minutes between instillation

Ophthalmic suspension (Inveltys, Alrex, Lotemax, Eysuvis): Shake bottle for several seconds before using

Lotemax or Lotemax SM gel: Invert closed bottle and shake once to fill tip before instilling drops

Lotemax ointment: Apply thin ribbon to conjunctival sac; do not wear contact lenses while using this product

Storage

All formulations

  • Do not use if tamper-evident overcap seal is not intact
  • Store upright at 15-25°C (59-77°F); do not freeze
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Images

BRAND FORM. UNIT PRICE PILL IMAGE
Lotemax ophthalmic (eye)
-
0.5 % gel
Lotemax ophthalmic (eye)
-
0.5 % drops
Lotemax ophthalmic (eye)
-
0.5 % drops
Lotemax ophthalmic (eye)
-
0.5 % ointment
Lotemax ophthalmic (eye)
-
0.5 % drops
Alrex ophthalmic (eye)
-
0.2 % drops
Alrex ophthalmic (eye)
-
0.2 % drops
loteprednol etabonate ophthalmic (eye)
-
0.5 % drops
loteprednol etabonate ophthalmic (eye)
-
0.5 % drops
loteprednol etabonate ophthalmic (eye)
-
0.5 % drops
Inveltys ophthalmic (eye)
-
1 % drops
Lotemax SM ophthalmic (eye)
-
0.38 % gel

Copyright © 2010 First DataBank, Inc.

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Patient Handout

Patient Education
loteprednol etabonate ophthalmic (eye)

LOTEPREDNOL GEL - OPHTHALMIC

(LOE-te-PRED-nol)

COMMON BRAND NAME(S): Lotemax

USES: This medication is used to treat eye inflammation and pain after eye surgery. Loteprednol works by relieving symptoms such as swelling, redness, and itching. It belongs to a class of drugs known as corticosteroids.

HOW TO USE: Do not wear contact lenses while you are using this medication. Sterilize contact lenses according to the manufacturer's directions, and check with your doctor before you begin using them again.To apply the eye gel, wash your hands first. To avoid contamination, do not touch the bottle tip or let it touch your eye or any other surface. Turn the bottle upside down and shake once to fill the tip with the gel. Gently pull down the lower eyelid to make a pouch. Place the prescribed number of drops into the pouch. Gently close the eye and roll the eyeball in all directions to spread the medication. Try not to blink or rub your eye.Repeat these steps for your other eye if so directed.If you are using another kind of eye medication (for example, drops, ointments, or other gels), wait at least 5 to 10 minutes before applying other medications. Use eye drops before eye ointments or gels to allow the drops to enter the eye.Use this medication regularly to get the most benefit from it. To help you remember, use it at the same times each day.Apply as directed by your doctor, usually 4 times a day. The dosage and length of treatment are based on your medical condition and response to treatment. Do not increase your dose or use this drug more often than prescribed. Your condition will not improve any faster, and your risk of side effects will increase.Continue to use this medication for the full time prescribed. Do not stop using this medication without consulting your doctor. Some conditions may become worse when this drug is suddenly stopped. Your dose may need to be gradually decreased.Do not use this product if it becomes contaminated (for example, the gel turns a dark color or develops particles in it). Using contaminated eye medication can cause infection, serious damage to the eye, and loss of vision. Ask your doctor or pharmacist for more information.Tell your doctor if your condition does not improve after a few days or if it worsens.

SIDE EFFECTS: Temporary blurred vision may occur when you apply this medication. A feeling as if something is in your eye may also occur. If these effects persist or worsen, tell your doctor or pharmacist promptly.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Using this medication for prolonged periods or in high doses may cause serious side effects, including serious eye problems (such as cataracts and high pressure inside the eyes). Tell your doctor right away if you have any serious side effects, including: vision problems/changes, eye pain, headache, dizziness.This medication may mask the signs of an eye infection. It may also put you at greater risk of developing an eye infection, especially with prolonged use. Report right away any new or worsening symptoms such as eye discharge/swelling/redness/itching/pain, vision problems/changes, or no improvement of your current eye condition. Your doctor will need to adjust your treatment.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using loteprednol, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: eye infections, cataracts, glaucoma, severe nearsightedness (myopia), diabetes.After you apply this drug, your vision may become temporarily blurred. Do not drive, use machinery, or do any activity that requires clear vision until you are sure you can perform such activities safely.Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).If you develop a new eye infection or injury, or require eye surgery, ask your doctor if you should continue to use your current bottle of loteprednol eye gel or start a new bottle.During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.It is unknown if the medication in this product passes into breast milk. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

OVERDOSE: This medicine may be harmful if swallowed. If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

NOTES: Do not share this medication with others.This medication has been prescribed for your current condition only. Do not use it later for another eye condition unless your doctor directs you to do so. A different medication may be necessary in that case.Laboratory and/or medical tests (such as eye exams, measurement of the pressure inside the eyes) may be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.

STORAGE: Store at room temperature. Keep bottle upright and tightly closed when not in use. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Information last revised August 2021. Copyright(c) 2021 First Databank, Inc.

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

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Formulary

FormularyPatient Discounts

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To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

Adding plans allows you to:

  • View the formulary and any restrictions for each plan.
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The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
PA Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL Quantity Limits
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST Step Therapy
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR Other Restrictions
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.