Prednisone 10 mg Tablet, 100-count
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the Corticosteroid class.
Where does this data come from?
🏭 Manufacturer & labeler
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🩺 Clinical
- Prednisone calms down your immune system and reduces inflammation in your body. It's used for a huge range of conditions — everything from asthma and severe allergies to Crohn's di...
- Why did my doctor put me on prednisone — what does it actually do?
- Yes, morning really does matter — your body naturally produces its own cortisol hormone between 2 a.m. and 8 a.m., and taking prednisone at that time works with your body's rhythm...
- Do I really have to take it in the morning? And does it matter if I take it with food?
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Prednisone — tap one for details:
Prednisone may be associated with lower levels of 8 nutrients — worth a chat with your pharmacist, not a cause for alarm.
Where does this data come from?
Ask a licensed pharmacist directly — free, answered by our team.
💊 What it looks like
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII EWQ57Q8I5X
Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
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UNII 70097M6I30
Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
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UNII ETJ7Z6XBU4
Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
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UNII 5856J3G2A2
A starch-based powder made from potatoes and processed with sodium. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the medicine can be absorbed.
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UNII O8232NY3SJ
A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
5 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.056 | $5.60 / 100 tablet |
| Medicaid paysCMS SDUD · 12 mo | $7.98 | $797.51 / 100 tablet |
| Medicare drug plans payPart D · Q2 2026 | $0.2837 | $28.37 / 100 tablet |
| Medicare Part B allowsASP · J7512 | $0.004 / J7512 unit | — |
Where does this data come from?
🧾 Billing & reimbursement
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| PredniSONE 10 mg 00054-9817-25 | Hikma | 100 tablets | $0.056 | AB | Availability likely | — |
| Prednisone 10 mg 00378-0641-01 | Mylan | 100 tablets | $0.056 | — | Availability likely | — |
| Prednisone 10 mg 00591-5442-01 | Actavis | 100 tablets | $0.056 | — | Availability likely | — |
| Prednisone 10 mg 00904-6923-61 | Major | 100 tablets | $0.056 | AB | Availability likely | — |
| Prednisone 10 mg 59651-0487-01 | Aurobindo | 100 tablets | $0.056 | AB | Availability likely | — |
| prednisone 10 mg 60219-1707-01 | Amneal | 100 tablets | $0.056 | AB | Availability likely | — |
| Prednisone 10 mgthis 60687-0134-01 | American | 100 tablets | $0.056 | AB | Availability likely | — |
| Prednisone 10 mg 60687-0914-01 | American | 100 tablets | $0.056 | AB | Availability likely | — |
| PredniSONE Tablets, USP, 10 mg 63561-0121-01 | Granulation | 100 tablets | $0.056 | AB | Availability likely | — |
| Prednisone 10 mg 70954-0059-10 | ANI | 100 tablets | $0.056 | AB | Availability likely | — |
| PredniSONE 10 mg 00054-0017-20 | Hikma | 100 tablets | $0.060 | AB | FDA listed | +8% |
| Prednisone 10 mg 00603-5338-15 | Par | 21 tablets | $0.573 | AB | Availability likely | +923% |
| prednisone 10 mg 00615-8440-05 | NCS | 15 tablets | — | AB | FDA listed | — |
| Prednisone 10 mg 10135-0777-01 | Marlex | 100 tablets | — | AB | FDA listed | — |
| PredniSONE 10 mg 42708-0045-21 | QPharma, | 21 tablets | — | — | FDA listed | — |
| Prednisone 10 mg 42708-0115-21 | QPharma, | 21 tablets | — | AB | FDA listed | — |
| prednisone 10 mg 42708-0166-21 | QPharma | 21 tablets | — | AB | FDA listed | — |
| Prednisone 10 mg 50090-3137-00 | A-S | 10 tablets | — | AB | FDA listed | — |
| Prednisone 10 mg 50090-5202-00 | A-S | 60 tablets | — | AB | FDA listed | — |
| Prednisone 10 mg 50090-7023-00 | A-S | 100 tablets | — | AB | FDA listed | — |
| Prednisone 10 mg 50090-7024-00 | A-S | 10 tablets | — | AB | FDA listed | — |
| Prednisone 10 mg 50090-7025-00 | A-S | 60 tablets | — | AB | FDA listed | — |
| prednisone 10 mg 50090-7218-00 | A-S | 10 tablets | — | AB | FDA listed | — |
| prednisone 10 mg 50090-7219-00 | A-S | 60 tablets | — | AB | FDA listed | — |
| prednisone 10 mg 50090-7369-00 | A-S | 10 tablets | — | AB | FDA listed | — |
| prednisone 10 mg 50090-7371-00 | A-S | 60 tablets | — | AB | FDA listed | — |
| Prednisone 10 mg 51407-0922-10 | Golden | 1000 tablets | — | — | FDA listed | — |
| Prednisone 10 mg 51655-0410-20 | Northwind | 20 tablets | — | AB | FDA listed | — |
| PredniSONE 10 mg 51655-0493-49 | Northwind | 42 tablets | — | — | FDA listed | — |
| Prednisone 10 mg 51655-0935-20 | Northwind | 20 tablets | — | — | FDA listed | — |
| Prednisone 10 mg 54348-0506-10 | PharmPak, | 10 tablets | — | AB | FDA listed | — |
| Prednisone 10 mg 55154-3564-00 | Cardinal | 10 tablets | — | AB | FDA listed | — |
| Prednisone 10 mg 63187-0037-05 | Proficient | 5 tablets | — | AB | FDA listed | — |
| Prednisone 10 mg 63187-0300-05 | Proficient | 5 tablets | — | AB | FDA listed | — |
| Prednisone 10 mg 63629-2257-01 | Bryant | 1000 tablets | — | AB | FDA listed | — |
| prednisone 10 mg 64380-0784-01 | Strides | 100 tablets | — | AB | FDA listed | — |
| Prednisone 10 mg 66267-0171-15 | NuCare | 15 tablets | — | AB | FDA listed | — |
| Prednisone 10 mg 66267-0812-10 | NuCare | 100 tablets | — | AB | FDA listed | — |
| prednisone 10 mg 67046-1579-03 | Coupler | 30 tablets | — | AB | FDA listed | — |
| Prednisone 10 mg 67296-0140-01 | Redpharm | 10 tablets | — | AB | Discontinued | — |
| Prednisone 10 mg 68071-2661-00 | NuCare | 10 tablets | — | AB | FDA listed | — |
| Prednisone 10 mg 68071-3641-01 | NuCare | 10 tablets | — | AB | FDA listed | — |
| Prednisone 10 mg 68071-3746-00 | NuCare | 10 tablets | — | AB | FDA listed | — |
| Prednisone 10 mg 68071-3821-03 | NuCare | 30 tablets | — | AB | FDA listed | — |
| prednisone 10 mg 68788-8166-02 | Preferred | 21 tablets | — | AB | FDA listed | — |
| prednisone 10 mg 70518-3476-00 | REMEDYREPACK | 21 tablets | — | AB | Discontinued | — |
| prednisone 10 mg 70518-4038-00 | REMEDYREPACK | 48 tablets | — | AB | FDA listed | — |
| PredniSONE 10 mg 70518-4191-01 | REMEDYREPACK | 30 tablets | — | — | FDA listed | — |
| prednisone 10 mg 70518-4354-00 | REMEDYREPACK | 30 tablets | — | AB | FDA listed | — |
| Prednisone 10 mg 70518-4560-00 | REMEDYREPACK | 18 tablets | — | AB | FDA listed | — |
| prednisone 10 mg 70518-4660-00 | REMEDYREPACK | 14 tablets | — | AB | FDA listed | — |
| Prednisone 10 mg 71205-0362-05 | Proficient | 5 tablets | — | AB | FDA listed | — |
| Prednisone 10 mg 71205-0421-10 | Proficient | 10 tablets | — | AB | FDA listed | — |
| prednisone 10 mg 71205-0729-10 | Proficient | 10 tablets | — | AB | FDA listed | — |
| prednisone 10 mg 71205-0818-05 | Proficient | 5 tablets | — | AB | FDA listed | — |
| Prednisone 10 mg 71335-0335-00 | Bryant | 10 tablets | — | AB | Discontinued | — |
| prednisone 10 mg 71335-2069-00 | Bryant | 10 tablets | — | AB | FDA listed | — |
| prednisone 10 mg 71335-2122-01 | Bryant | 5 tablets | — | AB | FDA listed | — |
| PredniSONE Tablets, USP, 10 mg 71335-2736-00 | Bryant | 12 tablets | — | AB | FDA listed | — |
| PredniSONE Tablets, USP, 10 mg 71335-2752-00 | Bryant | 10 tablets | — | AB | FDA listed | — |
| PredniSONE Tablets, USP, 10 mg 71335-3044-01 | Bryant | 100 tablets | — | AB | FDA listed | — |
| PredniSONE Tablets, USP, 10 mg 71335-3045-01 | Bryant | 1000 tablets | — | AB | FDA listed | — |
| PredniSONE Tablets, USP, 10 mg 72162-2485-00 | Bryant | 1000 tablets | — | AB | FDA listed | — |
| Prednisone 10 mg 72189-0589-10 | Direct_Rx | 10 tablets | — | AB | FDA listed | — |
| Prednisone 10 mg 72789-0401-10 | PD-Rx | 10 tablets | — | AB | FDA listed | — |
| PredniSONE Tablets, USP, 10 mg 72789-0475-01 | PD-Rx | 100 tablets | — | AB | FDA listed | — |
| PredniSONE Tablets, USP, 10 mg 72789-0513-10 | PD-Rx | 10 tablets | — | AB | FDA listed | — |
| Prednisone 10 mg 76420-0068-20 | Asclemed | 20 tablets | — | AB | FDA listed | — |
| prednisone 10 mg 76420-0412-00 | Asclemed | 1000 tablets | — | AB | FDA listed | — |
| Prednisone 10 mg 80425-0193-01 | Advanced | 21 tablets | — | AB | FDA listed | — |
| prednisone 10 mg 80425-0484-01 | Advanced | 21 tablets | — | AB | FDA listed | — |
| PredniSONE 10 mg 80425-0485-01 | Advanced | 21 tablets | — | — | FDA listed | — |
| Prednisone 10 mg 80425-0491-01 | Advanced | 21 tablets | — | AB | FDA listed | — |
| prednisone 10 mg 85766-0001-00 | Sportpharm | 1000 tablets | — | AB | FDA listed | — |
| Prednisone 10 mg 87063-0044-01 | ASCLEMED | 100 tablets | — | AB | FDA listed | — |
| Prednisone 10 mg 50090-1001-00 | A-S | 21 tablets | — | AB | FDA listed | — |
| Prednisone 10 mg 50090-1002-00 | A-S | 48 tablets | — | AB | Discontinued | — |
| PredniSONE 10 mg 55289-0330-05 | PD-Rx | 5 tablets | — | — | FDA listed | — |
| prednisone 10 mg 51655-0972-20 | Northwind | 20 tablets | — | AB | FDA listed | — |
| PredniSONE 10 mg 51655-0726-21 | Northwind | 21 tablets | — | AB | FDA listed | — |
| prednisone 10 mg 87441-0069-01 | Unit | 30 tablets | — | AB | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
🗺️ Medicaid utilization & spend
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
Where does this data come from?
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 60687-0134-01 You're viewing this | 100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-134-01) / 1 TABLET in 1 BLISTER PACK (60687-134-11) | 2015-09-14 | Active |
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE PredniSONE Tablets are indicated in the following conditions: Endocrine Disorders Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance) Congenital adrenal hyperplasia Nonsuppurative thyroiditis Hypercalcemia associated with cancer Rheumatic Disorders As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: Psoriatic arthritis Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy) Ankylosing spondylitis Acute and subacute bursitis Acute nonspecific tenosynovitis Acute gouty arthritis Post-traumatic osteoarthritis Synovitis of osteoarthritis Epicondylitis Collagen Diseases During an exacerbation or as maintenance therapy in selected cases of: Systemic lupus erythematosus Systemic dermatomyositis (polymyositis) Acute rheumatic carditis Dermatologic Diseases Pemphigus Bullous dermatitis herpetiformis Severe erythema multiforme (Stevens-Johnson syndrome) Exfoliative dermatitis Mycosis fungoides Severe psoriasis Severe seborrheic dermatitis Allergic States Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment: Seasonal or perennial allergic rhinitis Bronchial asthma Contact dermatitis Atopic dermatitis Serum sickness Drug hypersensitivity reactions Ophthalmic Diseases Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as: Allergic corneal marginal ulcers Herpes zoster ophthalmicus Anterior segment inflammation Diffuse posterior uveitis and choroiditis Sympathetic ophthalmia Allergic conjunctivitis Keratitis Chorioretinitis Optic neuritis Iritis and iridocyclitis Respiratory Diseases Symptomatic sarcoidosis Loeffler's syndrome not manageable by other means Berylliosis Aspiration pneumonitis Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy Hematologic Disorders Idiopathic thrombocytopenic purpura in adults Secondary thrombocytopenia in adults Acquired (autoimmune) hemolytic anemia Erythroblastopenia (RBC anemia) Congenital (erythroid) hypoplastic anemia Neoplastic Diseases For palliative management of: Leukemias and lymphomas in adults Acute leukemia of childhood Edematous States To induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus Gastrointestinal Diseases To tide the patient over a critical period of the disease in: Ulcerative colitis Regional enteritis Miscellaneous Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy Trichinosis with neurologic or myocardial involvement
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION Gastric irritation may be reduced if taken before, during, or immediately after meals or with food or milk. The maximal activity of the adrenal cortex is between 2 am and 8 am, and it is minimal between 4 pm and midnight. Exogenous corticosteroids suppress adrenocorticoid activity the least when given at the time of maximal activity (am) for single dose administration.
Therefore, it is recommended that prednisone be administered in the morning prior to 9 am and when large doses are given, administration of antacids between meals to help prevent peptic ulcers. Multiple dose therapy should be evenly distributed in evenly spaced intervals throughout the day. Dietary salt restriction may be advisable in patients.
Do not stop taking this medicine without first talking to your doctor. Avoid abrupt withdraw of therapy. The initial dosage of PredniSONE Tablets may vary from 5 mg to 60 mg per day, depending on the specific disease entity being treated.
In situations of less severity lower doses will generally suffice, while in selected patients higher initial doses may be required. The initial dosage should be maintained or adjusted until a satisfactory response is noted. If after a reasonable period of time there is a lack of satisfactory clinical response, PredniSONE should be discontinued and the patient transferred to other appropriate therapy.
IT SHOULD BE EMPHASIZED THAT DOSAGE REQUIREMENTS ARE VARIABLE AND MUST BE INDIVIDUALIZED ON THE BASIS OF THE DISEASE UNDER TREATMENT AND THE RESPONSE OF THE PATIENT. After a favorable response is noted, the proper maintenance dosage should be determined by decreasing the initial drug dosage in small increments at appropriate time intervals until the lowest dosage which will maintain an adequate clinical response is reached. It should be kept in mind that constant monitoring is needed in regard to drug dosage.
Included in the situations which may make dosage adjustments necessary are changes in clinical status secondary to remissions or exacerbations in the disease process, the patient's individual drug responsiveness, and the effect of patient exposure to stressful situations not directly related to the disease entity under treatment; in this latter situation, it may be necessary to increase the dosage of PredniSONE for a period of time consistent with the patient's condition. If after long-term therapy the drug is to be stopped, it is recommended that it be withdrawn gradually rather than abruptly.
Multiple Sclerosis In the treatment of acute exacerbations of multiple sclerosis daily doses of 200 mg of prednisolone for a week followed by 80 mg every other day for 1 month have been shown to be effective. (Dosage range is the same for prednisone and prednisolone.) Alternate Day Therapy Alternate day therapy is a corticosteroid dosing regimen in which twice the usual daily dose of corticoid is administered every other morning. The purpose of this mode of therapy is to provide the patient requiring long-term pharmacologic dose treatment with the beneficial effects of corticoids while minimizing certain undesirable effects, including pituitary-adrenal suppression, the Cushingoid state, corticoid withdrawal symptoms, and growth suppression in children.
The rationale for this treatment schedule is based on two major premises: (a) the anti-inflammatory or therapeutic effect of corticoids persists longer than their physical presence and metabolic effects and (b) administration of the corticosteroid every other morning allows for re-establishment of more nearly normal hypothalamic-pituitary-adrenal (HPA) activity on the off-steroid day. A brief review of the HPA physiology may be helpful in understanding this rationale. Acting primarily through the hypothalamus a fall in free cortisol stimulates the pituitary gland to produce increasing amounts of corticotropin (ACTH) while a rise in free cortisol inhibits ACTH secretion.
Normally the HPA system is characterized by diurnal (…
⛔ Contraindications ▾
CONTRAINDICATIONS Prednisone tablets are contraindicated in systemic fungal infections and known hypersensitivity to components.
⚠️ Warnings ▾
WARNINGS General Rare instances of anaphylactoid reactions have occurred in patients receiving corticosteroid therapy (see ADVERSE REACTIONS: Allergic Reactions ). Increased dosage of rapidly acting corticosteroids is indicated in patients on corticosteroid therapy subjected to any unusual stress before, during and after the stressful situation. Cardio-Renal Average and large doses of hydrocortisone or cortisone can cause elevation of blood pressure, salt and water retention, and increased excretion of potassium.
These effects are less likely to occur with the synthetic derivatives except when used in large doses. Dietary salt restriction and potassium supplementation may be necessary. All corticosteroids increase calcium excretion.
Literature reports suggest an apparent association between use of corticosteroids and left ventricular free wall rupture after a recent myocardial infarction; therefore, therapy with corticosteroids should be used with great caution in these patients. Endocrine Corticosteroids can produce reversible hypothalamic-pituitary adrenal (HPA) axis suppression with the potential for corticosteroid insufficiency after withdrawal of treatment. Adrenocortical insufficiency may result from too rapid withdrawal of corticosteroids and may be minimized by gradual reduction of dosage.
This type of relative insufficiency may persist for up to 12 months after discontinuation of therapy; therefore, in any situation of stress occurring during that period, hormone therapy should be reinstituted. If the patient is receiving steroids already, dosage may have to be increased. Metabolic clearance of corticosteroids is decreased in hypothyroid patients and increased in hyperthyroid patients.
Changes in thyroid status of the patient may necessitate adjustment in dosage. Infection General Patients who are on corticosteroids are more susceptible to infections than are healthy individuals. There may be decreased resistance and inability to localize infection when corticosteroids are used.
Infection with any pathogen (viral, bacterial, fungal, protozoan or helminthic) in any location of the body may be associated with the use of corticosteroids alone or in combination with other immunosuppressive agents that affect cellular immunity, humoral immunity, or neutrophil function. 1 These infections may be mild, but may be severe and at times fatal. With increasing doses of corticosteroids, the rate of occurrence of infectious complications increases.
2 Corticosteroids may also mask some signs of current infection. Fungal Infections Corticosteroids may exacerbate systemic fungal infections and therefore should not be used in the presence of such infections unless they are needed to control life-threatening drug reactions. There have been cases reported in which concomitant use of amphotericin B and hydrocortisone was followed by cardiac enlargement and congestive heart failure (see PRECAUTIONS: Drug Interactions : Amphotericin B Injection and Potassium-Depleting Agents ).
Special Pathogens Latent disease may be activated or there may be an exacerbation of intercurrent infections due to pathogens, including those caused by Amoeba, Candida, Cryptococcus, Mycobacterium, Nocardia, Pneumocystis, Toxoplasma . It is recommended that latent amebiasis or active amebiasis be ruled out before initiating corticosteroid therapy in any patient who has spent time in the tropics or any patient with unexplained diarrhea. Similarly, corticosteroids should be used with great care in patients with known or suspected Strongyloides (threadworm) infestation.
In such patients, corticosteroid-induced immunosuppression may lead to Strongyloides hyperinfection and dissemination with widespread larval migration, often accompanied by severe enterocolitis and potentially fatal gram-negative septicemia. Corticosteroids should not be used in cerebral malaria. Tuberculosis The use of prednisone in active tuberculosis should be restricted to those cases of fulminating…
🤒 Adverse Reactions ▾
ADVERSE REACTIONS (listed alphabetically, under each subsection) The following adverse reactions have been reported with prednisone or other corticosteroids: Allergic Reactions anaphylactoid or hypersensitivity reactions, anaphylaxis, angioedema. Cardiovascular System bradycardia, cardiac arrest, cardiac arrhythmias, cardiac enlargement, circulatory collapse, congestive heart failure, ECG changes caused by potassium deficiency, edema, fat embolism, hypertension or aggravation of hypertension, hypertrophic cardiomyopathy in premature infants, myocardial rupture following recent myocardial infarction (see WARNINGS: Cardio-Renal ), necrotizing angiitis, pulmonary edema, syncope, tachycardia, thromboembolism, thrombophlebitis, vasculitis.
Dermatologic acne, acneiform eruptions, allergic dermatitis, alopecia, angioedema, angioneurotic edema, atrophy and thinning of skin, dry scaly skin, ecchymoses and petechiae (bruising), erythema, facial edema, hirsutism, impaired wound healing, increased sweating, Karposi’s sarcoma (see PRECAUTIONS: General Precautions ), lupus erythematosus-like lesions, perineal irritation, purpura, rash, striae, subcutaneous fat atrophy, suppression of reactions to skin tests, striae, telangiectasis, thin fragile skin, thinning scalp hair, urticaria.
Endocrine Adrenal insufficiency-greatest potential caused by high potency glucocorticoids with long duration of action (associated symptoms include; arthralgias, buffalo hump, dizziness, life-threatening hypotension, nausea, severe tiredness or weakness), amenorrhea, postmenopausal bleeding or other menstrual irregularities, decreased carbohydrate and glucose tolerance, development of cushingoid state, diabetes mellitus (new onset or manifestations of latent), glycosuria, hyperglycemia, hypertrichosis, hyperthyroidism (see WARNINGS: Endocrine ), hypothyroidism, increased requirements for insulin or oral hypoglycemic agents in diabetics, lipids abnormal, moon face, negative nitrogen balance caused by protein catabolism, secondary adrenocortical and pituitary unresponsiveness (particularly in times of stress, as in trauma, surgery or illness) (see WARNINGS: Endocrine ), suppression of growth in pediatric patients.
Fluid and Electrolyte Disturbances congestive heart failure in susceptible patients, fluid retention, hypokalemia, hypokalemic alkalosis, metabolic alkalosis, hypotension or shock-like reaction, potassium loss, sodium retention with resulting edema. Gastrointestinal abdominal distention, abdominal pain, anorexia which may result in weight loss, constipation, diarrhea, elevation in serum liver enzyme levels (usually reversible upon discontinuation), gastric irritation, hepatomegaly, increased appetite and weight gain, nausea, oropharyngeal candidiasis, pancreatitis, peptic ulcer with possible perforation and hemorrhage, perforation of the small and large intestine (particularly in patients with inflammatory bowel disease), ulcerative esophagitis, vomiting.
Hematologic anemia, neutropenia (including febrile neutropenia). Metabolic negative nitrogen balance due to protein catabolism. Musculoskeletal arthralgias, aseptic necrosis of femoral and humeral heads, increase risk of fracture, loss of muscle mass, muscle weakness, myalgias, osteopenia, osteoporosis (see PRECAUTIONS: Musculoskeletal ), pathologic fracture of long bones, steroid myopathy, tendon rupture (particularly of the Achilles tendon), vertebral compression fractures.
Neurological/Psychiatric amnesia, anxiety, benign intracranial hypertension, convulsions, delirium, dementia (characterized by deficits in memory retention, attention, concentration, mental speed and efficiency, and occupational performance), depression, dizziness, EEG abnormalities, emotional instability and irritability, euphoria, hallucinations, headache, impaired cognition, incidence of severe psychiatric symptoms, increased intracranial pressure with papilledema (pseudotumor cerebri) usually following discontinuation of treatme…
🔄 Drug Interactions ▾
Drug Interactions Amphotericin B Injection and Potassium-Depleting Agents When corticosteroids are administered concomitantly with potassium-depleting agents (e.g., amphotericin B, diuretics ), patients should be observed closely for development of hypokalemia. In addition, there have been cases reported in which concomitant use of amphotericin B and hydrocortisone was followed by cardiac enlargement and congestive heart failure. Antibiotics Macrolide antibiotics have been reported to cause a significant decrease in corticosteroid clearance (see PRECAUTIONS: Drug Interactions : Hepatic Enzyme Inducers, Inhibitors and Substrates ).
Anticholinesterases Concomitant use of anticholinesterase agents (e.g., neostigmine, pyridostigmine ) and corticosteroids may produce severe weakness in patients with myasthenia gravis. If possible, anticholinesterase agents should be withdrawn at least 24 hours before initiating corticosteroid therapy. If concomitant therapy must occur, it should take place under close supervision and the need for respiratory support should be anticipated.
Anticoagulants, Oral Co-administration of corticosteroids and warfarin usually results in inhibition of response to warfarin, although there have been some conflicting reports. Therefore, coagulation indices should be monitored frequently to maintain the desired anticoagulant effect. Antidiabetics Because corticosteroids may increase blood glucose concentrations, dosage adjustments of antidiabetic agents may be required.
Antitubercular drugs Serum concentrations of isoniazid may be decreased. Bupropion Since systemic steroids, as well as bupropion, can lower the seizure threshold, concurrent administration should be undertaken only with extreme caution; low initial dosing and small gradual increases should be employed. Cholestyramine Cholestyramine may increase the clearance of corticosteroids.
Cyclosporine Increased activity of both cyclosporine and corticosteroids may occur when the two are used concurrently. Convulsions have been reported with this concurrent use. Digitalis Glycosides Patients on digitalis glycosides may be at increased risk of arrhythmias due to hypokalemia.
Estrogens, Including Oral Contraceptives Estrogens may decrease the hepatic metabolism of certain corticosteroids, thereby increasing their effect. Fluoroquinolones Post-marketing surveillance reports indicate that the risk of tendon rupture may be increased in patients receiving concomitant fluoroquinolones (e.g., ciprofloxacin, levofloxacin ) and corticosteroids, especially in the elderly. Tendon rupture can occur during or after treatment with quinolones.
Hepatic Enzyme Inducers, Inhibitors and Substrates Drugs which induce cytochrome P450 3A4 (CYP 3A4) enzyme activity (e.g., barbiturates, phenytoin, carbamazepine, rifampin ) may enhance the metabolism of corticosteroids and require that the dosage of the corticosteroid be increased. Drugs which inhibit CYP 3A4 (e.g., ketoconazole, itraconazole, ritonavir, indinavir, macrolide antibiotics such as erythromycin ) have the potential to result in increased plasma concentrations of corticosteroids. Glucocorticoids are moderate inducers of CYP 3A4.
Co-administration with other drugs that are metabolized by CYP 3A4 (e.g., indinavir, erythromycin ) may increase their clearance, resulting in decreased plasma concentration. Ketoconazole Ketoconazole has been reported to decrease the metabolism of certain corticosteroids by up to 60%, leading to increased risk of corticosteroid side effects. In addition, ketoconazole alone can inhibit adrenal corticosteroid synthesis and may cause adrenal insufficiency during corticosteroid withdrawal.
Nonsteroidal Anti-Inflammatory Agents (NSAIDS) Concomitant use of aspirin (or other nonsteroidal anti-inflammatory agents ) and corticosteroids increases the risk of gastrointestinal side effects. Aspirin should be used cautiously in conjunction with corticosteroids in hypoprothrombinemia. The clearance of salicylat…
🤰 Pregnancy ▾
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.
🧒 Pediatric Use ▾
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 >2 years of age), and aggressive lymphomas and leukemias (patients >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 ▾
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.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY Naturally occurring glucocorticoids (hydrocortisone and cortisone), which also have salt-retaining properties, are used as replacement therapy in adrenocortical deficiency states. Their synthetic analogs are primarily used for their potent anti-inflammatory effects in disorders of many organ systems. Glucocorticoids cause profound and varied metabolic effects. In addition, they modify the body's immune responses to diverse stimuli.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED PredniSONE Tablets are available in the following strengths and package sizes: 5 mg (white, round, scored, debossed “5094” on one side and debossed “V” on the reverse side) Unit dose packages of 100 (10 x10) NDC 60687-122-01 10 mg (white, round, scored, debossed “5093” on one side and debossed “V” on the reverse side) Unit dose packages of 100 (10 x10) NDC 60687-134-01 20 mg (peach, round, scored, debossed “5092” on one side and debossed “V” on the reverse side) Unit dose packages of 100 (10 x10) NDC 60687-145-01 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
FOR YOUR PROTECTION: Do not use if blister is torn or broken.
📦 Storage and Handling ▾
Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. FOR YOUR PROTECTION: Do not use if blister is torn or broken.
📋 Description ▾
DESCRIPTION PredniSONE Tablets contain prednisone which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. Prednisone is a white to practically white, odorless, crystalline powder.
It is very slightly soluble in water; slightly soluble in alcohol, chloroform, dioxane, and methanol. The chemical name for prednisone is pregna-1,4-diene-3,11,20-trione monohydrate, 17,21-dihydroxy-. The structural formula is represented below: PredniSONE Tablets are available in 5 strengths: 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg.
Inactive ingredients: 1 mg — colloidal silicon dioxide, lactose monohydrate, magnesium stearate, pregelatinized starch, sodium starch glycolate; 2.5 mg — colloidal silicon dioxide, lactose monohydrate, magnesium stearate, pregelatinized starch, sodium starch glycolate; 5 mg — colloidal silicon dioxide, lactose monohydrate, magnesium stearate, pregelatinized starch, sodium starch glycolate; 10 mg — colloidal silicon dioxide, lactose monohydrate, magnesium stearate, pregelatinized starch, sodium starch glycolate; 20 mg — FD&C Yellow #6 Lake, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate.
Chemical structure
💬 Information for Patients ▾
Information for Patients Patients should be warned not to discontinue the use of corticosteroids abruptly or without medical supervision. As prolonged use may cause adrenal insufficiency and make patients dependent on corticosteroids, they should advise any medical attendants that they are taking corticosteroids and they should seek medical advice at once should they develop an acute illness including fever or other signs of infection. Following prolonged therapy, withdrawal of corticosteroids may result in symptoms of the corticosteroid withdrawal syndrome including, myalgia, arthralgia, and malaise.
Persons who are on corticosteroids should be warned to avoid exposure to chickenpox or measles. Patients should also be advised that if they are exposed, medical advice should be sought without delay.