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Respectively and diarrhea no difference among the three groups Nausea, flatulence, abdominal pain, constipation, and dry mouth occurred at similar rates among patients taking esomeprazole magnesium delayed-release capsules or possibly or probably related to esomeprazole magnesium delayed-release capsules reaction, asthenia, back pain, chest pain, substernal chest pain, esomeprazole ec tablets 20 mg edema, peripheral edema, hot flushes, fatigue, fever, flu-like disorder, generalized aggravated, dyspepsia, dysphagia, dysplasia GI, epigastric pain, eructation, esophageal disorder, frequent stools, gastroenteritis, GI hemorrhage, GI symptoms not otherwise specified, hiccup, melena, mouth disorder, pharynx disorder, rectal disorder, serum gastrin increased, tongue disorder, tongue edema, Hematologic: anemia, anemia hypochromic, cervical lymphadenopathy, epistaxis, leukocytosis, leukopenia, thrombocytopenia; hyponatremia, increased alkaline phosphatase, thirst, Vitamin B-12 deficiency, arthropathy, cramps, esomeprazole ec tablets 20 mg syndrome, hernia, polymyalgia rheumatica; appetite increased, confusion, depression aggravated, dizziness, hypertonia, nervousness, hypoesthesia, impotence, insomnia, migraine, migraine aggravated, paresthesia, pruritus, pruritus ani, rash, rash erythematous, rash maculo-papular, skin dysuria, fungal infection, hematuria, micturition frequency, moniliasis, phosphatase, ALT, AST, hemoglobin, white blood cell count, platelets, serum gastrin, potassium, sodium, thyroxine and thyroid stimulating hormonesee CLINICAL PHARMACOLOGY.

Over 2, 00 patients were treated magnesium delayed-release capsules were well tolerated in both short and esophagitis was assessed in four randomized comparative clinical trials, which included 1, 40 patients on esomeprazole magnesium delayed-release capsules 20 mg, 2, 34 patients on esomeprazole magnesium delayed-release capsules 40 mg, and 3, 08 patients on omeprazole 20 mg daily.

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Esomeprazole magnesium delayed-release capsules had no effect on thyroid function when given in oral doses of 20 or 40 mg for 4 weeks. Other effects of esomeprazole magnesium delayed-release capsules on the endocrine system were assessed using omeprazole studies.

The AUC after administration of a single 40 mg dose of esomeprazole magnesium delayed-release capsules is decreased by 43% to 53% after food intake compared to fasting conditions. Esomeprazole magnesium delayed-release capsules should be taken at least one hour before meals. Omeprazole given in oral doses of 30 or 40 mg for 2 to 4 esomeprazole ec 20 mg had no effect on carbohydrate metabolism, circulating levels of parathyroid hormone, cortisol, estradiol, testosterone, esomeprazole ec 20 mg, cholecystokinin, or secretin.

No patient developed ECL cell carcinoids, dysplasia, or neoplasia in the gastric mucosa.

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This increase in exposure is esomeprazole ec 20 mg considered clinically relevant. Similar differences have esomeprazole ec 20 mg seen for intravenous administration of esomeprazole. Increasing the infusion duration from 3 minutes to 10 minutes or 30 minutes was predicted to produce steady-state Cmax values that were comparable to those observed in adult patients at the 40 mg and 20 mg esomeprazole sodium for injection doses, respectively see Use in Specific Populations 8.

The AUC and Cmax values of esomeprazole were slightly higher 13% in females than in males at steady state when dosed orally.

No patient developed ECL cell carcinoids, dysplasia, or neoplasia in the gastric mucosa. In over 1, 00 patients treated with esomeprazole magnesium 10, 20 or 40 mg/day up to 6 to 12 months, the prevalence of ECL cell hyperplasia increased with time and dose.

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After administering the granules, the nasogastric tube should be flushed with additional water. Attach the syringe to a nasogastric tube and deliver the contents of the syringe through the nasogastric tube into the stomach.

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Atrial fibrillation, supraventricular tachycardia and abnormal QT interval. Hypomagnesemia, symptomatic esomeprazole ec 20 mg asymptomatic, reported rarely in patients receiving long-term therapy 3 months or, in most cases, 1 year with proton-pump inhibitors, including esomeprazole. 33232Serious adverse effects include tetany, seizures, tremors, carpopedal spasm, arrhythmias e.

Respectively and extensive metabolizers Cmax and AUC decreased by 49. 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 Cmax and AUC decreased by 37.

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    Hypomagnesaemia may also be associated with hypokalaemia. ery rare. not known cannot be estimated from the available data Hypomagnesaemia see section 4. severe hypomagnesaemia can correlate with hypocalcaemia.

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    No carcinoids were seen in these rats. An increased incidence of treatment-related ECL cell hyperplasia was observed at the end of 1 year 94% treated vs 10% controls By the second year the difference between treated and control rats was much smaller 46% vs 26% but still showed more hyperplasia in the treated group. 6 times the human dose of 40 mg/day on a body surface area basis for 1 year, then followed for an esomeprazole ec 20 mg year without the drug.

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    Patients receiving esomeprazole remained in remission longer and experienced fewer recurrences than patients receiving placebo; although esomeprazole 10 mg daily provided less benefit than esomeprazole 20 or 40 mg daily, no additional benefit of the 40-mg daily dosage over the 20-mg daily dosage was reported.

    Efficacy of esomeprazole in the treatment of endoscopically diagnosed erosive esophagitis was established in 4 controlled studies in patients receiving esomeprazole 20 or 40 mg daily or omeprazole 20 mg daily for 8 weeks. The percentage of patients who were symptom-free was substantially higher in the group receiving esomeprazole than in the group receiving placebo; no additional benefit of the 40-mg dosage over the 20-mg dosage was reported.

    Efficacy in the long-term maintenance esomeprazole ec tablets 20 mg healing was established in 2 controlled studies in patients with endoscopically confirmed healing of erosive esophagitis receiving esomeprazole 10, 20, or 40 mg daily or placebo for 6 months. Rates of healing and sustained resolution of heartburn achieved with esomeprazole were similar to or exceeded those achieved with omeprazole. Efficacy in patients with symptomatic GERD was established in 2 controlled studies esomeprazole ec tablets 20 mg patients with a 6-month or longer history of heartburn episodes, no endoscopic evidence of erosive esophagitis, and heartburn for at least 4 of the 7 days immediately prior to randomization; patients received esomeprazole 20 or 40 mg daily or placebo for 4 weeks. esomeprazole ec tablets 20 mg

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    Daily treatment with any acid-suppressing medications over a long period of time e. longer than 3 years may lead to malabsorption of cyanocobalamin vitamin B-12 caused by hypo- or achlorhydria. and Clinical Pharmacology 12. hen using NEXIUM esomeprazole ec tablets 20 mg alternative anti-platelet therapy see Drug Interactions 7.

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    The healing rates at Weeks 4 and 8 were evaluated and are shown in the Table 9: In these four studies, the range of median days to the start of sustained resolution defined esomeprazole ec tablets 20 mg 7 consecutive esomeprazole ec tablets 20 mg with no heartburn was 5 days for NEXIUM 40 mg, 7 esomeprazole ec tablets 20 mg 8 days for NEXIUM 20 mg and 7 to 9 days for omeprazole 20 mg.

    The healing rates of NEXIUM 40 mg, NEXIUM 20 mg, and omeprazole 20 mg the approved dose for this indication were evaluated in patients with endoscopically diagnosed erosive esophagitis in four multicenter, double-blind, esomeprazole ec tablets 20 mg studies.

    A 28-day toxicity study with a 14-day recovery phase was conducted in juvenile rats with esomeprazole magnesium at doses of 70 to 280 mg /kg/day about 17 to 68 times a daily oral human dose of 40 mg on a body surface area basis An increase in the number of deaths at the high dose of 280 mg/kg/day was observed when juvenile rats were administered esomeprazole magnesium from postnatal day 7 through postnatal day 35.

    Comparable findings described above have also been observed in this study with another esomeprazole salt, esomeprazole strontium, at equimolar doses of esomeprazole. n addition, doses equal to or greater than 140 mg/kg/day about 34 times a daily oral human dose of 40 mg on a body surface area basis produced treatment-related decreases in body weight approximately 14% and body weight gain, decreases in femur weight and femur length, and affected overall growth.

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