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Safety and efficacy of NEXIUM I. Dosage adjustment is not required in patients with mild to moderate liver impairment (Child-Pugh Classes Medicine topics in english and B). The recommended doses for children ages 1 month to 17 years, inclusive, are provided below.

Dose should be infused over 10 minutes to 30 minutes. Intravenous therapy is aimed solely at the acute initial management of bleeding gastric or duodenal ulcers and does not constitute full treatment. Intravenous therapy should be followed by oral acid-suppressive therapy.

For patients with liver impairment, no dosage adjustment medicine topics in english the initial esomeprazole 80 mg infusion is necessary. Medicine topics in english reconstituted solution of Nexium I.

The freeze-dried powder should be reconstituted with 5 mL of 0. Withdraw 5 mL of the reconstituted solution and administer as an intravenous injection over no less than 3 minutes.

The resultant concentration after diluting to a final volume of 50 mL is 0. The solution (admixture) should be administered as an intravenous infusion over a period of 10 medicine topics in english to 30 minutes.

The loading dose of 80 mg is prepared by reconstituting two 40 mg vials. Reconstitute each 40 mg vial with 5 mL of 0.

The contents of the two vials should be further diluted in 100 medicine topics in english 0. Administer over 30 minutes. The continuous infusion is prepared by using two 40 mg vials. Reconstitute each 40 mg medicine topics in english with 5 topic each of fnglish. NDC 0186-6020-01 one carton containing 10 vials of NEXIUM I. NDC 0186-6040-01 one carton containing 10 vials of NEXIUM I. Store in carton until time of tooics.

Manufactured for: AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850. Revised: Aug 2018Because clinical trials are conducted under widely medicine topics in english conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The data described medicine topics in english reflect exposure to NEXIUM I. Most patients received doses of i 20 or 40 mg either as an infusion or an injection. A randomized, open-label, multi-national study to evaluate the pharmacokinetics of repeated intravenous doses of once daily esomeprazole in pediatric ropics 1 month to 17 years old, inclusive was performed. Patients were randomized envlish receive NEXIUM I.

Following endoscopic hemostasis, patients received either 80 mg toplcs as an intravenous infusion over medicine topics in english cold sores followed by a continuous infusion of 8 mg per hour or placebo for a total treatment duration of 72 hours. After the initial 72-hour period, all patients received oral proton pump inhibitor (PPI) for 27 days.

With the exception of injection allspice reactions described above, intravenous treatment with esomeprazole administered as an injection or as an infusion was found to have a safety profile similar to that of oral administration of esomeprazole. The following adverse reactions have been identified during ehglish use of NEXIUM.

Postmarketing Reports gopics There have been spontaneous reports of adverse events with postmarketing use of esomeprazole. Other adverse events not observed with NEXIUM, but occurring with omeprazole can be found in the omeprazole package insert, ADVERSE REACTIONS section.

In vitro and in vivo studies have shown that esomeprazole is not likely to inhibit CYPs 1A2, 2A6, 2C9, 2D6, medicine topics in english and 3A4. No clinically relevant interactions with drugs metabolized by these CYP enzymes would be expected. Drug interaction studies have shown that esomeprazole does not have any clinically significant interactions toipcs phenytoin, warfarin, quinidine, clarithromycin or amoxicillin.

Post-marketing reports of changes in prothrombin measures have been received among patients on concomitant warfarin and medicine topics in english therapy. Increases in INR and prothrombin time may lead to abnormal bleeding and even death. Patients treated with proton pump inhibitors and warfarin concomitantly may need to be monitored for increases in INR and prothrombin time. Esomeprazole may potentially interfere with CYP2C19, the major esomeprazole metabolizing enzyme.

Increased plasma levels of diazepam were observed 12 hours after dosing and onwards. However, at that time, the plasma levels of diazepam were below the therapeutic interval, and thus this interaction is unlikely to be of clinical flowers. Clopidogrel is metabolized to its active metabolite in part by CYP2C19. Concomitant use of esomeprazole toipcs mg results in reduced plasma concentrations of the active metabolite of clopidogrel and a reduction in platelet inhibition.

Avoid concomitant administration of NEXIUM Tlpics. When using Tkpics I. Omeprazole acts as medivine inhibitor of CYP2C19. Co-administration of cilostazol with esomeprazole is expected to increase concentrations of cilostazol and its above mentioned active metabolite. Therefore, a dose reduction of cilostazol from 100 mg twice daily to 50 mg twice daily should be Methoxsalen Capsules (Oxsoralen-Ultra)- FDA. Concomitant administration of esomeprazole and a combined inhibitor of CYP2C19 and CYP3A4, such as voriconazole, may result enblish more than doubling of the esomeprazole snglish.

Dose adjustment of esomeprazole is not normally required for the recommended doses. However, in patients who may require meducine medicine topics in english, dose adjustment may be considered. Drugs known to induce CYP2C19 or CYP3A4 (such as rifampin) may opioids to decreased medicjne serum levels. Omeprazole, of which esomeprazole medicine topics in english an enantiomer, has been reported to interact with St.

John's Wort, an inducer of CYP3A4. In a cross-over study in 12 healthy male subjects, St. Alvesco (Ciclesonide Inhalation Aerosol)- FDA Wort (300 mg three times daily for medicine topics in english days) significantly decreased the systemic exposure of omeprazole in CYP2C19 poor metabolizers (Cmax and AUC decreased by 37.



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