Methylprednisolone Sodium Succinate Injection

NDC: 43598-129-25

Methylprednisolone Sodium Succinate for Injection USP, 125 mg, 2 mL Single-Dose Vial — Dr. Reddy's (25/Carton)

Indications and Usage

Injectable corticosteroid indicated, when oral therapy is not feasible, for severe allergic, dermatologic, endocrine, gastrointestinal, hematologic, neoplastic, nervous system, ophthalmic, renal, respiratory, and rheumatic disorders, including palliative management of leukemias and lymphomas and acute exacerbations of multiple sclerosis.

Dosage and Administration

Initial dosage typically ranges from 10 to 40 mg depending on the condition being treated; higher doses (up to 30 mg/kg) may be used in life-threatening situations. Reconstitute using only Water for Injection or Bacteriostatic Water for Injection and use within 48 hours. Not for epidural or intrathecal administration.

Warnings and Precautions

• Serious neurologic events, some fatal, have been reported with epidural injection; not approved for this route
• Contains benzyl alcohol after reconstitution, which has been associated with serious toxicity, including "gasping syndrome," in neonates
• May cause adrenal suppression and immunosuppression, increasing susceptibility to infection and masking its signs
• May cause fluid retention, elevated blood pressure, cataracts, glaucoma, GI perforation, osteoporosis, and psychiatric disturbances

Contraindications

Contraindicated in systemic fungal infections, intrathecal administration, and patients with known hypersensitivity to any component; the 40 mg presentation is also contraindicated in patients with cow's milk hypersensitivity due to lactose content.

Adverse Reactions

Reported reactions include anaphylaxis, cardiac arrhythmias and hypertension, hyperglycemia, skin atrophy, osteoporosis and aseptic necrosis, increased intraocular pressure, psychiatric effects, and gastrointestinal perforation.

Storage and Handling

Protect from light. Store unreconstituted product at 20°C to 25°C (68°F to 77°F). Store reconstituted solution at the same temperature and use within 48 hours.

How Supplied

Sterile, white to off-white lyophilized powder equivalent to 125 mg methylprednisolone, supplied in a 2 mL single-dose vial, 25 vials per carton.

Professional use only. Clinical information summarized from FDA-approved prescribing information (Structured Product Labeling); refer to the full prescribing information via DailyMed for complete details.

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