METHYLPREDNISOLONE ACETATE- methylprednisolone acetate injection, suspension

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

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

Tillgänglig från:

Sandoz Inc

INN (International namn):

METHYLPREDNISOLONE ACETATE

Sammansättning:

METHYLPREDNISOLONE ACETATE 40 mg in 1 mL

Administreringssätt:

INTRA-ARTICULAR

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

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

Produktsammanfattning:

Methylprednisolone acetate injectable suspension, USP is available in the following strengths and package sizes: 40 mg per mL NDC 0781-3131-71 single-dose vial of 1 mL in boxes of 1 NDC 0781-3131-95 single-dose vial of 1 mL in boxes of 10 80 mg per mL NDC 0781-3132-71 single-dose vial of 1 mL in boxes of 1 NDC 0781-3132-95 single-dose vial of 1 mL in boxes of 10 Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].

Bemyndigande status:

Abbreviated New Drug Application

Produktens egenskaper

METHYLPREDNISOLONE ACETATE- METHYLPREDNISOLONE ACETATE INJECTION,
SUSPENSION
SANDOZ INC
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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 AND USAGE
A.