CORTAREN CORTICOSTEROID/ANTI-INFLAMMATORY SYSTEM- dexamethasone sodium phosphate kit

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

DEXAMETHASONE SODIUM PHOSPHATE (UNII: AI9376Y64P) (DEXAMETHASONE - UNII:7S5I7G3JQL)

Disponível em:

IT3 Medical LLC

DCI (Denominação Comum Internacional):

DEXAMETHASONE SODIUM PHOSPHATE

Composição:

DEXAMETHASONE PHOSPHATE 4 mg in 1 mL

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

Intravenous or Intramuscular Injection 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, those products labeled for intravenous or intramuscular use are indicated as follows: • 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)    Acute adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; mineralocorticoid supplementation may be necessary, particularly when synthetic analogs are used)    Preoperatively, and in the event of serious trauma or illness, in patients with known adrenal insufficiency or when adrenocortical reserve is doubtful    Shock unresponsive to conventional therapy if adrenocortical insufficiency exists or is suspe

Resumo do produto:

STORE AT :20 ° to 25 °C (68 ° to 77 °F) [see USP Controlled Room Temperature]. Protect from freezing. Sensitive to heat. Do not autoclave. Protect from light. Store container in carton until contents have been used. Do not use if precipitate is present. www.fresenius-kabi.us 45799H Revised: March 2017 These solutions are not for spinal anesthesia. Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] MARCAINE ―Solutions of MARCAINE that do not contain epinephrine may be autoclaved. Autoclave at 15-pound pressure, 121°C (250°F) for 15 minutes. Tray of 10 (5 mg/mL) Single-dose vial Hospira, Inc., Lake Forest, IL 60045 USA LAB-1178-1.0 Revised: 11/2017 Kenalog® -40 Injection (triamcinolone acetonide injectable suspension, USP) is supplied in vials providing 40 mg triamcinolone acetonide per mL. Bristol-Myers Squibb Company Princeton, NJ 08543 USA Product of Spain 1221153A7 Revised: January 2016 Assembled and Distributed by IT3 Medical, LLC 190 E Stacy Rd, Ste 306-298, Allen, TX 75002 For questions or comments: [e-mail], www.IT3-Medical.com Store at controlled room temperature, 20°–25°C (68°–77°F), avoid freezing and protect from light. Do not refrigerate.

Status de autorização:

Abbreviated New Drug Application

Características técnicas

CORTAREN CORTICOSTEROID/ANTI-INFLAMMATORY SYSTEM- DEXAMETHASONE
SODIUM PHOSPHATE
IT3 MEDICAL LLC
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CORTAREN CORTICOSTEROID/ANTI-INFLAMMATORY SYSTEM
DEXAMETHASONE SODIUM PHOSPHATE INJECTION, USP
Rx only
DESCRIPTION:
Dexamethasone sodium phosphate is a water-soluble inorganic ester of
dexamethasone. It occurs as a white or slightly yellow crystalline
powder, is odorless or
has a slight odor of alcohol, is exceedingly hygroscopic and is freely
soluble in water.
Dexamethasone sodium phosphate is an adrenocortical steroid
anti-inflammatory drug.
Chemically, dexamethasone sodium phosphate is
9-Fluoro-11ß,17,21-trihydroxy-16α-
methylpregna-1, 4-diene-3,20-dione 21-(dihydrogen phosphate) disodium
salt and has
the following structural formula:
Dexamethasone Sodium Phosphate Injection, USP is a sterile solution of
dexamethasone
sodium phosphate in water for injection for intravenous (IV),
intramuscular (IM), intra-
articular, soft-tissue or intralesional use.
Each mL contains dexamethasone sodium phosphate equivalent to
dexamethasone
phosphate 4 mg or dexamethasone 3.33 mg; benzyl alcohol 10 mg added as
preservative; sodium citrate dihydrate 11 mg; sodium sulfite 1 mg as
an antioxidant;
Water for Injection q.s. Citric acid and/or sodium hydroxide may have
been added for
pH adjustment (7.0 to 8.5). Air in the container is displaced by
nitrogen.
CLINICAL PHARMACOLOGY:
Dexamethasone sodium phosphate has a rapid onset but short duration of
action when
compared with less soluble preparations. Because of this, it is
suitable for the treatment
of acute disorders responsive to adrenocortical steroid therapy.
Naturally occurring glucocorticoids (hydrocortisone and cortisone),
which also have salt-
retaining properties, are used as replacement therapy in
adrenocortical deficiency
states. Their synthetic analogs, including dexamethasone, are
primarily used for their
potent anti-inflammatory effects in disorders of many organ systems.
Glucocorticoids cause profound and varied metabolic effects. In
addition, they modify
the