DEXAMETHASONE SODIUM PHOSPHATE injection

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

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

Disponível em:

REMEDYREPACK INC.

Via de administração:

INTRAMUSCULAR

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

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.

Resumo do produto:

Dexamethasone Sodium Phosphate Injection, USP (Preservative Free) equivalent to 10 mg dexamethasone phosphate, is supplied in a single dose vial as follows: NDC: 70518-1922-00 NDC: 70518-1922-01 PACKAGING: 1 mL in 1 VIAL, TYPE 0 PACKAGING: 25 in 1 CARTON 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. Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

Status de autorização:

Abbreviated New Drug Application

Características técnicas

DEXAMETHASONE SODIUM PHOSPHATE- DEXAMETHASONE SODIUM PHOSPHATE
INJECTION
REMEDYREPACK INC.
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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
supplement