Prednisone

What is Prednisone?

• Prednisone (RAYOS) is a corticosteroid used to suppress the immune system and decrease inflammation in conditions such as asthma, COPD, and rheumatologic diseases.

Prednisone

Prednisone

Prednisone-from-xtal-3D

What are the uses of this medicine?

RAYOS is a corticosteroid used

• 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
• for palliation of certain neoplastic conditions

How does this medicine work?

• The pharmacological effects of prednisone which are due to its corticosteroid properties include: promotion of gluconeogenesis; increased deposition of glycogen in the liver; inhibition of the utilization of glucose; anti-insulin activity; increased catabolism of protein; increased lipolysis; stimulation of fat synthesis and storage; increased glomerular filtration rate and resulting increase in urinary excretion of urate (creatinine excretion remains unchanged); and increased calcium excretion.
• Prednisone can stimulate secretion of various components of gastric juice. Suppression of the production of corticotropin may lead to suppression of endogenous corticosteroids. Prednisone has slight mineralocorticoid activity, whereby entry of sodium into cells and loss of intracellular potassium is stimulated.

Who Should Not Use this medicine ?

This medicine cannot be used in patients:

• who have known hypersensitivity to prednisone or to any of the excipients.

What drug interactions can this medicine cause?

• Aminoglutethimide may lead to loss of corticosteroid-induced adrenal suppression.
• Concomitant use of Amphotericin B and hydrocortisone was followed by cardiac enlargement and congestive heart failure.
• Concomitant use of anticholinesterase agents and corticosteroids may produce severe weakness in patients with myasthenia gravis.
• Co-administration of corticosteroids and warfarin usually results in inhibition of response to warfarin, although there have been some conflicting reports.
• Because corticosteroids may increase blood glucose concentrations, dosage adjustments of antidiabetic agents may be required.
• Drugs such as barbiturates, phenytoin, ephedrine, and rifampin, which induce hepatic microsomal drug metabolizing enzyme activity may enhance the metabolism of corticosteroids and require that the dosage of the corticosteroid be increased.
• Ketoconazole has been reported to decrease the metabolism of certain corticosteroids by up to 60% leading to increased risk of corticosteroid side effects.
• Concomitant use of aspirin or other nonsteroidal anti-inflammatory drugs and corticosteroids increases the risk of gastrointestinal side effects.

Is this medicine FDA approved?

• Prednisone was patented in 1954 and approved for medical use in the United States in 1955.

How should this medicine be used?

• 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.

Recommended dosage:

• Initial dose: RAYOS 5 mg administered once per day. Patients currently on immediate-release prednisone, prednisolone, or methylprednisolone should be switched to RAYOS at an equivalent dose based on relative potency.
• Maintenance dose: Use lowest dosage that will maintain an adequate clinical response.
• Discontinuation: Withdraw gradually if discontinuing long-term or high-dose therapy.

Administration:

• RAYOS should be taken daily with food.
• RAYOS should be swallowed whole and not broken, divided, or chewed.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Delayed-release tablets: 1 mg, 2 mg, and 5 mg prednisone

This medicine is available in fallowing brand namesː

• RAYOS

What side effects can this medication cause?

The most common side effects of this medicine include:

• fluid retention
• alteration in glucose tolerance
• elevation in blood pressure
• behavioral and mood changes
• increased appetite
• weight gain

What special precautions should I follow?

• Hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing's syndrome, and hyperglycemia. Monitor patients for these conditions with chronic use.
• Corticosteroids may increase the risks related to infections with any pathogen, including viral, bacterial, fungal, protozoan, or helminthic infections. Signs and symptoms of infection may be masked.
• Corticosteroids can cause elevation of blood pressure, salt, and water retention, and increased excretion of potassium and calcium. Monitor blood pressure and sodium, potassium serum levels.
• There is an increased risk of gastrointestinal perforation in patients with certain GI disorders. Signs and symptoms may be masked.
• Corticosteroids use may be associated with central nervous system effects ranging from euphoria, insomnia, mood swings, personality changes, and severe depression, to frank psychotic manifestations. Existing conditions may be aggravated.
• 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. Monitor bone density in patients receiving long term corticosteroid therapy.
• Prolonged use of corticosteroids may produce posterior subcapsular cataracts, glaucoma with possible damage to the optic nerves, and may enhance the establishment of secondary ocular infections due to fungi or viruses. Monitor intraocular pressure if corticosteroid therapy is continued for more than 6 weeks
• Administration of live or live, attenuated vaccines is contraindicated in patients receiving immunosuppressive doses of corticosteroids. Do not administer to patients receiving immunosuppressive doses of corticosteroids.
• Long-term use of corticosteroids can have negative effects on growth and development in children. Monitor pediatric patients on long-term corticosteroid therapy.
• Prednisone can cause fetal harm when administered to a pregnant woman. Advise patients of potential harm to the fetus.
• 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.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• moon face, abnormal fat deposits, fluid retention, excessive appetite, weight gain, hypertrichosis, acne, striae, ecchymosis, increased sweating, pigmentation, dry scaly skin, thinning scalp hair, increased blood pressure, tachycardia, thrombophlebitis, decreased resistance to infection, negative nitrogen balance with delayed bone and wound healing, headache, weakness, menstrual disorders, accentuated menopausal symptoms, neuropathy, fractures, osteoporosis, peptic ulcer, decreased glucose tolerance, hypokalemia, and adrenal insufficiency.
• Hepatomegaly and abdominal distention have been observed in children.

Management of overdosage:

• Treatment of acute overdosage is by immediate gastric lavage or emesis followed by supportive and symptomatic therapy.
• For chronic overdosage in the face of severe disease requiring continuous steroid therapy the dosage of prednisone may be reduced only temporarily, or alternate day treatment may be introduced.

Can this medicine be used in pregnancy?

• Based on findings from human and animal studies, corticosteroids, including RAYOS, can cause fetal harm when administered to a pregnant woman.

Can this medicine be used 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.

What are the active and inactive ingredients in this medicine?

Active ingredient:

• prednisone

Inactive ingredients:

• Lactose Monohydrate
• Povidone, unspecified
• Croscarmellose Sodium
• Silicon Dioxide
• Magnesium Stearate
• Ferric Oxide Red
• Ferric Oxide Yellow
• Dibasic Calcium Phosphate Dihydrate
• Glyceryl Dibehenate
• Water

Who manufactures and distributes this medicine?

Distributed by:

• Horizon Therapeutics USA, Inc.

Deerfield, IL

What should I know about storage and disposal of this medication?

• Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F).
• Protect RAYOS tablets from light and moisture.
• Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

• Dailymed label info on Prednisone
• FDA Prednisone