METHYLPREDNISOLONE SODIUM SUCCINATE injection, powder, for solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Hikma Pharmaceuticals USA Inc.

Administration route:

INTRAMUSCULAR

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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, USP, is indicated as follows: Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, perennial or seasonal allergic rhinitis, serum sickness, transfusion reactions. Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema multiforme (Stevens-Johnson syndrome). 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. To tide the patient over a critical period of the disease in regional enteritis (systemic therapy) and ulcerative colitis. 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. Trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy. For the palliative management of leukemias and lymphomas. Acute exacerbations of multiple sclerosis; cerebral edema associated with primary or metastatic brain tumor, or craniotomy. Sympathetic ophthalmia, uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids. To induce diuresis or remission of proteinuria in idiopathic nephrotic syndrome or that due to lupus erythematosus. Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis. 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 sterile powder is contraindicated: - In systemic fungal infections and patients with known hypersensitivity to the product and its constituents; - 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. The use of Methylprednisolone Sodium Succinate for Injection is contraindicated in premature infants because when reconstituted will contain benzyl alcohol. (See WARNINGS  and PRECAUTIONS: Pediatric Use)

Product summary:

Methylprednisolone Sodium Succinate for Injection, USP is available in the following packages: Manufactured by: HIKMA FARMACÊUTICA (PORTUGAL), S.A. Estrada do Rio da Mó, nº 8, 8A e 8B – Fervença, 2705 – 906 Terrugem SNT PORTUGAL Distributed by: HIKMA PHARMACEUTICALS USA INC. BERKELEY HEIGHTS, NJ 07922 USA PIN521-WES/3 Revised: December 2023

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

METHYLPREDNISOLONE SODIUM SUCCINATE- METHYLPREDNISOLONE SODIUM
SUCCINATE INJECTION, POWDER, FOR SOLUTION
HIKMA PHARMACEUTICALS USA INC.
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METHYLPREDNISOLONE SODIUM SUCCINATE FOR INJECTION, USP
AFTER RECONSTITUTING AS DIRECTED, CONTAINS BENZYL ALCOHOL. NOT FOR USE
IN
NEONATES.
FOR INTRAVENOUS OR INTRAMUSCULAR ADMINISTRATION
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 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), and the molecular weight is 496.53. The structural formula is
represented below:
Methylprednisolone Sodium Succinate, USP 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, USP, is available in two
strengths and packages
for intravenous or intramuscular administration:
500 MG (MULTIPLE USE VIAL)—Each 8 mL (when mixed) contains
Methylprednisolone
Sodium Succinate, USP equivalent to 500 mg methylprednisolone; also
6.4 mg
monobasic sodium phosphate anhydrous; and 69.6 mg dibasic sodium
phosphate dried.
1 GRAM (MULTIPLE USE VIAL)—Each 16 mL (when mixed) contains
Methylprednisolone
Sodium Succinate, USP equivalent to 1 gram methylprednisolone; also
12.8 mg
monobasic sodium phosphate anhydrous; and 139.2 mg dibasic sodium
phosphate
dried.
IMPORTANT — Use only Bacteriostatic Water For Injection with Benzyl
Alcohol when
reconstituting Methylprednisolone Sodium Suc