ReadySharp Dexamethasone

READYSHARP DEXAMETHASONE- dexamethasone sodium phosphate injection
Terrain Pharmaceuticals

DESCRIPTION

Dexamethasone sodium phosphate, a synthetic adrenocortical steroid, is a white or slightly yellow crystalline powder. It is freely soluble in water and is exceedingly hygroscopic. The molecular weight is 516.41. It is designated chemically as 9-fluoro-11β,17-dihydroxy-16α-methyl-21-(phosphonooxy)pregna-1,4-diene-3, 20-dione disodium salt.

The molecular formula is: C 22 H 28 FNa 2 O 8 P and the structural formula is:

Structural formula
(click image for full-size original)

Dexamethasone Sodium Phosphate Injection is a sterile solution of dexamethasone sodium phosphate for intravenous and intramuscular use. The 4 mg/mL strength may also be used for intra-articular, intralesional and soft tissue administration.

Each mL of Dexamethasone Sodium Phosphate Injection 4 mg/mL contains dexamethasone sodium phosphate, equivalent to 4 mg dexamethasone phosphate or 3.33 mg dexamethasone. Inactive ingredients per mL: 1 mg sodium sulfite anhydrous, 19.4 mg sodium citrate anhydrous and 10.42 mg (0.01 mL) benzyl alcohol (preservative) in Water for Injection.

Each mL of Dexamethasone Sodium Phosphate Injection 10 mg/mL contains dexamethasone sodium phosphate, equivalent to 10 mg dexamethasone phosphate or 8.33 mg dexamethasone. Inactive ingredients per mL: 1.5 mg sodium sulfite anhydrous, 16.5 mg sodium citrate anhydrous and 10.42 mg (0.01 mL) benzyl alcohol (preservative) in Water for Injection.

The pH of both concentrations is 7.0-8.5; sodium hydroxide and/or citric acid used, if needed, for pH adjustment. Sealed under nitrogen.

CLINICAL PHARMACOLOGY

Dexamethasone sodium phosphate injection has a rapid onset but short duration of action when compared with less soluble preparations. Because of this, it is suitable for the treatment of acute disorders responsive to adrenocortical steroid therapy.

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

At equipotent anti-inflammatory doses, dexamethasone almost completely lacks the sodium-retaining property of hydrocortisone and closely related derivatives of hydrocortisone.

INDICATIONS AND USAGE

A. By Intravenous or Intramuscular Injection When Oral Therapy is not Feasible:

1. ENDOCRINE DISORDERS

Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance)

Acute adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; mineralocorticoid supplementation may be necessary, particularly when synthetic analogs are used)

Preoperatively, and in the event of serious trauma or illness, in patients with known adrenal insufficiency or when adrenocortical reserve is doubtful

Shock unresponsive to conventional therapy if adrenocortical insufficiency exists or is suspected

Congenital adrenal hyperplasia

Nonsuppurative thyroiditis

Hypercalcemia associated with cancer

2. RHEUMATIC DISORDERS

As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in:

Post-traumatic osteoarthritis

Synovitis of osteoarthritis

Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy)

Acute and subacute bursitis

Epicondylitis

Acute nonspecific tenosynovitis

Acute gouty arthritis

Psoriatic arthritis

Ankylosing spondylitis

3. COLLAGEN DISEASES

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

Systemic lupus erythematosus

Acute rheumatic carditis

4. DERMATOLOGIC DISEASES

Pemphigus

Severe erythema multiforme (Stevens-Johnson syndrome)

Exfoliative dermatitis

Bullous dermatitis herpetiformis

Severe seborrheic dermatitis

Severe psoriasis

Mycosis fungoides

5. ALLERGIC STATES

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

Bronchial asthma

Contact dermatitis

Atopic dermatitis

Serum sickness

Seasonal or perennial allergic rhinitis

Drug hypersensitivity reactions

Urticarial transfusion reactions

Acute noninfectious laryngeal edema (epinephrine is the drug of first choice)

6. OPHTHALMIC DISEASES

Severe acute and chronic allergic and inflammatory processes involving the eye, such as:

Herpes zoster ophthalmicus

Iritis, iridocyclitis

Chorioretinitis

Diffuse posterior uveitis and choroiditis

Optic neuritis

Sympathetic ophthalmia

Anterior segment inflammation

Allergic conjunctivitis

Keratitis

Allergic corneal marginal ulcers

7. GASTROINTESTINAL DISEASES

To tide the patient over a critical period of the disease in:

Ulcerative colitis (Systemic therapy)

Regional enteritis (Systemic therapy)

8. RESPIRATORY DISEASES

Symptomatic sarcoidosis

Berylliosis

Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy

Loeffler’s syndrome not manageable by other means

Aspiration pneumonitis

9. HEMATOLOGIC DISORDERS

Acquired (autoimmune) hemolytic anemia

Idiopathic thrombocytopenic purpura in adults (IV only; IM administration is contraindicated)

Secondary thrombocytopenia in adults

Erythroblastopenia (RBC anemia)

Congenital (erythroid) hypoplastic anemia

10. NEOPLASTIC DISEASES

For palliative management of:

Leukemias and lymphomas in adults

Acute leukemia of childhood

11. EDEMATOUS STATES

To induce diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type, or that due to lupus erythematosus

12. MISCELLANEOUS

Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy

Trichinosis with neurologic or myocardial involvement

13. DIAGNOSTIC TESTING OF ADRENOCORTICAL HYPERFUNCTION

14. CEREBRAL EDEMA associated with primary or metastatic brain tumor, craniotomy or head injury. Use in cerebral edema is not a substitute for careful neurosurgical evaluation and definitive management such as neurosurgery or other specific therapy.

B. By Intra-Articular or Soft Tissue Injection

As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in:

Synovitis of osteoarthritis

Rheumatoid arthritis

Acute and subacute bursitis

Acute gouty arthritis

Epicondylitis

Acute nonspecific tenosynovitis

Post-traumatic osteoarthritis

C. By Intralesional Injection

Keloids

Localized hypertrophic, infiltrated, inflammatory lesions of: lichen planus, psoriatic plaques, granuloma annulare, and lichen simplex chronicus (neurodermatitis)

Discoid lupus erythematosus

Necrobiosis lipoidica diabeticorum

Alopecia areata

May also be useful in cystic tumors of an aponeurosis or tendon (ganglia).

CONTRAINDICATIONS

Systemic fungal infections (see WARNINGS regarding amphotericin B).

Hypersensitivity to any component of this product, including sulfites (see WARNINGS).

WARNINGS

Serious Neurologic Adverse Reactions with Epidural Administration

Serious neurologic events, some resulting in death, have been reported with epidural injection of corticosteroids. Specific events reported include, but are not limited to, spinal cord infarction, paraplegia, quadriplegia, cortical blindness, and stroke. These serious neurologic events have been reported with and without use of fluoroscopy. The safety and effectiveness of epidural administration of corticosteroids has not been established, and corticosteroids are not approved for this use.

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