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.

• LOTEMAX is also indicated for the treatment of post-operative inflammation following ocular surgery.

LOTEMAX is less effective than prednisolone acetate 1% in two 28-day controlled clinical studies in acute anterior uveitis, where 72% of patients treated with LOTEMAX 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 LOTEMAX and 6% with prednisolone acetate 1%. LOTEMAX should not be used in patients who require a more potent corticosteroid for this indication. 

The initial prescription and renewal of the medication order beyond 14 days 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. 

If this product is used for 10 days or longer, intraocular pressure should be monitored even though it may be difficult in children and uncooperative patients.

LOTEMAX 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. 

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.

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. Fungal cultures should be taken when appropriate.

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.

The use of steroids after cataract surgery may delay healing and increase the incidence of bleb formation.

Animal Studies: embryotoxic (delayed ossification) and teratogenic (increased incidence of meningocele, abnormal left common carotid artery, and limb flexures).

Systemic steroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects.

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• Use in patients under the age of 18. GoToSource 

• Dry eye. GoToSource

• Prophylaxis after photorefractive keratectomy. GoToSource

• Perioperative management of pterygium. GoToSource

• Asthma and allergic rhinitis. GoToSource

Posterior subcapsular cataracts (type of cataract, small opaque or cloudy area on back surface of the lens), glaucoma (increased pressure within the eyeball), delayed wound healing, potentiation of infection, viral reactivation and corneal stromal calcification. GoToSource

Increased blood glucose levels in patients with diabetes. GoToSource

Elevated intraocular pressure. GoToSource

Anterior chamber inflammation, photophobia, corneal edema, conjunctival hyperemia, eye pain and iritis (inflammation of the iris of the eye). GoToSource

No major injury lawsuits reported.