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Sulfacetamide and prednisolone (Ophthalmic route)

Pronunciation:

sul-fa-SET-a-mide, pred-NIS-oh-lone AS-e-tate

Classifications:

Pharmacologic—

Prednisolone

Chemical—

Sulfonamide

Uses of This Medicine:

Sulfacetamide and prednisolone combination is used to treat eye infections and inflammation, including conjunctivitis and chronic anterior uveitis. It also prevents damage caused by chemicals, radiation, or foreign objects entering the eye.

Sulfacetamide is a sulfa drug that belongs to the class of medicines, known as antibiotics. It works by killing the bacteria or preventing their growth. Prednisolone is a steroid medicine that is used to relieve the redness, itching, and swelling caused by eye infections.

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

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of sulfacetamide and prednisolone eye drops and eye ointment in children 6 years of age and older. Safety and efficacy have not been established in children younger than 6 years of age.

Older adults—

No information is available on the relationship of age to the effects of sulfacetamide and prednisolone eye drops and eye ointment in geriatric patients.

Pregnancy—

Pregnancy CategoryExplanation
All TrimestersCAnimal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast-feeding—

Prednisolone

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Sulfacetamide

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

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 required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Aceclofenac
  • Acemetacin
  • Aldesleukin
  • Amtolmetin Guacil
  • Asparaginase
  • Bemiparin
  • Bromfenac
  • Bufexamac
  • Bupropion
  • Celecoxib
  • Ceritinib
  • Choline Salicylate
  • Clonixin
  • Darunavir
  • Dexibuprofen
  • Dexketoprofen
  • Diclofenac
  • Diflunisal
  • Dipyrone
  • Droxicam
  • Etodolac
  • Etofenamate
  • Etoricoxib
  • Felbinac
  • Fenoprofen
  • Fepradinol
  • Feprazone
  • Floctafenine
  • Flufenamic Acid
  • Flurbiprofen
  • Ibuprofen
  • Idelalisib
  • Indomethacin
  • Ketoprofen
  • Ketorolac
  • Lornoxicam
  • Loxoprofen
  • Lumiracoxib
  • Meclofenamate
  • Mefenamic Acid
  • Meloxicam
  • Morniflumate
  • Nabumetone
  • Nadroparin
  • Naproxen
  • Nepafenac
  • Niflumic Acid
  • Nimesulide
  • Nimesulide Beta Cyclodextrin
  • Olaparib
  • Oxaprozin
  • Oxyphenbutazone
  • Parecoxib
  • Phenylbutazone
  • Piketoprofen
  • Piroxicam
  • Pixantrone
  • Pranoprofen
  • Proglumetacin
  • Propyphenazone
  • Proquazone
  • Ritonavir
  • Rofecoxib
  • Salicylic Acid
  • Salsalate
  • Sodium Salicylate
  • Sorafenib
  • Sulindac
  • Tenoxicam
  • Tiaprofenic Acid
  • Tolfenamic Acid
  • Tolmetin
  • Valdecoxib

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Alcuronium
  • Aminolevulinic Acid
  • Amobarbital
  • Aspirin
  • Atracurium
  • Desogestrel
  • Dienogest
  • Drospirenone
  • Estradiol Cypionate
  • Estradiol Valerate
  • Ethinyl Estradiol
  • Ethynodiol Diacetate
  • Etonogestrel
  • Fosphenytoin
  • Gallamine
  • Hexafluorenium
  • Levonorgestrel
  • Licorice
  • Medroxyprogesterone Acetate
  • Mestranol
  • Metocurine
  • Norelgestromin
  • Norethindrone
  • Norgestimate
  • Norgestrel
  • Phenytoin
  • Primidone
  • Rifampin
  • Saiboku-To
  • Vecuronium

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Cataract or
  • Cornea (part of the eye) problems, history of or
  • Glaucoma or
  • Sclera (part of the eye) problems, history of—Use with caution. May make these conditions worse.
  • Cataract surgery, recent—May cause side effects to become worse.
  • Eye infection with pus—Use with caution. Prednisolone may mask or enhance the infection.
  • 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.

Proper Use of This Medicine:

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.

Precautions While Using This Medicine:

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

If your symptoms do not improve after 2 days or if they become worse, check with your eye doctor (ophthalmologist) right away.

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

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

Sulfacetamide can cause a rare type of brain damage, known as kernicterus, in newborns when it is given to pregnant women during the later part of their pregnancy. This could be life-threatening and requires immediate medical attention. Talk to your doctor about this risk.

Serious skin reactions can occur with this medicine. Check with your doctor right away if you have 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 with this medicine.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur 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. Also, your health care professional may 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 or 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.


Last Updated: 9/4/2017
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