loteprednol etabonate 2 mg/mL
loteprednol etabonate · SUSPENSION/ DROPS · Amneal Pharmaceuticals NY LLC
loteprednol etabonate is a suspension/ drops containing loteprednol etabonate at 2 mg/mL, taken ophthalmic. Manufactured by Amneal Pharmaceuticals NY LLC.
Key Facts
- Brand Name
- loteprednol etabonate
- Generic Name
- loteprednol etabonate
- NDC Code (Product)
60219-1366- Manufacturer
- Amneal Pharmaceuticals NY LLC
- Strength
- 2 mg/mL
- Dosage Form
- SUSPENSION/ DROPS
- Route
- OPHTHALMIC
- Marketing Status
- Application #
- ANDA216345
- Marketing Start
- 12/18/2024
Recall History
Cardinal Health Inc.
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
SUN PHARMACEUTICAL INDUSTRIES INC
Superpotent Drug: Out of Specification (OOS) results observed for unit dose content.
Bausch & Lomb
Failed Stability Specifications: Out of specification for viscosity.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE Loteprednol etabonate is indicated for the treatment of steroid responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe such as allergic conjunctivitis, acne rosacea, superficial punctate keratitis, herpes zoster keratitis, iritis, cyclitis, selected infective conjunctivitides, when the inherent hazard of steroid use is accepted to obtain an advisable diminution in edema and inflammation. Loteprednol etabonate is less effective than prednisolone acetate 1% in two 28-day controlled clinical studies in acute anterior uveitis, where 72% of patients treated with loteprednol etabonate experienced resolution of anterior chamber cells, compared to 87% of patients treated with prednisolone acetate 1%. The incidence of patients with clinically significant increases in IOP (≥10 mmHg) was 1% with loteprednol etabonate and 6% with prednisolone acetate 1%. Loteprednol etabonate should not be used in patients who require a more potent corticosteroid for this indication. Loteprednol etabonate is also indicated for the treatment of post-operative inflammation following ocular surgery.
Dosage & Administration
DOSAGE AND ADMINISTRATION SHAKE VIGOROUSLY BEFORE USING. Steroid Responsive Disease Treatment: Apply one to two drops of loteprednol etabonate into the conjunctival sac of the affected eye four times daily. During the initial treatment within the first week, the dosing may be increased, up to 1 drop every hour, if necessary. Care should be taken not to discontinue therapy prematurely. If signs and symptoms fail to improve after two days, the patient should be re-evaluated (See PRECAUTIONS ). Post-Operative Inflammation: Apply one to two drops of loteprednol etabonate into the conjunctival sac of the operated eye four times daily beginning 24 hours after surgery and continuing throughout the first 2 weeks of the post-operative period.
Warnings
WARNINGS Prolonged use of corticosteroids may result in glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision, and in posterior subcapsular cataract formation. Steroids should be used with caution in the presence of glaucoma. Prolonged use of corticosteroids may suppress the host response and thus increase the hazard of secondary ocular infections. In those diseases causing thinning of the cornea or sclera, perforations have been known to occur with the use of topical steroids. In acute purulent conditions of the eye, steroids may mask infection or enhance existing infection. Use of ocular steroids may prolong the course and may exacerbate the severity of many viral infections of the eye (including herpes simplex). Employment of a corticosteroid medication in the treatment of patients with a history of herpes simplex requires great caution. The use of steroids after cataract surgery may delay healing and increase the incidence of bleb formation.
Contraindications
CONTRAINDICATIONS Loteprednol etabonate, 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. Loteprednol etabonate is also contraindicated in individuals with known or suspected hypersensitivity to any of the ingredients of this preparation and to other corticosteroids.
Adverse Reactions
ADVERSE REACTIONS To report SUSPECTED ADVERSE REACTIONS, contact Sentiss at 1-855-473-6847 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . Reactions associated with ophthalmic steroids include elevated intraocular pressure, which may be associated with optic nerve damage, visual acuity and field defects, posterior subcapsular cataract formation, secondary ocular infection from pathogens including herpes simplex, and perforation of the globe where there is thinning of the cornea or sclera. Ocular adverse reactions occurring in 5-15% of patients treated with loteprednol etabonate ophthalmic suspension (0.2%-0.5%) in clinical studies included abnormal vision/blurring, burning on instillation, chemosis, discharge, dry eyes, epiphora, foreign body sensation, itching, injection, and photophobia. Other ocular adverse reactions occurring in less than 5% of patients include conjunctivitis, corneal abnormalities, eyelid erythema, keratoconjunctivitis, ocular irritation/pain/discomfort, papillae, and uveitis. Some of these events were similar to the underlying ocular disease being studied. Non-ocular adverse reactions occurred in less than 15% of patients. These include headache, rhinitis …
Frequently Asked Questions
What is loteprednol etabonate used for?
loteprednol etabonate contains loteprednol etabonate. It is a suspension/ drops taken ophthalmic. Consult your doctor for specific uses.
Is loteprednol etabonate a controlled substance?
loteprednol etabonate is not classified as a controlled substance by the DEA.
What is the generic name for loteprednol etabonate?
The generic name for loteprednol etabonate is loteprednol etabonate. There are 10 other brand versions of loteprednol etabonate.
What is the NDC code for loteprednol etabonate 2 mg/mL?
The NDC (National Drug Code) for loteprednol etabonate 2 mg/mL is 60219-1366, listed by Amneal Pharmaceuticals NY LLC.
Other loteprednol etabonate Dosages
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/g70244-036
- Loteprednol Etabonate5 mg/mL82260-299
- LOTEPREDNOL ETABONATE2 mg/mL0574-4080
- Lotemax SM3.8 mg/g24208-507
- LOTEPREDNOL ETABONATE5 mg/mL60219-1362
- Loteprednol Etabonate5 mg/mL62756-232
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)