LOTEMAX 5 mg/g
loteprednol etabonate · GEL · Bausch & Lomb Incorporated
Lotemax is a prescription eye gel containing loteprednol etabonate, a corticosteroid used to reduce inflammation and discomfort in the eyes. It is applied directly to the eye to treat conditions such as post-operative inflammation, allergic conjunctivitis, and other inflammatory eye conditions.
Key Facts
- Brand Name
- LOTEMAX
- Generic Name
- loteprednol etabonate
- NDC Code (Product)
24208-503- Manufacturer
- Bausch & Lomb Incorporated
- Strength
- 5 mg/g
- Dosage Form
- GEL
- Route
- OPHTHALMIC
- Marketing Status
- Application #
- NDA202872
- Marketing Start
- 10/12/2012
Recall History
No Recall HistoryFull Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE LOTEMAX ® SM (loteprednol etabonate ophthalmic gel) 0.38% is a corticosteroid indicated for the treatment of post-operative inflammation and pain following ocular surgery. LOTEMAX ® SM is a corticosteroid indicated for the treatment of post-operative inflammation and pain following ocular surgery. ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Invert closed bottle and shake once to fill tip before instilling drops. Apply one drop of LOTEMAX ® SM into the conjunctival sac of the affected eye three times daily beginning the day after surgery and continuing throughout the first 2 weeks of the post-operative period. Invert closed bottle and shake once to fill tip before instilling drops. ( 2 ) Apply one drop of LOTEMAX ® SM into the conjunctival sac of the affected eye three times daily beginning the day after surgery and continuing throughout the first 2 weeks of the post-operative period. ( 2 )
Contraindications
4 CONTRAINDICATIONS LOTEMAX ® SM, 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, in mycobacterial infection of the eye and fungal diseases of ocular structures. LOTEMAX ® SM, 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 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. Adverse reactions associated with ophthalmic steroids 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. There were no treatment-emergent adverse drug reactions that occurred in more than 1% of subjects in the three times daily group compared to vehicle. There were no treatment-emergent adverse drug reactions that occurred in more than 1% of subjects in the three times daily group compared to vehicle. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Bausch & Lomb Incorporated at 1-800-553-5340 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Frequently Asked Questions
What is LOTEMAX used for?
Lotemax is a prescription eye gel containing loteprednol etabonate, a corticosteroid used to reduce inflammation and discomfort in the eyes. It is applied directly to the eye to treat conditions such as post-operative inflammation, allergic conjunctivitis, and other inflammatory eye conditions.
Is LOTEMAX a controlled substance?
LOTEMAX is not classified as a controlled substance by the DEA.
What is the generic name for LOTEMAX?
The generic name for LOTEMAX is loteprednol etabonate. There are 10 other brand versions of loteprednol etabonate.
What is the NDC code for LOTEMAX 5 mg/g?
The NDC (National Drug Code) for LOTEMAX 5 mg/g is 24208-503, listed by Bausch & Lomb Incorporated.
Other LOTEMAX Dosages
Other Loteprednol Brands
See all →- Inveltys10 mg/mL0065-9307
- 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
- loteprednol etabonate2 mg/mL60219-1366
- 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)