Eysuvis 2.5 mg/mL
loteprednol etabonate · SUSPENSION/ DROPS · ALCON LABORATORIES, INC.
Eysuvis is a suspension/ drops containing loteprednol etabonate at 2.5 mg/mL, taken ophthalmic. Manufactured by ALCON LABORATORIES, INC..
Key Facts
- Brand Name
- Eysuvis
- Generic Name
- loteprednol etabonate
- NDC Code (Product)
71571-333- Manufacturer
- ALCON LABORATORIES, INC.
- Strength
- 2.5 mg/mL
- Dosage Form
- SUSPENSION/ DROPS
- Route
- OPHTHALMIC
- Marketing Status
- Application #
- NDA210933
- Marketing Start
- 11/18/2020
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE EYSUVIS is a corticosteroid indicated for the short-term (up to two weeks) treatment of the signs and symptoms of dry eye disease. EYSUVIS is a corticosteroid indicated for the short-term (up to two weeks) treatment of the signs and symptoms of dry eye disease. ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Shake for two to three seconds before using. ( 2 ) Instill one to two drops of EYSUVIS into each eye four times daily. ( 2 ) 2.1 Dosage Information Instill one to two drops of EYSUVIS into each eye four times daily for up to two weeks. This product should only be renewed after examination under magnification such as a slit lamp and evaluation of the intraocular pressure. [see Warnings and Precautions (5.1) and (5.2) ] . 2.2 Administration Instructions Instruct patient to wash hands well before each use. Shake for two to three seconds before using. If the patient is using other eye drops in addition to EYSUVIS, advise the patient to wait at least 5 minutes between instillation of EYSUVIS and other eye drops. If a dose is missed, take the missed dose when remembered.
Contraindications
4 CONTRAINDICATIONS EYSUVIS, as with other ophthalmic corticosteroids, is contraindicated in 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. EYSUVIS, as with other ophthalmic corticosteroids, is contraindicated in 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. ( 4 )
Adverse Reactions
6 ADVERSE REACTIONS Adverse reactions associated with ophthalmic corticosteroids include elevated intraocular pressure, which may be associated with infrequent optic nerve damage, visual acuity and field defects, posterior subcapsular cataract formation, delayed wound healing and 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 adverse drug reaction following the use of EYSUVIS for two weeks was instillation site pain, which was reported in 5% of patients. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Alcon Laboratories, Inc. at 1-800-757-9195 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The most common adverse reaction observed in clinical trials with EYSUVIS was instillation site pain, which was reported in 5% of patients.
Frequently Asked Questions
What is Eysuvis used for?
Eysuvis contains loteprednol etabonate. It is a suspension/ drops taken ophthalmic. Consult your doctor for specific uses.
Is Eysuvis a controlled substance?
Eysuvis is not classified as a controlled substance by the DEA.
What is the generic name for Eysuvis?
The generic name for Eysuvis is loteprednol etabonate. There are 12 other brand versions of loteprednol etabonate.
What is the NDC code for Eysuvis 2.5 mg/mL?
The NDC (National Drug Code) for Eysuvis 2.5 mg/mL is 71571-333, listed by ALCON LABORATORIES, INC..
Other Loteprednol Brands
See all →- Inveltys10 mg/mL0065-9307
- LOTEMAX5 mg/mL24208-299
- LOTEMAX5 mg/g24208-503
- Loteprednol etabonate and Tobramycin5 mg/mL62332-801
- loteprednol etabonate5 mg/mL70748-300
- Loteprednol Etabonate5 mg/g70244-036
- Loteprednol Etabonate5 mg/mL82260-299
- LOTEPREDNOL ETABONATE2 mg/mL0574-4080
- Lotemax SM3.8 mg/g24208-507
- LOTEPREDNOL ETABONATE5 mg/mL60219-1362
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)