Prednisone delayed release

Prednisone delayed release is an FDA-registered drug product whose active ingredient is PREDNISONE. It is labelled by Dr. Reddys Laboratories Inc. taken by oral and marketed as a human prescription drug product. Identifiers on file: NDC 43598-888, application ANDA218035, label effective 20260430. It is one of 88 FDA drug label records sharing the active ingredient PREDNISONE. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing PREDNISONE are most often described in connection with: prednisone delayed-release, diseases conditions, nervous system, specific infectious, organ transplantation, acute exacerbations, lupus erythematosus, maintenance therapy. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

1 INDICATIONS AND USAGE Prednisone delayed-release tablets are indicated in the treatment of the following diseases or conditions: Prednisone delayed-release tablets are a corticosteroid indicated as an anti-inflammatory or immunosuppressive agent for certain allergic, dermatologic, gastrointestinal, hematologic, ophthalmologic, nervous system, renal, respiratory, rheumatologic, specific infectious diseases or conditions and organ transplantation ( 1 ) for the treatment of certain endocrine conditions ( 1 ) for palliation of certain neoplastic conditions ( 1 ) 1.1 Allergic Conditions Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in adults and pediatric populations with: Atopic dermatitis Drug hypersensitivity reactions Seasonal or perennial allergic rhinitis Serum sickness 1.2 Dermatologic Diseases Bullous dermatitis herpetiformis Contact dermatitis Exfoliative erythroderma Mycosis fungoides Pemphigus Severe erythema multiforme (Stevens-Johnson syndrome) 1.3 Endocrine Conditions Congenital adrenal hyperplasia Hypercalcemia of malignancy Nonsuppurative thyroiditis Primary or secondary adrenocortical insufficiency: hydrocortisone or cortisone is the first choice: synthetic analogs may be used in conjunction with mineralocorticoids where applicable 1.4 Gastrointestinal Diseases During acute episodes in: Crohn's Disease Ulcerative colitis 1.5 Hematologic Diseases Acquired (autoimmune) hemolytic anemia Diamond-Blackfan anemia Idiopathic thrombocytopenic purpura in adults Pure red cell aplasia Secondary thrombocytopenia in adults 1.6 Neoplastic Conditions For the treatment of: Acute leukemia Aggressive lymphomas 1.7 Nervous System Conditions Acute exacerbations of multiple sclerosis Cerebral edema associated with primary or metastatic brain tumor, craniotomy or head injury 1.8 Ophthalmic Conditions Sympathetic ophthalmia Uveitis and ocular inflammatory conditions unresponsive to topical steroids 1.9 Conditions Related to Organ Transplantation Acute or chronic solid organ rejection 1.10 Pulmonary Diseases Acute exacerbations of chronic obstructive pulmonary disease (COPD) Allergic bronchopulmonary aspergillosis Aspiration pneumonitis Asthma Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate chemotherapy Hypersensitivity pneumonitis Idiopathic bronchiolitis obliterans with organizing pneumonia Idiopathic eosinophilic pneumonias Idiopathic pulmonary fibrosis Pneumocystis carinii pneumonia (PCP) associated with hypoxemia occurring in an HIV(+) individual who is also under treatment with appropriate anti-PCP antibiotics. Symptomatic sarcoidosis 1.11 Renal Conditions To induce a diuresis or remission of proteinuria in nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus 1.12 Rheumatologic Conditions As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: Acute gouty arthritis During an exacerbation or as maintenance therapy in selected cases of: Ankylosing spondylitis Dermatomyositis/polymyositis Polymyalgia rheumatica Psoriatic arthritis Relapsing polychondritis Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low dose maintenance therapy) Sjogren's syndrome Systemic lupus erythematosus Vasculitis 1.13 Specific Infectious Diseases Trichinosis with neurologic or myocardial involvement. Tuberculous meningitis with subarachnoid block or impending block used concurrently with appropriate antituberculous chemotherapy.

2 DOSAGE AND ADMINISTRATION Individualize dosing based on disease severity and patient response. The timing of administration should take into account the delayed-release pharmacokinetics and the disease or condition being treated ( 2 , 12.1 ): Initial dose: Prednisone delayed-release tablets 5 mg administered once per day. Patients currently on immediate-release prednisone, prednisolone, or methylprednisolone should be switched to prednisone delayed-release tablets at an equivalent dose based on relative potency. ( 2.1 , 2.4 ) Maintenance dose: Use lowest dosage that will maintain an adequate clinical response. ( 2.1 ) Discontinuation: Withdraw gradually if discontinuing long-term or high-dose therapy. ( 2.1 ) Prednisone delayed-release tablets should be taken daily with food. ( 2.3 , 12.3 ) Prednisone delayed-release tablets should be swallowed whole and not broken, divided, or chewed. ( 2.3 ) 2.1 Recommended Dosing Dosage of prednisone delayed-release tablets should be individualized according to the severity of the disease and the response of the patient. For pediatric patients, the recommended dosage should be governed by the same considerations rather than strict adherence to the ratio indicated by age or body weight. The maximal activity of the adrenal cortex is between 2 am and 8 am and is minimal between 4 pm and midnight. Exogenous corticosteroids suppress adrenocorticoid activity the least when given at the time of maximal activity. Prednisone delayed-release tablet is a delayed-release formulation of prednisone which releases the active substance beginning approximately 4 hours after intake [ see Clinical Pharmacology (12.3) ]. The timing of prednisone delayed-release tablets administration should take into account the delayed-release pharmacokinetics and the disease or condition being treated. The initial dosage of prednisone delayed-release tablets may vary from 5 to 60 mg per day depending on the specific disease entity being treated. Patients currently on immediate release prednisone, prednisolone, or methylprednisolone should be switched to prednisone delayed-release tablets at an equivalent dose based on relative potency (2.4). 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 there is a lack of satisfactory clinical response, prednisone delayed-release 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 delayed-release tablets for a period of time consistent with the patient's condition. If a period of spontaneous remission occurs in a chronic condition, treatment should be discontinued. If after long-term therapy the drug is to be stopped, it is recommended that it be withdrawn gradually rather than abruptly. 2.2 Recommended Monitoring Blood pressure, body weight, routine laboratory studies (including 2-hour postprandial blood glucose and serum potassium), and chest X-ray should be obtained at regular intervals during prolonged therapy with prednisone delayed-release tablets. Upper GI X-rays are desirable in patients with known or suspected peptic ulcer disease. 2.3 Method of Administration Prednisone delayed-release tablets are for oral administration. Prednisone delayed-release tablets should be taken daily with food. [see Clinical Pharmacology (12.3) ] Prednisone delayed-release tablets should not be broken, divided, or chewed because the delayed release of prednisone is dependent on an intact coating [see Description ( 11 )] . 2.4 Corticosteroid Comparison Chart For the purpose of comparison, one 5 mg prednisone delayed-release tablet is the equivalent milligram dosage of the following various corticosteroids: Betamethasone, 0.75 mg Paramethasone, 2 mg Cortisone, 25 mg Prednisolone, 5 mg Dexamethasone, 0.75 mg Prednisone, 5 mg Hydrocortisone, 20 mg Triamcinolone, 4 mg Methylprednisolone, 4 mg These dose relationships apply only to oral or intravenous administration of these compounds. When these substances or their derivatives are injected intramuscularly or into joint spaces, their relative properties may be greatly altered.

4 CONTRAINDICATIONS Prednisone delayed-release tablets are contraindicated in patients who have known hypersensitivity to prednisone or to any of the excipients. Rare instances of anaphylaxis have occurred in patients receiving corticosteroid therapy [ see Adverse Reactions (6) ]. Known hypersensitivity to prednisone or any excipients in the formulation ( 4 , 6 )

6 ADVERSE REACTIONS Common adverse reactions for corticosteroids include fluid retention, alteration in glucose tolerance, elevation in blood pressure, behavioral and mood changes, increased appetite and weight gain. Allergic Reactions: Anaphylaxis, angioedema Cardiovascular: Bradycardia, cardiac arrest, cardiac arrhythmias, cardiac enlargement, circulatory collapse, congestive heart failure, fat embolism, hypertension, hypertrophic cardiomyopathy in premature infants, myocardial rupture following recent myocardial infarction, pulmonary edema, syncope, tachycardia, thromboembolism, thrombophlebitis, vasculitis Dermatologic: Acne, allergic dermatitis, cutaneous and subcutaneous atrophy, dry scalp, edema, facial erythema, hyper or hypopigmentation, impaired wound healing, increased sweating, petechiae and ecchymoses, rash, sterile abscess, striae, suppressed reactions to skin tests, thin fragile skin, thinning scalp hair, urticaria Endocrine: Abnormal fat deposits, decreased carbohydrate tolerance, development of Cushingoid state, hirsutism, manifestations of latent diabetes mellitus and increased requirements for insulin or oral hypoglycemic agents in diabetics, menstrual irregularities, moon facies, secondary adrenocortical and pituitary unresponsiveness (particularly in times of stress, as in trauma, surgery or illness), suppression of growth in children Fluid and Electrolyte Disturbances: Fluid retention, potassium loss, hypertension, hypokalemic alkalosis, sodium retention Gastrointestinal: Abdominal distention, elevation in serum liver enzymes levels (usually reversible upon discontinuation), hepatomegaly, hiccups, malaise, nausea, pancreatitis, peptic ulcer with possible perforation and hemorrhage, ulcerative esophagitis General: Increased appetite and weight gain Metabolic: Negative nitrogen balance due to protein catabolism Musculoskeletal: Osteonecrosis of femoral and humeral heads, charcot-like arthropathy, loss of muscle mass, muscle weakness, osteoporosis, pathologic fracture of long bones, steroid myopathy, tendon rupture, vertebral compression fractures Neurological: Arachnoiditis, convulsions, depression, emotional instability, euphoria, headache, increased intracranial pressure with papilledema (pseudo-tumor cerebri) usually following discontinuation of treatment, insomnia, meningitis, mood swings, neuritis, neuropathy, paraparesis/paraplegia, paresthesia, personality changes, sensory disturbances, vertigo Ophthalmic: Exophthalmos, glaucoma, increased intraocular pressure, posterior subcapsular cataracts, and central serous chorioretinopathy Reproductive: Alteration in motility and number of spermatozoa Common adverse reactions for corticosteroids include fluid retention, alteration in glucose tolerance, elevation in blood pressure, behavioral and mood changes, increased appetite and weight gain. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Dr. Reddy's Laboratories Inc., at 1-888-375-3784 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of prednisone delayed-release tablets was evaluated in 375 rheumatoid arthritis patients in two controlled trials. Patients treated with prednisone delayed-release tablets ranged in age from 20 to 80 years (median age 56 years), with 85% female, 99% Caucasian, 1% African-American, and < 1% Asian. Patients received prednisone delayed-release tablets 3 mg to 10 mg once daily at 10 pm; the majority (84%) received ≤ 5 mg. The clinical trial experience did not raise new safety concerns beyond those already established for immediate-release prednisone. 6.2 Postmarketing Experience Adverse reactions have been identified during post approval use of prednisone delayed-release tablets. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The postmarketing experience has not raised new safety concerns beyond those already established for immediate-release prednisone.

FDA lists 88 drug label records with PREDNISONE as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

What is Prednisone delayed release used for?
1 INDICATIONS AND USAGE Prednisone delayed-release tablets are indicated in the treatment of the following diseases or conditions: Prednisone delayed-release tablets are a corticosteroid indicated as an anti-inflammatory or immunosuppressive agent for certain allergic, dermatologic, gastrointestinal, hematologic, ophthalmologic, nervous system, renal, respiratory, rheumatologic, specific …

Who makes Prednisone delayed release?
Dr. Reddys Laboratories Inc. is the labeler of record for Prednisone delayed release. 88 FDA label records share the active ingredient PREDNISONE, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does Prednisone delayed release come in?
administered by oral. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Prednisone delayed release prescription or over-the-counter?
The FDA label for this product is recorded as human prescription drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing PREDNISONE?
Yes. 88 FDA drug label records list PREDNISONE as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has Prednisone delayed release been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.