Ocu-Lone C

Name: Ocu-Lone C

What is Ocu-Lone C (sulfacetamide and prednisolone ophthalmic)?

Sulfacetamide is an antibiotic. It is used to treat bacterial infections.

Prednisolone is a steroid. It is used to treat the swelling associated with bacterial infections of the eye.

Sulfacetamide and prednisolone ophthalmic is used to treat bacterial infections of the eyes.

Sulfacetamide and prednisolone ophthalmic may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about Ocu-Lone C (sulfacetamide and prednisolone ophthalmic)?

Contact your doctor if your symptoms begin to get worse or if you do not see any improvement in your condition after a few days.

Do not touch the dropper or tube opening to any surface, including your eyes or hands. The dropper or tube opening is sterile. If it becomes contaminated, it could cause an infection in your eye.

Apply light pressure to the inside corner of your eye (near your nose) after each drop to prevent the fluid from draining down your tear duct.

Who should not use Ocu-Lone C (sulfacetamide and prednisolone ophthalmic)?

Do not use sulfacetamide and prednisolone ophthalmic if you have a viral or fungal infection in your eye. It is used to treat infections caused by bacteria only.

Do not use sulfacetamide and prednisolone ophthalmic if you have ever had an allergic reaction to a sulfa-based drug.

It is not known whether sulfacetamide and prednisolone ophthalmic will harm an unborn baby. Do not use this medication without first talking to your doctor if you are pregnant.

It is also not known whether sulfacetamide and prednisolone ophthalmic passes into breast milk. Do not use this medication without first talking to your doctor if you are breast-feeding a baby.

What happens if I overdose?

An overdose of this medication is unlikely to occur. If you do suspect an overdose, wash the eye with water and call an emergency room or poison control center near you. If the drops or ointment have been ingested, drink plenty of fluid and call an emergency center for advice.

For the Consumer

Applies to prednisolone / sulfacetamide sodium ophthalmic: ophthalmic ointment, ophthalmic solution, ophthalmic suspension

For Healthcare Professionals

Applies to prednisolone / sulfacetamide sodium ophthalmic: ophthalmic ointment, ophthalmic solution, ophthalmic suspension

General

The frequency of the reported side effects is unknown. Reactions occurring from the combination product include cataract, dizziness, eye discharge, eyelid edema, eyelid erythema, eye irritation, eye pain, eye pruritus, and hypersensitivity including rash, skin pruritus, urticaria, ocular hyperemia, and visual disturbance/blurred vision.[Ref]

Ocular

Frequency not reported: Cataract, eye discharge, eyelid edema, eyelid erythema, eye irritation, eye pain, eye pruritus, ocular hyperemia, vision blurred, intraocular pressure increased, glaucoma developed, optic nerve damage, posterior subcapsular cataract formation, secondary bacterial ocular infection, fungal infection of cornea, viral infection of cornea, vision disturbed, mydriasis, loss of accommodation, ptosis, acute anterior uveitis, perforation of the globe

Prednisolone:
-Frequency not reported: Intraocular pressure increased, glaucoma developed, optic nerve damage, posterior subcapsular cataract formation[Ref]

Immunologic

Rarely, fatalities have occurred due to severe reactions to sulfonamides including Stevens-Johnson syndrome, toxic epidermal necrolysis, fulminant hepatic necrosis, agranulocytosis, aplastic anemia, and other blood dyscrasias.[Ref]

Frequency not reported: Hypersensitivity, allergic sensitization

Sulfacetamide sodium:
-Frequency not reported: Allergic sensitization[Ref]

Dermatologic

Frequency not reported: Rash, pruritus, urticaria[Ref]

Local

Sulfacetamide sodium:
-Frequency not reported: Local irritation[Ref]

Other

Prednisolone:
-Frequency not reported: Wound healing delayed[Ref]

Nervous system

Frequency not reported: Dizziness[Ref]

Endocrine

Frequency not reported: Systemic hypercorticoidism[Ref]

Some side effects of Ocu-Lone C may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

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