CORTISONE ACETATE Tablet (2016)

Βιβλιογραφική αναφορά

Συγγραφείς

Hikma Pharmaceuticals USA Inc.

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1. 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, ...

2. Clinical Pharmacology

Naturally occurring glucocorticoids (hydrocortisone and cortisone), which also have salt-retaining properties, are used as replacement therapy in adrenocortical deficiency states. They are also used for ...

3. Indications and Usage

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 ...

4. Contraindications

Systemic fungal infections Hypersensitivity to this product

5. 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. Drug-induced secondary ...

6.1. General

Following prolonged therapy, withdrawal of corticosteroids may result in symptoms of the corticosteroid withdrawal syndrome including fever, myalgia, arthralgia, and malaise. This may occur in patients ...

6.2. Information for Patients

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 ...

7. Adverse Reactions

Fluid and Electrolyte Disturbances: Sodium retention, Fluid retention, Congestive heart failure in susceptible patients, Potassium loss Hypokalemic alkalosis Hypertension Musculoskeletal: ...

9. Overdosage

Reports of acute toxicity and/or death following overdosage of glucocorticoids are rare. In the event of overdosage, no specific antidote is available; treatment is supportive and symptomatic. The intraperitoneal ...

10. 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 ...

11. How Supplied

Cortisone Acetate Tablets, USP 25 mg: White, Round, Scored Tablet; Imprinted West-ward 202. Bottles of 100 tablets. NDC 0143-9700-01 Manufactured by: HIKMA Pharmaceuticals P.O. Box 182400, Amman 11118 ...

12. Storage and Handling

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from light and moisture. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. ...