Nexium


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Related to Nexium: omeprazole

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.

esomeprazole

(es-o-mep-ra-zole) ,

NexIUM

(trade name)

Classification

Therapeutic: antiulcer agents
Pharmacologic: proton pump inhibitors
Pregnancy Category: B

Indications

Oral: Intravenous: GERD/erosive esophagitis (IV therapy should only be used if PO therapy is not possible/appropriate). Oral: Hypersecretory conditions, including Zollinger-Ellison syndrome. Oral: With amoxicillin and clarithromycin to eradicate Helicobacter pylori in duodenal ulcer disease or history of duodenal ulcer disease. Oral: Decrease risk of gastric ulcer during continuous NSAID therapy.

Action

Binds to an enzyme on gastric parietal cells in the presence of acidic gastric pH, preventing the final transport of hydrogen ions into the gastric lumen.

Therapeutic effects

Diminished accumulation of acid in the gastric lumen with lessened gastroesophageal reflux.
Healing of duodenal ulcers.
Decreased incidence of gastric ulcer during continuous NSAID therapy.

Pharmacokinetics

Absorption: 90% absorbed following oral administration; food ↓ absorption.
Distribution: Unknown.
Protein Binding: 97%.
Metabolism and Excretion: Extensively metabolized by the liver (cytochrome P450 [CYP450] system, primarily CYP2C19 isoenzyme, but also the CYP3A4 isoenzyme) genetic implication (the CYP2C19 enzyme system exhibits genetic polymorphism; 15–20% of Asian patients and 3–5% of Caucasian and Black patients may be poor metabolizers and may have significantly ↑ esomeprazole concentrations and an ↑ risk of adverse effects); <1% excreted unchanged in urine.
Half-life: Children 1–11 yrs: 0.42–0.88 hr; Adults: 1.0–1.5 hr.

Time/action profile (blood levels*)

ROUTEONSETPEAKDURATION
POrapid1.6 hr24 hr
IVrapidend of infusion24 hr
*Resolution of symptoms takes 5–8 days

Contraindications/Precautions

Contraindicated in: Hypersensitivity; Lactation: Not recommended;Concurrent use of atazanavir or nelfinavir.
Use Cautiously in: Severe hepatic impairment;Patients using high-doses for >1 year (↑ risk of hip, wrist, or spine fractures); Obstetric: Use only if clearly needed.

Adverse Reactions/Side Effects

Central nervous system

  • headache

Gastrointestinal

  • pseudomembranous colitis (life-threatening)
  • abdominal pain
  • constipation
  • diarrhea
  • dry mouth
  • flatulence
  • nausea

Fluid and Electrolyte

  • hypomagnesemia (especially if treatment duration ≥3 mo)

Musculoskeletal

  • bone fracture

Interactions

Drug-Drug interaction

May ↓ levels of atazanavir and nelfinavir (avoid concurrent use with either of these antiretrovirals).May ↑ levels and risk of toxicity of saquinavir (may need to ↓ dose of saquinavir).May ↓ absorption of drugs requiring acid pH, including ketoconazole, itraconazole, atazanavir, ampicillin, and iron salts.May ↑ risk of bleeding with warfarin (monitor INR and PT).Voriconazole may ↑ levels.May ↓ the antiplatelet effects of clopidogrel ; avoid concurrent use.May ↑ levels of cilostazol ; consider ↓ dose of cilostazol from 100 mg twice daily to 50 mg twice daily.Rifampin may ↓ levels and may ↓ response (avoid concurrent use).Hypomagnesemia ↑ risk of digoxin toxicity.May ↑ levels of tacrolimus and methotrexate.St. John's wort may ↓ levels and may ↓ response (avoid concurrent use).

Route/Dosage

Gastroesophageal Reflux Disease
Oral (Adults) Healing of erosive esophagitis—20 mg or 40 mg once daily for 4–8 wk; Maintenance of healing of erosive esophagitis—20 mg once daily; Symptomatic GERD—20 mg once daily for 4 wk (additional 4 wk may be considered for nonresponders).
Oral (Children 12–17 yr) Short-term treatment of GERD—20–40 mg once daily for up to 8 wk.
Oral (Children 1–11 yr) Short-term treatment of GERD—10 mg once daily for up to 8 wk; Healing of erosive esophagitis—<20 kg: 10 mg once daily for 8 wk; ≥20 kg: 10–20 mg once daily for 8 wk.
Oral (Infants and Children 1 mo–<1 yr) >7.5–12 kg—10 mg once daily for up to 6 wk; >5–7.5 kg—5 mg once daily for up to 6 wk; 3–5 kg—2.5 mg once daily for up to 6 wk;
Intravenous (Adults) 20 or 40 mg once daily.
Intravenous (Children 1–17 yr) <55 kg—10 mg once daily; ≥55 kg—20 mg once daily.
Intravenous (Children 1 mo-<1 yr) 0.5 mg/kg once daily.
H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence (Triple Therapy)
Oral (Adults) 40 mg once daily for 10 days with amoxicillin 1000 mg twice daily for 10 days and clarithromycin 500 mg twice daily for 10 days.
Decrease Gastric Ulcer During Continuous NSAID Therapy
Oral (Adults) 20 or 40 mg once daily for up to 6 mo.
Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome
Oral (Adults) 40 mg twice daily.

Hepatic Impairment

Oral Intravenous (Adults) Severe hepatic impairment—Dose should not exceed 20 mg/day.

Availability (generic available)

Delayed-release capsules: 20 mg, 40 mg Cost: 20 mg $713.55 / 90, 40 mg $731.22 / 90
Delayed-release oral suspension packets: 10 mg/pkt, 20 mg/pkt, 40 mg/pkt Cost: All strengths $268.01 / 30 pkts
Powder for injection (requires reconstitution): 20 mg/vial, 40 mg/vial
In combination with: naproxen (Vimovo).

Nursing implications

Nursing assessment

  • Assess routinely for epigastric or abdominal pain and frank or occult blood in the stool, emesis, or gastric aspirate.
  • Monitor bowel function. Diarrhea, abdominal cramping, fever, and bloody stools should be reported to health care professional promptly as a sign of pseudomembranous colitis.
  • Lab Test Considerations: May cause ↑ serum creatinine, uric acid, total bilirubin, alkaline phosphatase, AST, and ALT.
    • May alter hemoglobin, WBC, platelets, serum sodium, potassium, and thyroxine levels.
    • May cause hypomagnesemia. Monitor serum magnesium prior to and periodically during therapy.

Potential Nursing Diagnoses

Acute pain (Indications)

Implementation

  • Do not confuse Nexium with Nexavar.
  • Antacids may be used while taking esomeprazole.
  • Oral: Administer at least 1 hr before meals. Capsules should be swallowed whole.
    • Delayed-release capsules: For patients with difficulty swallowing, place 1 tbsp of applesauce in an empty bowl. Open capsule and carefully empty the pellets inside onto applesauce. Mix pellets with applesauce and swallow immediately. Applesauce should not be hot and should be soft enough to swallow without chewing. Do not store applesauce mixture for future use. Tap water, orange juice, apple juice, and yogurt have also been used. Do not crush or chew pellets.
    • For patients with an NG tube, delayed-release capsules can be opened and intact granules emptied into a 60-mL syringe and mixed with 50 mL of water. Replace plunger and shake syringe vigorously for 15 sec. Hold syringe with tip up and check for granules in tip. Attach syringe to NG tube and administer solution. After administering, flush syringe with additional water. Do not administer if granules have dissolved or disintegrated. Administer immediately after mixing.
    • For Delayed-release oral suspension: Mix contents of packet with 1 tbsp (15 mL) of water, leave 2–3 min to thicken, stir and drink within 30 min.
    • For Delayed-Release Oral Suspension Nasogastric or Gastric Tube: Add 15 mL of water to a syringe and then add contents of packet. Shake the syringe, leave 2–3 min to thicken. Shake the syringe and inject through the nasogastric or gastric tube within 30 min.
  • Intravenous Administration
  • Reconstitute each vial with 5 mL of 0.9% NaCl, LR, or D5W. Do not administer solutions that are discolored or contain a precipitate. Stable at room temperature for up to 12 hr.
  • Rate: Administer over at least 3 min.
  • Intermittent Infusion: Diluent: Dilute reconstituted solution to a volume of 50 mL with D5W, 0.9% NaCl, or LR for adults and with 0.9% NaCl for pediatric patients.Concentration: 0.8 mg/mL (40-mg vial) or 0.4 mg/mL (20-mg vial). Solutions diluted with 0.9% NaCl or LR are stable for 12 hr and those diluted with D5W are stable for 6 hr at room temperature.
  • Rate: Administer over 10–30 min.
  • Y-Site Compatibility: ceftaroline, doripenem
  • Y-Site Incompatibility: tacrolimus, telavancin. Do not administer with other medication or solutions. Flush line with 0.9% NaCl, LR, or D5W before and after administration.

Patient/Family Teaching

  • Instruct patient to take medication as directed for the full course of therapy, even if feeling better. Take missed doses as soon as remembered but not if almost time for next dose. Do not double doses. Advise patient to read the Patient Information sheet prior to starting therapy and with each Rx refill in case of changes.
  • Advise patient to avoid alcohol, products containing aspirin or NSAIDs, and foods that may cause an increase in GI irritation.
  • Advise patient to report onset of black, tarry stools; diarrhea; abdominal pain; or persistent headache to health care professional promptly.
  • Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and consult health care professional before taking any new medications, especially St. John's wort.
  • Advise patient to notify health care professional if signs of hypomagnesemia (seizures, dizziness, abnormal or fast heartbeat, jitteriness, jerking movements or shaking, muscle weakness, spasms of the hands and feet, cramps or muscle aches, spasm of the voice box) occur.
  • Caution patient to notify health care professional if fever and diarrhea occur, especially if stool contains blood, pus, or mucus. Advise patient not to treat diarrhea without consulting health care professional.
  • Advise female patient to notify health care professional if pregnancy is planned or suspected or if breast feeding.

Evaluation/Desired Outcomes

  • Decrease in abdominal pain or prevention of gastric irritation and bleeding. Healing of duodenal ulcers can be seen on x-ray examination or endoscopy.
  • Decrease in symptoms of GERD and erosive esophagitis. Sustained resolution of symptoms usually occurs in 5–8 days. Therapy is continued for 4–8 wk after initial episode.
  • Decreased incidence of gastric ulcer during continuous NSAID therapy.
  • Eradication of H. pylori in duodenal ulcer disease.
  • Decrease in symptoms of hypersecretory conditions, including Zollinger-Ellison.

Nexium

(nĕk′sē-əm)
A trademark for the magnesium salt of the drug esomeprazole.

Nexium®

Esomeprazole, the Purple pill Internal medicine An agent used to manage diagnostically confirmed erosive esophagitis
References in periodicals archive ?
Engaging videos on acid reflux disease and NEXIUM as a treatment option: informative visual content that provides background on the role of stomach acid in digesting food and how NEXIUM works by inhibiting proton pumps in the stomach.
On February 26, 2010, AstraZeneca submitted a regulatory filing for Nexium for approval in Japan, the only major market yet to launch.
Astra said in a statement to the stock exchange: "AstraZeneca is evaluating Ranbaxy's notice and continues to have full confidence in its intellectual property protecting Nexium.
At the time of purchase, present the card to the pharmacist along with your insurance card and a valid prescription for NEXIUM (esomeprazole magnesium).
Payments will be based on the number of valid claims filed as well as on the dollar amounts and/or number of prescriptions paid for NEXIUM.
Combined inhibitor of CYP 2C19 and 3A4 may raise esomeprazole levels NEXIUM may increase systemic exposure of cilostazol and an active metabolite.
In total, six studies have found the risk of fracture significantly increased for those patients over 50 years of age who took a prescription-strength PPI, like Nexium, or who took any PPI regularly for more than one year.
Before treatment with NEXIUM, patients had moderate-to-severe nighttime heartburn and GERD-related sleep disturbances on 3 out of 7 days.
NEXIUM already is approved for the risk reduction in the occurrence of gastric ulcers associated with continuous non-steroidal anti-inflammatory drug (NSAID) therapy in patients at risk for developing gastric ulcers.
The crux of the allegations is that AstraZeneca deceptively promoted Nexium as a "more powerful and more effective" drug than Prilosec.
5 mg and 5 mg strengths of NEXIUM for Delayed-Release Oral Suspension-