Država: Sjedinjene Američke Države
Jezik: engleski
Izvor: NLM (National Library of Medicine)
ESOMEPRAZOLE SODIUM (UNII: L2C9GWQ43H) (ESOMEPRAZOLE - UNII:N3PA6559FT)
Mylan Institutional LLC
INTRAVENOUS
PRESCRIPTION DRUG
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
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)] .
Abbreviated New Drug Application
ESOMEPRAZOLE SODIUM- ESOMEPRAZOLE SODIUM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION MYLAN INSTITUTIONAL LLC ---------- 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: • • DOSAGE AND ADMINISTRATION GERD with Erosive Esophagitis. (2.1): • • Risk Reduction of Rebleeding of Gastric and Duodenal Ulcers (2.2): • Dosage Adjustment for Hepatic Impairment (2.3): • Preparation and Administration (2.4, 2.5): • 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 • • WARNINGS AND PRECAUTIONS • • • • • • • • • • 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 Pročitajte cijeli dokument