Prednicot (Oral)

Prednisone helps reduce inflammation in different parts of the body. It is used to treat various conditions, including inflammation (swelling), severe allergies, adrenal issues, arthritis, asthma, blood or bone marrow disorders, endocrine issues, eye or vision problems, stomach or bowel issues, lupus, skin conditions, kidney issues, ulcerative colitis, and flare-ups of multiple sclerosis. Prednisone is a corticosteroid (cortisone-like medicine or steroid). It acts on the immune system to help reduce swelling, redness, itching, and allergic reactions.

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

If you will be taking this medicine for a long time, it is very important for your doctor to monitor you regularly for any side effects that may occur from this medicine. You may need blood or urine tests to check for these side effects.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to avoid getting pregnant. If you think you may be pregnant while using this medicine, inform your doctor immediately.

If you are using this medicine for a long time, let your doctor know about any extra stress or anxiety in your life, including other health issues and emotional stress. Your dose of this medicine may need to be adjusted temporarily during times of increased stress.

Taking too much of this medicine or using it for a long time may raise your risk of adrenal gland problems. Contact your doctor right away if you experience more than one of these symptoms while using this medicine: blurred vision, dizziness or fainting, a fast, irregular, or pounding heartbeat, increased thirst or urination, irritability, or unusual tiredness or weakness.

This medicine may make you more susceptible to infections. Avoid close contact with sick individuals and wash your hands frequently. If you come into contact with chickenpox or measles, notify your doctor immediately. If you develop a fever, chills, sore throat, or any other signs of infection, call your doctor right away.

Contact your doctor immediately if you notice blurred vision, difficulty reading, eye pain, or any other changes in your vision during or after treatment. Your doctor may refer you to an ophthalmologist (eye doctor) for further evaluation.

While you are being treated with prednisone, do not get any immunizations (vaccines) without your doctor's approval. Prednisone may weaken your immune system, which can reduce the effectiveness of vaccines or increase the risk of infection from the vaccine. Additionally, avoid close contact with anyone in your household who receives live virus vaccines, as they could transmit the virus to you. Examples of live vaccines include measles, mumps, influenza (nasal flu vaccine), poliovirus (oral form), rotavirus, and rubella. Keep your distance and do not spend long periods in the same room with them. If you have questions about this, consult your doctor.

This medicine may cause changes in mood or behavior for some patients. Inform your doctor right away if you experience depression, mood swings, an unusual sense of well-being, trouble sleeping, or personality changes while taking this medicine.

This medicine might lead to thinning of the bones (osteoporosis) or slow growth in children if used for a long time. Inform your doctor if you experience any bone pain or if you are at an increased risk for osteoporosis. If your child is taking this medicine, let the doctor know if you think your child is not growing properly.

Make sure any doctor or dentist treating you is aware that you are using this medicine. This medicine may affect the results of certain skin tests.

Do not take other medicines unless you have discussed them with your doctor. This includes prescription or over-the-counter (OTC) medicines, as well as herbal or vitamin supplements.

In deciding to use a medicine, you and your doctor need to think about the risks compared to the benefits of the medicine. The following points should be considered 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 professional know about any other allergies you have, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients closely.

Pediatric

Studies have not shown any specific problems in children that would limit the use of prednisone. However, children using prednisone for a long time may have slower growth and bone issues. Recommended doses should not be exceeded, and patients should be closely monitored during treatment.

Geriatric

Studies have not indicated any specific problems in elderly patients that would limit the use of prednisone. However, older adults may be more likely to have age-related liver, kidney, or heart issues, which may require careful consideration and possible dose adjustments.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medicine while breastfeeding. Weigh the potential benefits against the risks before using this medicine during breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while others may be used together even if there is a chance of interaction. In these cases, your doctor may adjust the dose or take other precautions. It is very important for your healthcare professional to know if you are taking any of the following medicines while you are on this medicine. The following interactions are significant but may not include all possible interactions.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medicine 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 necessary in some cases. If both medicines are prescribed together, your doctor may adjust the dose or the frequency of use for one or both medicines.

• Aceclofenac
• Acemetacin
• Aldesleukin
• Alfentanil
• Amiodarone
• Amtolmetin Guacil
• Asparaginase
• Aspirin
• Atogepant
• Balofloxacin
• Bemiparin
• Benzhydrocodone
• Besifloxacin
• Bromfenac
• Bufexamac
• Buprenorphine
• Bupropion
• Celecoxib
• Ceritinib
• Choline Salicylate
• Ciprofloxacin
• Clonixin
• Codeine
• Daclatasvir
• Darunavir
• Desogestrel
• Dexibuprofen
• Dexketoprofen
• Diclofenac
• Dienogest
• Diflunisal
• Dihydrocodeine
• Dipyrone
• Dronedarone
• Drospirenone
• Droxicam
• Elvitegravir
• Enoxacin
• Estetrol
• Estradiol
• Ethinyl Estradiol
• Ethynodiol
• Etodolac
• Etofenamate
• Etonogestrel
• Etoricoxib
• Felbinac
• Fenoprofen
• Fentanyl
• Fepradinol
• Feprazone
• Fexinidazole
• Fleroxacin
• Floctafenine
• Flufenamic Acid
• Flumequine
• Flurbiprofen
• Gatifloxacin
• Gemifloxacin
• Gestodene
• Hemin
• Hydrocodone
• Ibuprofen
• Indomethacin
• Ketoprofen
• Ketorolac
• Levofloxacin
• Levonorgestrel
• Lomefloxacin
• Lopinavir
• Lornoxicam
• Loxoprofen
• Lumateperone
• Lumiracoxib
• Lurasidone
• Lutetium Lu 177 Dotatate
• Macimorelin
• Meclofenamate
• Medroxyprogesterone
• Mefenamic Acid
• Meloxicam
• Meperidine
• Mestranol
• Methadone
• Morniflumate
• Moxifloxacin
• Nabumetone
• Nadifloxacin
• Nadroparin
• Naproxen
• Nepafenac
• Nifedipine
• Niflumic Acid
• Nimesulide
• Nimesulide Beta Cyclodextrin
• Nirmatrelvir
• Nomegestrol
• Norelgestromin
• Norethindrone
• Norfloxacin
• Norgestimate
• Norgestrel
• Ofloxacin
• Oxaprozin
• Oxycodone
• Oxyphenbutazone
• Parecoxib
• Pazufloxacin
• Pefloxacin
• Pentazocine
• Phenylbutazone
• Piketoprofen
• Piperaquine
• Piroxicam
• Pranoprofen
• Proglumetacin
• Propyphenazone
• Proquazone
• Prulifloxacin
• Ritonavir
• Rofecoxib
• Rufloxacin
• Salicylic Acid
• Salsalate
• Sargramostim
• Segesterone
• Sodium Salicylate
• Somatrogon-ghla
• Sparfloxacin
• Sufentanil
• Sulindac
• Tacrolimus
• Telaprevir
• Tenoxicam
• Tiaprofenic Acid
• Tolfenamic Acid
• Tolmetin
• Tosufloxacin
• Tramadol
• Ubrogepant
• Ulipristal
• Valdecoxib
• Voxilaprevir
• Zolpidem
• Zuranolone

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

• Alcuronium
• Alfalfa
• Amobarbital
• Aprobarbital
• Atracurium
• Auranofin
• Butabarbital
• Butalbital
• Clarithromycin
• Fluconazole
• Fosphenytoin
• Gallamine
• Hexafluorenium
• Ketoconazole
• Licorice
• Mephobarbital
• Metocurine
• Montelukast
• Ospemifene
• Pancuronium
• Phenobarbital
• Phenytoin
• Primidone
• Rifampin
• Rifapentine
• Saiboku-To
• Secobarbital
• Vecuronium
• Warfarin

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used around the time of eating food or specific types of food due to possible interactions. Using alcohol or tobacco with certain medicines may also cause interactions. Discuss with your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical conditions may affect how you can use this medicine. Be sure to tell your doctor if you have any other medical issues, especially:

• Cataracts or
• Congestive heart failure or
• Cushing's syndrome (adrenal gland problem) or
• Diabetes or
• Eye infection or
• Glaucoma or
• Recent heart attack or
• Hyperglycemia (high blood sugar) or
• Hypertension (high blood pressure) or
• Infection (e.g., bacterial, virus, fungus, or parasite) or
• Mood changes, including depression or
• Myasthenia gravis (severe muscle weakness) or
• Osteoporosis (weak bones) or
• Active or history of peptic ulcer or
• Personality changes or
• Stomach or intestinal problems (e.g., diverticulitis, ulcerative colitis) or
• Thyroid problems or
• Inactive tuberculosis—Use with caution. This may worsen these conditions.

• 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 stronger because the medicine may take longer to be removed from the body.

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

Check with your doctor right away if you notice any of the following side effects:

More common

• Aggression
• agitation
• blurred vision
• decrease in the amount of urine
• dizziness
• fast, slow, pounding, or irregular heartbeat or pulse
• headache
• irritability
• mood changes
• 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
• troubled breathing at rest
• weight gain

Incidence not known

• Severe abdominal or stomach cramping or burning
• abdominal or stomach pain
• 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
• fever or chills
• flushed, dry skin
• fractures
• fruit-like breath odor
• full or round face, neck, or trunk
• Severe and continuous heartburn or indigestion
• increased hunger
• increased thirst
• increased urination
• loss of appetite
• loss of sexual desire or ability
• lower back or side pain
• menstrual irregularities
• muscle pain or tenderness
• muscle wasting or weakness
• nausea
• pain in the back, ribs, arms, or legs
• painful or difficult urination
• skin rash
• 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. Your health care professional may also be able to tell you how 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 can report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Deltasone
• Prednicot
• predniSONE Intensol
• Rayos
• Sterapred
• Sterapred DS

In Canada

• APO-predniSONE
• Teva-predniSONE
• Winpred

Available Dosage Forms:

• Tablet
• Solution
• Tablet, Delayed Release

Therapeutic Class: Endocrine-Metabolic Agent

Pharmacologic Class: Adrenal Glucocorticoid

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.

Take this medicine with food or milk to avoid stomach irritation.

Swallow the delayed-release tablet whole. Do not crush, break, or chew it.

Measure the oral liquid with a marked measuring spoon, oral syringe, or medicine cup. The average household teaspoon may not hold the right amount of liquid.

Prednisone Intensol™ solution is a concentrated liquid. Measure the concentrated liquid with the special oral dropper that comes with the package.

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 forms (concentrated solution, solution, delayed-release tablets, and 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—Use and dose must be determined by your doctor.

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.

Throw away any unused Prednisone Intensol™ solution 90 days after the bottle is opened for the first time.

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