METHYLPREDNISOLONE SODIUM SUCCINATE injection, powder, lyophilized, for solution

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

METHYLPREDNISOLONE SODIUM SUCCINATE (UNII: LEC9GKY20K) (METHYLPREDNISOLONE - UNII:X4W7ZR7023)

זמין מ:

REMEDYREPACK INC.

מסלול נתינה (של תרופות):

INTRAVENOUS

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

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, the intravenous or intramuscular use of Methylprednisolone Sodium Succinate for Injection sterile powder is indicated as follows: Allergic states : Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, serum sickness, transfusion reactions. Dermatologic diseases : Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema multiforme (Stevens-Johnson syndrome). 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), congenital adrenal hyperplasia, hypercalcemia associated with cancer, nonsuppurative thyroiditis. Gastrointestinal diseases : To tide the patient over a critical period of the disease in regional enteritis (systemic therapy) and ulcerative colitis. Hematologic disorders : Acquired (autoimmune) hemolytic anemia, congenital (erythroid) hypoplastic anemia (Diamond-Blackfan anemia), idiopathic thrombocytopenic purpura in adults (intravenous administration only; intramuscular administration is contraindicated), pure red cell aplasia, selected cases of secondary thrombocytopenia. Miscellaneous : Trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy. Neoplastic diseases : For the palliative management of leukemias and lymphomas. Nervous System : Acute exacerbations of multiple sclerosis; cerebral edema associated with primary or metastatic brain tumor, or craniotomy. Ophthalmic diseases: Sympathetic ophthalmia, uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids. Renal diseases: To induce diuresis or remission of proteinuria in idiopathic nephrotic syndrome or that due to lupus erythematosus. Respiratory diseases: Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis. Rheumatic disorders: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis; acute rheumatic carditis; ankylosing spondylitis; psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). For the treatment of dermatomyositis, temporal arteritis, polymyositis, and systemic lupus erythematosus. Methylprednisolone Sodium Succinate for Injection sterile powder is contraindicated: - in systemic fungal infections and patients with known hypersensitivity to the product and its constituents. The Methylprednisolone Sodium Succinate for Injection, USP 40 mg presentation includes lactose monohydrate produced from cow's milk. This presentation is therefore contraindicated in patients with a known or suspected hypersensitivity to cow's milk or its components or other dairy products because it may contain trace amounts of milk ingredients. - for intrathecal administration. Reports of severe medical events have been associated with this route of administration. Intramuscular corticosteroid preparations are contraindicated for idiopathic thrombocytopenic purpura. After mixing as directed, methylprednisolone contains benzyl alcohol. The use of methylprednisolone, reconstituted with benzyl alcohol are contraindicated for use in premature infants. (See WARNINGS and PRECAUTIONS, Pediatric Use .)

leaflet_short:

Methylprednisolone Sodium Succinate for Injection, USP sterile powder is available as follows: The container closure is not made with natural rubber latex. NDC: 70518-3128-00 NDC: 70518-3128-01 PACKAGING: 25 in 1 TRAY PACKAGING: 2 mL in 1 VIAL SINGLE DOSE TYPE 0 Protect from light. Store unreconstituted product at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Store solution at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Use solution within 48 hours after mixing. Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

מצב אישור:

Abbreviated New Drug Application

מאפייני מוצר

METHYLPREDNISOLONE SODIUM SUCCINATE- METHYLPREDNISOLONE SODIUM
SUCCINATE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
REMEDYREPACK INC.
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METHYLPREDNISOLONE SODIUM SUCCINATE FOR INJECTION, USP
AFTER MIXING AS DIRECTED, CONTAINS BENZYL ALCOHOL.
NOT FOR USE IN NEONATES.
FOR INTRAVENOUS OR INTRAMUSCULAR ADMINISTRATION
Rx only
DESCRIPTION
Methylprednisolone Sodium Succinate for Injection, USP sterile powder
is an anti-
inflammatory glucocorticoid, which contains methylprednisolone sodium
succinate as
the active ingredient. Methylprednisolone sodium succinate, USP, is
the sodium
succinate ester of methylprednisolone, and it occurs as a white, or
nearly white,
odorless hygroscopic, amorphous solid. It is very soluble in water and
in alcohol; it is
insoluble in chloroform and is very slightly soluble in acetone.
The chemical name for methylprednisolone sodium succinate is
pregna-1,4-diene-3,20-
dione, 21-(3-carboxy-1-oxopropoxy)-11,
17-dihydroxy-6-methyl-monosodium salt, (6α,
11β). The structural formula is represented below:
Methylprednisolone sodium succinate is soluble in water; it may be
administered in a
small volume of diluent and is well suited for intravenous use in
situations where high
blood levels of methylprednisolone are required rapidly.
Methylprednisolone Sodium Succinate for Injection, USP is available in
three strengths
for intravenous or intramuscular administration.
40 MG (SINGLE-DOSE VIAL)Each mL (when mixed as directed) contains
methylprednisolone sodium succinate equivalent to 40 mg
methylprednisolone; also 1.6
mg monobasic sodium phosphate anhydrous; 17.46 mg dibasic sodium
phosphate dried
and 25 mg lactose hydrous; and benzyl alcohol.
125 MG (SINGLE-DOSE VIAL)Each 2 mL (when mixed as directed) contains
methylprednisolone sodium succinate equivalent to 125 mg
methylprednisolone; also 1.6
mg monobasic sodium phosphate anhydrous; and 17.4 mg dibasic sodium
phosphate
mg monobasic sodium phosphate anhydrous; and 17.4 mg dibasic sodium
phosphate
dried; and benzyl alcohol.
1 G (MULTIPLE DOSE