esomeprazole magnesium


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esomeprazole magnesium

Nexium

Pharmacologic class: Proton pump inhibitor

Therapeutic class: Antiulcer agent

Pregnancy risk category C

Action

Reduces gastric acid production by inhibiting enzyme activity in gastric parietal cells, preventing transport of hydrogen ions into gastric lumen

Availability

Capsules (delayed-release): 20 mg, 40 mg

Powder for delayed-release oral suspension: 2.5-mg, 5-mg, 10-mg, 20-mg, 40-mg packets

Indications and dosages

Treatment of gastroesophageal reflux disease (GERD); healing of erosive esophagitis

Children ages 1 month to younger than 1 year weighing 3 kg (6.5 lb) to 5 kg: 2.5 mg P.O. daily for up to 6 weeks

Adults: 20 to 40 mg P.O. once daily for 4 to 8 weeks

Children ages 1 month to younger than 1 year weighing more than 7.5 kg to 12 kg (16.5 to 26 lb): 10 mg P.O. daily for up to 6 weeks

Children ages 1 month to younger than 1 year weighing more than 5 kg (11 lb) to 7.5 kg: 5 mg P.O. daily for up to 6 weeks

Children ages 1 to 11 weighing 20 kg (44 lb) or more: 10 or 20 mg P.O. daily for 8 weeks

Children ages 1 to 11 weighing less than 20 kg (44 lb): 10 mg P.O. daily for 8 weeks

Treatment of GERD; maintenance of healing of erosive esophagitis

Adults: 20 mg P.O. once daily

Symptomatic GERD

Adults: 20 mg P.O. once daily for 4 weeks

Children ages 12 to 17: 20 or 40 mg P.O. daily for up to 8 weeks

Children ages 1 to 11: 10 mg P.O. daily for up to 8 weeks

Helicobacter pylori eradication to decrease risk of duodenal ulcer recurrence

Adults: 40 mg P.O. once daily for 10 days, given in combination with amoxicillin 1,000 mg b.i.d. for 10 days and with clarithromycin 500 mg b.i.d. for 10 days

Treatment of pathological hypersecretory conditions including Zollinger-Ellison syndrome

Adults: 40 mg P.O. b.i.d.

Risk reduction of NSAID-associated gastric ulcer

Adults: 20 or 40 mg P.O. once daily for up to 6 months

Contraindications

• Hypersensitivity to proton pump inhibitors

Precautions

Use cautiously in:

• severe hepatic impairment

• increased risk of hip, wrist, and spine fractures

• pregnant or breastfeeding patients

• children younger than age 18 (safety not established).

Administration

• Give 1 hour before or 2 hours after a meal.

• Know that contents of capsules may be mixed with applesauce.

• Don't crush capsules or pellets.

• Be aware that hypomagnesemia has been reported rarely in patients treated with proton pump inhibitors for at least 3 months. For patients expected to be on prolonged treatment or who take proton pump inhibitors with drugs such as digoxin or drugs that may cause hypomagnesemia (such as diuretics), consider monitoring magnesium level before starting treatment.

Adverse reactions

CNS: headache, dizziness, asthenia, vertigo, apathy, anxiety, paresthesia, insomnia, abnormal dreams

EENT: sinusitis, epistaxis

GI: nausea, vomiting, diarrhea, constipation, abdominal pain, flatulence, dry mouth

Metabolic: hypomagnesemia

Musculoskeletal: hip, wrist, spine fractures (with long-term daily use)

Respiratory: upper respiratory tract infection, cough

Skin: rash, inflammation, urticaria, pruritus, alopecia, dry skin

Interactions

Drug-drug. CYP2C19 or CYP3A4 inducers (such as rifampin): reduced esomeprazole level

Digoxin, iron salts, ketoconazole: altered absorption and effects of these drugs

Methotrexate: increased serum methotrexate level

Drug-diagnostic tests. Alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, bilirubin, creatinine, uric acid: increased levels

Hemoglobin, platelets, potassium, sodium, thyroxine, white blood cells: altered levels

Serum chromogranin A (CgA): increased level (may cause falsepositive results in diagnostic investigations for neuroendocrine tumors)

Drug-herbs. St. John's wort: reduced esomeprazole level

Patient monitoring

• Monitor neurologic status, especially for dizziness, headache, paresthesia, and asthenia.

• Watch for signs and symptoms of EENT and respiratory infections.

• Assess nutritional and hydration status in light of adverse GI effects.

• Check for rash and other signs of hypersensitivity.

• Monitor liver function test results if patient is on long-term therapy.

• Continue to monitor patients periodically who are expected to be on prolonged treatment or who take proton pump inhibitors with drugs such as digoxin or drugs that may cause hypomagnesemia.

Patient teaching

• Instruct patient to take drug 1 hour before or 2 hours after a meal.

• If patient has trouble swallowing capsule, tell him to open it, sprinkle pellets into soft food (such as applesauce), and take right away.

• Instruct patient to recognize and report signs or symptoms of hypomagnesemia.

• Caution patient to avoid driving and other hazardous activities until he knows how drug affects concentration and alertness.

• Advise female patient to tell prescriber if she's pregnant or breastfeeding.

• As appropriate, review all other significant adverse reactions and interactions, especially those related to the drugs and tests mentioned above.

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References in periodicals archive ?
Esomeprazole Magnesium Delayed-Release Capsules USP, 20 mg and 40 mg are the therapeutic equivalent to the reference listed drug, Nexium Delayed-Release Capsules, 20 mg and 40 mg, of AstraZeneca Pharmaceuticals LP.
According to the company, the Nexium 24HR (esomeprazole magnesium) capsules are indicated to treat frequent heartburn (occurs two or more days a week).The annual retail sales for the last 12 months were in excess of USD300m.
To conduct dissolution testing for delayed release capsules of esomeprazole magnesium, a 150x4.6mm, 5 pm column should be used at a flow rate of 1 mL/min and an injection volume of 20 [micro]L.
She had a history of esomeprazole magnesium use for GERD of greater than 3 years and was also taking meloxicam and ibuprofen for her osteoarthritis.
The safety of the fixed-dose combination of enteric-coated naproxen 500 mg and immediate-release esomeprazole magnesium 20 mg has been evaluated for 6 to 12 months in patients with RA, osteoarthritis, or some other condition requiring daily NSAIDs.
pylori eradication by concomitant therapy with four proton pump inhibitors―lansoprazole, omeprazole, rabeprazole sodium and esomeprazole magnesium hydrate-manufactured and marketed by the four companies in Japan under five brand names.
The PPI products listed in the communication are AcipHex (rabeprazole sodium); Dexilant (dexlansoprazole); Nexium (esomeprazole magnesium); omeprazole over-the-counter (OTC), Prevacid (lansoprazole) and OTC Prevacid 24hr; Prilosec (omeprazole) and its OTC product, Protonix (pantoprazole sodium), Wmaovo (esomeprazole magnesium and naproxen); and Zegerid (omeprazole and sodium bicarbonate) and its OTC product.
The PPI products listed in the communication are AcipHex (rabeprazole sodium); Dexi-lant (dexlansoprazole); Nexium (esomeprazole magnesium); omeprazole over-the-counter (OTC); Prevacid (lansoprazole) and OTC Prevacid 24hr; Prilosec (omeprazole) and its OTC product, Protonix (pantoprazole sodium); Vimovo (esomeprazole magnesium and naproxen); and Zegerid (omeprazole and sodium bicarbonate) and its OTC product.
The PPI products listed in the communication are AcipHex (rabeprazole sodium); Dexilant (dexlansoprazole); Nexium (esomeprazole magnesium); omeprazole over-the-counter (OTC);Prevacid (lansoprazole) and OTC Prevacid 24hr; Prilosec (omeprazole) and its OTC product, Protonix (pantoprazole sodium); Vimovo (esomeprazole magnesium and naproxen); and Zegerid (omeprazole and sodium bicarbonate) and its OTC product.
Esomeprazole magnesium (Nexium), dexlansoprazole (Dexilant), omeprazole (Prilosec), omeprazole with sodium bicarbonate (Zegerid), lansoprazole (Prevacid), pantoprazole (Protonix), rabeprazole (Aciphex), and naproxen with esomeprazole magnesium (Vimovo) are available by prescription to treat conditions such as gastroesophageal reflux disease (GERD), ulcers of the stomach and small intestine, and inflammation of the esophagus.
The Federal Court of Canada has dismissed AstraZeneca's request to prohibit the Canadian Minister of Health from issuing a Notice of Compliance (NOC) for the regulatory applications for generic esomeprazole magnesium submitted by Apotex Inc., a Canadian-owned pharmaceutical company.
On the same date, the company also submitted a supplemental NDA for Nexium (esomeprazole magnesium) for risk reduction of low-dose aspirin-associated peptic ulcers.