Pred-G

DRUG DESCRIPTION

PRED-G (gentamicin and prednisolone acetate) sterile ophthalmic suspension is a topical anti-inflammatory/anti-infective combination product for ophthalmic use.

Structural Formulae:

Pred G (gentamicin sulfate and prednisolone acetate)  structural formula illustration

Chemical Names:

Prednisolone acetate: 11?,17,21-Trihydroxypregna-1,4-diene-3,20-dione 21-acetate.

Gentamicin sulfate is the sulfate salt of gentamicin C1, gentamicin C2, and gentamicin C1A which are produced by the growth of Micromonospora purpurea.

Contains: Actives: Gentamicin sulfate equivalent to 0.3% gentamicin base; prednisolone acetate (microfine suspension) 1.0%. Preservative: Benzalkonium chloride 0.005%. Inactives: edetate disodium; hypromellose; polyvinyl alcohol 1.4%; polysorbate 80; purified water; sodium chloride; and sodium citrate, dihydrate. May contain sodium hydroxide and/or hydrochloric acid to adjust the pH (5.4 to 6.6).

PRED-G (gentamicin and prednisolone acetate) suspension is formulated with a pH from 5.4 to 6.6 and its osmolality ranges from 260 to 340 mOsm/kg.

What are the possible side effects of gentamicin and prednisolone ophthalmic (Pred-G, Pred-G S.O.P.)?

Serious side effects are not expected with this medication.

Some burning, stinging, irritation, itching, redness, blurred vision, eyelid itching, eyelid swelling, or sensitivity to light may occur.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at...

Read All Potential Side Effects and See Pictures of Pred-G

What are the precautions when taking gentamicin and prednisolone acetate (Pred-G)?

Before using this medication, tell your doctor or pharmacist if you are allergic to gentamicin or prednisolone; or to aminoglycoside antibiotics (e.g., neomycin, tobramycin); or to corticosteroids (e.g., dexamethasone, hydrocortisone); or if you have any other allergies. This product may contain inactive ingredients (such as preservatives like benzalkonium chloride), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: other eye problems (e.g., glaucoma).

After you apply this drug, your vision may become temporarily unstable. Do not drive, use machinery, or do any activity that requires clear vision until you are sure you can perform...

Read All Potential Precautions of Pred-G


Pred-G Consumer (continued)

SIDE EFFECTS: Stinging/burning of the eyes for 1 to 2 minutes may occur when this medication is applied. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Use of this medication for prolonged/repeated periods may result in a new fungal eye infection and may increase your risk for other eye problems (e.g., glaucoma, cataracts, delayed wound healing). Do not use this medication for longer than prescribed. Tell your doctor immediately if any of these unlikely but serious side effects occur: new or worsening eye symptoms (e.g., discharge, swelling, redness), vision problems, eye pain.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using this medication, tell your doctor or pharmacist if you are allergic to gentamicin or prednisolone; or to aminoglycoside antibiotics (e.g., neomycin, tobramycin); or to corticosteroids (e.g., dexamethasone, hydrocortisone); or if you have any other allergies. This product may contain inactive ingredients (such as preservatives like benzalkonium chloride), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: other eye problems (e.g., glaucoma).

After you apply this drug, your vision may become temporarily unstable. Do not drive, use machinery, or do any activity that requires clear vision until you are sure you can perform such activities safely.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known if this drug passes into breast milk. Consult your doctor before breast-feeding.


Pred-G Patient Information Including Side Effects

Brand Names: Pred-G, Pred-G S.O.P.

Generic Name: gentamicin and prednisolone ophthalmic (Pronunciation: JEN ta MYE sin pred NIS oh lone)

  • What is gentamicin and prednisolone ophthalmic (Pred-G)?
  • What are the possible side effects of gentamicin and prednisolone ophthalmic (Pred-G)?
  • What is the most important information I should know about gentamicin and prednisolone ophthalmic (Pred-G)?
  • Who should not use gentamicin and prednisolone ophthalmic (Pred-G)?
  • How should I use gentamicin and prednisolone ophthalmic (Pred-G)?
  • What happens if I miss a dose (Pred-G)?
  • What happens if I overdose (Pred-G)?
  • What should I avoid while using gentamicin and prednisolone ophthalmic (Pred-G)?
  • What other drugs will affect gentamicin and prednisolone ophthalmic (Pred-G)?
  • Where can I get more information?

What is gentamicin and prednisolone ophthalmic (Pred-G)?

Gentamicin 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.

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

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

What are the possible side effects of gentamicin and prednisolone ophthalmic (Pred-G)?

Serious side effects are not expected with this medication.

Some burning, stinging, irritation, itching, redness, blurred vision, eyelid itching, eyelid swelling, or sensitivity to light may occur.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about gentamicin and prednisolone ophthalmic (Pred-G)?

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.

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