METHYLPREDNISOLONE ACETATE injection, suspension

Country: Ամերիկայի Միացյալ Նահանգներ

language: անգլերեն

source: NLM (National Library of Medicine)

active_ingredient:

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

MAH:

Rebel Distributors Corp

INN:

METHYLPREDNISOLONE ACETATE

composition:

METHYLPREDNISOLONE ACETATE 40 mg in 1 mL

administration_route:

INTRA-ARTICULAR

prescription_type:

PRESCRIPTION DRUG

therapeutic_indication:

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 erythroderma, 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 c

leaflet_short:

Methylprednisolone acetate injectable suspension, USP is available in the following strengths and package sizes: 40 mg per mL NDC 21695-849-10 bottles of 10 mL 80 mg per mL NDC 21695-850-05 bottles of 5 mL Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].

authorization_status:

Abbreviated New Drug Application

SPC

METHYLPREDNISOLONE ACETATE- METHYLPREDNISOLONE ACETATE INJECTION,
SUSPENSION
REBEL DISTRIBUTORS CORP
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METHYLPREDNISOLONE ACETATE INJECTABLE SUSPENSION, USP
NOT FOR INTRAVENOUS USE
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
40 MG
80 MG
Polyethylene glycol 3350
29 mg
28 mg
Myristyl gamma picolinium chloride
0.19 mg
0.19 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 sterile injectable suspension, USP 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, in alcohol, in chloroform, and
in 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-inflammatory effects in disorders of
many organ systems.
Glucocorticoids cause profound and varied metabolic effects. In
addition, they modify the body’s
immune response to diverse stimuli.
INDICATIONS