P-CARE D80MX- methylprednisolone acetate, povidone-iodine, isopropyl alcohol, bupivacaine hcl, sodium chloride, lidocaine hcl ki

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

RX PHARMA-PACK, INC.

INN (International Name):

METHYLPREDNISOLONE ACETATE

Composition:

METHYLPREDNISOLONE ACETATE 40 mg in 1 mL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

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 Sodium Chloride Injection, USP, 0.9%, preservative free, is available as follows: 63323-186-02 Trays of 25 NDC 63323-186-04 2 mL fill, in a 3 mL Single-Dose vial NDC 63323-186-01 10 mL Single-Dose vial NDC 63323-186-03 20 mL Single-Dose vial Preservative Free . Discard unused portion. Use only if solution is clear and seal intact. Store at 20º to 25ºC (68º to 77ºF) [see USP Controlled Room Temperature]. Fresenius-Kabi Logo www.fresenius-kabi.com/us 45764E Revised: October 2018 Xylocaine® (lidocaine HCl Injection, USP) Xylocaine® -MPF (lidocaine HCl Injection, USP) Xylocaine® (lidocaine HCl and epinephrine Injection, USP) with Epinephrine 1:100,000 Xylocaine® (lidocaine HCl and epinephrine Injection, USP) with Epinephrine 1:200,000 0.5% (250 mg per 50 mL) (5 mg per mL) Xylocaine® -MPF (lidocaine HCl and epinephrine Injection, USP) with Epinephrine 1:200,000 For single-dose vials and ampules: Discard unused portion. All solutions should be stored at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light. All trademarks are the property of Fresenius Kabi USA, LLC. Fresenius-Kabi Logo www.fresenius-kabi.com/us 4 5 1 1 7 5 F Revised: March 2019 These solutions are not for spinal anesthesia. Store at 20 to 25°C (68 to 77°F); excursions permitted between 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature.] MARCAINE ―Solutions of MARCAINE that do not contain epinephrine may be autoclaved. Autoclave at 15-pound pressure, 121°C (250°F) for 15 minutes. MARCAINE with epinephrine 1:200,000 (as bitartrate)―Solutions of MARCAINE that contain epinephrine should not be autoclaved and should be protected from light. Do not use the solution if its color is pinkish or darker than slightly yellow or if it contains a precipitate. For single-dose vials: Discard unused portion. Distributed by Hospira, Inc., Lake Forest , IL 60045 USA Revised: 11/2018

Authorization status:

New Drug Application

Summary of Product characteristics

P-CARE D80MX- METHYLPREDNISOLONE ACETATE, POVIDONE-IODINE, ISOPROPYL
ALCOHOL, BUPIVACAINE
HCL, SODIUM CHLORIDE, LIDOCAINE HCL
RX PHARMA-PACK, INC.
----------
P-CARE D80MX
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 sodim 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 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