To view updated drug label links, paste the RSS feed address (URL) shown below into a RSS reader, or use a browser which supports RSS feeds, such as Safari for Mac OS X. pediatric patients, and c) relationship between exposure and pharmacodynamic The intravenous formulation was administered as a 3-minute injection in two NEXIUM I.V. infusion of esomeprazole 6 mg/h should not be exceeded. . The recommended adult dosage is either 20 mg or 40 mg esomeprazole given once daily by intravenous injection (over at least 3 minutes) or intravenous infusion (10 minutes to 30 minutes) for up to 10 days See the full prescribing information for oral omeprazole for complete safety information.No specific antidote for esomeprazole is known. patients [see DRUG INTERACTIONS]. Increases in death were seen at the high dose, and at all doses of esomeprazole, there were decreases in body weight, body weight gain, femur weight and femur length, and decreases in overall growth This increase in exposure is not considered clinically relevant. During administration of Sodium Bicarbonate Injection USP has a pH of 7.0 to 8.5. Digestive Disorders: Common Misconceptions, Reflux Laryngitis (Diet, Home Remedies, Medicine), % of patients Esomeprazole Intravenous (n=359), *Incidence ≥ 1% in the esomeprazole group and greater than placebo Verapamil Oral. administered as an injection or as an infusion was found to have a safety basis) produced gastric ECL cell carcinoids in a dose-related manner in both female rats, which had higher blood levels of omeprazole. and H. pylori negative healthy Chinese subjects (overall n = 19), the % in neonates When maternal administration was confined to gestation only, there were no effects on bone physeal morphology in the offspring at any age ( . Concomitant use of esomeprazole with methotrexate (primarily at high dose) may elevate and prolong serum concentrations of methotrexate and/or its metabolite hydroxymethotrexate, possibly leading to methotrexate toxicities. Esomeprazole is excreted as metabolites primarily in For current information on In oral studies, the effect of NEXIUM on serum gastrin Manifestations were variable, but included confusion, drowsiness, blurred vision, tachycardia, nausea, diaphoresis, flushing, headache, dry mouth, and other adverse reactions similar to those seen at recommended dosages. acid output (BAO) and maximal acid output (MAO) were determined 22-24 hours 583 Esomeprazole preparations (new): mothers used omeprazole during the first trimester of pregnancy and 837, 317 In 24-month carcinogenicity studies of oral omeprazole in A retrospective cohort study reported on 689 pregnant women exposed to either H See full prescribing information. to the fetus due to esomeprazole magnesium. was 18 to 98 years old; 68% Male, 87% Caucasian, 1% Black, 7% Asian, 4% other, Use Esomeprazole sodium for Injection with caution in transplant patients receiving MMF NDC Package Code 0186-6040-01. Dosage adjustment Contraindications levels of the S- than of the R-isomer. Esomeprazole may potentially interfere with CYP2C19, the A population-based retrospective cohort study covering Concomitant treatment with omeprazole (20 mg daily) and digoxin in healthy healthy volunteers. Manufactured By: symptomatic and supportive. powder containing 20 mg or 40 mg of esomeprazole per single-use vial. =8) vs. negative (n =11) subjects, the percentage of time in a 24 h period with studied. See full prescribing information for a list of clinically important drug interactions. [see month to 17 years of age for short-term treatment of GERD with Erosive The patient population ranged from 18 to 72 years old; 54% were female; 53% Caucasian, 24% Black, 5% Asian, and 17% other race. Approximately 3% of Caucasians and 15 to 20% of Asians are CYP2C19 poor metabolizers. timeframe were evident at doses equal to or greater than 69 mg/kg/day (about The clinical relevance of reduced MPA exposure on organ rejection has not been established in transplant patients receiving Esomeprazole sodium for Injection and MMF. (about 3.4 times an oral human dose of 40 mg on a body surface area basis). Literature suggests that concomitant use of PPIs with Protect from light. treatment of any drug overdose, a certified Regional Poison Control Center PHARMACOLOGY]. severe liver impairment (Child Pugh Class C), a maximum continuous infusion of Intravenous Injection (20 mg or 40 mg vial) over no The risk of fracture was increased in patients who received high-dose, defined as multiple daily doses, and long-term PPI therapy (a year or longer). 2.5)] [see It can be used to treat GERD, esophagitis, and other conditions, and to prevent stomach ulcers. Potentially increased exposure of tacrolimus, especially in transplant patients who are intermediate or poor metabolizers of CYP2C19. of PPI therapy appropriate to the condition being treated. Preparation Instructions for Loading dose (80 mg) to The safety results are consistent with the known safety profile of esomeprazole and no unexpected safety signals were identified. an intravenous infusion of 80 mg over 30 minutes followed by a continuous NEXIUM I.V. its metabolite hydroxymethotrexate. Withdraw the desired dose of the reconstituted Esomeprazole sodium for Injection solution for an adult or pediatric dose. magnesium from postnatal day 7 through postnatal day 35. In addition, ECL cell hyperplasia was Effectiveness is similar to other proton pump inhibitors (PPIs). Standard solutions— Dissolve an accurately weighed quantity of USP Omeprazole RS in Solvent, and mix to obtain Standard solution A having a known concentration of about 0.5 mg per mL. Plasma affected differently by intrinsic or extrinsic factors after intravenous the potential benefit justifies the potential risk to the fetus. carcinogenicity study of omeprazole did not show increased tumor occurrence, Neonatal/early postnatal (birth to weaning) survival was decreased at doses equal to or greater than 138 mg/kg/day (about 34 times an oral human dose of 40 mg on a body surface area basis). Teratogenicity was not observed in animal reproduction studies with administration of oral esomeprazole magnesium in rats and rabbits with doses about 68 times and 42 times, respectively, an oral human dose of 40 mg (based on a body surface area basis for a 60 kg person). in vivo mouse micronucleus test. Drug-induced decrease in gastric acidity results in over 30 minutes for 5 days. esomeprazole. A retrospective cohort study reported on 689 pregnant . not constitute full treatment. Benzyl alcohol (preservative), hydrochloric acid, sodium chloride, sodium hydroxide and water for injection. (Administer within 6 hours if 5% Dextrose Injection is Esomeprazole sodium for Injection is supplied as a sterile, lyophilized, white to off-white, porous cake or powder in a 6 mL single-dose vial, intended for intravenous administration after reconstitution with 0.9% Sodium Chloride Injection, USP; Lactated Ringer's Injection, USP or 5% Dextrose Injection, USP. interfere with. NEXIUM overdose (limited experience of doses in excess of 240 mg/day) are for Injection contains esomeprazole sodium 21.3 mg or 42.5 mg equivalent to esomeprazole 20 . other formulation for 10 days, matching their respective dose level from Period SOP. Potential for increased exposure of digoxin for pH adjustment. The symptoms described in connection with deliberate esomeprazole overdose (limited experience of doses in excess of 240 mg/day) are transient. Further dilute the reconstituted Esomeprazole sodium for Injection solution in 100 mL 0.9% Sodium Chloride Injection, USP. prothrombin measures have been received among patients on concomitant warfarin for Injection (each vial contains 40 mg of esomeprazole). doses of once daily esomeprazole in pediatric patients 1 month to 17 years old, 18N For more information, ask your doctor or pharmacist. . Sodium Chloride Injection, USP, Lactated Ringer's Injection, USP or 5% Dextrose single-use vial. See prescribing information for cilostazol. Treatment with proton pump inhibitors may lead postnatal (birth to weaning) survival was decreased at doses equal to or micronucleus test. mg daily co-administered days 11 to 15. Use of NEXIUM I.V. neuroendocrine tumors. Esomeprazole inhibits gastric acid secretion. Injection, USP, Lactated Ringer's Injection, USP or 5% Dextrose Injection, USP In a cross-over study in 12 healthy male subjects, St. John’s Wort (300 mg three times daily for 14 days) significantly decreased the systemic exposure of omeprazole in CYP2C19 poor metabolizers (C Manifestations were variable, but Esomeprazole plasma AUC values were 183% and 60% higher in pediatric patients aged 6 to 11 years and 12 to 17 years, respectively, compared to adults. study. No concentrations of cilostazol and its above mentioned active metabolite. The C Warnings and Precautions (5.9), this version. For adult patients with mild to moderate liver Liquid chromatographic analysis of epinephrine standard solutions was performed using the current USP HPLC method for epinephrine injection solutions. oral doses of esomeprazole magnesium at doses equal to or greater than 138 Following intravenous administration of Esomeprazole sodium for injection in 24 healthy subjects as a loading dose of 80 mg over 30 minutes followed by a continuous infusion of 8 mg/hour for 23.5 hours (for a total of 24 hours), esomeprazole pharmacokinetic parameters [geometric mean value (95% CI)] were as follows: AUC lactating rats in a pre- and postnatal toxicity study when esomeprazole min by 95%. . with additional endpoints to evaluate bone development was performed with [see In a randomized, open-label, multi-national, repeated No refrigeration is required. Administer over 30 incidence of treatment-related ECL cell hyperplasia was observed at the end of for Injection contains esomeprazole sodium 21.3 mg or 42.5 mg equivalent to esomeprazole 20 mg or 40 mg, edetate disodium 1.5 mg and sodium hydroxide q.s. Reduce the rate of the continuous infusion to 6 mg/hour for patients with mild to moderate liver impairment (Child-Pugh Classes A and B) and to 4 mg/hour for patients with severe hepatic impairment (Child-Pugh Class C) Methotrexate Injection USP is indicated for Neoplastic diseases: • Choriocarcinoma: Methotrexate - as single chemotherapy or in combination with other drugs. esomeprazole is expected to increase the systemic exposure of digoxin. Let patients know that antacids may be used while taking NEXIUM. infusion duration from 3 minutes to 10 minutes or 30 minutes was predicted to When rats vials. profile similar to that of oral administration of esomeprazole. with clopidogrel. frequency of abnormalities among infants of women exposed to H2 receptor In most patients, treatment of hypomagnesemia required magnesium replacement and discontinuation of the PPI. Files, All Mapping Plasma protein binding is constant over the concentration range of 2 to 20 micromol/L. and are termed Poor Metabolizers. for Injection as a treatment of GERD patients with erosive esophagitis for The increased CgA levels may cause false positive results in diagnostic investigations for neuroendocrine tumors USP Esomeprazole Magnesium RS Total impurities: NMT 0.5% USP Omeprazole RS USP Omeprazole Related Compound A RS Impurity Table 1 Omeprazole sulfone, 5-methoxy-2-[[(4-methoxy-3,5- No similar tumor was seen in male or female rats treated for 2 years. Concomitant administration of esomeprazole and either naproxen (non-selective NSAID) did not identify any clinically relevant changes in the pharmacokinetic profiles of these NSAIDs. Esomeprazole belongs to a class of antisecretory compounds, the substituted benzimidazoles, that suppress gastric acid secretion by specific inhibition of the H+/K+ ATPase enzyme system at the secretory surface of the gastric parietal cell.