SOLU-MEDROL injection, powder, for solution

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

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

Dostępny od:

HF Acquisition Co. LLC, DBA HealthFirst

Droga podania:

INTRAMUSCULAR

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

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.)

Podsumowanie produktu:

SOLU-MEDROL® is supplied in the following dosage forms. NDC 51662-1264-1 SOLU-MEDROL® 40MG PER VIAL 1mL ACT-O-VIAL® NDC 51662-1264-2 Pouch of 1 SOLU-MEDROL® 40MG PER VIAL 1mL ACT-O-VIAL® NDC 51662-1264-3 Case of 25 Pouches of SOLU-MEDROL® 40MG PER VIAL 1mL 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 autoryzacji:

New Drug Application

Charakterystyka produktu

SOLU-MEDROL- SOLU-MEDROL INJECTION, POWDER, FOR SOLUTION
HF ACQUISITION CO. LLC, DBA HEALTHFIRST
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SOLU-MEDROL® 40MG PER VIAL 1ML ACT-O-VIAL®
SPL UNCLASSIFIED
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
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-retainin