ESOMEPRAZOLE SODIUM injection, powder, lyophilized, for solution

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

ESOMEPRAZOLE SODIUM (UNII: L2C9GWQ43H) (ESOMEPRAZOLE - UNII:N3PA6559FT)

Disponibil de la:

Mylan Institutional LLC

Calea de administrare:

INTRAVENOUS

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

Esomeprazole sodium for injection is indicated for the short-term treatment of GERD with EE in adults and pediatric patients 1 month to 17 years, inclusively as an alternative to oral therapy when oral esomeprazole is not possible or appropriate. Esomeprazole sodium for injection is indicated for risk reduction of rebleeding of gastric or duodenal ulcers following therapeutic endoscopy for acute bleeding gastric or duodenal ulcers in adults. Risk Summary There are no adequate and well-controlled studies with esomeprazole in pregnant women. Esomeprazole is the s-isomer of omeprazole. Available epidemiologic data fail to demonstrate an increased risk of major congenital malformations or other adverse pregnancy outcomes with first trimester omeprazole use. Reproduction studies in rats and rabbits resulted in dose-dependent embryo-lethality at omeprazole doses that were approximately 3.4 to 34 times an oral human dose of 40 mg (based on a body surface area for a 60 kg person). Teratogenicity was not observed in a

Rezumat produs:

Esomeprazole sodium for injection is supplied in a single-dose vial as a white to off-white, lyophilized porous cake or powder for reconstitution containing 40 mg of esomeprazole. Esomeprazole sodium for injection is available as follows: 67457-392-99 40 mg/vial One carton containing 10 vials of esomeprazole sodium for injection Storage Store at 20° to 25°C (68° to 77°F), excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature.] Protect from light. Store in carton until time of use. Following reconstitution and administration, discard any unused portion of esomeprazole solution [see Dosage and Administration (2.4,2.5)] .

Statutul autorizaţiei:

Abbreviated New Drug Application

Caracteristicilor produsului

ESOMEPRAZOLE SODIUM- ESOMEPRAZOLE SODIUM INJECTION, POWDER,
LYOPHILIZED, FOR SOLUTION
MYLAN INSTITUTIONAL LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ESOMEPRAZOLE SODIUM
FOR INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION
FOR ESOMEPRAZOLE
SODIUM FOR INJECTION.
ESOMEPRAZOLE SODIUM FOR INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 2005
RECENT MAJOR CHANGES
Warnings and Precautions, Acute Tubulointerstitial Nephritis (5.2)
11/2020
INDICATIONS AND USAGE
Esomeprazole sodium for injection is a proton pump inhibitor (PPI)
indicated for the:
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DOSAGE AND ADMINISTRATION
GERD with Erosive Esophagitis. (2.1):
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Risk Reduction of Rebleeding of Gastric and Duodenal Ulcers (2.2):
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Dosage Adjustment for Hepatic Impairment (2.3):
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Preparation and Administration (2.4, 2.5):
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DOSAGE FORMS AND STRENGTHS
For Injection: 40 mg of esomeprazole as a white to off-white
lyophilized porous cake or powder in a single-
dose vial for reconstitution. (3)
CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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Short-term treatment of Gastroesophageal Reflux Disease (GERD) with
erosive esophagitis (EE) in
adults and pediatric patients 1 month to 17 years of age, as an
alternative to oral therapy when oral
esomeprazole is not possible or appropriate. (1.1)
Risk reduction of rebleeding of gastric or duodenal ulcers following
therapeutic endoscopy for acute
bleeding gastric or duodenal ulcers in adults. (1.2)
The recommended adult dosage is either 20 mg or 40 mg once daily by
intravenous injection (no less
than 3 minutes) or intravenous infusion (10 minutes to 30 minutes) for
up to 10 days.
The recommended pediatric dosage is based upon age and weight. See
full prescribing information.
The recommended adult dosage is 80 mg administered as an intravenous
infusion over 30 minutes,
followed by a continuous infusion of 8 mg/hour for a total treatment
duration of 72 hours.
See full prescribing info