METHYLPREDNISOLONE ACETATE injection, suspension

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

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

Prieinama:

Amneal Pharmaceuticals LLC

Vartojimo būdas:

INTRA-ARTICULAR

Recepto tipas:

PRESCRIPTION DRUG

Terapinės indikacijos:

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 methylprednisolone acetate injectable 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, 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 adrenal hyperplasia, hypercalcemia associated with cancer, nonsupportive thyroiditis. Gastrointestinal Diseases : To tide the patient over a critical period of the disease in regional enteritis (systemic therapy) and ulcerative colitis. Hematologic Disorders : Acquired (autoimmune) hemolytic anemia, congenital (erythroid) hypoplastic anemia (Diamond Blackfan anemia), pure red cell aplasia, select cases of secondary thrombocytopenia. Miscellaneous : Trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy. Neoplastic Diseases : For palliative management of: leukemias and lymphomas. Nervous System : Cerebral edema associated with primary or metastatic brain tumor or craniotomy. Ophthalmic Diseases : Sympathetic ophthalmia, temporal arteritis, uveitis, ocular inflammatory conditions unresponsive to topical corticosteroids. Renal Diseases : To induce diuresis or remission of proteinuria in idiopathic nephrotic syndrome, or that due to lupus erythematosus. Respiratory Diseases : Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis. Rheumatic Disorders : As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis; acute rheumatic carditis; ankylosing spondylitis; psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). For the treatment of dermatomyositis, polymyositis, and systemic lupus erythematosus. B. For Intra-articular Or Soft Tissue Administration ( See WARNINGS) Methylprednisolone acetate injectable suspension is indicated as adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis, acute and subacute bursitis, acute nonspecific tenosynovitis, epicondylitis, rheumatoid arthritis, synovitis of osteoarthritis. C. For Intralesional Administration Methylprednisolone acetate injectable suspension is indicated for intralesional use in alopecia areata, discoid lupus erythematosus; keloids, localized hypertrophic, infiltrated inflammatory lesions of granuloma annulare, lichen planus, lichen simplex chronicus (neurodermatitis) and psoriatic plaques; necrobiosis lipoidica diabeticorum. Methylprednisolone acetate injectable suspension also may be useful in cystic tumors of an aponeurosis or tendon (ganglia). Methylprednisolone acetate injectable suspension is contraindicated in patients with known hypersensitivity to the product and its constituents. Intramuscular corticosteroid preparations are contraindicated for idiopathic thrombocytopenic purpura. Methylprednisolone acetate injectable suspension is contraindicated for intrathecal administration. This formulation of methylprednisolone acetate has been associated with reports of severe medical events when administered by this route. Methylprednisolone acetate injectable suspension is contraindicated in systemic fungal infections, except when administered as an intra-articular injection for localized joint conditions (see WARNINGS: Infections, Fungal Infections ).

Produkto santrauka:

Methylprednisolone Acetate Injectable Suspension, USP is supplied as a white to off-white homogenous suspension in single-dose vial available in the following strengths and package sizes: 40 mg/mL (1 mL) Single vial in a carton:            NDC 70121-1573-1 25 vials in a carton:                 NDC 70121-1573-5 80 mg/mL (1 mL) Single vial in a carton:          NDC 70121-1574-1 25 vials in a carton:               NDC 70121-1574-5 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. This product’s label may have been updated. For current full prescribing information, please visit www.amneal.com. Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Ahmedabad 382213, INDIA Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 Rev. 02-2024-07

Autorizacija statusas:

Abbreviated New Drug Application

Prekės savybės

METHYLPREDNISOLONE ACETATE- METHYLPREDNISOLONE ACETATE INJECTION,
SUSPENSION
AMNEAL PHARMACEUTICALS LLC
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METHYLPREDNISOLONE ACETATE INJECTABLE SUSPENSION, USP
40 MG/ML (1 ML) AND 80 MG/ML (1 ML)
RX ONLY
SINGLE-DOSE VIAL
NOT FOR INTRAVENOUS USE
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:
##
40 MG/ML
80 MG/ML
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 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 injectable suspension, USP contains
methylprednisolone
acetate, USP which is the 6-methyl derivative of prednisolone.
Methylprednisolone
acetate, USP is a white or almost white crystalline powder which melts
at about 213°
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