Nexium (Esomeprazole) belongs to the group of medications known as PPIs (proton pump inhibitors). Proton pump inhibitors are used for treatment of conditions such as stomach ulcers or gastroesophageal reflux disease (GERD, reflux esophagitis) by reducing the amount of the amount of acid that your stomach produces. Nexium is also used along with antibiotics to treat stomach ulcers that may be caused by bacteria Helicobacter pylori.

Nexium can also be used to reduce the risk of stomach ulcers caused by medications that irritate the stomach known as NSAIDs. Nexium is also used to treat different conditions associated with the over-production of stomach acid, including Zollinger-Ellison syndrome.

The recommended dose of nexium reflux esophagitis treatment is 40 mg once daily for 4-8 weeks. Treatment may be alsomaintained at a dose of 20 mg once daily.

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To treat gastroesophageal reflux disease (GERD) or heartburn, the recommended does is 20 mg once daily for 2-4 weeks. To treat or to prevent stomach ulcers caused by NSAID use, the dose is 20 mg daily.

For treatment of stomach ulcers that are caused by Helicobacter pylori in adults, the dose of nexium is 20 mg twice daily taken with amoxicillin 1,000 mg twice daily and clarithromycin 500 mg twice daily – all for a week.

For children 1-11 years of age, the recommended dose of nexium to treat GERD is 10 mg to 20 mg (depending on the child’s weight) daily for 2 months.

There is limited experience with use of nexium during pregnancy. This medication should not be used during pregnancy unless you are sure that the benefits outweigh the risks.

This medication has not been studied for the breast-feeding period. If you are a breast-feeding mother and you take nexium, it may affect your child. Talk to your pharmacist about whether you should continue taking nexium.

The safety of Nexium was evaluated in over 15,000 patients (18-84 y.o.) in clinical trials worldwide that included over 8,500 patients in the US and over 6,500 patients in Canada and Europe . Over 300 patients were treated in long-term studies for up to a year. In general, Nexium was well tolerated in both short and long-term clinical trials.

A study was performed evaluating the safety of Nexium in treatment of GERD inchildren at the age 12-17. The safety in the treatment of healing of the erosive esophagitis was assessed in four randomized comparative clinical trials. They included more than one thousand patients taking Nexium 20 mg, more than 2 thousand patients on Nexium 40 mg, and 3 thousand patients on omeprazole 20 mg daily. The most frequent side events (>1%) in all three groups was headache and diarrhea. Abdominal pain, nausea, constipation, flatulence and dry mouth occurred at similar rates among patients taking Nexium or omeprazole.

Additional Nexium side events that were reported as possibly or probably related to Nexium with an incidence < 1% are listed below:

Body as a Whole: allergic reaction, abdomen enlarged, dysphagia, asthenia, back pain, chest pain, , facial edema, peripheral edema, hot flushes, fatigue, fever, flu-like disorder, generalized edema, leg edema, malaise, pain, rigors;

Cardiovascular side effects: flushing, hypertension, tachycardia;

Endocrine side effects: goiter;

Gastrointestinal side effects: bowel irregularity, constipation aggravated, GI hemorrhage, dyspepsia, dysplasia GI, epigastric pain, chest pain, esophageal disorder, frequent stools,gastroenteritis, GI symptoms not otherwise specified, hiccup, melena, mouth disorder, pharynx disorder, rectal disorder, serum gastrin increased, tongue disorders, tongue edema, ulcerative stomatitis, vomiting;

Hearing side effects: earache, tinnitus;

Hematologic side effects: anemia, anemia hypochromic, cervical lymphoadenopathy, leukocytosis, epistaxis, leukopenia, thrombocytopenia;

Hepatic side effects: bilirubinemia, hepatic function abnormal, SGOT increased, SGPT increased;

Metabolic/Nutritional side effects: hyperuricemia, hyponatremia, increased alkaline phosphatase, thirst, vitamin B12 deficiency, weight increase, glycosuria, weight decrease;

Musculoskeletal side effects: arthralgia, arthritis aggravated, arthropathy, cramps, fibromyalgia syndrome, hernia, polymyalgia rheumatica;

Nervous System/Psychiatric side effects: anorexia, appetite increased, confusion, depression aggravated, dizziness, vertigo, hypertonia,insomnia, nervousness, impotence, apathy,migraine, migraine aggravated, paresthesia, sleep disorder, somnolence, tremor, hypoesthesia,;

Reproductive side effects: dysmenorrhea, menstrual disorder, vaginitis;

Respiratory side effects: pharyngitis, asthma aggravated, coughing, dyspnea, larynx edema, rhinitis, sinusitis;

Skin and Appendages side effects: acne, angioedema, sweating increased, dermatitis, pruritus, pruritus ani, rash, skin inflammation, rash erythematous, urticaria;

Special Senses side effects: otitis media, parosmia, taste loss, dysuria, taste perversion;

Urogenital side effects: abnormal urine,albuminuria, cystitis, fungal infection, hematuria, moniliasis, genital moniliasis, micturition frequency, polyuria;

Visual side effects: visual field defect, conjunctivitis, vision abnormal.

Endoscopic findings that were reported as side effects include: esophagitis, esophageal stricture, duodenitis, esophageal ulceration, gastric ulcer, gastritis, hernia, esophageal varices, benign polyps or nodules, Barrett's esophagus, and also mucosal discoloration.

The incidence of treatment-related side effects during 6-month maintenance treatment was similar to placebo. There were no real differences in types of related side effects seen during maintenance treatment up to a year compared to short-term treatment.

Nexium Overdose

A single oral dose of Nexium at 500 mg/kg , was lethal to rats. The major signs of acute toxicity were reduced motor activity, changes in respiratory frequency, ataxia, tremor,and also intermittent clonic convulsions.

There have been some reports of overdosage with nexium. Reports have been received of overdosage with omeprazole in humans.

Doses ranged up to 2gm (120 times the usual recommended clinical dose). Manifestations were variable, but they included drowsiness, confusion, blurred vision, nausea, diaphoresis, tachycardia, flushing, headache, dry mouth, and other side nexium effects similar to those seen in normal clinical experience. No specific antidote for nexium is known. Since esomeprazole is extensively protein bound, it is not expected to be removed by dialysis. In case of overdosage, treatment should be supportive and symptomatic.

Main facts about Side Effects of Nexium
Nexium has been studied extensively in clinical trials, with over 15,000 people worldwide having been evaluated. And in these studies, the side effects occurred in a group of people taking the medication were documented and then they were compared to the side effects that occurred in the other group of people taking a placebo (that is a “sugar pill” that does not contain any active ingredients). As a result, it was possible to mention what side effects occurred, how often they appeared, and how they compared to the group not taking nexium.

The most common side effects of Nexium, occurring in more than 1 percent of patients, were: Diarrhea, Flatulence, Headache, Constipation, Nausea, Abdominal pain and Dry mouth.

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