ESOMEPRAZOLE SODIUM injection, powder, lyophilized, for solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Eugia US LLC

INN (International Name):

ESOMEPRAZOLE SODIUM

Composition:

ESOMEPRAZOLE 20 mg

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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. - Esomeprazole sodium for injection is contraindicated in patients with known hypersensitivity to substituted benzimidazoles or to any component of the formulation. Hypersensitivity reactions may include anaphylaxis, anaphylactic shock, angioedema, bronchospasm, acute tubulointerstitial nephritis, and urticaria [see Warnings and Precautions (5.2), Adverse Reactions (6.2)]. - Proton pump inhibitors (PPIs), including esomeprazole sodium for injection, are contraindicated in patients receiving rilpivirine-containing products [see Drug Interactions (7)]. Risk Summary

Product summary:

Esomeprazole sodium for injection is supplied as a sterile, freeze-dried, white to off-white, porous cake or powder containing 40 mg of esomeprazole per single-dose vial. 40 mg per vial: Single-Dose Vials in a Carton of 10 (each vial contains 40 mg of esomeprazole)                                                                NDC 55150-185-05 Storage Store at 20° to 25°C (68° to 77°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)] . The vial stopper is not made with natural rubber latex.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ESOMEPRAZOLE SODIUM - ESOMEPRAZOLE SODIUM INJECTION, POWDER,
LYOPHILIZED, FOR SOLUTION
EUGIA US 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
INDICATIONS AND USAGE
Esomeprazole sodium for injection is a proton pump inhibitor (PPI)
indicated for the:
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)
DOSAGE AND ADMINISTRATION
GERD with Erosive Esophagitis. (2.1):
•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.
Risk Reduction of Rebleeding of Gastric and Duodenal Ulcers (2.2):
•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.
Dosage Adjustment for Hepatic Impairment (2.3):
•See full prescribing information for dosage adjustment by severity
of impairment and by indication.
Preparation and Administration (2.4, 2.5):
•See full prescribing information for preparation and administration
instructions by indication.
DOSAGE FORMS AND STRENGTHS
For Injection: 40 mg of esomeprazole as a sterile, freeze-dried, white
to off-white, porous cake or
lyophilized powder in a single-dose vial for reconstitution. (3)
CONTRAINDICATION