Prednisone (13 brand names, 4 dosage forms, 1 route)
Available dosage forms: TABLET, TABLET, DELAYED RELEASE, SOLUTION, SYRUP.
Routes of administration: ORAL.
Brand Names
- CORTAN
- DELTA-DOME
- DELTASONE
- FERNISONE
- LIQUID PRED
- METICORTEN
- ORASONE
- PARACORT
- PREDNICEN-M
- PREDNISONE
- PREDNISONE INTENSOL
- RAYOS
- SERVISONE
Indications and Usage
Prednisone tablets are indicated in the following conditions: 1. 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 hyperplasiaHypercalcemia associated with cancerNonsuppurative thyroiditis 2. Rheumatic Disorders As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: Psoriatic arthritisRheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy)Ankylosing spondylitisAcute and subacute bursitisAcute nonspecific tenosynovitisAcute gouty arthritisPost-traumatic osteoarthritisSynovitis of osteoarthritisEpicondylitis 3. Collagen Diseases During an exacerbation or as maintenance therapy in selected cases of: Systemic lupus erythematosusSystemic dermatomyositis (polymyositis)Acute rheumatic carditis 4. Dermatologic Diseases Pemphigus Bullous dermatitis herpetiformisSevere erythema multiforme (Stevens-Johnson syndrome)Exfoliative dermatitisMycosis fungoidesSevere psoriasisSevere seborrheic dermatitis 5. Allergic States Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment: Seasonal or perennial allergic rhinitisBronchial asthmaContact dermatitisAtopic dermatitisSerum sicknessDrug hypersensitivity reactions 6. Ophthalmic Diseases Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as: Allergic corneal marginal ulcers Herpes zoster ophthalmicusAnterior segment inflammationDiffuse posterior uveitis and choroiditisSympathetic ophthalmiaAllergic conjunctivitisKeratitisChorioretinitisOptic neuritisIritis and iridocyclitis 7. Respiratory Diseases Symptomatic sarcoidosis Loeffler’s syndrome not manageable by other m
Dosage and Administration
The initial dosage of prednisone tablets may vary from 5 mg to 60 mg of prednisone 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 tablets 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 decrements 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 tablets 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.) ADT® (Alternate Day Therapy) ADT is a corticoster
Contraindications
Systemic fungal infections and known hypersensitivity to components.
Adverse Reactions
Fluid and Electrolyte Disturbances Sodium retention Fluid retention Congestive heart failure in susceptible patients Potassium loss Hypokalemic alkalosis Hypertension Musculoskeletal Muscle weakness Steroid myopathy Loss of muscle mass Osteoporosis Tendon rupture, particularly of the Achilles tendon Vertebral compression fractures Aseptic necrosis of femoral and humeral heads Pathologic fracture of long bones Gastrointestinal Peptic ulcer with possible perforation and hemorrhage Pancreatitis Abdominal distention Ulcerative esophagitis Dermatologic Impaired wound healing Thin fragile skin Petechiae and ecchymoses Facial erythema Increased sweating May suppress reactions to skin tests Metabolic Negative nitrogen balance due to protein catabolism Neurological Increased intracranial pressure with papilledema (pseudotumor cerebri) usually after treatment Convulsions Vertigo Headache Endocrine Menstrual irregularities Development of Cushingoid state Secondary adrenocortical and pituitary unresponsiveness, particularly in times of stress, as in trauma, surgery or illness Suppression of growth in children Decreased carbohydrate tolerance Manifestations of latent diabetes mellitus Increased requirements for insulin or oral hypoglycemic agents in diabetics Ophthalmic Posterior subcapsular cataracts Increased intraocular pressure Glaucoma Exophthalmos Additional Reactions Urticaria and other allergic, anaphylactic or hypersensitivity reactions T o report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Drug Interactions
The pharmacokinetic interactions listed below are potentially clinically important. Drugs that induce hepatic enzymes such as phenobarbital, phenytoin and rifampin may increase the clearance of corticosteroids and may require increases in corticosteroid dose to achieve the desired response. Drugs such as troleandomycin and ketoconazole may inhibit the metabolism of corticosteroids and thus decrease their clearance. Therefore, the dose of corticosteroid should be titrated to avoid steroid toxicity. Corticosteroids may increase the clearance of chronic high dose aspirin. This could lead to decreased salicylate serum levels or increase the risk of salicylate toxicity when corticosteroid is withdrawn. Aspirin should be used cautiously in conjunction with corticosteroids in patients suffering from hypoprothrombinemia. The effect of corticosteroids on oral anticoagulants is variable. There are reports of enhanced as well as diminished effects of anticoagulants when given concurrently with corticosteroids. Therefore, coagulation indices should be monitored to maintain the desired anticoagulant effect.