predniSONE Intensol (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 problems, eye or vision issues, stomach or bowel disorders, lupus, skin conditions, kidney problems, 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 decrease 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 that your doctor checks you regularly for any unwanted effects that may be caused by this medicine. 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 prevent pregnancy. If you think you have become pregnant while using this medicine, tell your doctor right away.

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

Using too much of this medicine or using it for a long time may increase your risk of adrenal gland problems. Talk to your doctor immediately if you have 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 likely to get infections than usual. 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 immediately.

Check with your doctor right away if you experience blurred vision, difficulty reading, eye pain, or any other change in vision 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 prednisone, do not get any immunizations (vaccines) without your doctor's approval. Prednisone 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. Additionally, you should not be around others 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. Avoid close contact with them and do not stay in the same room with them for long. If you have questions about this, talk to your doctor.

This medicine may cause changes in mood or behavior for some patients. Tell your doctor right away if you experience depression, mood swings, a false or unusual sense of well-being, trouble 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. Inform your doctor if you have any bone pain or if you are at increased risk for osteoporosis. If your child is using this medicine, tell the doctor if you think your child is not growing properly.

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 your doctor has discussed them with you. This includes prescription or nonprescription (over-the-counter [OTC]) medicines, as well as herbal or vitamin supplements.

In deciding to use a medicine, you and your doctor need to consider the risks and benefits. For this medicine, the following points should be kept in mind:

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 may have, such as to foods, dyes, preservatives, or animals. For over-the-counter products, read the label or package ingredients carefully.

Pediatric

Current studies have not shown any specific problems that would limit the use of prednisone in children. However, children may experience slower growth and bone issues if prednisone is used for a long time. It is important not to exceed recommended doses, and patients should be monitored closely during treatment.

Geriatric

Current studies have not indicated any specific problems that would limit the use of prednisone in older adults. However, elderly patients may have age-related liver, kidney, or heart issues, which could require caution and possible dose adjustments for those taking prednisone.

Breast Feeding

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

Interactions with Medicines

Some medicines should not be used together, while others may be used together with caution. Your doctor may need to adjust the dose or take other precautions. It is especially important for your healthcare professional to know if you are taking any of the medicines listed below. The following interactions are significant and may not include all possible interactions.

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

• Desmopressin
• Rotavirus Vaccine, Live

Using this medicine with any of the following medicines is generally not recommended but may be necessary in some situations. If both medicines are prescribed, your doctor may adjust the dose or how often you take 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 using both may be the best treatment for you. If both medicines are prescribed, your doctor may adjust the dose or how often you take one or both 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

Some medicines should not be used around the time of eating food or certain types of food due to possible interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. Discuss the use of your medicine with food, alcohol, or tobacco with your healthcare professional.

Other Medical Problems

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

• Cataracts or
• Congestive heart failure or
• Cushing's syndrome (adrenal gland issue) 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 issues (e.g., diverticulitis, ulcerative colitis) or
• Thyroid issues or
• Inactive tuberculosis—Use with caution. This may worsen these conditions.

• Fungal infections or
• Herpes simplex eye infection—This medicine should not be used in patients with these conditions.

• Kidney disease—Use with caution. The effects may be stronger because the medicine is removed from the body more slowly.

Along with its necessary effects, a medicine may cause some unwanted effects. Not all of these side effects will happen, but if they do, you may need medical help.

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

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

• Abdominal or stomach cramping or burning (severe)
• 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
• heartburn 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 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 happen 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 happen 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.

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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