Methylprednisolone Acetate Injection, USP, 40 mg/mL, 1 mL Single-Dose Vial

Product Specifications

Specification	Details
Manufacturer / Brand	Amneal Pharmaceuticals, LLC
Manufacturer # / SKU	70121157301
NDC Number	70121-1573-01 (Vial) / 70121-1573-1 (Box)
Active Ingredient	Methylprednisolone Acetate
Strength	40 mg / mL
Volume	1 mL
Container Type	Single-Dose Vial (SDV)
Formulation	Sterile Aqueous Suspension
Application	IM / Intra-synovial / Soft Tissue Injection
Storage	20°C to 25°C (68°F to 77°F); Do not freeze

Key Features

• Sustained Release: The acetate ester provides a slower rate of absorption, allowing for prolonged therapeutic activity at the site of injection.

• Versatile Administration: Indicated for various routes including intramuscular (systemic) and intra-articular (localized joint) injections.

• Single-Dose Safety: Packaged in a 1 mL single-dose vial to ensure sterility and minimize the risk of cross-contamination.

• Potent Anti-Inflammatory: Effectively suppresses symptoms of intense inflammation, particularly in rheumatologic and dermatologic disorders.

• High Tactile Control: Formulated as a smooth suspension for consistent flow through fine-gauge needles.

Clinical Applications

• Rheumatoid Arthritis: Short-term adjunctive therapy for acute episodes.

• Osteoarthritis: Intra-articular injection for localized relief of pain and inflammation.

• Severe Allergic Reactions: Systemic control of conditions like bronchial asthma or contact dermatitis.

• Dermatologic Conditions: Used for intralesional treatment of localized hypertrophic, inflammatory, or lichenified lesions.

⚠️ Usage Note: NOT FOR INTRAVENOUS (IV) USE. This is an aqueous suspension and must only be used for IM, intra-articular, or soft tissue injection.

⚠️ Safety Alert: Use strict aseptic technique. Do not use if the suspension has clumped or changed color.

⚠️ Contraindication: Do not administer to patients with systemic fungal infections or those with hypersensitivity to methylprednisolone.