DEPO-MEDROL- methylprednisolone acetate injection, suspension

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

methylprednisolone acetate (UNII: 43502P7F0P) (methylprednisolone - UNII:X4W7ZR7023)

Disponibil de la:

Dispensing Solutions, Inc.

INN (nume internaţional):

methylprednisolone acetate

Compoziție:

methylprednisolone acetate 80 mg in 1 mL

Calea de administrare:

INTRAMUSCULAR

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

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 erythroderma, 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), congeni

Rezumat produs:

DEPO-MEDROL Sterile Aqueous Suspension is available in the following strengths and package sizes: Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP].

Statutul autorizaţiei:

New Drug Application

Caracteristicilor produsului

DEPO-MEDROL - METHYLPREDNISOLONE ACETATE INJECTION, SUSPENSION
DISPENSING SOLUTIONS, INC.
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DEPO-MEDROL
METHYLPREDNISOLONE ACETATE INJECTABLE SUSPENSION, USP
DESCRIPTION
DEPO-MEDROL is an anti-inflammatory glucocorticoid for intramuscular,
intra-articular, soft tissue,
or intralesional injection. It is available in three strengths: 20
mg/mL; 40 mg/mL; 80 mg/mL.
Each mL of these preparations contains:
Methylprednisolone
acetate..................................20 MG
40 MG
80 MG
Polyethylene glycol
3350....................................29.5 mg
29.1 mg 28.2 mg
Polysorbate 80
....................................................1.97 mg
1.94
mg
1.88 mg
Monobasic sodium phosphate
..............................6.9 mg
6.8 mg 6.59 mg
Dibasic sodium phosphate
USP..........................1.44 mg
1.42 mg
1.37 mg
Benzyl alcohol added as a
preservative................9.3 mg
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., 3.5 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,11ß)-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