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FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Intraocular Pressure (IOP) Increase
5.2 Cataracts
5.3 Delayed Healing
5.4 Bacterial Infections
5.5 Viral Infections
5.6 Fungal Infections
5.7 Contact Lens Wear
6 ADVERSE REACTIONS
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.2 Lactation
8.4 Pediatric Use
8.5 Geriatric Use
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.3 Pharmacokinetics
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
14 CLINICAL STUDIES
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION
*Sections or subsections omitted from the full prescribing information are not listed.
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FULL PRESCRIBING INFORMATION
1 INDICATIONS AND USAGE
LOTEMAX® SM (loteprednol etabonate ophthalmic gel) 0.38% is a corticosteroid indicated for the treatment ofpost-operative inflammation and pain following ocular surgery.
2 DOSAGE AND ADMINISTRATION
Invert closed bottle and shake once to fill tip before instilling drops. Apply one drop of LOTEMAX® SM intothe conjunctival sac of the affected eye three times daily beginning the day after surgery and continuingthroughout the first 2 weeks of the post-operative period.
3 DOSAGE FORMS AND STRENGTHS
LOTEMAX® SM (loteprednol etabonate ophthalmic gel) 0.38% is a sterile preserved ophthalmic gel containing3.8 mg of loteprednol etabonate per gram of gel.
4 CONTRAINDICATIONS
LOTEMAX® SM, as with other ophthalmic corticosteroids, is contraindicated in most viral diseases of thecornea and conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella,in mycobacterial infection of the eye and fungal diseases of ocular structures.
5 WARNINGS AND PRECAUTIONS
5.1 Intraocular Pressure (IOP) Increase
Prolonged use of corticosteroids may result in glaucoma with damage to the optic nerve, defects in visual acuityand fields of vision. Steroids should be used with caution in the presence of glaucoma. If this product is used for10 days or longer, intraocular pressure should be monitored.
5.2 Cataracts
Use of corticosteroids may result in posterior subcapsular cataract formation.
5.3 Delayed Healing
The use of steroids after cataract surgery may delay healing and increase the incidence of bleb formation. Inthose diseases causing thinning of the cornea or sclera, perforations have been known to occur with the use oftopical 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, whereappropriate, fluorescein staining.
5.4 Bacterial Infections
Prolonged use of corticosteroids may suppress the host response and thus increase the hazard of secondaryocular infections. In acute purulent conditions of the eye, steroids may mask infection or enhance existinginfection.
5.5 Viral Infections
Employment of a corticosteroid medication in the treatment of patients with a history of herpes simplex requiresgreat caution. Use of ocular steroids may prolong the course and may exacerbate the severity of many viralinfections of the ey |
