ESOMEPRAZOLE SODIUM - esomeprazole sodium injection, powder, lyophilized, for solution

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

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

Prieinama:

Sun Pharmaceutical Industries Limited

INN (Tarptautinis Pavadinimas):

ESOMEPRAZOLE SODIUM

Sudėtis:

ESOMEPRAZOLE 20 mg in 5 mL

Vartojimo būdas:

INTRAVENOUS

Recepto tipas:

PRESCRIPTION DRUG

Terapinės indikacijos:

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

Produkto santrauka:

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.

Autorizacija statusas:

Abbreviated New Drug Application

Prekės savybės

ESOMEPRAZOLE SODIUM - ESOMEPRAZOLE SODIUM INJECTION, POWDER,
LYOPHILIZED, FOR SOLUTION
SUN PHARMACEUTICAL INDUSTRIES LIMITED
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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, 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