SOLU-MEDROL- methylprednisolone sodium succinate injection, powder, for solution

国: アメリカ合衆国

言語: 英語

ソース: NLM (National Library of Medicine)

有効成分:

methylprednisolone sodium succinate (UNII: LEC9GKY20K) (methylprednisolone - UNII:X4W7ZR7023)

から入手可能:

Cardinal Health 107, LLC

INN（国際名）:

methylprednisolone sodium succinate

構図:

methylprednisolone 125 mg in 1 mL

投与経路:

INTRAVENOUS

処方タイプ:

PRESCRIPTION DRUG

適応症:

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 intravenous or intramuscular use of SOLU-MEDROL Sterile Powder is indicated as follows: 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. Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema multiforme (Stevens-Johnson syndrome). 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, nonsuppurative thyroiditis. To tide the patient over a critical period of the disease in regional enteritis (systemic therapy) and ulcerative colitis. Acquired (autoimmune) hemolytic anemia, congenital (erythroid) hypoplastic anemia (Diamond-Blackfan anemia), idiopathic thrombocytopenic purpura in adults (intravenous administration only; intramuscular administration is contraindicated), pure red cell aplasia, selected cases of secondary thrombocytopenia. Trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy. For the palliative management of leukemias and lymphomas. Acute exacerbations of multiple sclerosis; cerebral edema associated with primary or metastatic brain tumor, or craniotomy. Sympathetic ophthalmia, uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids. To induce diuresis or remission of proteinuria in idiopathic nephrotic syndrome or that due to lupus erythematosus. Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis. 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, temporal arteritis, polymyositis, and systemic lupus erythematosus. SOLU-MEDROL Sterile Powder is contraindicated: Intramuscular corticosteroid preparations are contraindicated for idiopathic thrombocytopenic purpura. Additional contraindication for the use of SOLU-MEDROL Sterile Powder preserved with benzyl alcohol: Formulations preserved with benzyl alcohol are contraindicated for use in premature infants. (See WARNINGS and PRECAUTIONS, Pediatric Use .)

製品概要:

SOLU-MEDROL Sterile Powder preservative-free is available in the following packages: 40 mg Act-O-Vial System (Single-Dose Vial) Available overbagged with 5 x 1 mL vials per bag, NDC 55154-3940-5 125 mg Act-O-Vial System (Single-Dose Vial) Available overbagged with 5 x 2 mL vials per bag, NDC 55154-3941-5 This product's label may have been updated. For current full prescribing information, please visit www.pfizer.com.

認証ステータス:

New Drug Application

製品の特徴

SOLU-MEDROL- METHYLPREDNISOLONE SODIUM SUCCINATE INJECTION, POWDER,
FOR
SOLUTION
CARDINAL HEALTH 107, LLC
----------
SOLU-MEDROL (METHYLPREDNISOLONE SODIUM SUCCINATE FOR INJECTION, USP)
THE FORMULATIONS CONTAINING BENZYL ALCOHOL SHOULD NOT BE USED IN
NEONATES.
FOR INTRAVENOUS OR INTRAMUSCULAR ADMINISTRATION
DESCRIPTION
SOLU-MEDROL Sterile Powder is an anti-inflammatory glucocorticoid,
which contains
methylprednisolone sodium succinate as the active ingredient.
Methylprednisolone
sodium succinate, USP, is the sodium succinate ester of
methylprednisolone, and it
occurs as a white, or nearly white, odorless hygroscopic, amorphous
solid. It is very
soluble in water and in alcohol; it is insoluble in chloroform and is
very slightly soluble in
acetone.
The chemical name for methylprednisolone sodium succinate is
pregna-1,4-diene-3,20-
dione,21-(3-carboxy-1-oxopropoxy)-11,17-dihydroxy-6-methyl-monosodium
salt, (6α,
11β), and the molecular weight is 496.53. The structural formula is
represented below:
Methylprednisolone sodium succinate is soluble in water; it may be
administered in a
small volume of diluent and is well suited for intravenous use in
situations where high
blood levels of methylprednisolone are required rapidly.
SOLU-MEDROL is available in preservative and preservative-free
formulations:
PRESERVATIVE-FREE FORMULATIONS
40 MG ACT-O-VIAL SYSTEM (SINGLE-DOSE VIAL)—Each mL (when mixed)
contains
methylprednisolone sodium succinate equivalent to 40 mg
methylprednisolone; also
1.6 mg monobasic sodium phosphate anhydrous; 17.46 mg dibasic sodium
phosphate
dried; and 25 mg lactose hydrous.
125 MG ACT-O-VIAL SYSTEM (SINGLE-DOSE VIAL)—Each 2 mL (when mixed)
contains
methylprednisolone sodium succinate equivalent to 125 mg
methylprednisolone; also
®
1.6 mg monobasic sodium phosphate anhydrous; and 17.4 mg dibasic
sodium
phosphate dried.
500 MG ACT-O-VIAL SYSTEM (SINGLE-DOSE VIAL)—Each 4 mL (when mixed)
contains
methylprednisolone sodium succinate equivalent to 500 mg
methylprednisolone; also
6.4 mg monobasic s