DEXAMETHASONE SODIUM PHOSPHATE injection, solution

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

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

متاح من:

Amneal Pharmaceuticals LLC

طريقة التعاطي:

INTRA-ARTICULAR

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الخصائص العلاجية:

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.

ملخص المنتج:

Dexamethasone sodium phosphate injection USP, 4 mg/mL is supplied as a clear, colorless solution, in single-dose and multiple-dose vials as follows: 4 mg/mL, 1 mL vial 1 mL, Single-Dose Vial:                                    NDC 70121-1450-1 1 mL, 25 Single-Dose Vials in a Carton:           NDC 70121-1450-5 4 mg/mL, 5 mL vial 5 mL, Multiple-Dose Vial:                                 NDC 70121-1451-1 5 mL, 25 Multiple-Dose Vials in a Carton:        NDC 70121-1451-5 4 mg/mL, 30 mL vial 30 mL, Multiple-Dose Vial in a Carton:             NDC 70121-1452-1 Protect from light. Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. CAUTION: Federal law prohibits dispensing without a prescription. Discard unused portion of single-dose vials. Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Parenteral Unit Ahmedabad 382213, INDIA Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ  08807 Rev. 07-2020-02

الوضع إذن:

Abbreviated New Drug Application

خصائص المنتج

DEXAMETHASONE SODIUM PHOSPHATE- DEXAMETHASONE SODIUM
PHOSPHATE INJECTION, SOLUTION
AMNEAL PHARMACEUTICALS LLC
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DEXAMETHASONE SODIUM PHOSPHATE INJECTION USP, 4 MG PER 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 Pregna-1,4-diene-3,20-dione,
9-fluoro-11,17-dihydroxy-16-methyl-21-
(phosphonooxy)-, disodium salt, (11β,16α).
It occurs as a white to off-white powder, is exceedingly hygroscopic,
is soluble in water
and its solutions have a pH between 7.5 and 10.5. It has the following
structural
formula:
Dexamethasone sodium phosphate injection, USP is available in 4 mg/mL
concentration.
Each mL of dexamethasone sodium phosphate injection USP, 4 mg/mL,
contains 4.37
mg dexamethasone sodium phosphate, USP equivalent to 4 mg
dexamethasone
phosphate; 1 mg sodium sulfite; 10 mg benzyl alcohol (preservative);
and water for
injection (q.s.). Made isotonic with sodium citrate. pH adjusted with
citric acid or sodium
hydroxide.
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
22
28
2
8
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