READYSHARP-P40- lidocaine hydrochloride, bupivacaine hydrochloride, and methylprednisolone acetate kit

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Terrain Pharmaceuticals

INN (International Name):

METHYLPREDNISOLONE ACETATE

Composition:

METHYLPREDNISOLONE ACETATE 40 mg in 1 mL

Administration route:

INTRAMUSCULAR

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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: 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), congeni

Product summary:

Methylprednisolone Acetate Injectable Suspension USP is available as single-dose vials in the following strengths and package sizes: 40 mg per mL NDC 0703-0031-01 1 mL vials NDC 0703-0031-04 25 x 1 mL vials 80 mg per mL NDC 0703-0051-01 1 mL vials NDC 0703-0051-04 25 x 1 mL vials Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Teva Pharmaceuticals USA Sellersville, PA 18960 Rev. B 7/2014 Lidocaine Hydrochloride Injection, USP is supplied as follows: NDC Container Concentration Size Total (mg) Single-dose: 0409-4278-01 Glass Teartop Vial 0.5% (5 mg/mL) 50 mL 250 0409-4713-01 Glass Ampul 1% (10 mg/mL) 2 mL (bulk – 400 units) 20 0409-4713-02 Glass Ampul 1% (10 mg/mL) 5 mL 50 0409-4713-05 Glass Ampul 1% (10 mg/mL) 5 mL (bulk – 400 units) 50 0409-4713-20 Glass Ampul 1% (10 mg/mL) 20 mL 200 0409-4713-32 Glass Ampul 1% (10 mg/mL) 2 mL 20 0409-4713-62 Glass Ampul 1% (10 mg/mL) 2 mL (bulk – 800 units) 20 0409-4713-65 Glass Ampul 1% (10 mg/mL) 5 mL (bulk – 800 units) 50 0409-4279-02 Glass Teartop Vial 1% (10 mg/mL) 30 mL 300 0409-4270-01 Sterile Glass Teartop Vial 1% (10 mg/mL) 30 mL 300 0409-4776-01 Glass Ampul 1.5% (15 mg/mL) 20 mL 300 0409-4056-01 Sterile Glass Ampul 1.5% (15 mg/mL) 20 mL 300 0409-4282-01 Glass Ampul 2% (20 mg/mL) 2 mL 40 0409-4282-02 Glass Ampul 2% (20 mg/mL) 10 mL 200 Multiple-dose: 0409-4275-01 Plastic Fliptop Vial 0.5% (5 mg/mL) 50 mL 250 0409-4276-01 Plastic Fliptop Vial 1% (10 mg/mL) 20 mL 200 0409-4276-02 Plastic Fliptop Vial 1% (10 mg/mL) 50 mL 500 0409-4277-01 Plastic Fliptop Vial 2% (20 mg/mL) 20 mL 400 0409-4277-02 Plastic Fliptop Vial 2% (20 mg/mL) 50 mL 1000 Single-dose products are preservative-free. Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Lidocaine Hydrochloride Injection, USP solutions packaged in ampuls and glass teartop vials may be autoclaved one time only. Autoclave at 15 pounds pressure, 121°C (250°F) for 15 minutes. DO NOT AUTOCLAVE PRODUCT IN PLASTIC VIALS. Revised: February, 2010 Printed in USA                            EN-2421 Hospira, Inc., Lake Forest, IL 60045 USA These solutions are not for spinal anesthesia. Store at 20 to 25°C (68 to 77°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. Revised: 10/2011   Printed in USA                           EN-2916         Hospira, Inc., Lake Forest, IL 60045 USA

Authorization status:

New Drug Application

Summary of Product characteristics

READYSHARP-P40- LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE,
AND
METHYLPREDNISOLONE ACETATE
TERRAIN PHARMACEUTICALS
----------
READYSHARP-P40
METHYLPREDNISOLONE
ACETATE INJECTABLE SUSPENSION USP
SINGLE-DOSE VIAL
NOT FOR INTRAVENOUS USE
0031
0051
RX ONLY
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., 3.0 to 7.0).
The chemical name for methylprednisolone acetate USP is
pregna-1,4-diene-3,20-dione, 21-
(acetyloxy)-11,17-dihydroxy-6-methyl-,(6α,11β). The structural
formula is represented below:
C24H32O6 M.W. 416.51
C24H32O6 M.W. 416.51
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, 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 primaril