|Labeler Name||AstraZeneca Pharmaceuticals LP|
|Dosage & Substance||granule, delayed release esomeprazole magnesium|
|Date First Marketed||July 07, 2008|
1.1 Treatment of Gastroesophageal Reflux Disease (GERD)
NEXIUM is indicated for the short-term treatment (4 to 8 weeks) in the healing and symptomatic resolution of diagnostically confirmed erosive esophagitis. For those patients who have not healed after 4 to 8 weeks of treatment, an additional 4 to 8 week course of NEXIUM may be considered.
In infants 1 month to less than 1 year, NEXIUM is indicated for short-term treatment (up to 6 weeks) of erosive esophagitis due to acid-mediated GERD.
NEXIUM is indicated to maintain symptom resolution and healing of erosive esophagitis. Controlled studies do not extend beyond 6 months.
NEXIUM is indicated for short-term treatment (4 to 8 weeks) of heartburn and other symptoms associated with GERD in adults and children 1 year or older.
1.2 Risk Reduction of NSAID-Associated Gastric Ulcer
NEXIUM is indicated for the reduction in the occurrence of gastric ulcers associated with continuous NSAID therapy in patients at risk for developing gastric ulcers. Patients are considered to be at risk due to their age (≥ 60) and/or documented history of gastric ulcers. Controlled studies do not extend beyond 6 months.
1.3 Eradication to Reduce the Risk of Duodenal Ulcer Recurrence
Triple Therapy (NEXIUM plus amoxicillin and clarithromycin): NEXIUM, in combination with amoxicillin and clarithromycin, is indicated for the treatment of patients with infection and duodenal ulcer disease (active or history of within the past 5 years) to eradicate. Eradication of has been shown to reduce the risk of duodenal ulcer recurrenceand Clinical Studies (14)].
In patients who fail therapy, susceptibility testing should be done. If resistance to clarithromycin is demonstrated or susceptibility testing is not possible, alternative antimicrobial therapy should be instituted.
1.4 Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome
NEXIUM is indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison Syndrome.
NEXIUM is contraindicated in patients with known hypersensitivity to substituted benzimidazoles or to any component of the formulation. Hypersensitivity reactions may include anaphylaxis, anaphylactic shock, angioedema, bronchospasm, acute interstitial nephritis, and urticaria.
For information about contraindications of antibacterial agents (clarithromycin and amoxicillin) indicated in combination with NEXIUM, refer to the CONTRAINDICATIONS section of their package inserts.
The following serious adverse reactions are described below and elsewhere in labeling:
- Acute Interstitial Nephritis
- Associated Diarrhea
- Bone Fracture
- Cutaneous and Systemic Lupus Erythematosus
- Cyanocobalamin (Vitamin B-12) Deficiency
6.1 Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The safety of NEXIUM was evaluated in over 15,000 patients (aged 18 to 84 years) in clinical trials worldwide including over 8,500 patients in the United States and over 6,500 patients in Europe and Canada. Over 2,900 patients were treated in long-term studies for up to 6-12 months. In general, NEXIUM was well tolerated in both short and long-term clinical trials.
The safety in the treatment of healing of erosive esophagitis was assessed in four randomized comparative clinical trials, which included 1,240 patients on NEXIUM 20 mg, 2,434 patients on NEXIUM 40 mg, and 3,008 patients on omeprazole 20 mg daily. The most frequently occurring adverse reactions (≥1%) in all three groups were headache (5.5, 5, and 3.8, respectively) and diarrhea (no difference among the three groups). Nausea, flatulence, abdominal pain, constipation, and dry mouth occurred at similar rates among patients taking NEXIUM or omeprazole.
Additional adverse reactions that were reported as possibly or probably related to NEXIUM with an incidence <1% are listed below by body system:
abdomen enlarged, allergic reaction, asthenia, back pain, chest pain, substernal chest pain, facial edema, peripheral edema, hot flushes, fatigue, fever, flu-like disorder, generalized edema, leg edema, malaise, pain, rigors;
flushing, hypertension, tachycardia;
bowel irregularity, constipation aggravated, dyspepsia, dysphagia, dysplasia GI, epigastric pain, eructation, esophageal disorder, frequent stools, gastroenteritis, GI hemorrhage, GI symptoms not otherwise specified, hiccup, melena, mouth disorder, pharynx disorder, rectal disorder, serum gastrin increased, tongue disorder, tongue edema, ulcerative stomatitis, vomiting;
anemia, anemia hypochromic, cervical lymphadenopathy, epistaxis, leukocytosis, leukopenia, thrombocytopenia;
bilirubinemia, hepatic function abnormal, SGOT increased, SGPT increased;
glycosuria, hyperuricemia, hyponatremia, increased alkaline phosphatase, thirst, vitamin B12 deficiency, weight increase, weight decrease;
arthralgia, arthritis aggravated, arthropathy, cramps, fibromyalgia syndrome, hernia, polymyalgia rheumatica;
anorexia, apathy, appetite increased, confusion, depression aggravated, dizziness, hypertonia, nervousness, hypoesthesia, impotence, insomnia, migraine, migraine aggravated, paresthesia, sleep disorder, somnolence, tremor, vertigo, visual field defect;
dysmenorrhea, menstrual disorder, vaginitis;
asthma aggravated, coughing, dyspnea, larynx edema, pharyngitis, rhinitis, sinusitis;
acne, angioedema, dermatitis, pruritus, pruritus ani, rash, rash erythematous, rash maculo-papular, skin inflammation, sweating increased, urticaria;
otitis media, parosmia, taste loss, taste perversion;
abnormal urine, albuminuria, cystitis, dysuria, fungal infection, hematuria, micturition frequency, moniliasis, genital moniliasis, polyuria;
conjunctivitis, vision abnormal.
The following potentially clinically significant laboratory changes in clinical trials, irrespective of relationship to NEXIUM, were reported in ≤1% of patients: increased creatinine, uric acid, total bilirubin, alkaline phosphatase, ALT, AST, hemoglobin, white blood cell count, platelets, serum gastrin, potassium, sodium, thyroxine and thyroid stimulating hormone. Decreases were seen in hemoglobin, white blood cell count, platelets, potassium, sodium, and thyroxine.
Endoscopic findings that were reported as adverse reactions include: duodenitis, esophagitis, esophageal stricture, esophageal ulceration, esophageal varices, gastric ulcer, gastritis, hernia, benign polyps or nodules, Barrett’s esophagus, and mucosal discoloration.
The incidence of treatment-related adverse reactions during 6-month maintenance treatment was similar to placebo. There were no differences in types of related adverse reactions seen during maintenance treatment up to 12 months compared to short-term treatment.
Two placebo-controlled studies were conducted in 710 patients for the treatment of symptomatic gastroesophageal reflux disease. The most common adverse reactions that were reported as possibly or probably related to NEXIUM were diarrhea (4.3%), headache (3.8%), and abdominal pain (3.8%).
The safety of NEXIUM was evaluated in 316 pediatric and adolescent patients aged 1 to 17 years in four clinical trials for the treatment of symptomatic GERD. In 109 pediatric patients aged 1 to 11 years, the most frequently reported (at least 1%) treatment-related adverse reactions in these patients were diarrhea (2.8%), headache (1.9%) and somnolence (1.9%). In 149 pediatric patients aged 12 to 17 years the most frequently reported (at least 2%) treatment-related adverse reactions in these patients were headache (8.1%), abdominal pain (2.7%), diarrhea (2%), and nausea (2%).
The safety of NEXIUM was evaluated in 167 pediatric patients from birth to <1 year of age in three clinical trials. In a study that included 26 pediatric patients aged birth to 1 month there were no treatment related adverse reactions. In a study that included 43 pediatric patients age 1 to 11 months, inclusive the most frequently reported (at least 5%) adverse reactions, irrespective of causality, were irritability and vomiting. In a study that included 98 pediatric patients, age 1 to 11 months, inclusive exposed to esomeprazole for up to 6 weeks (including 39 patients randomized to the withdrawal phase), there were 4 treatment-related adverse reactions: abdominal pain (1%), regurgitation (1%), tachypnea (1%), and increased ALT (1%).
No new safety concerns were identified in pediatric patients.
Combination Treatment with Amoxicillin and Clarithromycin
In clinical trials using combination therapy with NEXIUM plus amoxicillin and clarithromycin, no additional adverse reactions specific to these drug combinations were observed. Adverse reactions that occurred were limited to those observed when using NEXIUM, amoxicillin, or clarithromycin alone.
The most frequently reported drug-related adverse reactions for patients who received triple therapy for 10 days were diarrhea (9.2%), taste perversion (6.6%), and abdominal pain (3.7%). No treatment-emergent adverse reactions were observed at higher rates with triple therapy than were observed with NEXIUM alone.
For more information on adverse reactions with amoxicillin or clarithromycin, refer to their package inserts, Adverse Reactions sections.
In clinical trials using combination therapy with NEXIUM plus amoxicillin and clarithromycin, no additional increased laboratory abnormalities particular to these drug combinations were observed.
For more information on laboratory changes with amoxicillin or clarithromycin, refer to their package inserts, Adverse Reactions section.
6.2 Postmarketing Experience
The following adverse reactions have been identified during post-approval use of NEXIUM. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. These reports are listed below by body system:
pancreatitis; stomatitis; microscopic colitis;
hepatic failure, hepatitis with or without jaundice;
anaphylactic reaction/shock; systemic lupus erythematosus;
GI candidiasis;associated diarrhea;
hypomagnesemia, with or without hypocalcemia and/or hypokalemia;
muscular weakness, myalgia, bone fracture;
hepatic encephalopathy, taste disturbance;
aggression, agitation, depression, hallucination;
alopecia, erythema multiforme, hyperhidrosis, photosensitivity, Stevens-Johnson syndrome, toxic epidermal necrolysis (some fatal), cutaneous lupus erythematosus.
5.1 Presence of Gastric Malignancy
In adults, symptomatic response to therapy with NEXIUM does not preclude the presence of gastric malignancy. Consider additional follow-up and diagnostic testing in adult patients who have a suboptimal response or an early symptomatic relapse after completing treatment with a PPI. In older patients, also consider an endoscopy.
5.2 Acute Interstitial Nephritis
Acute interstitial nephritis has been observed in patients taking PPIs including NEXIUM. Acute interstitial nephritis may occur at any point during PPI therapy and is generally attributed to an idiopathic hypersensitivity reaction. Discontinue NEXIUM if acute interstitial nephritis develops.
Published observational studies suggest that PPI therapy like NEXIUM may be associated with an increased risk ofassociated diarrhea, especially in hospitalized patients. This diagnosis should be considered for diarrhea that does not improveAdverse Reactions (6.2)].
Patients should use the lowest dose and shortest duration of PPI therapy appropriate to the condition being treated.
associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents. For more information specific to antibacterial agents (clarithromycin and amoxicillin) indicated for use in combination with NEXIUM, refer to Warnings and Precautions section of the corresponding prescribing information.
5.4 Bone Fracture
Several published observational studies suggest that proton pump inhibitor (PPI) therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist, or spine. The risk of fracture was increased in patients who received high-dose, defined as multiple daily doses, and long-term PPI therapy (a year or longer). Patients should use the lowest dose and shortest duration of PPI therapy appropriate to the condition being treated. Patients at risk for osteoporosis-related fractures should be managed according to established treatment guidelines.
5.5 Cutaneous and Systemic Lupus Erythematosus
5.6 Interaction with Clopidogrel
Avoid concomitant use of NEXIUM with clopidogrel. Clopidogrel is a prodrug. Inhibition of platelet aggregation by clopidogrel is entirely due to an active metabolite. The metabolism of clopidogrel to its active metabolite can be impaired by use with concomitant medications, such as esomeprazole, that inhibit CYP2C19 activity. Concomitant use of clopidogrel with 40 mg esomeprazole reduces the pharmacological activity of clopidogrel. When using NEXIUM consider alternative anti-platelet therapyand Clinical Pharmacology (12.3)].
5.7 Cyanocobalamin (Vitamin B-12) Deficiency
Daily treatment with any acid-suppressing medications over a long period of time (e.g., longer than 3 years) may lead to malabsorption of cyanocobalamin (vitamin B-12) caused by hypo- or achlorhydria. Rare reports of cyanocobalamin deficiency occurring with acid-suppressing therapy have been reported in the literature. This diagnosis should be considered if clinical symptoms consistent with cyanocobalamin deficiency are observed.
Hypomagnesemia, symptomatic and asymptomatic, has been reported rarely in patients treated with PPIs for at least three months, in most cases after a year of therapy. Serious adverse events include tetany, arrhythmias, and seizures. In most patients, treatment of hypomagnesemia required magnesium replacement and discontinuation of the PPI.
For patients expected to be on prolonged treatment or who take PPIs with medications such as digoxin or drugs that may cause hypomagnesemia (e.g., diuretics), health care professionals may consider monitoring magnesium levels prior to initiation of PPI treatment and periodically.
5.9 Interaction with St. John’s Wort or Rifampin
Drugs which induce CYP2C19 or CYP3A4 (such as St. John’s Wort or rifampin) can substantially decrease esomeprazole concentrations. Avoid concomitant use of NEXIUM with St. John’s Wort or rifampin.
5.10 Interactions with Diagnostic Investigations for Neuroendocrine Tumors
5.11 Interaction with Methotrexate
Literature suggests that concomitant use of PPIs with methotrexate (primarily at high dose; see methotrexate prescribing information) may elevate and prolong serum levels of methotrexate and/or its metabolite, possibly leading to methotrexate toxicities. In high-dose methotrexate administration a temporary withdrawal of the PPI may be considered in some patients.
Read the Medication Guide that comes with NEXIUM before you start taking NEXIUM and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or your treatment.
What is the most important information I should know about NEXIUM?
NEXIUM may help your acid-related symptoms, but you could still have serious stomach problems. Talk with your doctor.
NEXIUM can cause serious side effects, including:
- A type of kidney problem (acute interstitial nephritis). Some people who take proton pump inhibitor (PPI) medicines, including NEXIUM, may develop a kidney problem called acute interstitial nephritis that can happen at any time during treatment with NEXIUM. Call your doctor if you have a decrease in the amount that you urinate or if you have blood in your urine.
- Diarrhea. NEXIUM may increase your risk of getting severe diarrhea. This diarrhea may be caused by an infection (Clostridium difficile) in your intestines.
Call your doctor right away if you have watery stool, stomach pain, and fever that does not go away.
- Bone fractures. People who take multiple daily doses of PPI medicines for a long period of time (a year or longer) may have an increased risk of fractures of the hip, wrist, or spine. You should take NEXIUM exactly as prescribed, at the lowest dose possible for your treatment and for the shortest time needed. Talk to your doctor about your risk of bone fracture if you take NEXIUM.
- Certain types of lupus erythematosus. Lupus erythematosus is an autoimmune disorder (the body’s immune cells attack other cells or organs in the body). Some people who take PPI medicines, including NEXIUM, may develop certain types of lupus erythematosus or have worsening of the lupus they already have. Call your doctor right away if you have new or worsening joint pain or a rash on your cheeks or arms that gets worse in the sun.
NEXIUM can have other serious side effects. See “What are the possible side effects of NEXIUM?”
What is NEXIUM?
NEXIUM is a prescription medicine called a proton pump inhibitor (PPI). NEXIUM reduces the amount of acid in your stomach.
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.
GERD happens when acid in your stomach backs up into the tube (esophagus) that connects your mouth to your stomach. This may cause a burning feeling in your chest or throat, sour taste, or burping.
- 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 ( ), 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.
It is not known if NEXIUM is effective in children under 1 month of age.
Who should not take NEXIUM?
Do not take NEXIUM if you:
- are allergic to esomeprazole magnesium or any of the ingredients in NEXIUM. See the end of this Medication Guide for a complete list of ingredients in NEXIUM.
- are allergic to any other PPI medicine.
What should I tell my doctor before taking NEXIUM?
Before you take NEXIUM, tell your doctor if you:
- have been told that you have low magnesium levels in your blood.
- have liver problems.
- are pregnant or plan to become pregnant. It is not known if NEXIUM can harm your unborn baby.
- are breastfeeding or planning to breastfeed. NEXIUM may pass into your breast milk. Talk to your doctor about the best way to feed your baby if you take NEXIUM.
Tell your doctor about all of the medicines you take, including prescription and non-prescription drugs, vitamins and herbal supplements. NEXIUM may affect how other medicines work, and other medicines may affect how NEXIUM works.
Especially tell your doctor if you take:
- warfarin (Coumadin, Jantoven)
- ketoconazole (Nizoral)
- voriconazole (Vfend)
- atazanavir (Reyataz)
- nelfinavir (Viracept)
- saquinavir (Fortovase)
- products that contain iron
- digoxin (Lanoxin)
- St. John’s Wort (Hypericum perforatum)
- Rifampin (Rimactane, Rifater, Rifamate)
- cilostazol (Pletal)
- diazepam (Valium)
- tacrolimus (Prograf)
- erlotinib (Tarceva)
- clopidogrel (Plavix)
- myophenolate mofetil (Cellcept)
How should I take NEXIUM?
- 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. Do not crush or chew the granules. 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, call your doctor or local poison control center right away, or go to the nearest hospital emergency room.
- See the “Instructions for Use” at the end of this Medication Guide for instructions how to take NEXIUM For Delayed-Release Oral Suspension, and how to mix and give NEXIUM Delayed-Release Capsules and NEXIUM For Delayed-Release Oral Suspension, through a nasogastric tube or gastric tube.
What are the possible side effects of NEXIUM?
NEXIUM can cause serious side effects, including:
- See “What is the most important information I should know about NEXIUM?”
- Vitamin B-12 deficiency. NEXIUM reduces the amount of acid in your stomach. Stomach acid is needed to absorb vitamin B-12 properly. Talk with your doctor about the possibility of vitamin B-12 deficiency if you have been on NEXIUM for a long time (more than 3 years).
- Low magnesium levels in your body. Low magnesium can happen in some people who take a PPI medicine for at least 3 months. If low magnesium levels happen, it is usually after a year of treatment.
- You may or may not have symptoms of low magnesium. Tell your doctor right away if you have any of these symptoms:
- abnormal or fast heart beat
- jerking movements or shaking (tremors)
- muscle weakness
- spasms of the hands and feet
- cramps or muscle aches
- spasm of the voice box
- Your doctor may check the level of magnesium in your body before you start taking NEXIUM or during treatment if you will be taking NEXIUM for a long period of time.
The most common side effects with NEXIUM may include:
- abdominal pain
- dry mouth
Other side effects:
Serious allergic reactions. Tell your doctor if you get any of the following symptoms with NEXIUM:
- face swelling
- throat tightness
- difficulty breathing
Your doctor may stop NEXIUM if these symptoms happen.
Tell your doctor if you have any side effects that bother you or that do not go away. These are not all the possible side effects with NEXIUM.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store NEXIUM?
- Store NEXIUM at room temperature between 68°F to 77°F (20°C to 25°C).
- Keep the container of NEXIUM closed tightly.
Keep NEXIUM and all medicines out of the reach of children.
General information about NEXIUM
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use NEXIUM for a condition for which it was not prescribed. Do not give NEXIUM to other people, even if they have the same symptoms you have. It may harm them.
This Medication Guide summarizes the most important information about NEXIUM. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about NEXIUM that is written for health professionals.
For more information, go to www.purplepill.com or call 1-800-463-9486.
What are the ingredients in NEXIUM?
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 For Delayed-Release Oral Suspension: dextrose, xanthan gum, crospovidone, citric acid, iron oxide, and hydroxypropyl cellulose.
Instructions for Use
For instructions on taking Delayed-Release Capsules, see the section of this leaflet called “How should I take NEXIUM?”
Take NEXIUM For Delayed-Release Oral Suspension as follows:
- NEXIUM For Delayed-Release Oral Suspension comes in foil packets containing 2.5 mg, 5 mg, 10 mg, 20 mg, or 40 mg strengths.
- You should use an oral syringe to measure the amount of water needed to mix your dose. Ask your pharmacist for an oral syringe.
- If your prescribed dose is 2.5 mg or 5 mg, add 5 mL of water to a container, then add the contents of a foil packet containing the dose prescribed by your doctor.
- If your prescribed dose is 10 mg, 20 mg, or 40 mg, add 15 mL of water to a container, then add the contents of a foil packet containing the dose prescribed by your doctor.
- If you or your child are instructed to use more than one foil packet for the prescribed dose, follow the mixing instructions provided by your pharmacist or doctor.
- Leave 2 to 3 minutes to thicken.
- Stir and take dose within 30 minutes. If not used within 30 minutes, throw away this dose and mix a new dose.
- If any medicine remains after drinking, add more water, stir, and take dose right away.
- For young children, you can give the dose with an oral syringe. Rinse the oral syringe with water after each use.
NEXIUM Delayed-Release Capsules and NEXIUM For Delayed-Release Oral Suspension may be given through a nasogastric tube (NG tube) or gastric tube, as prescribed by your doctor. Follow the instructions below:
NEXIUM Delayed-Release Capsules:
- Open the capsule and empty the granules into a 60 mL catheter tipped syringe. Mix with 50 mL of water. Use only a catheter tipped syringe to give NEXIUM through a NG tube.
- Replace the plunger and shake the syringe well for 15 seconds. Hold the syringe with the tip up and check for granules in the tip.
- Give the medicine right away.
- Do not give the granules if they have dissolved or have broken into pieces.
- Attach the syringe to the NG tube. Give the medicine in the syringe through the NG tube into the stomach.
- After giving the granules, flush the NG tube with more water.
NEXIUM For Delayed-Release Oral Suspension:
- NEXIUM For Delayed-Release Oral Suspension comes in foil packets containing 2.5 mg, 5 mg, 10 mg, 20 mg, or 40 mg strengths.
- Use only a catheter tipped syringe to give NEXIUM through a NG tube or gastric tube.
- If your prescribed dose is 2.5 mg or 5 mg, add 5 mL of water to a catheter tipped syringe, then add the contents of a foil packet containing the dose prescribed by your doctor.
- If your prescribed dose is 10 mg, 20 mg, or 40 mg, add 15 mL of water to a catheter tipped syringe, then add the contents of a foil packet containing the dose prescribed by your doctor.
- Shake the syringe right away and then leave it for 2 to 3 minutes to thicken.
- Shake the syringe and give the medicine through the NG or gastric tube (French size 6 or larger) into the stomach within 30 minutes.
- Refill the syringe with the same amount of water (either 5 mL or 15 mL of water depending on your dose).
- Shake the syringe and flush any remaining medicine from the NG tube or gastric tube into the stomach.
This Medication Guide has been approved by the U.S. Food and Drug Administration.
AstraZeneca Pharmaceuticals LP
Wilmington, DE 19850
NEXIUM is a registered trademark of the AstraZeneca group of companies.
©2016 AstraZeneca Pharmaceuticals LP. All rights reserved
A single oral dose of esomeprazole at 510 mg/kg (about 124 times the human dose on a body surface area basis), was lethal to rats. The major signs of acute toxicity were reduced motor activity, changes in respiratory frequency, tremor, ataxia, and intermittent clonic convulsions.
The symptoms described in connection with deliberate NEXIUM overdose (limited experience of doses in excess of 240 mg/day) are transient. Single doses of 80 mg of esomeprazole were uneventful. Reports of overdosage with omeprazole in humans may also be relevant. Doses ranged up to 2,400 mg (120 times the usual recommended clinical dose). Manifestations were variable, but included confusion, drowsiness, blurred vision, tachycardia, nausea, diaphoresis, flushing, headache, dry mouth, and other adverse reactions similar to those seen in normal clinical experience (see omeprazole package insert -). 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.
The active ingredient in the proton pump inhibitor NEXIUM® (esomeprazole magnesium) Delayed-Release Capsules for oral administration and NEXIUM (esomeprazole magnesium) For Delayed-Release Oral Suspension is bis(5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole-1-yl) magnesium trihydrate. Esomeprazole is the S-isomer of omeprazole, which is a mixture of the S- and R- isomers. (Initial U.S. approval of esomeprazole magnesium: 2001). Its molecular formula is (C17H18N3O3S)2Mg x 3 H2O with molecular weight of 767.2 as a trihydrate and 713.1 on an anhydrous basis. The structural formula is:
The magnesium salt is a white to slightly colored crystalline powder. It contains 3 moles of water of solvation and is slightly soluble in water. The stability of esomeprazole magnesium is a function of pH; it rapidly degrades in acidic media, but it has acceptable stability under alkaline conditions. At pH 6.8 (buffer), the half-life of the magnesium salt is about 19 hours at 25°C and about 8 hours at 37°C.
NEXIUM is supplied in delayed-release capsules and in packets for a delayed-release oral suspension. Each delayed-release capsule contains 20 mg, or 40 mg of esomeprazole (present as 22.3 mg, or 44.5 mg esomeprazole magnesium trihydrate) in the form of enteric-coated granules with the following inactive ingredients: glyceryl monostearate 40-55, hydroxypropyl cellulose, hypromellose, magnesium stearate, methacrylic acid copolymer type C, polysorbate 80, sugar spheres, talc, and triethyl citrate. The capsule shells have the following inactive ingredients: 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.
Each packet of NEXIUM For Delayed-Release Oral Suspension contains 2.5 mg, 5 mg, 10 mg, 20 mg, or 40 mg of esomeprazole, in the form of the same enteric-coated granules used in NEXIUM Delayed-Release Capsules, and also inactive granules. The inactive granules are composed of the following ingredients: dextrose, xanthan gum, crospovidone, citric acid, iron oxide, and hydroxypropyl cellulose. The esomeprazole granules and inactive granules are constituted with water to form a suspension and are given by oral, nasogastric, or gastric administration.