SOLU-MEDROL injection, powder, for solution

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

METHYLPREDNISOLONE SODIUM SUCCINATE (UNII: LEC9GKY20K) (METHYLPREDNISOLONE - UNII:X4W7ZR7023)

Disponível em:

HF Acquisition Co. LLC, DBA HealthFirst

Via de administração:

INTRAMUSCULAR

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

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: 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, perennial or seasonal allergic rhinitis, serum sickness, transfusion reactions. Dermatologic diseases Bullous dermatitis herpetiformis, exfoliative erythroderma, 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, nonsuppurative 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), idiopathic thrombocytopenic purpura in adults (intravenous administration only; intramuscular administration is contraindicated), pure red cell aplasia, selected 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 the palliative management of leukemias and lymphomas. Nervous System Acute exacerbations of multiple sclerosis; cerebral edema associated with primary or metastatic brain tumor, or craniotomy. Ophthalmic diseases Sympathetic ophthalmia, uveitis and 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, temporal arteritis, polymyositis, and systemic lupus erythematosus. SOLU-MEDROL Sterile Powder is contraindicated: in systemic fungal infections and patients with known hypersensitivity to the product and its constituents. The SOLU-MEDROL 40 mg presentation includes lactose monohydrate produced from cow's milk. This presentation is therefore contraindicated in patients with a known or suspected hypersensitivity to cow's milk or its components or other dairy products because it may contain trace amounts of milk ingredients. for intrathecal administration. Reports of severe medical events have been associated with this route of administration. 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.)

Resumo do produto:

SOLU-MEDROL® is supplied in the following dosage forms. NDC 51662-1263-1 SOLU-MEDROL® 125MG PER VIAL 2mL ACT-O-VIAL® HF Acquisition Co LLC, DBA HealthFirst Mukilteo, WA 98275 NDC 51662-1263-2 Pouch containing a single SOLU-MEDROL® 125MG PER VIAL 2mL ACT-O-VIAL® HF Acquisition Co LLC, DBA HealthFirst Mukilteo, WA 98275 NDC 51662-1263-3 Case of 25 pouches - SOLU-MEDROL® 125MG PER VIAL 2mL ACT-O-VIAL® HF Acquisition Co LLC, DBA HealthFirst Mukilteo, WA 98275 Also supplied in the following manufacture supplied dosage forms SOLU-MEDROL Sterile Powder preserved with benzyl alcohol is available in the following packages: SOLU-MEDROL Sterile Powder preservative-free is available in the following packages: This product's label may have been updated. For current full prescribing information, please visit www.pfizer.com.

Status de autorização:

New Drug Application

Características técnicas

SOLU-MEDROL- SOLU-MEDROL INJECTION, POWDER, FOR SOLUTION
HF ACQUISITION CO. LLC, DBA HEALTHFIRST
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SOLU-MEDROL® 125MG PER VIAL 2ML ACT-O-VIAL®
SPL UNCLASSIFIED
he 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
Formulations preserved with Benzyl Alcohol
When necessary, the pH of each formula was adjusted with sodium
hydroxide so that
the pH of the reconstituted solution is within the USP specified range
of 7 to 8 and the
tonicities are, for the 40 mg per mL solution, 0.50 osmolar; for the
125 mg per 2 mL
solution, 0.40 osmolar; for the 1 gram per 8 mL solution, 0.44
osmolar; for the 2 gram
per 30.6 mL solutions, 0.42 osmolar. (Isotonic saline = 0.28 osmolar.)
CLINICAL PHARMACOLOGY
Glucocorticoids, naturally occurring and synthetic, are adrenocortical
steroids that are
readily absorbed from the gastrointestinal tract.
Naturally occurring glucocorticoids (hydrocortisone and cortisone),
which also have salt-
retaini