METHYLPREDNISOLONE SODIUM SUCCINATE- methylprednisolone sodium succinate 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:

Sagent Pharmaceuticals

INN (International Name):

Methylprednisolone Sodium Succinate

Composition:

Methylprednisolone 40 mg in 1 mL

Administration route:

INTRAVENOUS

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, perennial or seasonal allergic rhinitis, 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 particula

Product summary:

Methylprednisolone Sodium Succinate for Injection, USP is supplied as follows: Recommended diluent contains benzyl alcohol as a preservative. Store unreconstituted product at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Store solution 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light. Use solution within 48 hours after mixing. Lyophilized. Sterile, Nonpyrogenic. The container closure is not made with natural rubber latex. SAGENT® Mfd. for SAGENT Pharmaceuticals Schaumburg, IL 60195 (USA) Made in India ©2016 Sagent Pharmaceuticals, Inc. October 2016 SAGENT Pharmaceuticals®

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

METHYLPREDNISOLONE SODIUM SUCCINATE- METHYLPREDNISOLONE SODIUM
SUCCINATE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
SAGENT PHARMACEUTICALS
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METHYLPREDNISOLONE SODIUM SUCCINATE FOR INJECTION, USP
NOT FOR USE IN NEONATES -
AFTER MIXING AS DIRECTED, CONTAINS BENZYL ALCOHOL
(FOR INTRAVENOUS OR INTRAMUSCULAR USE)
SAGENT
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-l-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 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
several strengths and packages
for intravenous or intramuscular administration.
40 MG SINGLE-DOSE VIAL—Each mL (when reconstituted with 1 mL
bacteriostatic water for injection
with benzyl alcohol) contains methylprednisolone sodium succinate
equivalent to 40 mg
methylprednisolone; also 1.6 mg monobasic sodium phosphate anhydrous;
17.46 mg dibasic sodium
phosphate dried; 25 mg lactose monohydrate and benzyl alcohol as
preservative.
125 MG SINGLE-DOSE VIAL—Each 2 mL (when reconstituted with 2 mL
bacteriostatic water for injection
with benzyl alcohol) contains methylprednisolone sodium succinate
equivalent to 125 mg
methylprednisolone; also 1.6 mg mono