METHYLPREDNISOLONE ACETATE injection, suspension

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

METHYLPREDNISOLONE ACETATE (UNII: 43502P7F0P) (METHYLPREDNISOLONE - UNII:X4W7ZR7023)

Available from:

Proficient Rx LP

INN (International Name):

METHYLPREDNISOLONE ACETATE

Composition:

METHYLPREDNISOLONE ACETATE 40 mg in 1 mL

Administration route:

INTRAMUSCULAR

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 intramuscular use of Methylprednisolone Acetate Injectable Suspension USP is indicated as follows: Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, seasonal or perennial allergic rhinitis, serum sickness, transfusion reactions. Bullous dermatitis herpetiformis, exfoliative dermatitis, mycosis fungoides, pemphigus, severe erythema multiforme (Stevens-Johnson syndrome). 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 can

Product summary:

Methylprednisolone Acetate Injectable Suspension USP is available as single-dose vials in the following strengths and package sizes: 40 mg per mL NDC 63187-474-01 1 mL vials Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Teva Pharmaceuticals USA Sellersville, PA 18960 Rev. B 7/2014 Relabeled By: Proficient Rx LP Thousand Oaks, CA 91320

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

METHYLPREDNISOLONE ACETATE- METHYLPREDNISOLONE ACETATE INJECTION,
SUSPENSION
PROFICIENT RX LP
----------
METHYLPREDNISOLONE
ACETATE INJECTABLE SUSPENSION USP
SINGLE-DOSE VIAL
NOT FOR INTRAVENOUS USE
0031
0051
RX ONLY
DESCRIPTION
Methylprednisolone Acetate Injectable Suspension USP 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 acetate USP ....................................40
MG .............80 MG
Polyethylene glycol 3350
................................................29 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 USP is
pregna-1,4-diene-3,20-dione, 21-
(acetyloxy)-11,17-dihydroxy-6-methyl-,(6α,11β). The structural
formula is represented below:
C24 H32O6 M.W. 4 16.51
C24H32O6 M.W. 416.51
C
H O M.W. 416.51
Methylprednisolone Acetate Injectable Suspension USP contains
methylprednisolone acetate, USP
which is the 6-methyl derivative of prednisolone. Methylprednisolone
acetate USP is a white or
24
32
6
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 used primarily for their anti-i