Prednisone Delayed Release

Do not take it if

Quoted from the official label, section “Contraindications”.

How to take it

These directions are for this exact strength and form. Another one is different.

• 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.

Quoted from the official label, section “Dosage & Administration”.

Other warnings

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.

Other medicines

Quoted from the official label, section “Drug Interactions”.

If you take too much

In an emergency, call your local emergency number or a poison control centre.

Quoted from the official label, section “Overdosage”.

Use in children

• The efficacy and safety of prednisone 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 (> 2 years of age), and aggressive lymphomas and leukemias (> 1 month of age).
• However, some of these conclusions and other indications for pediatric use of corticosteroid, 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 prednisone in pediatric patients are similar to those in
• adults [ see Adverse Reactions (6) ].
• 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.
• Children 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 HPA axis suppression (i.e., cosyntropin stimulation and basal cortisol levels).
• Growth velocity may therefore be a more sensitive indicator of systemic corticosteroid exposure in children than some commonly used tests of HPA axis function.
• The linear growth of children treated with corticosteroids by any route should be monitored, and the potential growth effects of prolonged treatment should be weighed against clinical benefits obtained and the availability of other treatment alternatives.
• In order to minimize the potential growth effects of corticosteroids, children should be titrated to the lowest effective dose [ see Warnings and Precautions (5.9) ].

Quoted from the official label, section “Pediatric Use”.

Use in older people

• No overall differences in safety or effectiveness were observed between elderly subjects and younger subjects, and other reported clinical experience with prednisone has not identified differences in responses between the elderly and younger patients.
• However, the incidence of corticosteroid-induced side effects may be increased in geriatric patients and are dose-related.
• Osteoporosis is the most frequently encountered complication, which occurs at a higher incidence rate in corticosteroid-treated geriatric patients as compared to younger populations and in age-matched controls.
• Losses of bone mineral density appear to be greatest early on in the course of treatment and may recover over time after steroid withdrawal or use of lower doses (i.e., ≤ 5 mg/day).
• Prednisone doses of 7.5 mg/day or higher have been associated with an increased relative risk of both vertebral and nonvertebral fractures, even in the presence of higher bone density compared to patients with involution osteoporosis.
• Routine screening of geriatric patients, including regular assessments of bone mineral density and institution of fracture prevention strategies, along with regular review of prednisone indication should be undertaken to minimize complications and keep the prednisolone dose at the lowest acceptable level.
• Co-administration of certain bisphosphonates have been shown to retard the rate of bone loss in corticosteroid-treated males and postmenopausal females, and these agents are recommended in the prevention and treatment of corticosteroid-induced osteoporosis [ see Warnings and Precautions (5.6) ].
• It has been reported that equivalent weight-based doses yield higher total and unbound prednisolone plasma concentrations and reduced renal and non-renal clearance in elderly patients compared to younger populations.
• 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.
• This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function.
• Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

Quoted from the official label, section “Geriatric Use”.

Side effects

• 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.

Quoted from the official label, section “Adverse Reactions”.

What to discuss with your doctor

• Patients should be informed of the following information before initiating therapy with prednisone delayed-release tablets and periodically during the course of ongoing therapy.
• Patients should be warned not to discontinue the use of prednisone delayed-release tablets abruptly or without medical supervision, to advise any medical attendants that they are taking it, and to seek medical advice at once should they develop fever or other signs of infection.
• Patients should be told to take prednisone delayed-release tablets exactly as prescribed, follow the instructions on the prescription label, and not stop taking prednisone delayed-release tablets without first checking with their healthcare providers, as there may be a need for gradual dose reduction.
• Patients should discuss with their physician if they have had recent or ongoing infections or if they have recently received a vaccine.
• Persons who are on immunosuppressant doses of 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.
• There are a number of medicines that can interact with prednisone delayed-release tablets.
• Patients should inform their healthcare provider of all the medicines they are taking, including over-the-counter and prescription medicines (such as phenytoin, diuretics, digitalis or digoxin, rifampin, amphotericin B, cyclosporine, insulin or diabetes medicines, ketoconazole, estrogens including birth control pills and hormone replacement therapy, blood thinners such as warfarin, aspirin or other NSAIDs, barbiturates), dietary supplements, and herbal products.
• If patients are taking any of these drugs, alternate therapy, dosage adjustment, and/or special test may be needed during the treatment.
• For missed doses, patients should be told to take the missed dose as soon as they remember.
• If it is almost time for the next dose, the missed dose should be skipped and the medicine taken at the next regularly schedule time.
• Patients should not take an extra dose to make up for the missed dose.
• Patients should be told to take prednisone delayed-release tablets with food.
• Patients should be advised not to break, divide, or chew prednisone delayed-release tablets.
• Patients should be advised of common adverse reactions that could occur with prednisone delayed-release tablets use to include fluid retention, alteration in glucose tolerance, elevation in blood pressure, behavioral and mood changes, increased appetite and weight gain.
• Advise pregnant women and females of reproductive potential of the potential risk to a fetus.
• Advise females to inform their healthcare provider of a known or suspected pregnancy [see Warnings and Precautions (5.10) and Use in Specific Populations (8.1) ] .

Quoted from the official label, section “Patient Counseling Information”.

Strengths and forms

• FORMS AND STRENGTHS Delayed-release Tablets Prednisone delayed-release tablets 5 mg prednisone:
• Light Pink to pink, round, unscored, delayed release tablet, debossed with "5" on one side and plain on other side, mottled appearance, free from physical defects.
• Delayed-release tablets: 5 mg prednisone ( 3 )

Quoted from the official label, section “Dosage Forms & Strengths”.

What it looks like and how it is packed

• Prednisone delayed-release tablets (5 mg prednisone) are light Pink to pink, round, unscored, delayed release tablet, debossed with "5" on one side and plain on other side, mottled appearance, free from physical defects:
• NDC Number Size 43598-888-30 Bottle of 30 tablets 43598-888-01 Bottle of 100 tablets
• Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature].
• Protect prednisone delayed-release tablets from light and moisture.
• Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

Quoted from the official label, section “How Supplied”.

How to store it

• Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature].
• Protect prednisone delayed-release tablets from light and moisture.
• Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

Quoted from the official label, section “Storage and Handling”.

What is in it

• The active ingredient in prednisone delayed-release tablet is prednisone (a corticosteroid).
• Corticosteroids are adrenocortical steroids, both naturally occurring and synthetic.
• The molecular formula for prednisone is C 21 H 26 O 5 .
• The chemical name for prednisone is 17,21-dihydroxypregna-1,4-diene-3,11,20-trione, and the structural formula is:
• Prednisone, USP is a white to practically white crystalline powder and has a molecular weight of 358.44 g/mol.
• Prednisone, USP is practically insoluble in water, slightly soluble in ethanol (96 per cent) and in methylene chloride.
• Prednisone delayed-release tablet is a delayed-release prednisone tablet.
• It consists of a prednisone-containing core tablet in an inactive shell, which delays the onset of in vitro drug dissolution by approximately 4 hours.
• Each tablet contains 5 mg of prednisone, USP with the following inactive ingredients:
• dibasic calcium phosphate dihydrate, colloidal silicon dioxide, croscarmellose sodium, glycerol dibehenate, lactose monohydrate, magnesium stearate, povidone, and red ferric oxide.
• Each prednisone delayed-release tablet contains 30 mg of phosphorous.
• Each prednisone delayed-release tablet contains less than 5 mg of sodium. chemical-structure

Quoted from the official label, section “Description”.

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Details

Source: NDC Directory · 2026-09-13 · not reviewed by a clinician

Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).

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