Pred-G S.O.P.

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.

Use caution when driving, operating machinery, or performing other hazardous activities. Gentamicin and prednisolone ophthalmic may cause blurred vision. If you experience blurred vision, avoid these activities.

Use caution with contact lenses. Wear them only if your doctor approves. After applying this medication, wait at least 15 minutes before inserting contact lenses.

Avoid other eye medications unless your doctor approves.

• If you have an allergy to prednisolone, gentamicin, or any other part of Pred-G S.O.P. (prednisolone and gentamicin eye ointment).
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you have any of these health problems: A fungal, TB (tuberculosis), or viral infection of the eye.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Pred-G S.O.P. with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

• Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
• Use care when driving or doing other tasks that call for clear eyesight.
• Long-term use may raise the chance of cataracts or glaucoma. Talk with the doctor.
• Have your eye pressure checked if you are on Pred-G S.O.P. for a long time. Talk with your doctor.
• Do not use longer than you have been told by the doctor.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this medicine while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

Use Pred-G S.O.P. as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• To gain the most benefit, do not miss doses.
• Keep using this medicine as you have been told by your doctor or other health care provider, even if you feel well.
• For the eye only.
• Wash your hands before and after use.
• Do not touch the container tip to the eye, lid, or other skin.
• Gently pull down the lower lid and squeeze in how much the doctor told you to use.
• Let go of the lower eyelid and keep eyes closed for 1 to 2 minutes.

What do I do if I miss a dose?

• Use a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not use 2 doses or extra doses.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Change in eyesight, eye pain, or very bad eye irritation.

Applies to gentamicin / prednisolone ophthalmic: ophthalmic ointment, ophthalmic suspension

General

The most frequently reported side effects were ocular discomfort, irritation following instillation, and punctate keratitis.[Ref]

Ocular

Frequency not reported: Superficial punctate keratitis, ocular discomfort

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

Local

Frequency not reported: Burning, stinging, irritation[Ref]

Other

Frequency not reported: Secondary ocular infection developed

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

Immunologic

Gentamicin:
Frequency not reported: Allergic sensitization[Ref]

Some side effects of Pred-G S.O.P. may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.