Cortisone Acetate

Generic Name: cortisone acetate

Over-the-Counter (OTC)

Brand Names:

Cortisone Acetate

DESCRIPTION: Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. Cortisone acetate is a white or practically white, odorless, crystalline powder. It is stable in air. It is insoluble in water. The molecular weight is 402.48. It is designated chemically as 17,21-Dihydroxypregn-4-ene-3,11,20-trione 21-acetate.

Overview

DESCRIPTION: Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. Cortisone acetate is a white or practically white, odorless, crystalline powder. It is stable in air. It is insoluble in water. The molecular weight is 402.48. It is designated chemically as 17,21-Dihydroxypregn-4-ene-3,11,20-trione 21-acetate.

Uses

INDICATIONS AND USAGE: When oral therapy is not feasible: 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 mineralocorticoid supplementation is of particular importance). Congenital adrenal hyperplasia Nonsuppurative thyroiditis Hypercalcemia associated with cancer 2.

Dosage

DOSAGE AND ADMINISTRATION: For Oral Administration DOSAGE REQUIREMENTS ARE VARIABLE AND MUST BE INDIVIDUALIZED ON THE BASIS OF THE DISEASE AND THE RESPONSE OF THE PATIENT. The initial dosage varies from 25 to 300 mg a day depending on the disease being treated. In less severe diseases doses lower than 25 mg may suffice, while in severe diseases doses higher than 300 mg may be required. The initial dosage should be maintained or adjusted until the patient’s response is satisfactory. If satisfactory clinical response does not occur after a reasonable period of time, discontinue cortisone acetate tablets and transfer the patient to other therapy.

Side Effects

ADVERSE REACTIONS: Fluid and Electrolyte Disturbances Sodium retention Fluid retention Congestive heart failure in susceptible patients Potassium loss Hypokalemic alkalosis Hypertension Musculoskeletal Muscle weakness Steroid myopathy Loss of muscle mass Osteoporosis Vertebral compression fractures Aseptic necrosis of femoral and humeral heads Pathologic fracture of long bones Tendon rupture Gastrointestinal Peptic ulcer with possible perforation and hemorrhage Perforation of the small and large bowel, particularly in patients with inflammatory bowel disease Pancreatitis Abdominal distention Ulcerative esophagitis Dermatologic Impaired wound healing Thin fragile skin Petechiae and ecchymoses Erythema Increased sweating May suppress reactions to skin tests Other cutaneous reactions, such as...

Warnings

WARNINGS: In patients on corticosteroid therapy subjected to unusual stress, increased dosage of rapidly acting corticosteroids before, during, and after the stressful situation is indicated. Immunosuppression and Increased Risk of Infection Corticosteroids, including cortisone acetate tablets, suppress the immune system and increase the risk of infection with any pathogen, including viral, bacterial, fungal, protozoan, or helminthic pathogens. Corticosteroids can; Reduce resistance to new infections Exacerbate existing infections Increase the risk of disseminated infections Increase the risk of reactivation or exacerbation of latent infections Mask some signs of infection Corticosteroid-associated infections can be mild but can be severe and at times fatal. CONTRAINDICATIONS: • Systemic fungal infections • Hypersensitivity to this product

Storage

HOW SUPPLIED: Cortisone Acetate Tablets, USP 25 mg: white to off-white, round scored tablets, debossed with “C” bisect “E” on one side and “113” on the other side. Bottles of 30 tablets. NDC 62135-173-30 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from light and moisture. Preserve in well closed containers, as defined in the USP.

Frequently Asked Questions

What is Cortisone Acetate used for?

INDICATIONS AND USAGE: When oral therapy is not feasible: 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 mineralocorticoid supplementation is of particular importance). Congenital adrenal hyperplasia Nonsuppurative thyroiditis Hypercalcemia associated with cancer 2.

What are the side effects of Cortisone Acetate?

ADVERSE REACTIONS: Fluid and Electrolyte Disturbances Sodium retention Fluid retention Congestive heart failure in susceptible patients Potassium loss Hypokalemic alkalosis Hypertension Musculoskeletal Muscle weakness Steroid myopathy Loss of muscle mass Osteoporosis Vertebral compression fractures Aseptic necrosis of femoral and humeral heads Pathologic fracture of long bones Tendon rupture Gastrointestinal Peptic ulcer with possible perforation and hemorrhage Perforation of the small and large bowel, particularly in patients with inflammatory bowel disease Pancreatitis Abdominal distention Ulcerative esophagitis Dermatologic Impaired wound healing Thin fragile skin Petechiae and ecchymoses Erythema Increased sweating May suppress reactions to skin tests Other cutaneous reactions, such as...

What are the important warnings for Cortisone Acetate?

WARNINGS: In patients on corticosteroid therapy subjected to unusual stress, increased dosage of rapidly acting corticosteroids before, during, and after the stressful situation is indicated. Immunosuppression and Increased Risk of Infection Corticosteroids, including cortisone acetate tablets, suppress the immune system and increase the risk of infection with any pathogen, including viral, bacterial, fungal, protozoan, or helminthic pathogens. Corticosteroids can; Reduce resistance to new infections Exacerbate existing infections Increase the risk of disseminated infections Increase the risk of reactivation or exacerbation of latent infections Mask some signs of infection Corticosteroid-associated infections can be mild but can be severe and at times fatal. CONTRAINDICATIONS: • Systemic fungal infections • Hypersensitivity to this product

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Medical Disclaimer

This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.