INVELTYS- loteprednol etabonate suspension

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

LOTEPREDNOL ETABONATE (UNII: YEH1EZ96K6) (LOTEPREDNOL - UNII:Z8CBU6KR16)

Available from:

ALCON LABORATORIES, INC.

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

INVELTYS is a corticosteroid indicated for the treatment of post-operative inflammation and pain following ocular surgery. INVELTYS 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. Risk Summary INVELTYS is not absorbed systemically following topical ophthalmic administration and maternal use is not expected to result in fetal exposure to the drug. Risk Summary INVELTYS is not absorbed systemically by the mother following topical ophthalmic administration, and breastfeeding is not expected to result in exposure of the child to INVELTYS . Safety and effectiveness in pediatric patients have not been established. No overall differences in safety and effectiveness have been observed between elderly and younger patients. INSTRUCTIONS FOR USE INVELTYS [in-vel-tis] (loteprednol etabonate ophthalmic suspension) 1% for topical ophthalmic use This Instructions for Use contains information on how to properly administer INVELTYS. Important Information You Need to Know Before Using INVELTYS - INVELTYS is for use in the eye only. - Wash your hands before using INVELTYS. - Do not use if the tamper-evident seal is not intact. - Do not let the INVELTYS dropper tip touch your eye, fingers, or any other surfaces to avoid contamination or injury to your eye. - Use INVELTYS exactly as your healthcare provider tells you to. - If you are using INVELTYS with other eye (ophthalmic) medicines, you should wait at least 5 minutes between using INVELTYS and the other medicine. - If you wear contact lenses, remove them before using INVELTYS. - Put the pink cap back on INVELTYS after each use. Before you use INVELTYS for the first time: There are two caps on your bottle of INVELTYS. Hold the bottle firmly by its neck. Remove the white cap by twisting it clockwise (See Figure A) . Throw away the white cap. INVELTYS is now ready to use. Figure A Follow Steps 1 to 6 each time you use INVELTYS. If you use contact lenses, wait for 15 minutes before placing them back in. How should I store INVELTYS? - Store INVELTYS upright at 59ºF to 77ºF (15ºC to 25ºC). - Do not freeze. Keep INVELTYS and all medicines out of the reach of children. This Instructions for Use has been approved by the U.S. Food and Drug Administration. Manufactured for: Kala Pharmaceuticals, Inc. Arlington, MA 02476 Approved: 3/2022

Product summary:

INVELTYS (loteprednol etabonate ophthalmic suspension) 1% is a sterile ophthalmic suspension. It is supplied in a white low-density polyethylene plastic dropper bottle with a controlled-drop linear low-density polyethylene tip, a pink high-density polyethylene cap, and a white low-density polyethylene tamper-evident overcap in the following size: 2.8 mL in a 5 mL bottle (NDC 71571-121-28) Storage and Handling Do not use if tamper-evident overcap seal is not intact. The white tamper-evident overcap can be thrown away. Retain the pink cap and keep the bottle tightly closed when not in use. Store upright at 15°C to 25°C (59°F to 77°F). Do not freeze.

Authorization status:

New Drug Application

Summary of Product characteristics

INVELTYS- LOTEPREDNOL ETABONATE SUSPENSION
ALCON LABORATORIES, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
INVELTYS SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR INVELTYS.
INVELTYS (LOTEPREDNOL ETABONATE OPHTHALMIC SUSPENSION) 1%, FOR TOPICAL
OPHTHALMIC USE
INITIAL U.S. APPROVAL: 1998
INDICATIONS AND USAGE
INVELTYS is a corticosteroid indicated for the treatment of
post-operative inflammation and pain following
ocular surgery. (1)
DOSAGE AND ADMINISTRATION
Shake for one to two seconds before using. (2)
Instill one to two drops of INVELTYS into the affected eye twice daily
beginning the day after surgery and
continuing throughout the first 2 weeks of the post-operative period.
(2)
DOSAGE FORMS AND STRENGTHS
Ophthalmic suspension containing 10 mg/mL of loteprednol etabonate.
(3)
CONTRAINDICATIONS
INVELTYS 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)
WARNINGS AND PRECAUTIONS
Intraocular Pressure (IOP) Increase: Prolonged use of corticosteroids
may result in glaucoma with
damage to the optic nerve, defects in visual acuity and fields of
vision. If this product is used for 10 days
or longer, IOP should be monitored. (5.1)
Cataracts: Use of corticosteroids may result in posterior subcapsular
cataract formation. (5.2)
Delayed Healing: Use of steroids after cataract surgery may delay
healing and increase the incidence of
bleb formation. In those diseases causing thinning of the cornea or
sclera, perforations have been
known to occur with the use of topical steroids. The initial
prescription and renewal of the medication
order should be made by a physician only after examination of the
patient with the aid of magnification
such as slit lamp biomicroscopy and, where appropriate, fluorescein
staining. (5.3)
Bacterial Infecti