DEXAMETHASONE SODIUM PHOSPHATE- dexamethasone sodium phosphate injection, emulsion

Pajjiż: Stati Uniti

Lingwa: Ingliż

Sors: NLM (National Library of Medicine)

Ingredjent attiv:

DEXAMETHASONE SODIUM PHOSPHATE (UNII: AI9376Y64P) (DEXAMETHASONE - UNII:7S5I7G3JQL)

Disponibbli minn:

Fresenius Kabi USA, LLC

Rotta amministrattiva:

INTRAMUSCULAR

Tip ta 'preskrizzjoni:

PRESCRIPTION DRUG

Indikazzjonijiet terapewtiċi:

A. Intravenous or intramuscular administration.   When oral therapy is not feasible and the strength, dosage form, and route of administration of the drug reasonably lend the preparation to the treatment of the condition, those products labeled for intravenous or intramuscular use are indicated as follows: 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.      Allergic corneal marginal ulcers.      Keratitis. 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       anti-tuberculosis chemotherapy.      Loeffler’s syndrome not manageable by other means.      Aspiration pneumonitis. 9. Hematologic disorders.      Acquired (autoimmune) hemolytic anemia.      Idiopathic thrombocytopenic purpura in adults      (I.V. only; I.M. 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.   Nervous system.          Acute exacerbations of multiple sclerosis. 13. Miscellaneous.      Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate anti-tuberculosis chemotherapy.      Trichinosis with neurologic or myocardial involvement.      Diagnostic testing of adrenocortical hyperfunction.       Cerebral edema of diverse etiologies in conjunction with adequate neurological evaluation and management. B. Intra-articular or soft tissue administration.   When the strength and dosage form of the drug lend      the preparation to the treatment of the condition, those products labeled for intra-articular or soft      tissue administration are indicated 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. Intralesional administration. When the strength and dosage form of the drug lend the preparation to       the treatment of the condition, those products labeled for intralesional administration are       indicated for:      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.      They also may be useful in cystic tumors of an aponeurosis tendon (ganglia). Systemic fungal infection.

Sommarju tal-prodott:

Dexamethasone Sodium Phosphate Injection, USP (Preservative Free)   equivalent to 10 mg dexamethasone phosphate, is supplied as: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].  Sensitive to heat. Do not autoclave. Protect from freezing. Protect from light (keep in outer carton). Do NOT place syringe on a Sterile Field. Discard unused portion.

L-istatus ta 'awtorizzazzjoni:

Abbreviated New Drug Application

Karatteristiċi tal-prodott

DEXAMETHASONE SODIUM PHOSPHATE - DEXAMETHASONE SODIUM
PHOSPHATE INJECTION, EMULSION
FRESENIUS KABI USA, LLC
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DEXAMETHASONE SODIUM PHOSPHATE INJECTION, USP
FOR INTRAVENOUS OR INTRAMUSCULAR USE ONLY.
Rx only
DESCRIPTION:
Dexamethasone Sodium Phosphate Injection, USP, is a water-soluble
inorganic ester of
dexamethasone which produces a rapid response even when injected
intramuscularly.
Dexamethasone Sodium Phosphate, USP has a molecular weight of 516.41
and
chemically is Pregna-1,4-diene-3,20-dione,
9-fluoro-11,17-dihydroxy-16-methyl-21-
(phosphonooxy)-, disodium salt, (11ß, 16α).
It occurs as a white to creamy white powder, is exceedingly
hygroscopic, is soluble in
water and its solutions have a pH between 7.0 and 8.5. It has the
following structural
formula:
Each mL of Dexamethasone Sodium Phosphate Injection, USP (PRESERVATIVE
FREE)
contains Dexamethasone Sodium Phosphate, USP equivalent to 10 mg
dexamethasone
phosphate; 25.80 mg sodium citrate dihydrate; and water for injection,
q.s. pH adjusted
with citric acid or sodium hydroxide, if necessary. pH: 7.0 to 8.5.
CLINICAL PHARMACOLOGY:
ACTIONS
Naturally occurring glucocorticoids (hydrocortisone 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.
INDICATIONS AND USAGE:
_A. INTRAVENOUS OR INTRAMUSCULAR ADMINISTRATION._ When oral therapy is
not
feasible and the strength, dosage form, and route of administration of
the drug
reasonably lend the preparation to the treatment of the condition,
those products
labeled for intravenous or intramuscular use are indicated as follows:
1. _ENDOCRINE DISORDERS. _Primary or secondary adrenocortical
insufficiency
(hydrocortisone or cortisone is the drug of choice; synthetic analogs
may be us