Methylprednisolone Sodium Succinate

METHYLPREDNISOLONE SODIUM SUCCINATE- methylprednisolone sodium succinate injection, powder, for solution
Hikma Pharmaceuticals USA Inc.

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 chemical structure

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 Succinate for Injection, USP.

Use within 48 hours after mixing.

When necessary, the pH of each formula was adjusted with sodium hydroxide so that the pH of the reconstituted solution is within the USP specified range of 7 to 8 and the tonicities are, for the 500 mg per 8 mL and 1 gram per 16 mL solutions, 0.33 osmolar. (Isotonic saline = 0.28 osmolar)

CLINICAL PHARMACOLOGY

Glucocorticoids, naturally occurring and synthetic, are adrenocortical steroids that are readily absorbed from the gastrointestinal tract.

Naturally occurring glucocorticoids (hydrocortisone and cortisone), 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 the body’s immune responses to diverse stimuli.

Methylprednisolone is a potent anti-inflammatory steroid with greater anti-inflammatory potency than prednisolone and even less tendency than prednisolone to induce sodium and water retention.

Methylprednisolone Sodium Succinate has the same metabolic and anti-inflammatory actions as methylprednisolone. When given parenterally and in equimolar quantities, the two compounds are equivalent in biologic activity. Following the intravenous injection of Methylprednisolone Sodium Succinate, demonstrable effects are evident within one hour and persist for a variable period. Excretion of the administered dose is nearly complete within 12 hours. Thus, if constantly high blood levels are required, injections should be made every 4 to 6 hours. This preparation is also rapidly absorbed when administered intramuscularly and is excreted in a pattern similar to that observed after intravenous injection.

INDICATIONS AND USAGE

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:

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 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.

CONTRAINDICATIONS

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)

WARNINGS

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