DEXAMETHASONE SODIUM PHOSPHATE injection, solution

Land: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

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

Fáanlegur frá:

Cardinal Health 107, LLC

Stjórnsýsluleið:

INTRAMUSCULAR

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

Intravenous or Intramuscular Injection 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: • 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 • 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 • Collagen Diseases      During an exacerbation or as maintenance therapy in selected cases of:      Systemic lupus erythematosus      Acute rheumatic carditis • Dermatologic Diseases      Pemphigus      Severe erythema multiforme (Stevens-Johnson syndrome)      Exfoliative dermatitis      Bullous dermatitis herpetiformis      Severe seborrheic dermatitis      Severe psoriasis      Mycosis fungoides • 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) • 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 • Gastrointestinal Diseases      To tide the patient over a critical period of the disease in:      Ulcerative colitis (Systemic therapy)      Regional enteritis (Systemic therapy) • 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 • 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 • Neoplastic Diseases      For palliative management of:      Leukemias and lymphomas in adults      Acute leukemia of childhood • 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 • Miscellaneous      Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy      Trichinosis with neurologic or myocardial involvement • Diagnostic testing of adrenocortical hyperfunction • 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.      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      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) Systemic fungal infections (see WARNINGS regarding amphotericin B).  Hypersensitivity to any component of this product, including sulfites (see WARNINGS ).

Vörulýsing:

Product No.   16501 Dexamethasone Sodium Phosphate Injection, USP (equivalent to 4 mg per mL dexamethasone phosphate) 1 mL fill, in a 2 mL flip-top vial. Available overbagged with 5 x 1 mL single dose vials per bag, NDC 55154-9364-5 STORE AT:  20 ° to 25 °C (68 ° to 77 °F) [see USP Controlled Room Temperature].  Protect from freezing.  Sensitive to heat.  Do not autoclave.   Protect from light. Store container in carton until contents have been used.   Do not use if precipitate is present.

Leyfisstaða:

Abbreviated New Drug Application

Vara einkenni

DEXAMETHASONE SODIUM PHOSPHATE- DEXAMETHASONE SODIUM
PHOSPHATE INJECTION, SOLUTION
CARDINAL HEALTH 107, LLC
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DEXAMETHASONE SODIUM PHOSPHATE INJECTION, USP
Rx only
DESCRIPTION:
Dexamethasone sodium phosphate is a water-soluble inorganic ester of
dexamethasone. It occurs as a white or slightly yellow crystalline
powder, is odorless or
has a slight odor of alcohol, is exceedingly hygroscopic and is freely
soluble in water.
Dexamethasone sodium phosphate is an adrenocortical steroid
anti-inflammatory drug.
Chemically, dexamethasone sodium phosphate is
9-Fluoro-11ß,17,21-trihydroxy-16α-
methylpregna-1, 4-diene-3,20-dione 21-(dihydrogen phosphate) disodium
salt and has
the following structural formula:
Dexamethasone Sodium Phosphate Injection, USP is a sterile solution of
dexamethasone
sodium phosphate in water for injection for intravenous (IV),
intramuscular (IM), intra-
articular, soft-tissue or intralesional use.
Each mL contains dexamethasone sodium phosphate equivalent to
dexamethasone
phosphate 4 mg or dexamethasone 3.33 mg; benzyl alcohol 10 mg added as
preservative; sodium citrate dihydrate 11 mg; sodium sulfite 1 mg as
an antioxidant;
Water for Injection q.s. Citric acid and/or sodium hydroxide may have
been added for
pH adjustment (7.0 to 8.5). Air in the container is displaced by
nitrogen.
CLINICAL PHARMACOLOGY:
Dexamethasone sodium phosphate 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 s