SOLU-CORTEF- hydrocortisone 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:

HYDROCORTISONE SODIUM SUCCINATE (UNII: 50LQB69S1Z) (HYDROCORTISONE - UNII:WI4X0X7BPJ)

から入手可能:

Pharmacia & Upjohn Company LLC

INN（国際名）:

HYDROCORTISONE SODIUM SUCCINATE

構図:

HYDROCORTISONE 100 mg in 2 mL

投与経路:

INTRAMUSCULAR

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-CORTEF 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, 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, 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 the palliative management of leukemias and lymphomas. Nervous System: 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-CORTEF Sterile Powder is contraindicated in systemic fungal infections and patients with known hypersensitivity to the product and its constituents. Intramuscular corticosteroid preparations are contraindicated for idiopathic thrombocytopenic purpura. SOLU-CORTEF Sterile Powder is contraindicated for intrathecal administration. Reports of severe medical events have been associated with this route of administration.

製品概要:

SOLU-CORTEF Sterile Powder is available in the following packages: 100 mg Plain —NDC 0009-0825-01 100 mg ACT-O-VIAL (Single-Dose Vial) 250 mg ACT-O-VIAL (Single-Dose Vial)          2 mL —NDC 0009-0011-03          2 mL —NDC 0009-0013-05 25 × 2 mL —NDC 0009-0011-04 25 × 2 mL —NDC 0009-0013-06 500 mg ACT-O-VIAL (Single-Dose Vial) —NDC 0009-0016-12 1000 mg ACT-O-VIAL (Single-Dose Vial) —NDC 0009-0005-01 Store unreconstituted product at controlled room temperature 20° to 25°C (68° to 77°F). Store solution at controlled room temperature 20° to 25°C (68° to 77°F) and protect from light. Use solution only if it is clear. Unused solution should be discarded after 3 days. 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-CORTEF- HYDROCORTISONE SODIUM SUCCINATE INJECTION, POWDER, FOR
SOLUTION
PHARMACIA & UPJOHN COMPANY LLC
----------
SOLU-CORTEF
(HYDROCORTISONE SODIUM SUCCINATE FOR INJECTION, USP)
FOR INTRAVENOUS OR INTRAMUSCULAR ADMINISTRATION
DESCRIPTION
SOLU-CORTEF Sterile Powder is an anti-inflammatory glucocorticoid that
contains
hydrocortisone sodium succinate as the active ingredient. SOLU-CORTEF
Sterile Powder
is available in several packages for intravenous or intramuscular
administration.
100 MG PLAIN
Vials containing hydrocortisone sodium succinate equivalent to 100 mg
hydrocortisone,
0.8 mg monobasic sodium phosphate anhydrous, 8.73 mg dibasic sodium
phosphate
dried. SOLU-CORTEF 100 mg plain does not contain diluent (see DOSAGE
AND
ADMINISTRATION, PREPARATION OF SOLUTIONS).
ACT-O-VIAL SYSTEM (SINGLE-DOSE VIAL) IN FOUR STRENGTHS:
100 MG
ACT-O-VIAL
250 MG
ACT-O-VIAL
500 MG
ACT-O-VIAL
1000 MG
ACT-O-VIAL
EACH 2 ML
CONTAINS
(WHEN
MIXED):
EACH 2 ML
CONTAINS
(WHEN
MIXED):
EACH 4 ML
CONTAINS
(WHEN
MIXED):
EACH 8 ML
CONTAINS
(WHEN
MIXED):
Hydrocortisone
sodium succinate
equiv. to
100 mg
Hydrocortisone
equiv. to
250 mg
Hydrocortisone
equiv. to
500 mg
Hydrocortisone
equiv. to
1000 mg
Hydrocortisone
Monobasic sodium
phosphate anhydrous
0.8 mg
2 mg
4 mg
8 mg
Dibasic sodium
phosphate dried
8.73 mg
21.8 mg
44 mg
87.32 mg
The diluent, as part of the packaging presentation for the ACT-O-VIAL
system, is
comprised of Water for Injection only, and does not contain any
preservative.
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.
The chemical name for hydrocortisone sodium succinate is
pregn-4-ene-3,20-dione,21-
(3-carboxy-1-oxopropoxy)-11,17-dihydroxy-, monosodium salt, (11β)-
and its molecular
weight is 484.52.
The structural formula is represented below:
®
®
®
Hydrocortisone sodium succinate is a white or nearly white, odorless,
hygroscopic
amorphous solid. It is very soluble in water and in alcohol, very
slightly