P-CARE D40G- methylprednisolone acetate, povidone-iodine, isopropyl alcohol kit

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

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

Disponível em:

RX PHARMA-PACK, INC.

DCI (Denominação Comum Internacional):

METHYLPREDNISOLONE ACETATE

Composição:

METHYLPREDNISOLONE ACETATE 40 mg in 1 mL

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

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 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 par

Resumo do produto:

DEPO-MEDROL Sterile Aqueous Suspension is available as single-dose vials in the following strengths and package sizes: Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP]. This product's label may have been updated. For current full prescribing information, please visit www.pfizer.com. Pfizer Logo LAB-0160-13.0 July 2018 Aerosol Can Pain Ease 3.9 fl. oz. in Medium Stream P/N 0386-0008-03 Pain Ease 1.0 fl. oz. in Medium Stream P/N 0386-0008-04 Pain Ease 3.9 fl. oz. in Mist P/N 0386-0008-02 Pain Ease 1.0 fl. oz. in Mist P/N 0386-0008-01 Manufactured by: Gebauer Company Cleveland, OH 44128 1-800-321-9348 www.Gebauer.com © 2018 Gebauer Company

Status de autorização:

New Drug Application

Características técnicas

P-CARE D40G- METHYLPREDNISOLONE ACETATE, POVIDONE-IODINE, ISOPROPYL
ALCOHOL
RX PHARMA-PACK, INC.
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P-CARE D40G
DEPO-MEDROL - METHYLPREDNISOLONE ACETATE INJECTION, SUSPENSION
DEPO-MEDROL
(METHYLPREDNISOLONE ACETATE INJECTABLE SUSPENSION, USP)
PHARMACIA AND UPJOHN COMPANY LLC
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- ethyl-,(6α,11β)- and the molecular weight is
416.51. The structural formula is
represented below:
METHYLPREDNISOLONE ACETATE STRUCTURAL FORMULA
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 INTRA