METHYLPREDNISOLONE ACETATE injection, suspension

Valsts: Amerikas Savienotās Valstis

Valoda: angļu

Klimata pārmaiņas: NLM (National Library of Medicine)

Aktīvā sastāvdaļa:

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

Pieejams no:

Physicians Total Care, Inc.

SNN (starptautisko nepatentēto nosaukumu):

METHYLPREDNISOLONE ACETATE

Kompozīcija:

METHYLPREDNISOLONE ACETATE 40 mg in 1 mL

Ievadīšanas:

INTRAMUSCULAR

Receptes veids:

PRESCRIPTION DRUG

Ārstēšanas norādes:

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

Produktu pārskats:

Methylprednisolone acetate injectable suspension USP is available as single-dose vials in the following strengths and package sizes: Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Rx only Rev. A 11/2011 Teva Pharmaceuticals USA Sellersville, PA 18960 Distributed and additional labeling by: Physicians Total Care, Inc. Tulsa, Oklahoma       74146

Autorizācija statuss:

Abbreviated New Drug Application

Produkta apraksts

METHYLPREDNISOLONE ACETATE - METHYLPREDNISOLONE ACETATE INJECTION,
SUSPENSION
PHYSICIANS TOTAL CARE, INC.
----------
METHYLPREDNISOLONE
ACETATE INJECTABLE SUSPENSION USP
SINGLE-DOSE VIAL
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 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 to 7.
The chemical name for methylprednisolone acetate is
pregna-1,4-diene-3,20-dione, 21-(acetyloxy)-
11,17-dihydroxy-6-methyl-,(6α,11β). The structural formula is
represented below:
C
H O M.W. 4 16.51
Methylprednisolone acetate injectable suspension USP contains
methylprednisolone acetate USP which
is the 6-methyl derivative of prednisolone. Methylprednisolone acetate
USP is a white or 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.
24
32
6
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 sys