DEPO-MEDROL- methylprednisolone acetate injection, suspension

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

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

제공처:

REMEDYREPACK INC.

INN (국제 이름):

METHYLPREDNISOLONE ACETATE

구성:

METHYLPREDNISOLONE ACETATE 40 mg in 1 mL

관리 경로:

INTRAMUSCULAR

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

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 DEPO-MEDROL Sterile Aqueous Suspension is indicated as follows: Allergic States : 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. Dermatologic Diseases : Bullous dermatitis herpetiformis, exfoliative dermatitis, mycosis fungoides, pemphigus, severe erythema multiforme (Stevens-Johnson syndrome). Endocrine Disorders : 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 adr

제품 요약:

DEPO-MEDROL Sterile Aqueous Suspension is available as single-dose vials in the following strengths and package sizes: NDC: 70518-0516-00 1 in 1 PACKAGE, 1 mL in 1 VIAL SINGLE USE Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762 Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP]. Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

승인 상태:

New Drug Application

제품 특성 요약

DEPO-MEDROL- METHYLPREDNISOLONE ACETATE INJECTION, SUSPENSION
REMEDYREPACK INC.
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DEPO-MEDROL
(METHYLPREDNISOLONE ACETATE INJECTABLE SUSPENSION, USP)
SINGLE-DOSE VIAL
NOT FOR INTRAVENOUS USE
DESCRIPTION
DEPO-MEDROL 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
0.195 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 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:
DEPO-MEDROL Sterile Aqueous Suspension 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, 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-inflammatory effects in disorders of
many organ systems.
INDICATIONS AND USAGE
A. FOR INTRAMUSCULAR ADMINISTRATION
When oral therapy is not feasible and the strength, dosage form, and
route of administration of the drug
reasonably lend the preparation to the tre