Sulfacetamide and prednisolone (Ophthalmic)

Sulfacetamide and prednisolone combination is used to treat eye infections and inflammation, such as conjunctivitis and chronic anterior uveitis. It also helps prevent damage from chemicals, radiation, or foreign objects that may enter the eye.

Sulfacetamide is a sulfa drug that falls under the category of antibiotics. It works by killing bacteria or stopping their growth. Prednisolone is a steroid medicine that helps reduce redness, itching, and swelling caused by eye infections.

This medicine is available only with your doctor's prescription.

Your eye doctor will want to check your eyes at regular visits to ensure this medicine is working properly and to look for any unwanted effects, especially if you will be using this medicine for 10 days or longer.

If your symptoms do not get better after 2 days or if they get worse, contact your eye doctor (ophthalmologist) immediately.

Contact your doctor right away if you have an eye injury, eye infection, or if you plan to have eye surgery.

Prednisolone may slow down healing after eye surgery. It may also cause temporary vision issues. Talk to your doctor if you have any concerns.

Sulfacetamide can cause a rare type of brain damage called kernicterus in newborns when given to pregnant women in the later stages of their pregnancy. This can be life-threatening and requires immediate medical attention. Discuss this risk with your doctor.

Serious skin reactions can happen with this medicine. Contact your doctor right away if you experience blistering, peeling, or loosening of the skin, red skin lesions, severe acne or a skin rash, sores or ulcers on the skin, or fever or chills while using this medicine.

In deciding to use a medicine, you and your doctor need to consider the risks of taking it against the benefits it may provide. Here are some important points to think about for this medicine:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, let your healthcare provider know about any other allergies you have, such as to foods, dyes, preservatives, or animals. For non-prescription products, carefully read the label or package ingredients.

Pediatric

Studies have not shown any specific problems that would limit the use of sulfacetamide and prednisolone eye drops and eye ointment in children aged 6 years and older. Safety and effectiveness have not been established in children younger than 6 years.

Geriatric

There is no information available about how age affects the use of sulfacetamide and prednisolone eye drops and eye ointment in older adults.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication during breastfeeding. Consider the potential benefits versus the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines can be used together even if an interaction might occur. In those situations, your doctor may adjust the dose or take other precautions. It is especially important for your healthcare provider to know if you are taking any of the medicines listed below. The following interactions have been chosen for their potential significance and are not necessarily a complete list.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Desmopressin
• Methenamine
• Rotavirus Vaccine, Live

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in some cases. If both medicines are prescribed together, your doctor may adjust the dose or frequency of one or both medicines.

• Aceclofenac
• Acemetacin
• Aldesleukin
• Amtolmetin Guacil
• Asparaginase
• Aspirin
• Balofloxacin
• Bemiparin
• Besifloxacin
• Bromfenac
• Bufexamac
• Bupropion
• Celecoxib
• Ceritinib
• Choline Salicylate
• Ciprofloxacin
• Clonixin
• Desogestrel
• Dexibuprofen
• Dexketoprofen
• Diclofenac
• Dienogest
• Diflunisal
• Dipyrone
• Drospirenone
• Droxicam
• Enoxacin
• Estetrol
• Estradiol
• Ethinyl Estradiol
• Ethynodiol
• Etodolac
• Etofenamate
• Etoricoxib
• Felbinac
• Fenoprofen
• Fepradinol
• Feprazone
• Fleroxacin
• Floctafenine
• Flufenamic Acid
• Flumequine
• Flurbiprofen
• Gatifloxacin
• Gemifloxacin
• Gestodene
• Ibuprofen
• Indomethacin
• Ketoprofen
• Ketorolac
• Levofloxacin
• Levonorgestrel
• Lomefloxacin
• Lornoxicam
• Loxoprofen
• Lumiracoxib
• Lutetium Lu 177 Dotatate
• Macimorelin
• Meclofenamate
• Mefenamic Acid
• Meloxicam
• Mestranol
• Methotrexate
• Morniflumate
• Moxifloxacin
• Nabumetone
• Nadifloxacin
• Nadroparin
• Naproxen
• Nepafenac
• Niflumic Acid
• Nimesulide
• Nimesulide Beta Cyclodextrin
• Nomegestrol
• Norethindrone
• Norfloxacin
• Norgestimate
• Norgestrel
• Ofloxacin
• Oxaprozin
• Oxyphenbutazone
• Parecoxib
• Pazufloxacin
• Pefloxacin
• Phenylbutazone
• Piketoprofen
• Piroxicam
• Porfimer
• Pranoprofen
• Proglumetacin
• Propyphenazone
• Proquazone
• Prulifloxacin
• Rofecoxib
• Rufloxacin
• Salicylic Acid
• Salsalate
• Sargramostim
• Sodium Salicylate
• Somatrogon-ghla
• Sorafenib
• Sparfloxacin
• Sulindac
• Tenoxicam
• Tiaprofenic Acid
• Tolfenamic Acid
• Tolmetin
• Tosufloxacin
• Valdecoxib

Using this medicine with any of the following medicines may increase the risk of certain side effects, but using both may be the best treatment for you. If both are prescribed together, your doctor may adjust the dose or frequency of one or both medicines.

• Alcuronium
• Aminolevulinic Acid
• Amobarbital
• Atracurium
• Auranofin
• Fosphenytoin
• Gallamine
• Hexafluorenium
• Licorice
• Metocurine
• Phenytoin
• Primidone
• Rifampin
• Saiboku-To
• Vecuronium

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken around the time of eating certain foods due to possible interactions. Using alcohol or tobacco with certain medicines may also cause interactions. Talk to your healthcare provider about how to use your medicine with food, alcohol, or tobacco.

Other Medical Problems

Other medical problems may affect how this medicine works. Make sure to tell your doctor if you have any other medical issues, especially:

• Cataract or
• History of cornea (part of the eye) problems or
• Glaucoma or
• History of sclera (part of the eye) problems—Use with caution. These conditions may get worse.

• Recent cataract surgery—May worsen side effects.

• Eye infection with pus—Use with caution. Prednisolone may mask or make the infection worse.

• Fungal eye infection or
• Herpes simplex eye infection or
• Smallpox eye infection or
• Tuberculosis eye infection or
• Varicella (chickenpox) eye infection—Should not be used in patients with these conditions.

Along with its needed effects, a medicine may cause some unwanted effects. Not all of these side effects may occur, but if they do, they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

For eye drops and eye ointment

Incidence not known

• Black, tarry stools
• Blistering, peeling, or loosening of the skin
• Blurred vision
• Changes in vision
• Chest pain
• Chills
• Cough
• Dark urine
• Darkening of the skin
• Decreased vision
• Diarrhea
• Dizziness
• Eye pain
• Fainting
• Fever
• Headache
• Increased sensitivity of the eyes to light
• Joint or muscle pain
• Light-colored stools
• Loss of appetite
• Loss of vision
• Mental depression
• Nausea
• Pale skin
• Red skin lesions, often with a purple center
• Red, irritated eyes
• Slow wound healing
• Sore throat
• Sores, ulcers, or white spots on the lips or in the mouth
• Stomach pain
• Swollen or painful glands
• Tearing
• Tightness in the chest
• Trouble seeing
• Unpleasant breath odor
• Unusual bleeding or bruising
• Unusual tiredness or weakness
• Vomiting
• Vomiting of blood
• Yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Your health care professional may also be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue, are bothersome, or if you have any questions about them:

For eye drops and eye ointment

Incidence not known

• Bigger, dilated, or enlarged pupils of the eyes
• Drooping upper eyelids

For eye drops

Incidence not known

• Blurry vision
• Eye discharge
• Itching, redness, swelling, or other signs of eye or eyelid irritation

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

Pharmacologic Class: Prednisolone

Chemical Class: Sulfonamide

Use this medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. To do so may increase the chance of too much medicine being absorbed into the body and the chance of side effects.

To use the eye drops:

• Do not wear contact lenses while you are using this medicine.
• Wash your hands first with soap and water.
• Shake the bottle well before each use.
• Tilt your head back and, pressing your finger gently on the skin just beneath the lower eyelid, pull the lower eyelid away from the eye to make a space. Drop the medicine into this space.
• Let go of the eyelid and gently close your eye. Do not blink. Keep the eye closed and apply pressure to the inner corner of your eye with your finger for 1 or 2 minutes to allow the medicine to be absorbed by the eye.
• If you think you did not get the drop of medicine into your eye properly, use another drop.
• To keep the medicine as germ-free as possible, do not touch the applicator tip to any surface (including the eye). Keep the bottle tightly closed and upright when you are not using it.

To use the eye ointment:

• Wash your hands first with soap and water.
• Tilt your head back and, pressing your finger gently on the skin just beneath the lower eyelid, pull the lower eyelid away from the eye to make a space. Place a small amount (about 1/2 an inch) of ointment into this space.
• Look down before closing your eye. Apply pressure to the inner corner of your eye with your finger for 1 or 2 minutes to allow the medicine to be absorbed by the eye.
• To keep the medicine as germ-free as possible, do not touch the tip of the tube to any surface (including the eye). Keep the tube tightly closed.

To help clear up your infection completely, keep using this medicine for the full treatment time even if you feel better after the first few doses. The infection may not clear up if you stop using the medicine too soon. Do not miss any doses.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For eye infections: For ophthalmic dosage form (eye drops): Adults and children 6 years of age and older—Use two drops in the affected eye every 4 hours during the day and at bedtime. Your doctor may reduce your dose as needed. Children younger than 6 years of age—Use and dose must be determined by your doctor. For ophthalmic dosage form (eye ointment): Adults and children 6 years of age and older—Apply a small amount (about 1/2 an inch) into the eye 3 or 4 times a day and 1 or 2 times at night. Your doctor may reduce your dose as needed. Children younger than 6 years of age—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

The eye drops may also be stored in a cool, dry place. Keep it in an upright position. Do not freeze.