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Basic Drug Info
Drug Name:LOTEMAX
Manufacturer:Bausch & Lomb Incorporated
Other Info:

Revised April 2006Bausch & Lomb Incorporated, Tampa, Florida 33637U.S.

Patent No.

4,996,335U.S.

Patent No.

5,540,930U.S.

Patent No.

5,747,061┬ęBausch & Lomb IncorporatedLotemax is a registered trademark of Bausch & Lomb Incorporated.9067501 (Folded)9067401 (Flat)



Clinical Trials:


Indications and Usage

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

Allergic Conjunctivitis -- Conjunctivitis due to hypersensitivity to various allergens.

rosacea -- A cutaneous disorder primarily of convexities of the central part of the FACE, such as FOREHEAD; CHEEK; NOSE; and CHIN. It is characterized by FLUSHING; ERYTHEMA; EDEMA; RHINOPHYMA; papules; and ocular symptoms. It may occur at any age but typically after age 30. There are various subtypes of rosacea: erythematotelangiectatic, papulopustular, phymatous, and ocular (National Rosacea Society's Expert Committee on the Classification and Staging of Rosacea, J Am Acad Dermatol 2002; 46:584-7).

Punctate epithelial keratoconjunctivitis --

Herpes zoster keratitis --

Herpes zoster keratoconjunctivitis --

Iritis -- Inflammation of the iris characterized by circumcorneal injection, aqueous flare, keratotic precipitates, and constricted and sluggish pupil along with discoloration of the iris.

Cyclitis -- Inflammation of the ciliary body.

Infective conjunctivitis --

Edema -- Abnormal fluid accumulation in TISSUES or body cavities. Most cases of edema are present under the SKIN in SUBCUTANEOUS TISSUE.

Acute anterior uveitis --

Inflammation -- A pathological process characterized by injury or destruction of tissues caused by a variety of cytologic and chemical reactions. It is usually manifested by typical signs of pain, heat, redness, swelling, and loss of function.

Contraindications

LOTEMAX, 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.

LOTEMAX is also contraindicated in individuals with known or suspected hypersensitivity to any of the ingredients of this preparation and to other corticosteroids.
Virus Diseases -- A general term for diseases produced by viruses.

Corneal Diseases -- Diseases of the cornea.

Dendritic keratitis -- A form of herpetic keratitis characterized by the formation of small vesicles which break down and coalesce to form recurring dendritic ulcers, characteristically irregular, linear, branching, and ending in knoblike extremities. (Dictionary of Visual Science, 3d ed)

Vaccinia -- The cutaneous and occasional systemic reactions associated with vaccination using smallpox (variola) vaccine.

Chickenpox -- A highly contagious infectious disease caused by the varicella-zoster virus (HERPESVIRUS 3, HUMAN). It usually affects children, is spread by direct contact or respiratory route via droplet nuclei, and is characterized by the appearance on the skin and mucous membranes of successive crops of typical pruritic vesicular lesions that are easily broken and become scabbed. Chickenpox is relatively benign in children, but may be complicated by pneumonia and encephalitis in adults. (From Dorland, 27th ed)

Mycobacterium Infections -- Infections with bacteria of the genus MYCOBACTERIUM.

Mycoses -- disease caused by a fungus.

Hypersensitivity -- Altered reactivity to an antigen, which can result in pathologic reactions upon subsequent exposure to that particular antigen.

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.

This web-site is for informational purposes only and is not intended as a substitute for advice from your doctor. It should not to be used for self-diagnosis or treatment.