Země: Spojené státy
Jazyk: angličtina
Zdroj: NLM (National Library of Medicine)
ESOMEPRAZOLE SODIUM (UNII: L2C9GWQ43H) (ESOMEPRAZOLE - UNII:N3PA6559FT)
Sun Pharmaceutical Industries Limited
ESOMEPRAZOLE SODIUM
ESOMEPRAZOLE 20 mg in 5 mL
INTRAVENOUS
PRESCRIPTION DRUG
Esomeprazole sodium for injection is indicated for the short-term treatment of GERD with erosive esophagitis 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 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 interstitial nephritis, and urticaria [seeAdverse Reactions (6)]. Risk Summary There are no adequate and well-controlled studies with esomeprazole sodium for injection 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
Esomeprazole sodium for injection is supplied as a white to off-white, freeze-dried cake containing 20 mg or 40 mg of esomeprazole per single-use vial. NDC 62756-508-44 one carton containing 10 vials of esomeprazole sodium for injection (each vial contains 20 mg of esomeprazole). NDC 62756-509-44 one carton containing 10 vials of esomeprazole sodium for injection (each vial contains 40 mg of esomeprazole). Storage Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 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.
Abbreviated New Drug Application
ESOMEPRAZOLE SODIUM - ESOMEPRAZOLE SODIUM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION SUN PHARMACEUTICAL INDUSTRIES LIMITED ---------- 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, Atrophic Gastritis (5.2)removed 10/2016 Warnings and Precautions, Cutaneous and Systemic Lupus Erythematosus (5.5)10/2016 INDICATIONS AND USAGE Esomeprazole sodium is a proton pump inhibitor indicated for the treatment of: Gastroesophageal Reflux Disease (GERD) with erosive esophagitis (EE) in adults and pediatric patients greater than one month of age, when oral therapy is not possible or appropriate. (1.1) DOSAGE AND ADMINISTRATION GERD – with Erosive Esophagitis. (2.1): Adults: Dose is either 20 mg or 40 mg esomeprazole given once daily by intravenous injection (no less than 3 minutes) or intravenous infusion (10 minutes to 30 minutes). Pediatric: Give the following doses once daily as an intravenous infusion over 10 minutes to 30 minutes. (2.1): 1 year to 17 years: Body weight less than 55 kg: 10 mg Body weight 55 kg or greater: 20 mg 1 month to less than 1 year of age: 0.5 mg/kg For patients with severe liver impairment (Child-Pugh Class C), a maximum dose of 20 mg once daily of esomeprazole should not be exceeded. (2.1, 8.6, 12.3) DOSAGE FORMS AND STRENGTHS Esomeprazole sodium for injection is supplied as a freeze-dried cake containing 20 mg or 40 mg of esomeprazole per single-use vial. (3) CONTRAINDICATIONS Patients with known hypersensitivity to any component of the formulation or to substituted benzimidazoles (angioedema and anaphylaxis have occurred). (4) WARNINGS AND PRECAUTIONS • Gastric Malignancy: In adults, symptomatic response to therapy with esomeprazole sodium does not preclude the presence of gastric Přečtěte si celý dokument