PRED-ni-sone

Commonly used brand name(s)

In the U.S.

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

Available Dosage Forms:

• Tablet
• Syrup
• Solution
• Tablet, Delayed Release

Therapeutic Class: Endocrine-Metabolic Agent

Pharmacologic Class: Adrenal Glucocorticoid

Uses For prednisone

Prednisone 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, endocrine problems, eye or vision problems, stomach or bowel problems, lupus, skin conditions, kidney problems, ulcerative colitis, and flare-ups of multiple sclerosis. Prednisone is a corticosteroid (cortisone-like medicine or steroid). It works on the immune system to help relieve swelling, redness, itching, and allergic reactions.

prednisone is available only with your doctor's prescription.

Before Using prednisone

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 prednisone, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to prednisone 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 performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of prednisone in children. However, pediatric patients are more likely to have slower growth and bone problems if prednisone is used for a long time. Recommended doses should not be exceeded, and the patient should be carefully monitored during therapy.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of prednisone in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require caution and an adjustment in the dose for elderly patients receiving prednisone.

Pregnancy

Pregnancy Category Explanation All Trimesters D Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

Breast Feeding

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

Interactions with 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 prednisone, 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 prednisone 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.

• Rotavirus Vaccine, Live

Using prednisone 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.

• Aldesleukin
• Apixaban
• Asparaginase
• Bupropion
• Carbamazepine
• Ceritinib
• Clozapine
• Cobicistat
• Dabrafenib
• Daclatasvir
• Darunavir
• Donepezil
• Eliglustat
• Elvitegravir
• Eslicarbazepine Acetate
• Hydrocodone
• Idelalisib
• Itraconazole
• Lopinavir
• Mitotane
• Nifedipine
• Nilotinib
• Olaparib
• Palbociclib
• Piperaquine
• Pixantrone
• Ritonavir
• Siltuximab
• Telaprevir

Using prednisone 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
• Alfalfa
• Amobarbital
• Aprobarbital
• Aspirin
• Atracurium
• Balofloxacin
• Besifloxacin
• Butabarbital
• Butalbital
• Ciprofloxacin
• Clarithromycin
• Enoxacin
• Fleroxacin
• Fluconazole
• Flumequine
• Fosphenytoin
• Gallamine
• Gatifloxacin
• Gemifloxacin
• Hexafluorenium
• Ketoconazole
• Levofloxacin
• Licorice
• Lomefloxacin
• Mephobarbital
• Metocurine
• Montelukast
• Moxifloxacin
• Nadifloxacin
• Norfloxacin
• Ofloxacin
• Ospemifene
• Pancuronium
• Pazufloxacin
• Pefloxacin
• Phenobarbital
• Phenytoin
• Primidone
• Prulifloxacin
• Rifampin
• Rifapentine
• Rufloxacin
• Saiboku-To
• Secobarbital
• Sparfloxacin
• Tosufloxacin
• Vecuronium
• Warfarin

Interactions with Food/Tobacco/Alcohol

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 prednisone. 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
• Heart attack, recent 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
• Peptic ulcer, active or history of or
• Personality changes or
• Stomach or intestinal problems (e.g., diverticulitis, ulcerative colitis) or
• Thyroid problems 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 of prednisone

Take prednisone 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 prednisone 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 prednisone 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 prednisone 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 prednisone. 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 prednisone, 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.

Precautions While Using prednisone

If you will be taking prednisone for a long time, it is very important that your doctor check you at regular visits for any unwanted effects that may be caused by prednisone. Blood or urine tests may be needed to check for unwanted effects.

Using prednisone 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 prednisone, tell your doctor right away.

If you are using prednisone 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 prednisone might need to be changed for a short time while you have extra stress.

Using too much of prednisone or using it for a long time may increase your risk of having adrenal gland problems. Talk to your doctor right away if you have more than one of these symptoms while you are using prednisone: blurred vision; dizziness or fainting, a fast, irregular, or pounding heartbeat, increased thirst or urination, irritability; or unusual tiredness or weakness.

prednisone may cause you to get more 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 right away.

Check with your doctor right away if blurred vision, difficulty in reading, eye pain, 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 prednisone, do not have 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. 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. Do not get close to them and do not stay in the same room with them for very long. If you have questions about this, talk to your doctor.

prednisone 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 prednisone.

prednisone 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 prednisone, 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 prednisone. prednisone 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.

prednisone 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
• troubled breathing at rest
• weight gain

Incidence not known

• Abdominal or stomach cramping or burning (severe)
• abdominal or stomach pain
• backache
• bloody, , or tarry stools
• cough or hoarseness
• darkening of 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 back, ribs, arms, or legs
• painful or difficult urination
• skin rash
• sleeplessness
• 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.

See also: Side effects (in more detail)

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Usual Adult Dose for Nephrotic Syndrome

Initial (first three episodes): 2 mg/kg/day (maximum 80 mg/day) in divided doses 3 to 4 times/day until urine is protein free for 3 consecutive days (maximum: 28 days); followed by 1 to 1.5 mg/kg/dose given every other day for 4 weeks.
Maintenance dose for frequent relapses: 0.5 to 1 mg/kg/ dose given every other day for 3 to 6 months.

Usual Adult Dose for Anti-inflammatory

5 to 60 mg per day in divided doses 1 to 4 times/day.

Usual Pediatric Dose for Nephrotic Syndrome

Initial (first three episodes): 2 mg/kg/day (maximum 80 mg/day) in divided doses 3 to 4 times/day until urine is protein free for 3 consecutive days (maximum: 28 days); followed by 1 to 1.5 mg/kg/dose given every other day for 4 weeks.
Maintenance dose for frequent relapses: 0.5 to 1 mg/kg/ dose given every other day for 3 to 6 months.

Usual Pediatric Dose for Asthma

< I year:
acute: 10 mg orally every 12 hours.
maintenance: 10 mg orally very other day.

1 to 4 years:
acute: 20 mg orally every 12 hours.
maintenance: 20 mg orally every other day.

5 to 12 years:
acute: 30 mg orally every 12 hours.
maintenance: 30 mg orally every other day.

>12 years:
acute: 40 mg orally every 12 hours.
maintenance: 40 mg orally every other day.

Usual Pediatric Dose for Anti-inflammatory

0.05 to 2 mg/kg/day divided 1 to 4 times/day

Usual Pediatric Dose for Immunosuppression

0.05 to 2 mg/kg/day divided 1 to 4 times/day

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Prednisone is inactive and must be metabolized by the liver to prednisolone. This may be impaired in patients with liver disease.

Dose Adjustments

Dosage adjustment should be based on severity of condition treated and response of patient.

Precautions

Avoid abrupt withdrawal after long-term therapy.

Dialysis

Supplemental dose is not necessary.

Other Comments

Administer with meals to reduce gastrointestinal upset.

Prednisone Side Effects

General Precautions

The lowest possible dose of corticosteroids should be used to control the condition under treatment. When reduction in dosage is possible, the reduction should be gradual.

Since complications of treatment with glucocorticoids are dependent on the size of the dose and the duration of treatment, a risk/benefit decision must be made in each individual case as to dose and duration of treatment and as to whether daily or intermittent therapy should be used.

Kaposi's sarcoma has been reported to occur in patients receiving corticosteroid therapy, most often for chronic conditions. Discontinuation of corticosteroids may result in clinical improvement.

Cardio-Renal

As sodium retention with resultant edema and potassium loss may occur in patients receiving corticosteroids, these agents should be used with caution in patients with congestive heart failure, hypertension, or renal insufficiency.

Endocrine

Drug-induced secondary adrenocortical insufficiency may be minimized by gradual reduction of dosage. This type of relative insufficiency may persist for up to 12 months after discontinuation of therapy following large doses for prolonged periods; therefore, in any situation of stress occurring during that period, hormone therapy should be reinstituted. Since mineralocorticoid secretion may be impaired, salt and/or a mineralocorticoid should be administered concurrently.

There is an enhanced effect of corticosteroids on patients with hypothyroidism.

Gastrointestinal

Steroids should be used with caution in active or latent peptic ulcers, diverticulitis, fresh intestinal anastomoses, and nonspecific ulcerative colitis, since they may increase the risk of a perforation. Signs of peritoneal irritation following gastrointestinal perforation in patients receiving corticosteroids may be minimal or absent.

There is an enhanced effect due to decreased metabolism of corticosteroids in patients with cirrhosis.

Musculoskeletal

Corticosteroids decrease bone formation and increase bone resorption both through their effect on calcium regulation (i.e., decreasing absorption and increasing excretion) and inhibition of osteoblast function. This, together with a decrease in the protein matrix of the bone secondary to an increase in protein catabolism, and reduced sex hormone production, may lead to inhibition of bone growth in pediatric patients and the development of osteoporosis at any age. Growth and development of infants and children on prolonged corticosteroid therapy should be carefully observed. Special consideration should be given to patients at increased risk of osteoporosis (e.g., postmenopausal women) before initiating corticosteroid therapy.

Inclusion of therapy for osteoporosis prevention or treatment should be considered. To minimize the risk of glucocortoicoid-induced bone loss, the smallest possible effective dosage and duration should be used. Lifestyle modification to reduce the risk of osteoporosis (e.g., cigarette smoking cessation, limitation of alcohol consumption, participation in weight-bearing exercise for 30 to 60 minutes daily) should be encouraged. Calcium and vitamin D supplementation, bisphosphonate (e.g., alendronate, risedronate), and a weight-bearing exercise program that maintains muscle mass are suitable first-line therapies aimed at reducing the risk of adverse bone effects. Current recommendations suggest that all interventions be initiated in any patient in whom glucocorticoid therapy with at least the equivalent of 5 mg of prednisone for at least 3 months is anticipated; in addition, sex hormone replacement therapy (combined estrogen and progestin in women; testosterone in men) should be offered to such patients who are hypogonadal or in whom replacement is otherwise clinically indicated and biphosphonate therapy should be initiated (if not already) if bone mineral density (BMD) of the lumbar spine and/or hip is below normal.

Neuro-Psychiatric

Although controlled clinical trials have shown corticosteroids to be effective in speeding the resolution of acute exacerbations of multiple sclerosis, they do not show that they affect the ultimate outcome or natural history of the disease. The studies do show that relatively high doses of corticosteroids are necessary to demonstrate a significant effect (see DOSAGE AND ADMINISTRATION: Multiple Sclerosis).

An acute myopathy has been observed with the use of high doses of corticosteroids, most often occurring in patients with disorders of neuromuscular transmission (e.g., myasthenia gravis), or in patients receiving concomitant therapy with neuromuscular blocking drugs (e.g., pancuronium). This acute myopathy is generalized, may involve ocular and respiratory muscles, and may result in quadriparesis. Elevation of creatinine kinase may occur. Clinical improvement or recovery after stopping corticosteroids may require weeks to years.

Psychiatric derangements may appear when corticosteroids are used, ranging from euphoria, insomnia, mood swings, personality changes, and severe depression, to frank psychotic manifestations. Also, existing emotional instability or psychotic tendencies may be aggravated by corticosteroids.

Ophthalmic

Intraocular pressure may become elevated in some individuals. If steroid therapy is continued for more than 6 weeks, intraocular pressure should be monitored.

Carcinogenesis, Mutagenesis, Impairment Of Fertility

No adequate studies have been conducted in animals to determine whether corticosteroids have a potential for carcinogenesis or mutagenesis. Steroids may increase or decrease motility and number of spermatozoa in some patients.

Pregnancy

Teratogenic Effects

Pregnancy Category C

Corticosteroids have been shown to be teratogenic in many species when given in doses equivalent to the human dose. Animal studies in which corticosteroids have been given to pregnant mice, rats, and rabbits have yielded an increased incidence of cleft palate in the offspring. There are no adequate and well-controlled studies in pregnant women. Corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Infants born to mothers who have received substantial doses of corticosteroids during pregnancy should be carefully observed for signs of hypoadrenalism.

Nursing Mothers

Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. Because of the potential for serious adverse reactions in nursing infants from corticosteroids, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use

The efficacy and safety of corticosteroids in the pediatric population are based on the well-established course of effect of corticosteroids, which is similar in pediatric and adult populations. Published studies provide evidence of efficacy and safety in pediatric patients for the treatment of nephrotic syndrome (patients greater than 2 years of age), and aggressive lymphomas and leukemias (patients greater than 1 month of age). Other indications for pediatric use of corticosteroids, e.g., severe asthma and wheezing, are based on adequate and well-controlled trials conducted in adults, on the premises that the course of the diseases and their pathophysiology are considered to be substantially similar in both populations.

The adverse effects of corticosteroids in pediatric patients are similar to those in adults (see ADVERSE REACTIONS). Like adults, pediatric patients should be carefully observed with frequent measurements of blood pressure, weight, height, intraocular pressure, and clinical evaluation for the presence of infection, psychosocial disturbances, thromboembolism, peptic ulcers, cataracts, and osteoporosis. Pediatric patients who are treated with corticosteroids by any route, including systemically administered corticosteroids, may experience a decrease in their growth velocity. This negative impact of corticosteroids on growth has been observed at low systemic doses and in the absence of laboratory evidence of hypothalamic-pituitary-adrenal (HPA) axis suppression (i.e., cosyntropin stimulation and basal cortisol plasma levels). Growth velocity may therefore be a more sensitive indicator of systemic corticosteroid exposure in pediatric patients than some commonly used tests of HPA axis function. The linear growth of pediatric patients treated with corticosteroids should be monitored, and the potential growth effects of prolonged treatment should be weighed against clinical benefits obtained and the availability of treatment alternatives. In order to minimize the potential growth effects of corticosteroids, pediatric patients should be titrated to the lowest effective dose.

Geriatric Use

Clinical studies did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. In particular, the increased risk of diabetes mellitus, fluid retention and hypertension in elderly patients treated with corticosteroids should be considered.