DEXAMETHASONE SODIUM PHOSPHATE injection

देश: संयुक्त राज्य

भाषा: अंग्रेज़ी

स्रोत: NLM (National Library of Medicine)

सक्रिय संघटक:

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

थमां उपलब्ध:

Somerset Therapeutics, LLC

प्रशासन का मार्ग:

INTRAMUSCULAR

प्रिस्क्रिप्शन प्रकार:

PRESCRIPTION DRUG

चिकित्सीय संकेत:

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 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. Nervous System Acute exacerbations of multiple sclerosis 13. Miscellaneous Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate anti-tuberculous 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. 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. 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 infections.

उत्पाद समीक्षा:

Dexamethasone Sodium Phosphate Injection, USP (Preservative  Free) equivalent to 10 mg dexamethasone phosphate, is supplied in a single dose vial as follows: NDC    No              Strength          Vial  Size 70069-021 -25       10 mg/mL        1 mL Vial Packaged in twenty-fives. 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]. Sensitive to heat. Do not autoclave. Protect from freezing. Protect  from  light. Single  dose  vials  –Store  in  container  until  time  of  use.  Discard  unused  portion.   Manufactured for:  Somerset Therapeutics, LLC Hollywood, FL 33024 Made in India Code No.: KR/DRUGS/KTK/28/289/97 PSSO0376 ST-DEX21/P/04 Revised: 05/2021 Made in India Neutral Code No: TN/DRUGS/616/1996 PSMV0003 ST-DEX-MPPL/P/00 Revised: 05/2021

प्राधिकरण का दर्जा:

Abbreviated New Drug Application

उत्पाद विशेषताएं

DEXAMETHASONE SODIUM PHOSPHATE- DEXAMETHASONE SODIUM
PHOSPHATE INJECTION
SOMERSET THERAPEUTICS, 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 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 practically white powder, is 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 (PRESERVATIVE
FREE)
contains dexamethasone sodium phosphate, USP equivalent to 10 mg
dexamethasone
phosphate; 24.75 mg, sodium citrate, dihydrate; and Water for
Injection, q.s. pH
adjusted with citric acid monohydrate or sodium hydroxide, if
necessary. pH: 7.0 to 8.5.
ACTIONS
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
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