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.
Long-term safety of naproxen and esomeprazole magnesium fixed-dose combination: phase III study in patients at risk for NSAID-associated gastric ulcers.
Apotex, after receiving the Court's decision, must obtain an NOC or regulatory approval from the Minister of Health before launching a generic esomeprazole magnesium product in Canada.
Perrigo announced final Food and Drug Administration approval for its store-brand esomeprazole magnesium capsules in late August.
According to the company, VIMOVO (naproxen/esomeprazole magnesium) is a fixed-dose combination of delayed-release enteric-coated naproxen, a non-steroidal anti-inflammatory drug (NSAID), and immediate-release esomeprazole magnesium, a stomach acid-reducing proton pump inhibitor (PPI), approved for the relief of signs and symptoms of osteoarthritis, rheumatoid arthritis and ankylosing spondylitis and to decrease the risk of developing gastric ulcers in patients at risk of developing NSAID-associated gastric ulcers.
The Food and Drug Administration approved the proton pump inhibitor esomeprazole magnesium (Nexium, AstraZeneca) for short-term treatment of gastroesophageal reflux disease (GERD) in patients aged 1-11 years.
Contract awarded for esomeprazole magnesium trihydrate 2312-2016 list / naproxen, modified release coated tablet 20 mg / 500 mg code 10906
M2 EQUITYBITES-September 28, 2015-Dr Reddy's introduces Esomeprazole Magnesium Delayed-Release Capsules USP, 20 mg and 40 mg to the US market
127-2016, esomeprazole magnesium trihydrate / naproxen modified release coated tablet 20 mg / 500 mg.
Camber also recently launched esomeprazole magnesium delayed-release capsules (20 and 40 mg), the generic version of Nexium.
M2 PHARMA-September 28, 2015-Dr Reddy's introduces Esomeprazole Magnesium Delayed-Release Capsules USP, 20 mg and 40 mg to the US market