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Sterapred

Generic Name: Prednisone
Drug Category: Glucocorticoid
Litigation Alert Level: High
This drug has been approved for use by males and females over the age of 0 year old for a maximum duration of 10 years.

Approved Uses

Indicated for:

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
  • Post-traumatic osteoarthritis
  • Acute and subacute bursitis
  • Synovitis of osteoarthritis
  • Acute nonspecific tenosynovitis
  • Epicondylitis
  • Acute gouty arthritis

Collagen Disease:

During an exacerbation or as maintenance therapy in selected cases of:

  • Systemic lupus erythematosus
  • Acute rheumatic carditis

Dermatologic Diseases:

  • Pemphigus
  • Mycosis fungoides
  • Bullous dermatitis herpetiformis
  • Severe psoriasis
  • Severe erythema multiforme (Stevens-Johnson syndrome)
  • Severe seborrheic dermatitis
  • Exfoliative dermatitis

Allergic States:

Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment:

  • Seasonal or perennial allergic rhinitis
  • Atopic dermatitis
  • Bronchial asthma
  • Serum sickness
  • Contact dermatitis
  • 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
  • Optic neuritis
  • Sympathetic ophthalmia

Respiratory Diseases:

  • Symptomatic sarcoidosis
  • Loeffler’s syndrome not manageable by other means
  • Berylliosis
  • Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy
  • Aspiration pneumonitis

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
  • Systemic dermatomyositis (polymyositis)

Prednisone tablets are contraindicated in systemic fungal infections.

Persons who are on drugs which suppress the immune system are more susceptible to infections than healthy individuals. Chicken pox and measles, for example, can have a more serious or even fatal course in non-immune children or adults on corticosteroids. In such children or adults who have not had these diseases, particular care should be taken to avoid exposure.

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.

Administration of live or live, attenuated vaccines is contraindicated in patients receiving immunosuppressive doses of corticosteroids. Killed or inactivated vaccines may be administered to patients receiving immunosuppressive doses of corticosteroids; however, the response to such vaccines may be diminished.

Drug-induced secondary adrenocortical insufficiency may be minimized by gradual reduction of dosage. This type of relative insufficiency may persist for months after discontinuation of therapy; therefore, in any situation of stress occurring during that period, hormone therapy should be reinstituted. Since mineralocorticoid secretion may be impaired, salt and/or a mineralocorticoid should be administered concurrently.

There is an enhanced effect of corticosteroids on patients with hypothyroidism and in those with cirrhosis.

Corticosteroids should be used cautiously in patients with ocular herpes simplex because of possible corneal perforation.

Steroids should be used with caution in nonspecific ulcerative colitis; if there is a probability of impending perforation, abscess or other pyogenic infection; diverticulitis; fresh intestinal anastomosis; active or latent peptic ulcer; renal insufficiency; hypertension; osteoporosis; and myasthenia gravis.

Growth and development of infants and children on prolonged corticosteroid therapy should be carefully observed.

Kaposi’s sarcoma has been reported to occur in patients receiving corticosteroid therapy.

Psychic derangements may appear when corticosteroids are used, ranging from euphoria, insomnia, mood swings, personality changes, and severe depression, to frank psychotic manifestations. Also, existing emotional instability or psychotic tendencies may be aggravated by corticosteroids.

In patients on corticosteroid therapy subjected to unusual stress, increased dosage of rapidly acting corticosteroids before, during, and after the stressful situation is indicated.

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.

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.

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.

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.

Drug may cause fetal harm and decreased birth weight; maternal corticosteroid use during first trimester increases incidence of cleft lip with or without cleft palate.

GoToSource

Off-label Uses

• Drug-induced colonic strictures. GoToSource

• Renal symptoms in patients with henoch-schonlein purpura. GoToSource

• Hormone-refractory prostate cancer. GoToSource

• Adjunctive treatment for idiopathic recurrent miscarriage. GoToSource

• For patients undergoing detoxification for overuse of symptomatic migraine medications. GoToSource

• Alopecia areata. GoToSource

• Autoimmune hepatitis. GoToSource

• Bullous pemphigoid. GoToSource

• Infectious mononucleosis and epstein-barr. GoToSource

• Cystic fibrosis. GoToSource

• Idiopathic pulmonary hemosiderosis. GoToSource

• Prolong ambulation in patients with duchenne muscular dystrophy. GoToSource

• Ocular myasthenia gravis. GoToSource

• Nasal polyps. GoToSource

• Sudden hearing loss. GoToSource

• Ureteral stones. GoToSource

• Infantile spasms. GoToSource

Adverse Events

Kaposi’s sarcoma (cancer that develops from the cells that line lymph or blood vessels). GoToSource

Corticosteroid-induced osteoporosis. GoToSource

Avascular necrosis (death of bone tissue). GoToSource

Hirsutism (abnormal hair growth), hypertension (high blood pressure), steroid–induced diabetes, weight gain, acne, abdominal striae, mood swings, insomnia and fungal and parasitic infections. GoToSource 

Central serous chorioretinopathy (fluid under the retina). GoToSource 

Myopathy, (disease of muscle tissue), reduced levels of estrogen and testosterone, dyslipidemia (abnormal amount of lipids), atherosclerosis, accelerated coronary artery disease, arrhythmia, cushing’s syndrome (high levels of cortisol), cataracts, glaucoma, visual field loss or blindness, increased risk of pancreatitis and steroid psychosis. GoToSource

Fat redistribution, hypernatraemia (high blood sodium level), hypokalaemia (low blood potassium level), sodium and water retention, easy bruisability, and impaired wound healing and peptic ulcer disease. GoToSource

Growth suppression. GoToSource

Litigation

Lawsuits filed for avascular necrosis and central serous chorioretinopathy. 

 

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Site Last Updated March 28, 2024