Methedex

Adverse reactions have occurred with steroid/anti-infective combination drugs which can be attributed to the steroid component, the antiinfective component, or the combination. Exact incidence figures are not available since no denominator of treated patients is available.

Reactions occurring most often from the presence of the anti-infective ingredients are allergic sensitizations. The reactions due to the steroid component are: elevation of intraocular pressure (IOP) with possible development of glaucoma, and infrequent optic nerve damage; posterior subcapsular cataract formation; and delayed wound healing.

Secondary Infection: The development of secondary infection has occurred after use of combinations containing steroids and antimicrobials. Fungal infections of the cornea are particularly prone to develop coincidentally with long-term applications of steroids. The possibility of fungal invasion must be considered in any persistent corneal ulceration where steroid treatment has been used. Secondary bacterial ocular infection following suppression of host responses also occurs.

One or two drops topically in the conjunctival sac(s). In severe disease, drops may be used hourly, being tapered to discontinuation as the inflammation subsides. In mild disease, drops may be used up to four to six times daily.

Not more than 20 mL should be prescribed initially and the prescription should not be refilled without further evaluation as outlined in PRECAUTIONS above.

SHAKE WELL BEFORE USING.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Eye irritation.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Applies to dexamethasone / neomycin / polymyxin b ophthalmic: ophthalmic ointment, ophthalmic suspension

General

The most frequently reported side effects were ocular discomfort, keratitis, eye irritation, and allergic sensitization.[Ref]

Ocular

Uncommon (0.1% to 1%): Keratitis, intraocular pressure increased, vision blurred, photophobia, mydriasis, eyelid ptosis, eye pain, eye swelling, eye pruritus, ocular discomfort, foreign body sensation, eye irritation, ocular hyperemia, lacrimation increased
Frequency not reported: Corneal thinning

Dexamethasone:
Frequency not reported: Intraocular pressure increased, glaucoma, visual acuity reduced, visual field defect, posterior subcapsular cataract formation, globe perforation, keratitis, conjunctivitis, corneal ulcer, conjunctival hyperemia, optic nerve damage, wound healing delayed[Ref]

Immunologic

Uncommon (0.1% to 1%): Hypersensitivity
Frequency not reported: Allergic sensitization[Ref]

Nervous system

Frequency not reported: Headache[Ref]

Other

Frequency not reported: Secondary ocular infection developed, fungal infection developed[Ref]

Some side effects of dexamethasone / neomycin / polymyxin b ophthalmic may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Ointment: Apply a small amount (about 1/2 inch) into the conjunctival sac of the affected eye(s) up to 3 or 4 times a day

Suspension: Instill 1 to 2 drops into the conjunctival sac of the affected eye(s) up to 4 to 6 times a day; in severe disease, may be used hourly and tapered to discontinuation as inflammation subsides

Comments:
-A maximum of 20 mL of suspension or a maximum of 8 g of ointment should be prescribed initially and should not be refilled without further evaluation of the patient's condition.
-If signs/symptoms fail to improve after 2 days of treatment, the patient should be re-evaluated.

Uses:
-For the treatment of steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where bacterial infection or risk of bacterial ocular infection exists
-Ocular corticosteroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe where the inherent risk of corticosteroid use in certain infective conjunctivitides is accepted to obtain a diminution in edema and inflammation; also indicated in chronic anterior uveitis and corneal injury from chemical, radiation, or thermal burns; or penetration of foreign bodies.
-The anti-infective component of this drug is active against the following common bacterial eye pathogens: Staphylococcus aureus, Escherichia coli, Haemophilus influenzae, Klebsiella/Enterobacter species, Neisseria species, and Pseudomonas aeruginosa; this drug does not provide adequate coverage against Serratia marcescens and Streptococci including S pneumoniae

2 years or older:
-Suspension: Instill 1 to 2 drops into the conjunctival sac of the affected eye(s) up to 4 to 6 times a day; in severe disease, may be used hourly and tapered to discontinuation as inflammation subsides

Comments:
-A maximum of 20 mL of suspension should be prescribed initially and should not be refilled without further evaluation of the patient's condition.
-If signs/symptoms fail to improve after 2 days of treatment, the patient should be re-evaluated.

Uses:
-For the treatment of steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where bacterial infection or risk of bacterial ocular infection exists
-Ocular corticosteroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe where the inherent risk of corticosteroid use in certain infective conjunctivitides is accepted to obtain a diminution in edema and inflammation; also indicated in chronic anterior uveitis and corneal injury from chemical, radiation, or thermal burns; or penetration of foreign bodies
-The anti-infective component of this drug is active against the following common bacterial eye pathogens: Staphylococcus aureus, Escherichia coli, Haemophilus influenzae, Klebsiella/Enterobacter species, Neisseria species, and Pseudomonas aeruginosa; this drug does not provide adequate coverage against Serratia marcescens and Streptococci including S pneumoniae

2 years or older:
-Suspension: Instill 1 to 2 drops into the conjunctival sac of the affected eye(s) up to 4 to 6 times a day; in severe disease, may be used hourly and tapered to discontinuation as inflammation subsides

Comments:
-A maximum of 20 mL of suspension should be prescribed initially and should not be refilled without further evaluation of the patient's condition.
-If signs/symptoms fail to improve after 2 days of treatment, the patient should be re-evaluated.

Uses:
-For the treatment of steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where bacterial infection or risk of bacterial ocular infection exists
-Ocular corticosteroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe where the inherent risk of corticosteroid use in certain infective conjunctivitides is accepted to obtain a diminution in edema and inflammation; also indicated in chronic anterior uveitis and corneal injury from chemical, radiation, or thermal burns; or penetration of foreign bodies
-The anti-infective component of this drug is active against the following common bacterial eye pathogens: Staphylococcus aureus, Escherichia coli, Haemophilus influenzae, Klebsiella/Enterobacter species, Neisseria species, and Pseudomonas aeruginosa; this drug does not provide adequate coverage against Serratia marcescens and Streptococci including S pneumoniae

Data not available

Ophthalmic ointment: Safety and efficacy have not been established in patients younger than 18 years.

Ophthalmic suspension: Safety and efficacy have not been established in patients younger than 2 years.

Consult WARNINGS section for additional precautions.