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P-Care D80G
  • Professionals
  • FDA PI

P-Care D80G

Generic name: methylprednisolone acetate, povidone-iodine, isopropyl alcohol
Dosage form: kit

DEPO-MEDROL - methylprednisolone acetate injection, suspension

DEPO-MEDROL®
(methylprednisolone acetate injectable suspension, USP)

Pharmacia and Upjohn Company LLC

Single-Dose Vial

Not For Intravenous Use

P-Care D80G Description

DEPO-MEDROL is an anti-inflammatory glucocorticoid for intramuscular, intra-articular, soft tissue or intralesional injection. It is available as single-dose vials in two strengths: 40 mg/mL, 80 mg/mL.

Each mL of these preparations contains:

Methylprednisolone acetate40 mg80 mg
Polyethylene glycol 335029 mg 28 mg
Myristyl-gamma-picolinium chloride 0.195 mg 0.189 mg

Sodium Chloride was added to adjust tonicity.

When necessary, pH was adjusted with sodium hydroxide and/or hydrochloric acid.

The pH of the finished product remains within the USP specified range (e.g., 3.0 to 7.0.)

The chemical name for methylprednisolone acetate is pregna-1,4-diene-3,20-dione, 21-(acetyloxy)-11,17-dihydroxy-6-methyl-,(6α,11β)- and the molecular weight is 416.51. The structural formula is represented below:

Methylprednisolone Acetate Structural Formula

DEPO-MEDROL Sterile Aqueous Suspension contains methylprednisolone acetate which is the 6-methyl derivative of prednisolone. Methylprednisolone acetate is a white or practically white, odorless, crystalline powder which melts at about 215° with some decomposition. It is soluble in dioxane, sparingly soluble in acetone, alcohol, chloroform, and methanol, and slightly soluble in ether. It is practically insoluble in water.

CLINICAL PHARMACOLOGY

Glucocorticoids, naturally occurring and synthetic, are adrenocortical steroids.

Naturally occurring glucocorticoids (hydrocortisone and cortisone), which also have salt retaining properties, are used in replacement therapy in adrenocortical deficiency states. Their synthetic analogs are ..