DECADRON Oral solution (2017)

Βιβλιογραφική αναφορά

Συγγραφείς

Pragma Pharmaceuticals, LLC

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1. Description

Each 5 mL (teaspoonful) contains: Dexamethasone, USP 0.5 mg. Also contains: Benzoic Acid, USP (as preservative) 0.1% Alcohol (% v/v) 5.1% Inactive Ingredients: artificial raspberry flavor; citric...

2. Clinical Pharmacology

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

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 se...

6. Precautions

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 pati...

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 s...

7. Adverse Reactions

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

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 ...

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 0.75 to 9 mg a day ...

11. How Supplied

DECADRON Dexamethasone Elixir, USP 0.5 mg/5 mL is supplied as a clear, red, raspberry-flavored liquid in the following size: 8 fl oz (237 mL) bottle NDC 58463-010-08 Manufactured for: Pragma Pharma...

12. Storage and Handling

Store at 20˚-25˚C (68˚-77˚F) [See USP Controlled Room Temperature]. KEEP TIGHTLY CLOSED. AVOID FREEZING. Dispense in a tight container as defined in the USP.