METHYLPREDNISOLONE SODIUM SUCCINATE- methylprednisolone injection, powder, lyophilized, 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:

Amneal Pharmaceuticals LLC

INN (International Name):

METHYLPREDNISOLONE SODIUM SUCCINATE

Composition:

METHYLPREDNISOLONE 40 mg in 1 mL

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 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 is contraindicated: - in systemic fungal infections and patients with known hypersensitivity to the product and its constituents. The methylprednisolone sodium succinate, 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, is contraindicated for use in premature infants (see WARNINGS and PRECAUTIONS, Pediatric Use ).

Product summary:

Methylprednisolone sodium succinate for injection, USP is supplied as a white to off-white lyophilized cake or powder, available in the following packages: 40 mg/vial (1 mL) (Single-Dose Vial):                        NDC 70121-1000-1 25 vials in 1 carton:                                                     NDC 70121-1000-5 125 mg/vial (2 mL) (Single-Dose Vial):                      NDC 70121-1001-1 25 vials in 1 carton:                                                     NDC 70121-1001-5 This product’s label may have been updated. For current full prescribing information, please visit www.amneal.com. Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Parenteral Unit Ahmedabad 382213, INDIA Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 Rev. 07-2021-04

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

METHYLPREDNISOLONE SODIUM SUCCINATE- METHYLPREDNISOLONE INJECTION,
POWDER, LYOPHILIZED, FOR SOLUTION
AMNEAL PHARMACEUTICALS LLC
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METHYLPREDNISOLONE SODIUM SUCCINATE FOR INJECTION, USP
40 MG/VIAL (1 ML) AND 125 MG/VIAL (2 ML)
RX ONLY
After mixing as directed, contains Benzyl Alcohol.
Not for use in neonates.
FOR INTRAVENOUS OR INTRAMUSCULAR ADMINISTRATION
DESCRIPTION
Methylprednisolone sodium succinate for injection, USP is an
anti-inflammatory
glucocorticoid, which contains methylprednisolone sodium succinate,
USP 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), 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 for injection, USP is available in
below formulations:
FORMULATIONS
40 MG (SINGLE-DOSE VIAL)—Each mL (when mixed) contains
methylprednisolone
sodium succinate, USP equivalent to 40 mg methylprednisolone, USP.
Also contains
benzyl alcohol; lactose hydrous, 25 mg; monobasic sodium phosphate
anhydrous, 1.6
mg; and dibasic sodium phosphate dried, 17.46 mg.
125 MG (SINGLE-DOSE VIAL)—Each 2 mL (when mixed) contains
methylprednisolone
sodium succinate, USP equivalent to 125 mg methylprednisolone, USP.
Also contains
benzyl alcohol; monobasic sodium phosphate anhydrous, 1.6 mg; and
dibasic sodium
phosphate dried, 17.4 mg.
IMPORTANT - Use only Bacteriostatic Water for Inje