Nexium

What is Nexium?

• Nexium (esomeprazole magnesium) is a proton pump inhibitor used as a medication which reduces stomach acid.

Esomeprazole

Esomeprazole ball-and-stick model

Esomeprazole 2D structure

What are the uses of this medicine?

• Nexium (esomeprazole magnesium) is a prescription medicine called a proton pump inhibitor (PPI).

Nexium is used in adults:

• for 4 to 8 weeks to treat the symptoms of gastroesophageal reflux disease (GERD). Nexium may also be prescribed to heal acid-related damage to the lining of the esophagus (erosive esophagitis), and to help continue this healing.
• for up to 6 months to reduce the risk of stomach ulcers in some people taking pain medicines called non-steroidal anti-inflammatory drugs (NSAIDs).
• to treat patients with a stomach infection (Helicobacter pylori), along with the antibiotics amoxicillin and clarithromycin.
• for the long-term treatment of conditions where your stomach makes too much acid, including Zollinger-Ellison Syndrome. Zollinger-Ellison Syndrome is a rare condition in which the stomach produces a more than normal amount of acid.
• For children and adolescents 1 year to 17 years of age, Nexium may be prescribed for up to 8 weeks for short-term treatment of GERD.
• In children ages 1 month to less than 1 year of age, Nexium is only used to treat GERD with acid-related damage to the esophagus (erosive esophagitis) for up to 6 weeks.

Gastroesophageal reflux disease (GERD):

• GERD is a chronic condition (lasts a long time) that occurs when acid from the stomach backs up into the esophagus (food pipe) causing symptoms, such as heartburn, or damage to the lining of the esophagus. Common symptoms include frequent heartburn that will not go away, a sour or bitter taste in the mouth, and difficulty swallowing.

How does this medicine work?

• Esomeprazole is a proton pump inhibitor that suppresses gastric acid secretion by specific inhibition of the H+/K+-ATPase in the gastric parietal cell.
• The S- and R-isomers of omeprazole are protonated and converted in the acidic compartment of the parietal cell forming the active inhibitor, the achiral sulphenamide.
• By acting specifically on the proton pump, esomeprazole blocks the final step in acid production, thus reducing gastric acidity.
• This effect is dose-related up to a daily dose of 20 to 40 mg and leads to inhibition of gastric acid secretion.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• are allergic to any of the ingredients in Nexium.
• are allergic to any other Proton Pump Inhibitor (PPI) medicine.

What drug interactions can this medicine cause?

Nexium may affect how other medicines work, and other medicines may affect how Nexium works. Especially tell your doctor if you take:

• warfarin (Coumadin)
• ketoconazole (Nizoral)
• voriconazole (Vfend)
• atazanavir (Reyataz)
• nelfinavir (Viracept)
• saquinavir (Fortovase)
• products that contain iron
• digoxin (Lanoxin, Lanoxicaps)
• St.John’s Wort (Hypericum perforatum)
• Rifampin
• cilostazol (Pletal)
• diazepam (Valium)
• tacrolimus (Prograf)

Is this medicine FDA approved?

• Esomeprazole was approved for use in the United States in 2001 with similar indications as omeprazole includig peptic ulcer disease, gastroesophageal reflux disease and prevention of stress ulcers.

How should this medicine be used?

Recommended dosage: Gastroesophageal Reflux Disease (GERD): Healing of Erosive Esophagitis:

• 20 mg or 40 mg taken once Daily for 4 to 8 Weeks.

Maintenance of Healing of Erosive Esophagitis:

• 20 mg taken once Daily.

Symptomatic Gastroesophageal Reflux Disease:

• 20 mg taken once Daily for 4 Weeks.

• 1 month to less than 1 year: 2.5 mg, 5 mg or 10 mg (based on weight). Once daily, up to 6 weeks for erosive esophagitis (EE) due to acid-mediated GERD only.

Risk Reduction of NSAID-Associated Gastric Ulcer:

• 20 mg or 40 mg must be taken once daily for up to 6 months.

H. pylori Eradication (Triple Therapy):

• 40 mg Nexium must be taken once daily for 10 days.
• Amoxicillin 1000 mg taken twice daily for 10 days.
• Clarithromycin 500 mg must be taken twice daily for 10 days.

Pathological Hypersecretory Conditions:

• 40 mg taken twice daily.

Administration:

• Take Nexium exactly as prescribed by your doctor.
• Do not change your dose or stop Nexium without talking to your doctor.
• Take Nexium at least 1 hour before a meal.
• Swallow Nexium capsules whole. Never chew or crush Nexium.
• If you have difficulty swallowing Nexium capsules, you may open the capsule and empty the contents into a tablespoon of applesauce. Be sure to swallow the applesauce right away. Do not store it for later use.
• If you forget to take a dose of Nexium, take it as soon as you remember. If it is almost time for your next dose, do not take the missed dose. Take the next dose on time. Do not take a double dose to make up for a missed dose.
• If you take too much Nexium, tell your doctor right away.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Delayed-Release Capsules: 20 mg and 40 mg
• Nexium For Delayed-Release Oral Suspension: 2.5 mg, 5 mg, 10 mg, 20 mg, and 40 mg

This medicine is available in fallowing brand namesː

• Nexium ; Nexium 24HR

What side effects can this medication cause?

The most common side effects of this medicine include:

• Headache
• Diarrhea
• Nausea
• Gas
• Abdominal pain
• Constipation
• Dry mouth
• Drowsiness
• People who are taking multiple daily doses of proton pump inhibitor medicines for a long period of time may have an increased risk of fractures of the hip, wrist or spine.

Nexium may cause serious side effects include:

• Serious allergic reactions
• Low magnesium levels in your body

What special precautions should I follow?

• Symptomatic response to therapy with Nexium does not preclude the presence of gastric malignancy.
• Atrophic gastritis has been noted occasionally in gastric corpus biopsies from patients treated long-term with omeprazole, of which esomeprazole is an enantiomer.
• Long-term and multiple daily dose PPI therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist or spine.
• Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients on penicillin therapy as Part of H. pylori Triple Therapy.
• Hypomagnesemia has been reported rarely with prolonged treatment with PPIs.
• Avoid concomitant use of Nexium with St John’s Wort or rifampin due to the potential reduction in esomeprazole levels.
• Increases in intragastric pH may result in hypergastrinemia and enterochromaffin-like cell hyperplasia and increased chromogranin A levels which may interfere with diagnostic investigations for neuroendocrine tumors.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• reduced motor activity
• tremor
• ataxia
• intermittent clonic convulsions
• confusion
• drowsiness
• blurred vision
• tachycardia
• nausea
• diaphoresis
• flushing
• headache
• dry mouth

Management of overdosage:

• No specific antidote for esomeprazole is known. Since esomeprazole is extensively protein bound, it is not expected to be removed by dialysis.
• In the event of overdosage, treatment should be symptomatic and supportive.
• As with the management of any overdose, the possibility of multiple drug ingestion should be considered.
• For current information on treatment of any drug overdose contact a Poison Control Center at 1–800–222–1222.

Can this medicine be used in pregnancy?

• Pregnant women with omeprazole use during the first trimester do not show an increased risk of congenital anomalies or adverse pregnancy outcomes.
• There are, however, no adequate and well controlled studies of Nexium use in pregnancy.

Can this medicine be used in children?

• The safety and effectiveness of Nexium have been established in pediatric patients 1 to 17 years of age for short-term treatment (up to eight weeks) of GERD.
• The safety and effectiveness of Nexium have been established in pediatric patients 1 month to less than 1 year for short-term treatment (up to 6 weeks) of acid-mediated GERD with erosive esophagitis.
• However, the safety and effectiveness of Nexium have not been established in patients less than 1 month of age.

What are the active and inactive ingredients in this medicine?

• Active ingredient: esomeprazole magnesium trihydrate
• Inactive ingredients in Nexium Delayed-Release Capsules (including the capsule shells): glyceryl monostearate 40-55, hydroxypropyl cellulose, hypromellose, magnesium stearate, methacrylic acid copolymer type C, polysorbate 80, sugar spheres, talc, triethyl citrate, gelatin, FD&C Blue #1, FD&C Red #40, D&C Red #28, titanium dioxide, shellac, ethyl alcohol, isopropyl alcohol, n-butyl alcohol, propylene glycol, sodium hydroxide, polyvinyl pyrrolidone, and D&C Yellow #10.
• Inactive granules in Nexium Delayed-Release Oral Suspension: dextrose, xanthan gum, crospovidone, citric acid, iron oxide, and hydroxypropyl cellulose.

Who manufactures and distributes this medicine?

• Nexium is a registered trademark of the AstraZeneca group of companies.

Distributed by:

• AstraZeneca LP
• Wilmington, DE

What should I know about storage and disposal of this medication?

• Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F).
• Keep Nexium Delayed-Release Capsules container tightly closed.
• Dispense in a tight container if the Nexium Delayed-Release Capsules product package is subdivided.

• Dailymed label info on Nexium
• FDA Nexium

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