DEXAMETHASONE SODIUM PHOSPHATE injection, solution

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

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

Beschikbaar vanaf:

Somerset Therapeutics, LLC

Toedieningsweg:

INTRAMUSCULAR

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

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 leukemic 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. Systemic fungal infections.

Product samenvatting:

Dexamethasone Sodium Phosphate Injection, USP (Preserved) 10 mg/mL is clear, colorless solution and is supplied as follows: The vial stopper closure is not made with natural rubber latex. Storage Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light. Store container in carton until contents are used. For Product Inquiry call 1-800-417-9175. Manufactured for: Somerset Therapeutics, LLC Hollywood, FL 33024 Made in India Code No.: KR/DRUGS/KTK/28/289/97 ST-DEX22/P/01 Issued: November, 2019

Autorisatie-status:

Abbreviated New Drug Application

Productkenmerken

DEXAMETHASONE SODIUM PHOSPHATE- DEXAMETHASONE SODIUM
PHOSPHATE INJECTION, SOLUTION
SOMERSET THERAPEUTICS, LLC
----------
DEXAMETHASONE SODIUM PHOSPHATE INJECTION, USP 10 MG/ML
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, C
H
FNa O P, has a molecular weight of 516.41
and chemically is Pregn-4-ene-3, 20-dione, 9-fluoro-11,
17-dihydroxy-16-methyl-21
(phosphonooxy)-, disodium salt, (11β, 16α).
It occurs as a white to practically white powder, is exceedingly
hygroscopic, is soluble in
water and its solutions have a pH between 7.5 and 9.5. It has the
following structural
formula:
Each mL of Dexamethasone Sodium Phosphate Injection, USP (Preserved)
10 mg/mL
contains dexamethasone sodium phosphate, USP equivalent to 10 mg
dexamethasone
phosphate; 13.5 mg sodium citrate, dihydrate; 10 mg benzyl alcohol;
and Water for
Injection, q.s. pH adjusted with citric acid or sodium hydroxide, if
necessary. pH: 7.0 to
8.5.
CLINICAL PHARMACOLOGY
Naturally occurring glucocorticoids (hydrocortisone), 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_
22
28
2
8
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
mine