DEXAMETHASONE SODIUM PHOSPHATE injection

Land: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

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

Fáanlegur frá:

Gland Pharma Limited

Stjórnsýsluleið:

INTRAVENOUS

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

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 infections.

Vörulýsing:

Dexamethasone Sodium Phosphate Injection USP, 4 mg/mL, is a sterile, clear colorless to almost colorless solution free from foreign visible particles supplied as; Dexamethasone Sodium Phosphate Injection, USP (Preservative Free) equivalent to 10 mg dexamethasone phosphate, is supplied as follows: This container closure is not made with natural rubber latex. Storage Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature]. Protect from light. Single dose vials–Store in container until time of use. Discard unused portion. Manufactured by: Gland Pharma Limited Pashamylaram, Patancheru, Hyderabad – 502 307, India Revised: February 2024

Leyfisstaða:

Abbreviated New Drug Application

Vara einkenni

DEXAMETHASONE SODIUM PHOSPHATE - DEXAMETHASONE SODIUM
PHOSPHATE INJECTION
GLAND PHARMA LIMITED
----------
DEXAMETHASONE SODIUM PHOSPHATE - DEXAMETHASONE SODIUM PHOSPHATE
INJECTION, SOLUTION
DEXAMETHASONE SODIUM PHOSPHATE INJECTION
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 C
H
FNa O P, has a molecular weight of
516.4 and chemically is 9-fluoro-11β, 17,
21-trihydroxy-16α-methylpregna-1,4-diene-
3,20-dione, 21-(dihydrogen phosphate) disodium salt.
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:
Dexamethasone Sodium Phosphate Injection, USP is available in 4 mg/mL
and 10 mg/mL
concentrations.
Each mL of Dexamethasone Sodium Phosphate Injection USP, 4 mg/mL
contains
dexamethasone sodium phosphate, USP equivalent to 4 mg of
dexamethasone
phosphate; 11 mg sodium citrate anhydrous; 1 mg sodium sulfite; 10 mg
benzyl alcohol
(preservative); water for injection, q.s. NaOH and/or citric acid
monohydrate to adjust
pH if necessary.
Each mL of Dexamethasone Sodium Phosphate Injection USP, 10 mg/mL
(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 or sodium hydroxide, if
necessary. pH: 7.0 to
8.5.
22
28
2
8
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