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Cortisone Acetate Tablets, USP
Cortisone acetate is a glucocorticoid. Gluco-corticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. Cortisone acetate is a white to practically white, odorless, crystalline powder. It is insoluble in water; freely soluble in chloroform; soluble in dioxane; sparingly soluble in acetone; slightly soluble in alcohol.
The chemical name for cortisone acetate is pregn-4-ene-3,11,20-trione, 21-(acetyloxy)-17-hydroxy and the molecular weight is 402.49. The structural formula is represented below:
Cortisone Acetate Tablets are available in 2 strengths: 5 mg or 10 mg. Inactive ingredients: calcium stearate, corn starch, lactose, mineral oil, sorbic acid, sucrose.
Cortisone acetate is 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 mineralocor-ticoid supplementation is of particular importance)
Congenital adrenal hyperplasia
Hypercalcemia associated with cancer
Nonsuppurative thyroiditis
2.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
3.Collagen Diseases
During an exacerbation or as maintenance therapy in selected cases of:
Systemic lupus erythematosus
Acute rheumatic carditis
Systemic dermatomyositis (polymyositis)
4.Dermatologic Diseases
Pemphigus
Exfoliative dermatitis
Bullous dermatitis herpetiformis
Mycosis fungoides Severe erythema multiforme (Stevens-Johnson syndrome)
Severe psoriasis
Severe seborrheic dermatitis
5.Allergic States
Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment.
Seasonal or perennial allergic rhinitis
Contact dermatitis
Atopic dermatitis
Serum sickness
Drug hypersensitivity reactions
Bronchial asthma
6.Ophthalmic Diseases
Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as:
Allergic conjunctivitis
Anterior segment inflammation
Keratitis
Allergic corneal marginal ulcers
Diffuse posterior uveitis and choroiditis
Herpes zoster ophthalmicus
Iritis and iridocyclitis
Optic neuritis
Chorioretinitis
Sympathetic ophthalmia
7.Respiratory Diseases
Symptomatic sarcoidosis
Loeffler’s syndrome not manageable by other means
Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy
Berylliosis
Aspiration pneumonitis
8.Hematologic Disorders
Idiopathic thrombocytopenic purpura in adults
Acquired (autoimmune) hemolytic anemia
Secondary thrombocytopenia in adults
Erythroblastopenia (RBC anemia)
Congenital (erythroid) hypoplastic anemia
9.Neoplastic Diseases
For palliative management of:
Leukemias and lymphomas in adults
Acute leukemia of childhood
10.Edematous States
To induce a diuresis or remission of protein-uria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus
11.Gastrointestinal Diseases
To tide the patient over a critical period of the disease in: Ulcerative colitis Regional enteritis
12.Miscellaneous
Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy
Trichinosis with neurologic or myocardial involvement
The initial dosage of cortisone acetate may vary from 25 to 300 mg 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, cortisone acetate 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 cortisone acetate 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.
Cortisone Acetate Tablets, USP are available in the following strengths and package sizes:
5 mg
(white, round, scored, imprinted UPJOHN 15)
Bottles of 50 …………………………………………….. NDC 0009-0015-01
10 mg
(white, round, scored, imprinted UPJOHN 23)
Bottles of 100 …………………………………………….. NDC 0009-0023-01
Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP].
Pharmacia & Upjohn Company
A subsidiary of Pharmacia Corporation Kalamazoo, MI 49001, USA, Revised February 2002, 810 931 813 692851
Fluid and electrolyte disturbances
Sodium retention
Potassium loss
Fluid retention
Hypokalemic alkalosis
Congestive heart failure in susceptible patients
Hypertension
Musculoskeletal
Muscle weakness
Vertebral compression fractures
Steroid myopathy
Aseptic necrosis of femoral and humeral heads
Loss of muscle mass
Osteoporosis
Tendon rupture, particularly of the Achilles tendon
Pathologic fracture of long bones
Gastrointestinal
Peptic ulcer with possible perforation and hemorrhage
Abdominal distention
Ulcerative esophagitis
Pancreatitis
Increases in alanine transaminase (ALT, SGPT), aspartate transaminase (AST, SGOT) and alkaline phosphatase have been observed following corticosteroid treatment. These changes are usually small, not associated with any clinical syndrome and are reversible upon discontinuation.
Dermatologic
Impaired wound healing
Facial erythema
Thin fragile skin
Increased sweating
Petechiae and ecchymoses
May suppress reactions to skin tests
Neurological
Increased intracranial pressure with papil-ledema (pseudotumor cerebri) usually after treatment
Convulsions
Vertigo
Headache
Endocrine
Menstrual irregularities
Suppression of growth in children
Development of Cushingoid state
Decreased carbohydrate tolerance
Secondary adrenocortical and pituitary unresponsiveness, particularly in times of stress, as in trauma, surgery or illness
Manifestations of latent diabetes mellitus Increased requirements for insulin or oral hypoglycemic agents in diabetics
Ophthalmic
Posterior subcapsular cataracts Glaucoma
Increased intraocular pressure Exophthalmos
Metabolic
Negative nitrogen balance due to protein catabolism
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 cortico-steroids in patients suffering from hypopro-thrombinemia. 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.
In patients on corticosteroid therapy subjected to unusual stress, increased dosage of rapidly acting corticosteroids before, during, and after the stressful situation is indicated.
Corticosteroids may mask some signs of infection, and new infections may appear during their use. Infections with any pathogen including viral, bacterial, fungal, protozoan or helminthic infections, in any location of the body, may be associated with the use of corti-costeroids alone or in combination with other immunosuppressive agents that affect cellular immunity, humoral immunity, or neutrophil function.1
These infections may be mild, but can be severe and at times fatal. With increasing doses of corticosteroids, the rate of occurrence of infectious complications increases.2 There may be decreased resistance and inability to localize infection when corticosteroids are used.
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.
Usage in pregnancy: Since adequate human reproduction studies have not been done with corticosteroids, the use of these drugs in pregnancy, nursing mothers or women of childbearing potential requires that the possible benefits of the drug be weighed against the potential hazards to the mother and embryo or fetus. Infants born of mothers who have received substantial doses of corticosteroids during pregnancy, should be carefully observed for signs of hypoadrenalism.
Average and large doses of hydrocortisone or cortisone can cause elevation of blood pressure, salt and water retention, and increased excretion of potassium. These effects are less likely to occur with the synthetic derivatives except when used in large doses. Dietary salt restriction and potassium supplementation may be necessary. All corticosteroids increase calcium excretion.
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. Indicated immunization procedures may be undertaken in patients receiving nonimmuno-suppressive doses of corticosteroids.
The use of cortisone acetate in active tuberculosis should be restricted to those cases of fulminating or disseminated tuberculosis in which the corticosteroid is used for the management of the disease in conjunction with an appropriate antituberculous regimen.
If corticosteroids are indicated in patients with latent tuberculosis or tuberculin reactivity, close observation is necessary as reactivation of the disease may occur. During prolonged corticosteroid therapy, these patients should receive chemoprophylaxis.
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. How the dose, route and duration of corticosteroid administration affects the risk of developing a disseminated infection is not known. The contribution of the underlying disease and/or prior corticosteroid treatment to the risk is also not known. If exposed to chicken pox, prophylaxis with varicella zoster immune globulin (VZIG) may be indicated. If exposed to measles, prophylaxis with pooled intramuscular immunoglobulin (IG) may be indicated. (See the respective package inserts for complete VZIG and IG prescribing information.) If chicken pox develops, treatment with antiviral agents may be considered. Similarly, corticosteroids should be used with great care in patients with known or suspected Strongyloides (threadworm) infestation. In such patients, corticosteroid-induced immunosuppression may lead to Strongyloides hyperinfection and dissemination with widespread larval migration, often accompanied by severe enterocolitis and potentially fatal gram-negative septicemia.
General Precautions
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 mineralo-corticoid 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.
The lowest possible dose of corticosteroid should be used to control the condition under treatment, and when reduction in dosage is possible, the reduction should be gradual.
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.
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 anastomoses, 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. Discontinuation of corticosteroids may result in clinical remission.
Information for PatientsPersons who are on immunosuppressant doses of corticosteroids should be warned to avoid exposure to chicken pox or measles. Patients should also be advised that if they are exposed, medical advice should be sought without delay.
REFERENCES
1 Fekety R. Infections associated with cortico-steroids and immunosuppressive therapy. In: Gorbach SL, Bartlett JG, Blacklow NR, eds.
Infectious Diseases. Philadelphia: WBSaunders Company 1992:1050-1.
2 Stuck AE, Minder CE, Frey FJ. Risk of infectious complications in patients taking glucocor-ticoids. Rev Infect Dis 1989:11(6):954-63.
Systemic fungal infections and known hypersensitivity to components.
ACTIONS
Naturally occurring glucocorticoids (hydrocor-tisone and cortisone), which also have salt-retaining properties, are used as replacement therapy in adrenocortical deficiency states. Their synthetic analogs are primarily used for their potent anti-inflammatory effects in disorders of many organ systems.
Glucocorticoids cause profound and varied metabolic effects. In addition, they modify the body’s immune responses to diverse stimuli.
Persons who are on immunosuppressant doses of corticosteroids should be warned to avoid exposure to chicken pox or measles. Patients should also be advised that if they are exposed, medical advice should be sought without delay.
