Loteprednol

What is Loteprednol?

• Loteprednol (Inveltys, Lotemax, Lotemax SM) is used for the treatment of postoperative inflammation and pain following ocular surgery.
• Loteprednol (Lotemax) is used to reduce eye swelling caused by allergies, certain eye infections, ocular rosacea (condition that can cause swelling, redness, and itching of the eye), herpes zoster (shingles; a rash that can occur in people who have had chickenpox in the past and can affect the eyes), and other eye conditions.

Loteprednol

Loteprednol etabonate

What are the uses of this medicine?

• Loteprednol (Inveltys, Lotemax, Lotemax SM) used to treat swelling and pain after cataract surgery (procedure to treat clouding of the lens in the eye).

How does this medicine work?

• Corticosteroids inhibit the inflammatory response to a variety of inciting agents and probably delay or slow healing.
• They inhibit the edema, fibrin deposition, capillary dilation, leukocyte migration, capillary proliferation, fibroblast proliferation, deposition of collagen, and scar formation associated with inflammation.
• While glucocorticoids are known to bind to and activate the glucocorticoid receptor, the molecular mechanisms involved in glucocorticoid/glucocorticoid receptor-dependent modulation of inflammation are not clearly established.
• However, corticosteroids are thought to inhibit prostaglandin production through several independent mechanisms.

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

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

What drug interactions can this medicine cause?

• Tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.

Is this medicine FDA approved?

• It was patented in 1980 and approved for medical use in 1998.

How should this medicine be used?

Recommended dosage:

• Apply one to two drops of Loteprednol into the conjunctival sac of the affected eye four times daily beginning the day after surgery and continuing throughout the first 2 weeks of the postoperative period.

Administration:

• Ophthalmic loteprednol comes as a suspension (liquid) and a gel to instill in the eyes and as an eye ointment to apply to the eye.
• When used to treat eye swelling and pain after eye surgery, loteprednol 0.5% (Lotemax) eye drops, eye gel and eye ointment are usually applied 4 times a day beginning the day after surgery and continuing for 2 weeks.
• Loteprednol 0.38% gel (Lotemax SM) is usually instilled 3 times a day beginning the day after surgery and continuing for 2 weeks.
• Loteprednol 1% eye drops (Inveltys) are usually instilled 2 times a day beginning the day after surgery and continuing for 2 weeks.
• Invert closed bottle and shake once to fill tip before instilling drops.
• When you use ophthalmic loteprednol, be careful not to let the tip of the bottle or tube touch your eyes, fingers, face, or any surface.
• If the tip does touch another surface, bacteria may get into the medication.
• Using eye medication that is contaminated with bacteria may cause serious damage to the eye or loss of vision.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As a suspension (liquid) and a gel to instill in the eyes and as an eye ointment

This medicine is available in fallowing brand namesː

• Inveltys, Lotemax, Lotemax SM

What side effects can this medication cause?

The most common side effects of this medicine include:

• anterior chamber inflammation
• eye pain
• foreign body sensation

Loteprednol may cause serious side effects which may include:

• elevated intraocular pressure
• optic nerve damage
• visual acuity and field defects
• posterior subcapsular cataract formation
• delayed wound healing
• secondary ocular infection
• thinning of the cornea or sclera

What special precautions should I follow?

• 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.
• Use of corticosteroids may result in posterior subcapsular cataract formation.
• The 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.
• Prolonged use of corticosteroids may suppress the host response and thus increase the hazard of secondary ocular infection. In acute purulent conditions, steroids may mask infection or enhance existing infection.
• Employment of a corticosteroid medication in the treatment of patients with a history of herpes simplex requires great caution. Use of ocular steroids may prolong the course and may exacerbate the severity of many viral infections of the eye (including herpes simplex).
• Fungal infections of the cornea are particularly prone to develop coincidentally with long-term local steroid application. Fungus invasion must be considered in any persistent corneal ulceration where a steroid has been used or is in use.
• Patients should not wear contact lenses during their course of therapy with Loteprednol.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• There are no adequate and well-controlled studies with loteprednol etabonate in pregnant women.

Can this medicine be used in children?

• The safety and effectiveness of LOTEMAX have been established in the pediatric population.
• Safety and effectiveness of LOTEMAX® SM in pediatric patients have not been established.
• Safety and effectiveness of INVELTYS in pediatric patients have not been established.

What are the active and inactive ingredients in this medicine?

LOTEMAX:

Active:

• LOTEPREDNOL ETABONATE

Inactives:

• BORIC ACID
• EDETATE DISODIUM
• GLYCERIN
• POLYCARBOPHIL
• PROPYLENE GLYCOL
• SODIUM CHLORIDE
• TYLOXAPOL
• WATER
• SODIUM HYDROXIDE
• BENZALKONIUM CHLORIDE

Who manufactures and distributes this medicine?

INVELTYS Manufactured for:

• Kala Pharmaceuticals, Inc.
• Arlington, MA
• Marks designated ® are owned by Kala Pharmaceuticals, Inc.

LOTEMAX Distributed by:

• Bausch + Lomb, a division of
• Bausch Health US, LLC
• Bridgewater, NJ USA

Manufactured by:

• Bausch & Lomb Incorporated
• Tampa, FL USA

LOTEMAX® SM

• Distributed by: Bausch + Lomb, a division of Bausch Health US, LLC, Bridgewater, NJ, USA
• Manufactured by: Bausch & Lomb Incorporated, Tampa, FL USA

What should I know about storage and disposal of this medication?

LOTEMAX® SM; LOTEMAX:

• Store upright at 15º to 25ºC (59º to 77ºF).
• After opening, LOTEMAX® SM can be used until the expiration date on the bottle.

INVELTYS:

• Store upright at 15°C to 25°C (59°F to 77°F).
• Do not freeze.

• Dailymed label info on Loteprednol
• FDA Loteprednol

Loteprednol Resources
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