Dosing & Uses
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
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
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
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.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
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
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| Inveltys ophthalmic (eye) - | 1 % drops |  | |
| Lotemax SM ophthalmic (eye) - | 0.38 % gel |  | |
| Lotemax ophthalmic (eye) - | 0.5 % drops |  | |
| Lotemax ophthalmic (eye) - | 0.5 % drops |  | |
| Lotemax ophthalmic (eye) - | 0.5 % gel |  | |
| 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 % gel |  | |
| loteprednol etabonate ophthalmic (eye) - | 0.5 % drops |  | |
| loteprednol etabonate ophthalmic (eye) - | 0.5 % drops |  |
Copyright © 2010 First DataBank, Inc.
Patient Handout
loteprednol etabonate ophthalmic (eye)
LOTEPREDNOL 0.2% SUSPENSION - OPHTHALMIC
(LOE-te-PRED-nol)
COMMON BRAND NAME(S): Alrex
USES: This medication is used to temporarily relieve seasonal allergy symptoms of the eyes such as swelling, redness, and itching. Loteprednol belongs to a class of drugs known as corticosteroids.
HOW TO USE: If you wear contact lenses, ask your doctor if you should wear them during treatment with this medicine. You should not wear contact lenses if your eyes are red. Sterilize contact lenses according to the manufacturer's directions, and check with your doctor before you begin using them again.If your doctor does approve the wearing of contact lenses during treatment with this medication, remove the lenses before using the eye drops. The preservative in this product may be absorbed by contact lenses. Wait at least 10 to 15 minutes after each dose of the eye drop before wearing the lenses again.To apply eye drops, wash your hands first. Shake the bottle well before using. To avoid contamination, do not touch the dropper tip or let it touch your eye or any other surface.Tilt your head back, look upward, and pull down the lower eyelid to make a pouch. Hold the dropper directly over your eye and place 1 drop into the pouch. Look downward and gently close your eyes for 1 to 2 minutes. Place one finger at the corner of your eye (near the nose) and apply gentle pressure. This will prevent the medication from draining out. Try not to blink and do not rub your eye. Repeat these steps for your other eye if so directed and if your dose is for more than 1 drop.Apply this medication as directed by your doctor, usually 4 times a day. Do not rinse the dropper. Replace the dropper cap after each use.If you are using another kind of eye medication (for example, other drops or ointments), wait at least 5 to 10 minutes before applying other medications. Use eye drops before eye ointments to allow the drops to enter the eye.Use this medication regularly in order to get the most benefit from it. To help you remember, use it at the same times each day.The dosage and length of treatment are based on your medical condition and response to treatment. Do not use this medication more often or for longer than prescribed because doing so may increase your risk of side effects.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 the drug is suddenly stopped. Your dose may need to be gradually decreased.Do not use this product if it becomes contaminated (for example, drops turn a dark color). Use of contaminated eye medication can cause infection, serious damage to the eye, and loss of vision. Contact your doctor or pharmacist for more information.Tell your doctor if your condition does not improve after 2 days or if it worsens.
SIDE EFFECTS: Stinging/burning of the eyes for 1 to 2 minutes and temporary blurred vision may occur when you apply this medication. If any of these effects last or get worse, 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.Use of this medication for prolonged periods or in high doses may cause serious eye problems (such as high pressure inside the eyes and cataracts). Tell your doctor right away if any of these serious side effects occur: vision problems, eye pain.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 any new or worsening symptoms such as eye discharge/swelling/redness, vision problems, or no improvement of your current eye condition. Your doctor will need to adjust your treatment.Tell your doctor right away if you have any serious side effects, including: headache, dizziness.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, recent eye surgery, cataracts, glaucoma (open-angle type), 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 can do it 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 drops 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 this medication 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.Avoid substances such as pollen and other irritants that may trigger an allergic reaction. Applying cold compresses over the eyes and using lubricating eye drops may also help reduce allergic eye symptoms.This medication has been prescribed for your current condition only. Do not use it later for another eye condition unless told to do so by your doctor. A different medication may be necessary in that case.With long-term use, lab and/or medical tests (such as eye exams, measurement of the pressure inside the eyes) may be done while you are using this medication. Keep all medical and lab appointments. 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. Do not freeze. Keep bottle upright 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 May 2023. Copyright(c) 2023 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.
Formulary
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