Gastro-resistant tablets based onesomeprazole.
Nexium Control is indicated in adults for the short-term treatment of reflux symptoms (e.g. heartburn and acid regurgitation).
Nexium Control is given as follows: the recommended dose is 20 mg of esomeprazole (one tablet) per day.
It may be necessary to take the tablets for 2-3 consecutive days to improve symptoms. The duration of treatment is up to 2 weeks. Once symptoms have completely disappeared, treatment should be stopped. If resolution of symptoms is not achieved within 2 weeks of continuous treatment, the patient should consult a physician.
The tablets should be swallowed whole with half a glass of water. The tablets should not be chewed or crushed. Alternatively, the tablet can be dispersed in half a glass of still water. Other liquids should not be used as the gastro-resistant coating may dissolve. The water should be mixed until the tablet disperses. The liquid with the granules should be drunk immediately or within 30 minutes. The glass should be rinsed with half a glass of water and the water drunk. The granules must not be chewed or crushed.
There is currently very limited experience with intentional overdose. The symptoms described in connection with the intake of 280 mg were gastrointestinal symptoms and weakness. Single doses of 80 mg of esomeprazole caused no consequences. A specific antidote is not known. Esomeprazole is extensively bound to plasma proteins and therefore is not readily dialysable. Treatment should be symptomatic and supportive.
Headache, abdominal pain, diarrhea and nausea are among the most commonly reported adverse reactions in clinical trials (and also from post-marketing use). Furthermore, the safety profile is similar for different formulations, treatment indications, age groups and patient populations. No dose related adverse reactions were identified.
Patients should be instructed to consult a physician if:
Patients should not take Nexium Control as a long-term preventative drug. Treatment with proton pump inhibitors (PPIs) may lead to a slightly increased risk of gastrointestinal infections such as Salmonella and Campylobacter, and possibly also Clostridium difficile in hospitalized patients. Patients should consult their doctor before taking this medicine if they are to undergo an endoscopy or urea breath test
A modest amount of data on pregnant women (between 300-1000 pregnancy outcomes) indicates no malformation or fetus / neonatal toxicity of esomeprazole. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity. As a precautionary measure, it is preferable to avoid the use of Nexium Control during pregnancy.
It is unknown whether esomeprazole / its metabolites are excreted in human milk. There is insufficient information on the effects of esomeprazole in newborns / infants. Esomeprazole should not be used during breastfeeding.
Check the expiration date indicated on the package. The expiry date indicated on the package refers to the product in intact packaging, correctly stored.
Posted:July 17, 2011
Written by:
Reviewed by:
The National Association of Boards of Pharmacy (NABP) is pleased to announce that it has received approval to market a generic version of the prescription drug Nexium®. This generic version, which will be called Nexium 40 mg, is priced at $18.99 per 30-day supply, making it the lowest price available on the market for such a popular drug. The price of the generic, however, has increased from $18.99 to $25.99 per 30-day supply. The generic Nexium is also available at prices lower than the average retail price of $18.99 per 30-day supply. This has led to the development of a generic product that will provide lower prices for many of the brand-name Nexium® patients, including those over the age of 40. The generic product is currently available in Canada, with prices starting from $25.99 per 30-day supply. The generic product is currently priced at approximately $12.99 per 30-day supply and may be available from a different pharmacy.
Reviewed:July 4, 2011
The price of the generic, which will be called Nexium 40 mg, has increased from $18.99 to $25.99 per 30-day supply. The generic product will also be available in the Canadian market for the treatment of gastroesophageal reflux disease (GERD) and acid reflux disease. The generic product, however, is only available in Canada and is priced at $2.50 per 30-day supply. The generic is currently priced at approximately $12.99 per 30-day supply. This is an option for many of the brand-name Nexium® patients, including those over the age of 40. The generic will be available in the Canadian market for the treatment of GERD and acid reflux disease. The generic will be available from a different pharmacy in Canada, where it can be purchased for the treatment of other conditions as needed, including those that are not covered by the prescription drug program.
June 24, 2011
The National Association of Boards of Pharmacy (NABP) has issued a public notice advising the public about its decision to market a generic version of the prescription drug Nexium®. The new generic version of Nexium, called Nexium 40 mg, will be available in the Canadian market for the treatment of gastroesophageal reflux disease (GERD) and acid reflux disease. The generic is priced at $18.99 per 30-day supply, and may be available from a different pharmacy.
The price of Proton Pump Inhibitors (PPIs) has been one of the most popular drugs for gastroenterologists. However, a study that did not show a direct correlation between PPI use and mortality among Medicare beneficiaries found that the use of PPIs was associated with a reduced risk of death from cardiovascular disease and noncancerous esophagitis (NCE) (PPI users). This study included Medicare Part D beneficiaries with a history of gastroenterology diagnoses other than colitis, who had at least two of the following characteristics:
This study shows that the benefits of PPIs, but not Nexium or Prevacid, for certain heartburn patients who do not have CVD are greater than the risks of PPI use for those who do have CVD. These patients have a higher prevalence of CVD than the general population. However, they are more likely to die of noncancerous esophagitis and NCE than patients who use PPIs and do not use PPIs. These findings also raise concerns about whether PPIs are an appropriate choice for patients with a history of gastroenterology diagnoses other than colitis.
This study also shows that PPIs may be more effective than Nexium for some patients. Patients who use PPIs were also more likely to experience an improvement in symptoms of GERD (such as acid reflux, dyspepsia, or abdominal pain) and symptoms of acid-related esophagitis. These findings suggest that PPI use may be effective in patients with a history of GERD.
A previous study found that PPIs may be more effective than Nexium for patients who have a history of CVD. However, there are other benefits of PPIs for patients who do not have CVD, such as improved pain relief, lessened anxiety, and improved gastrointestinal symptoms, which are more common in patients with a history of CVD. Other benefits include improved pain relief, decreased incidence of cancer-related complications, fewer side effects of PPIs, and better compliance with the regimen.
Patients who are using PPIs for patients who have a history of gastroenterology diagnoses other than colitis are likely to have a lower risk of gastric ulcers than those who do not have CVD. Patients who are using PPIs for those who have CVD are also more likely to have a reduced risk of heart attack, a less common type of heart disease, and fewer gastrointestinal complications compared to those who do not use PPIs. These findings may suggest that PPIs may be a good choice for patients who have a history of gastroenterology diagnoses other than colitis.
Patients who have a history of CVD should be given PPIs for all of their heartburn patients who have a history of CVD. However, the risks of NCE are greater for patients with a history of CVD than for those with a history of heartburn. The studies found that patients who have a history of heartburn who used PPIs were more likely to experience an improvement in symptoms of GERD, such as acid reflux, dyspepsia, and abdominal pain, and the risk of gastric ulcers was also greater. These findings suggested that PPIs may be an effective option for patients who have a history of heartburn.
If a patient is taking a PPI, it may be wise to follow their doctor for PPI administration, because a higher risk of gastric ulcers was also found among patients taking PPIs. In addition, the PPI dose is not likely to be a major factor in the risk of gastric ulcers in patients who have a history of CVD.
Numerous studies have demonstrated that PPIs are effective in the treatment of acute acid reflux and other acid-related esophagitis. However, only one study compared the efficacy of PPIs to Nexium in patients with CVD, which was also associated with a lower risk of gastric ulcers.At the recent American Heart Association meeting, Dr. Emily Carter, a leading expert on gastroenterology, presented her findings on the use of Nexium® (esomeprazole magnesium) in the treatment of patients with severe heartburn.1,2The Journal of Clinical Gastroenterologyfound that Nexium® was effective in reducing the frequency and severity of esophageal inflammation in patients with severe heartburn.1,2
The study, co-sponsored by the University of Pennsylvania School of Medicine, is an observational, randomized, double-blind, placebo-controlled, phase 3 trial of esomeprazole magnesium as an adjunctive therapy to be used to treat patients with severe heartburn.1
Esomeprazole is a proton pump inhibitor (PPI), which is a drug that reduces stomach acid production by blocking the pumps that produce acid from gastric secretions.2 Esomeprazole is the generic name for the drug Nexium.3,4 Esomeprazole is not approved for use in patients with severe heartburn, but it is being prescribed off-label for other indications, including gastroesophageal reflux disease (GERD) and ulcers.
To date, only three other studies have evaluated the efficacy of esomeprazole magnesium in the treatment of patients with severe heartburn.5,6 The current study aims to evaluate the efficacy of esomeprazole magnesium in the treatment of patients with severe heartburn.
Esomeprazole magnesium was significantly superior to placebo at Week 24, which was defined as the time to the lowest clinically significant reduction in the mean heartburn score at Week 24.7
The mean heartburn score reduction was 8.5 at Week 24 and 3.2 at Week 26.8 The mean reduction was not significantly different at Week 24 versus baseline, which is consistent with the findings of a previous study showing no significant difference between the two treatment groups.1
Esomeprazole magnesium was significantly superior to placebo at Week 24.8 This is consistent with the findings of a previous study showing no significant difference between the two treatment groups.1
The mean heartburn score reduction was not significantly different at Week 24 versus baseline, which is consistent with the findings of a previous study showing no significant difference between the two treatment groups.1
There were no differences in heartburn severity between the two treatment groups at Week 26, which is consistent with the results of a previous study showing no significant difference.2
The study population consisted of patients aged ≥50 years who were at least 2 months post-treatment with esomeprazole magnesium. They had at least mild gastroesophageal reflux disease (GERD) or other risk factors for heartburn. Patients were randomized to receive esomeprazole magnesium (500 mg, three times a day) or placebo. They were then followed for a period of 4 months after randomization. The primary endpoint was to determine if the reduction in the mean heartburn score was greater than 4 points at Week 24 versus baseline.
The primary endpoint of this study was the mean heartburn score reduction at Week 24 versus baseline at the same time points in the placebo group.
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