Brand Name
US Brand Name
Bubbli-Pred
Cotolone
Flo-Pred
Millipred
Millipred DP
Orapred
Orapred ODT
Pediapred
Prelone
Veripred 20
Canadian Brand Name
Pms-prednisoLONE
Description
Prednisolone provides relief for inflamed areas of the body. It is used to treat a number of different conditions, such as inflammation (swelling), severe allergies, adrenal problems, arthritis, asthma, blood or bone marrow problems, eye or vision problems, lupus, skin conditions, kidney problems, ulcerative colitis, and flare-ups of multiple sclerosis. Prednisolone is a corticosteroid (cortisone-like medicine or steroid). It works on the immune system to help relieve swelling, redness, itching, and allergic reactions.
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Tablet
- Syrup
- Solution
- Tablet, Disintegrating
Before Using
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.
Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of prednisolone disintegrating tablets and oral liquid in children younger than 2 years of age to treat nephrotic syndrome and in children younger than 1 month of age to treat cancer (eg, aggressive lymphoma and leukemia). Safety and efficacy have not been established. Because prednisolone may cause slowed growth in children, those who will be using it for a long time should have their weight and growth measured by a doctor regularly.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of prednisolone in the elderly. However, elderly patients are more likely to have age-related kidney and bone problems, which may require caution and an adjustment in the dose for elderly patients receiving prednisolone.
Breastfeeding
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.
Drug Interactions
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
- 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
- Aspirin
- Balofloxacin
- Bemiparin
- Besifloxacin
- Bromfenac
- Bufexamac
- Bupropion
- Carbamazepine
- Celecoxib
- Ceritinib
- Choline Salicylate
- Ciprofloxacin
- Clonixin
- Cosyntropin
- Desogestrel
- Dexibuprofen
- Dexketoprofen
- Diclofenac
- Dienogest
- Diflunisal
- Dipyrone
- Drospirenone
- Droxicam
- Enoxacin
- Estetrol
- Estradiol
- Ethinyl Estradiol
- Ethynodiol
- Etodolac
- Etofenamate
- Etoricoxib
- Felbinac
- Fenoprofen
- Fepradinol
- Feprazone
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
- Amobarbital
- Apixaban
- Atracurium
- Auranofin
- Gallamine
- Hexafluorenium
- Licorice
- Metocurine
- Primidone
- Rivaroxaban
- 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:
- Cataracts or
- Congestive heart failure or
- Cushing's syndrome (adrenal gland problem) or
- Diabetes or
- Eye infection or
- Glaucoma or
- Hyperglycemia (high blood sugar) or
- Hypertension (high blood pressure) or
- Infection (eg, bacterial, virus, or fungus) or
- Mood changes, including depression or
- Myasthenia gravis (severe muscle weakness) or
- Osteoporosis (weak bones) or
- Peptic ulcer, active or history of or
- Personality changes or
- Stomach or intestinal problems (eg, diverticulitis, ulcerative colitis) or
- Tuberculosis, inactive—Use with caution. May make these conditions worse.
- Fungal infections or
- Herpes simplex eye infection—Should not be used in patients with these conditions.
- Kidney disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.
Proper Use
Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance for unwanted effects.
This medicine comes with a patient instruction insert. Read and follow the instructions in the insert carefully. Ask your doctor if you have any questions.
Swallow the disintegrating tablet whole. Do not break or use half.
This medicine should be taken with food to avoid stomach irritation.
Measure the oral liquid with the special oral syringe that comes with the package. The average household teaspoon may not hold the right amount of liquid.
If you use this medicine for a long time, do not suddenly stop using it without checking first with your doctor. You may need to slowly decrease your dose before stopping it completely.
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 oral dosage form (solution, suspension, syrup, tablets):
- Dose depends on medical condition:
- Adults—At first, 5 to 60 milligrams (mg) per day. Your doctor may adjust your dose as needed.
- Children—Dose is based on body weight and must be determined by your doctor. The dose is usually 0.14 to 2 mg per kilogram (kg) of body weight per day, divided and taken 3 or 4 times a day. Your doctor may adjust your dose as needed.
- Dose depends on medical condition:
Missed Dose
If you miss a dose of this medicine, take 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. Do not double doses.
Storage
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
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.
Precautions
It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly and to decide if you should continue to receive it. Blood or urine tests may be needed to check for unwanted effects.
Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using this medicine, tell your doctor right away.
Using too much of this medicine or using it for a long time may increase your risk of having adrenal gland problems. Talk to your doctor if you have darkening of the skin, diarrhea, dizziness, fainting, loss of appetite, mental depression, nausea, skin rash, unusual tiredness or weakness, or vomiting.
You may get infections more easily while using this medicine. Avoid people who are sick or have infections and wash your hands often. If you are exposed to chickenpox or measles, tell your doctor right away. If you start to have a fever, chills, sore throat, or any other sign of an infection, call your doctor right away.
This medicine may cause changes in mood or behavior for some patients. Tell your doctor right away if you have depression, mood swings, a false or unusual sense of well-being, trouble with sleeping, or personality changes while taking this medicine.
This medicine might cause thinning of the bones (osteoporosis) or slow growth in children if used for a long time. Tell your doctor if you have any bone pain or if you have an increased risk for osteoporosis. If your child is using this medicine, tell the doctor if you think your child is not growing properly.
This medicine may cause slow growth in children. If your child is using this medicine, tell the doctor if you think your child is not growing properly.
If you are using this medicine for a long time, tell your doctor about any extra stress or anxiety in your life, including other health concerns and emotional stress. Your dose of this medicine might need to be changed for a short time while you have extra stress.
Check with your doctor right away if blurred vision, difficulty in reading, or any other change in vision occurs during or after treatment. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).
While you are being treated with prednisolone, do not have any immunizations (vaccines) without your doctor's approval. Prednisolone may lower your body's resistance and the vaccine may not work as well or you might get the infection the vaccine is meant to prevent. In addition, you should not be around other persons living in your household who receive live virus vaccines because there is a chance they could pass the virus on to you. Some examples of live vaccines include measles, mumps, influenza (nasal flu vaccine), poliovirus (oral form), rotavirus, and rubella. If you have questions about this, talk to your doctor.
This medicine may increase your risk for cancer, including Kaposi's sarcoma. Tell your doctor right away if you have flat, painless spots that are red or purple on white skin and bluish, brownish, or black on dark skin.
Make sure any doctor or dentist who treats you knows that you are using this medicine. This medicine may affect the results of certain skin tests.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Side Effects
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:
More common
- Aggression
- agitation
- anxiety
- blurred vision
- decrease in the amount of urine
- dizziness
- fast, slow, pounding, or irregular heartbeat or pulse
- headache
- irritability
- mental depression
- mood changes
- nervousness
- noisy, rattling breathing
- numbness or tingling in the arms or legs
- pounding in the ears
- shortness of breath
- swelling of the fingers, hands, feet, or lower legs
- trouble thinking, speaking, or walking
- trouble breathing at rest
- weight gain
Incidence not known
- Backache
- bloody, black, or tarry stools
- cough or hoarseness
- darkening of the skin
- decrease in height
- decreased vision
- diarrhea
- dry mouth
- eye pain
- eye tearing
- facial hair growth in females
- fainting
- fatigue
- fever or chills
- flushed, dry skin
- fractures
- fruit-like breath odor
- full or round face, neck, or trunk
- heartburn and/or indigestion (severe and continuous)
- increased hunger
- increased thirst
- increased urination
- loss of appetite
- loss of sexual desire or ability
- lower back or side pain
- menstrual irregularities
- muscle pain, tenderness, wasting, or weakness
- nausea
- pain in back, ribs, arms, or legs
- painful or difficult urination
- skin rash
- sleeplessness
- stomach pain
- sweating
- trouble healing
- trouble sleeping
- unexplained weight loss
- unusual tiredness or weakness
- vision changes
- vomiting
- vomiting of material that looks like coffee grounds
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:
More common
- Increased appetite
Incidence not known
- Abnormal fat deposits on the face, neck, and trunk
- acne
- dry scalp
- lightening of normal skin color
- red face
- reddish purple lines on the arms, face, legs, trunk, or groin
- swelling of the stomach area
- thinning of the scalp hair
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.
DRG-20075189
