METHYLPREDNISOLONE ACETATE- methylprednisolone acetate injection, suspension

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

Sandoz Inc

Via di somministrazione:

INTRAMUSCULAR

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

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

Dettagli prodotto:

Methylprednisolone acetate injectable suspension, USP is available in the following strengths and package sizes: 400 mg/10 mL (40 mg/mL) NDC 0781-3136-70 multidose vials of 10 mL in boxes of 1 NDC 0781-3136-92 multidose vials of 10 mL in boxes of 10 400 mg/5 mL (80 mg/mL) NDC 0781-3137-75 multidose vials of 5 mL in boxes of 1 NDC 0781-3137-95 multidose vials of 5 mL in boxes of 10 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Stato dell'autorizzazione:

Abbreviated New Drug Application

Scheda tecnica

METHYLPREDNISOLONE ACETATE- METHYLPREDNISOLONE ACETATE INJECTION,
SUSPENSION
SANDOZ INC
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METHYLPREDNISOLONE ACETATE INJECTABLE SUSPENSION, USP
NOT FOR USE IN NEONATES
CONTAINS BENZYL ALCOHOL
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 in two strengths: 40
mg/mL; 80 mg/mL.
Each mL of these preparations contains:
METHYLPREDNISOLONE ACETATE
40 MG
80 MG
Polyethylene glycol 3350
29.1 mg
28.2 mg
Polysorbate 80
1.94 mg
1.88 mg
Monobasic sodium phosphate
6.8 mg
6.59 mg
Dibasic sodium phosphate USP
1.42 mg
1.37 mg
Benzyl alcohol added as a preservative
9.16 mg
8.88 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.
Glucoco