Esoméprazole Arrow strontium is used to treat conditions where there is too much acid in the stomach. It is used to treat duodenal and gastric ulcers, erosive esophagitis, gastroesophageal reflux disease (GERD), and the Zollinger-Ellison syndrome. Esoméprazole Arrow is also used with antibiotics (eg, amoxicillin, clarithromycin) to treat ulcers that are caused by the H. pylori bacteria. Esoméprazole Arrow strontium is also used to prevent stomach ulcers and stomach irritation in patients taking pain and arthritis drugs called NSAIDs, such as aspirin or ibuprofen, for long periods of time.
Esoméprazole Arrow strontium is a proton pump inhibitor (PPI). It works by decreasing the amount of acid that is produced by the stomach.
Esoméprazole Arrow strontium is available only with your doctor’s prescription.
Esoméprazole Arrow indications
An indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.
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Treatment of Gastroesophageal Reflux Disease (GERD)
Healing of Erosive Esophagitis
Esoméprazole Arrow Magnesium Delayed-Release Capsules are 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 Esoméprazole Arrow Magnesium Delayed-Release Capsules may be considered.
Maintenance of Healing of Erosive Esophagitis
Esoméprazole Arrow Magnesium Delayed-Release Capsules are indicated to maintain symptom resolution and healing of erosive esophagitis. Controlled studies do not extend beyond 6 months.
Symptomatic Gastroesophageal Reflux Disease
Esoméprazole Arrow Magnesium Delayed-Release Capsules are 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.
Risk Reduction of NSAID-Associated Gastric Ulcer
Esoméprazole Arrow Magnesium Delayed-Release Capsules are 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.
H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence
Triple Therapy (Esoméprazole Arrow Magnesium Delayed-Release Capsules plus amoxicillin and clarithromycin): Esoméprazole Arrow Magnesium Delayed-Release Capsules, in combination with amoxicillin and clarithromycin, is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or history of within the past 5 years) to eradicate H. pylori. Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence.
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.
Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome
Esoméprazole Arrow Magnesium Delayed-Release Capsules are indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison Syndrome.
How should I use Esoméprazole Arrow?
Use Esoméprazole Arrow delayed-release capsules as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Esoméprazole Arrow delayed-release capsules comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Esoméprazole Arrow delayed-release capsules refilled.
Take Esoméprazole Arrow delayed-release capsules by mouth on an empty stomach at least 1 hour before a meal.
Swallow Esoméprazole Arrow delayed-release capsules whole. Do not break, crush, or chew before swallowing.
If you have difficulty swallowing the capsule, you may add 1 tablespoon of applesauce to an empty bowl. Open the capsule and empty the pellets onto the applesauce. Mix the pellets with the applesauce and swallow the mixture right away. The applesauce used should not be hot and should be soft enough to be swallowed without chewing. Do not chew or crush the pellets. Do not store the mixture for future use.
If the patient is taking Esoméprazole Arrow delayed-release capsules through a nasogastric (NG) tube or gastric tube, follow the instructions for use in the extra patient leaflet.
You may take antacids while you are using Esoméprazole Arrow delayed-release capsules if you are directed to do so by your doctor.
Continue to take Esoméprazole Arrow delayed-release capsules even if you feel well. Do not miss any doses.
If you miss a dose of Esoméprazole Arrow delayed-release capsules, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use Esoméprazole Arrow delayed-release capsules.
Uses of Esoméprazole Arrow in details
There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.
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Use: Labeled Indications
Oral:
Esoméprazole Arrow magnesium and Esoméprazole Arrow strontium:
Gastroesophageal reflux disease (Rx only):
Healing of erosive esophagitis: Short-term (4 to 8 weeks) treatment of erosive esophagitis
Maintenance of healing of erosive esophagitis: Maintaining symptom resolution and healing of erosive esophagitis
Symptomatic gastroesophageal reflux disease: Short-term (4 to 8 weeks) treatment of symptomatic gastroesophageal reflux disease (GERD)
Helicobacter pylori eradication (Rx only): As part of a multidrug regimen for Helicobacter pylori eradication in patients with duodenal ulcer disease (active or history of within the past 5 years)
Risk reduction of nonsteroidal anti-inflammatory drug-associated gastric ulcer (Rx only): Prevention of gastric ulcers associated with continuous NSAID therapy in patients at risk (age ≥60 years and/or history of gastric ulcer)
Pathological hypersecretory conditions, including Zollinger-Ellison syndrome (Rx only): Treatment (long-term) of pathological hypersecretory conditions including Zollinger-Ellison syndrome
Esoméprazole Arrow magnesium:
Heartburn (OTC labeling): Treatment of frequent heartburn (≥2 days per week).
IV: Esoméprazole Arrow sodium:
Gastroesophageal reflux disease (Rx only): Short-term (≤10 days) treatment of gastroesophageal reflux disease (GERD) with erosive esophagitis in pediatric patients 1 month to 17 years of age and adults when oral therapy is not possible or appropriate
Risk reduction of ulcer rebleeding postprocedure (Rx only): Decrease the risk of rebleeding postendoscopy for acute bleeding gastric or duodenal ulcers in adults
Off Label Uses
Barrett esophagus
Data from a meta-analysis of observational studies evaluating acid suppressive therapy and the risk of esophageal adenocarcinoma or high-grade dysplasia in patients with Barrett esophagus showed that proton pump inhibitors were associated with a reduction in the risk of esophageal adenocarcinoma and high-grade dysplasia associated with Barrett esophagus; a longer duration of PPI use was associated with a greater protective effect.
Esoméprazole Arrow description
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Each tablet contains 20 mg or 40 mg Esoméprazole Arrow (as magnesium trihydrate).
Each tablet contains Esomeprazole as enteric-coated pellets (MUPS).
Esoméprazole Arrow MUPS is a proton pump inhibitor. The active ingredient in Esoméprazole Arrow MUPS is Esoméprazole Arrow magnesium trihydrate, a substituted benzimidazole. Esoméprazole Arrow is the S-isomer of omeprazole. It is optically stable in vivo, with negligible conversion to the R-isomer. The chemical name is di-(S)-5-methoxy-2-[[4-methoxy-3,5-dimethyl-2-pyridinyl)methyl] sulfinyl] -1H- benzimidazole magnesium salt trihydrate.
Its molecular formula is C34H36N6O6S2Mg·3H2O and has a molecular weight of 767.2 (trihydrate).
Excipients/Inactive Ingredients: Glycerol monostearate 40-55, hyprolose, hypromellose, iron oxide (E 172) (Tablet 20 mg, reddish-brown CI 77491, yellow, CI 77492) (Tablet 40 mg, reddish-brown CI 77491), magnesium stearate, methacrylic acid ethyl acrylate copolymer (1:1) dispersion 30 percent, cellulose microcrystalline, synthetic paraffin, macrogols, polysorbate 80, crospovidone, sodium stearyl fumarate, sugar spheres (sucrose and maize starch), talc, titanium dioxide (E 171), triethyl citrate.
Esoméprazole Arrow 20 mg: Sucrose 28 mg.
Esoméprazole Arrow 40 mg: Sucrose 30 mg.
Esoméprazole Arrow dosage
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Usual Adult Dose for Gastroesophageal Reflux Disease:
Esoméprazole Arrow Magnesium:
-20 mg orally once a day for 4 weeks
Esoméprazole Arrow Strontium:
-24.65 mg orally once a day for 4 to 8 weeks.
Comment:
-If symptoms do not resolve after 4 weeks, an additional 4 weeks may be considered.
GERD with Erosive Esophagitis:
Esoméprazole Arrow Sodium:
-20 mg or 40 mg IV injection once a day, over no less than 3 minutes; or IV infusion once a day, over no less than 10 to 30 minutes
Comment: Safety and efficacy of Esoméprazole Arrow sodium IV for Injection for more than 10 days have not been demonstrated.
Uses: Short term treatment of heartburn and symptomatic gastroesophageal reflux disease; short term treatment of GERD with erosive esophagitis, inclusively as an alternative to oral therapy, if unable to use oral route
Usual Adult Dose for Erosive Esophagitis:
Healing:
-Esoméprazole Arrow Magnesium: 20 to 40 mg orally once a day for 4 to 8 weeks
-Esoméprazole Arrow Strontium: 24.65 to 49.3 mg orally once a day for 4 to 8 weeks
-An additional 4 to 8 week course of therapy may be considered in patients not healed after initial treatment.
Maintenance of healing:
-Esoméprazole Arrow Magnesium: 20 mg orally once a day
-Esoméprazole Arrow Strontium: 24.65 mg orally once a daily
Comments:
-Esoméprazole Arrow Sodium injection may be used as an alternative to oral therapy, if unable to use oral route.
-Maintenance of healing: Controlled studies did not extend beyond six months.
Uses: Short-term treatment in the healing and symptomatic resolution of diagnostically confirmed erosive esophagitis; to maintain symptom resolution and healing of erosive esophagitis
Usual Adult Dose for Helicobacter pylori Infection:
Esoméprazole Arrow Magnesium:
Triple therapy:
-40 mg orally once a day for 10 days, along with amoxicillin 1000 mg and clarithromycin 500 mg orally twice a day for 10 days
Esoméprazole Arrow Strontium:
Triple therapy:
-49.3 mg orally once a day for 10 days, along with amoxicillin 1000 mg and clarithromycin 500 mg orally twice a day for 10 days
Comments:
-Susceptibility testing should be done in patients who fail therapy.
-If resistance to clarithromycin is demonstrated or susceptibility testing is not possible, alternative antimicrobial therapy should be instituted.
-Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence.
Use: Triple therapy (Esoméprazole Arrow plus amoxicillin and clarithromycin): Treatment of H. pylori infection and duodenal ulcer disease (active or history of within the past 5 years) to eradicate H. pylori
Usual Adult Dose for NSAID-Induced Gastric Ulcer:
Esoméprazole Arrow Magnesium:
-20 mg to 40 mg orally once daily for up to 6 months
Esoméprazole Arrow Strontium:
-24.65 mg to 49.3 mg orally once a day for up to 6 months
Comment:
-Patients older than 60 years and/or with history of gastric ulcers are considered to be at risk for developing gastric ulcers.
-Controlled studies do not extend beyond 6 months
Use: Reduction in the occurrence of gastric ulcers associated with continuous NSAID therapy in patients at risk for developing gastric ulcers.
Usual Adult Dose for Zollinger-Ellison Syndrome:
Esoméprazole Arrow Magnesium:
-40 mg orally twice a day
Esoméprazole Arrow Strontium:
-49.3 mg orally twice a day
Comment: Doses up to 240 mg daily have been used.
Use: Long term treatment of pathological hypersecretory conditions, including Zollinger-Ellison Syndrome
Usual Adult Dose for Pathological Hypersecretory Conditions:
Esoméprazole Arrow Magnesium:
-40 mg orally twice a day
Esoméprazole Arrow Strontium:
-49.3 mg orally twice a day
Comment: Doses up to 240 mg daily have been used.
Use: Long term treatment of pathological hypersecretory conditions, including Zollinger-Ellison Syndrome
Usual Adult Dose for Duodenal Ulcer Prophylaxis:
Esoméprazole Arrow Sodium:
-Initial dose: 80 mg IV infusion over 30 minutes
-Maintenance dose: 8 mg/hr IV continuous infusion for a total of 72 hours (includes initial 30 minute dose plus 71.5 hours of continuous infusion)
Comments:
-Intravenous therapy is aimed solely at the acute initial management of bleeding gastric or duodenal ulcers and does not constitute full treatment.
-Intravenous therapy should be followed by oral acid-suppressive therapy.
Use: Risk reduction of rebleeding of gastric or duodenal ulcers following therapeutic endoscopy
Usual Adult Dose for Gastric Ulcer Prophylaxis:
Esoméprazole Arrow Sodium:
-Initial dose: 80 mg IV infusion over 30 minutes
-Maintenance dose: 8 mg/hr IV continuous infusion for a total of 72 hours (includes initial 30 minute dose plus 71.5 hours of continuous infusion)
Comments:
-Intravenous therapy is aimed solely at the acute initial management of bleeding gastric or duodenal ulcers and does not constitute full treatment.
-Intravenous therapy should be followed by oral acid-suppressive therapy.
Use: Risk reduction of rebleeding of gastric or duodenal ulcers following therapeutic endoscopy
Usual Pediatric Dose for Gastroesophageal Reflux Disease:
Esoméprazole Arrow Magnesium:
Less than 1 year:
-Data not available
1 to 11 years:
-10 mg once a day for up to 8 weeks
-Comment: Doses over 1 mg/kg/day have not been studied.
12 to 17 years:
-20 mg once a day for 4 weeks
Esoméprazole Arrow Sodium:
GERD with Erosive Esophagitis:
Less than 1 month:
-Not recommended.
1 month to less than 1 year:
-0.5 mg/kg IV infused over 10 to 30 minutes
1 to 17 years:
-Less than 55 kg: 10 mg IV infused over 10 to 30 minutes
-55 kg or more: 20 mg IV infused over 10 to 30 minutes
Esoméprazole Arrow Strontium: Not recommended.
Uses: Short term treatment of symptomatic GERD; short term treatment of GERD with erosive esophagitis, inclusively as an alternative to oral therapy, if unable to use oral route
Usual Pediatric Dose for Erosive Esophagitis:
Esoméprazole Arrow Magnesium:
Healing:
Less than 1 year:
-Data not available
1 to 11 years:
-Less than 20 kg: 10 mg once a day for 8 weeks
-20 kg or more: 10 mg or 20 mg once a day for 8 weeks
12 to 17 years:
-20 or 40 mg once a day for 4 to 8 weeks
Comment: Doses over 1 mg/kg/day have not been studied.
Erosive Esophagitis due to acid-mediated GERD:
Less than 1 month:
-Data not available
1 month to less than 1 year old:
-3 kg to 5 kg: 2.5 mg once a day
-Greater than 5 kg to 7.5 kg: 5 mg once a day
-Greater than 7.5 kg to 12 kg: 10 mg once a day
Duration of therapy: For up to 6 weeks
Comment: Doses over 1.33 mg/kg/day have not been studied.
1 year and older:
-Data not available
Uses: Short-term treatment in the healing and symptomatic resolution of diagnostically confirmed erosive esophagitis; short term treatment of erosive esophagitis due to acid-mediated GERD in infants
Effects of Esoméprazole Arrow on the Pharmacokinetics of Other Drugs: The decreased intragastric acidity during treatment with Esoméprazole Arrow, might increase or decrease the absorption of drugs if the mechanism of absorption is influenced by gastric acidity. In common with the use of other inhibitors of acid secretion or antacids, the absorption of ketoconazole and itraconazole can decrease during treatment with Esoméprazole Arrow.
Esoméprazole Arrow inhibits CYP2C19, the major Esoméprazole Arrow-metabolising enzyme. Thus, when Esoméprazole Arrow is combined with drugs metabolised by CYP2C19 eg, diazepam, citalopram, imipramine, clomipramine, phenytoin, etc, the plasma concentrations of these drugs may be increased and a dose reduction could be needed. This should be considered especially when prescribing Esoméprazole Arrow for on-demand therapy.
Concomitant administration of Esoméprazole Arrow 30 mg resulted in a 45% decrease in clearance of the CYP2C19 substrate diazepam. Concomitant administration of Esoméprazole Arrow 40 mg resulted in a 13% increase in trough plasma levels of phenytoin in epileptic patients. It is recommended to monitor the plasma concentrations of phenytoin when treatment with Esoméprazole Arrow is introduced or withdrawn.
Esoméprazole Arrow has been shown to have no clinically relevant effects on the pharmacokinetics of amoxicillin, quinidine or warfarin.
Effects of Other Drugs on the Pharmacokinetics of Esoméprazole Arrow: Esoméprazole Arrow is metabolised by CYP2C19 and CYP3A4. Concomitant administration of Esoméprazole Arrow and a CYP3A4 inhibitor, clarithromycin (500 mg twice daily), resulted in a doubling of the exposure (AUC) to Esoméprazole Arrow. Dose adjustment of Esoméprazole Arrow is not required.
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.
Adults
The safety of intravenous Esoméprazole Arrow is based on results from clinical trials conducted in four different populations including patients having symptomatic GERD with or without a history of erosive esophagitis (n=199), patients with erosive esophagitis (n=160), healthy subjects (n=204) and patients with bleeding gastric or duodenal ulcers (n=375).
Symptomatic GERD and Erosive Esophagitis Trials
The data described below reflect exposure to Esoméprazole Arrow I.V. for Injection in 359 patients. Esoméprazole Arrow I.V. for Injection was studied only in actively-controlled trials. The population was 18 to 77 years of age; 45% Male, 52% Caucasian, 17% Black, 3% Asian, 28% Other, and had either erosive reflux esophagitis (44%) or GERD (56%). Most patients received doses of either 20 or 40 mg either as an infusion or an injection. Adverse reactions occurring in ≥ 1% of patients treated with intravenous Esoméprazole Arrow (n=359) in clinical trials are listed below:
Table 2 : Adverse reactions occurring at an incidence ≥ 1% in the Esoméprazole Arrow I.V. group
Adverse Reactions
% of patients Esoméprazole Arrow
Intravenous (n=359)
Headache
10.9
Flatulence
10.3
Nausea
6.4
Abdominal pain
5.8
Diarrhea
3.9
Mouth dry
3.9
Dizziness/vertigo
2.8
Constipation
2.5
Injection site reaction
1.7
Pruritus
1.1
Intravenous treatment with Esoméprazole Arrow 20 and 40 mg administered as an injection or as an infusion was found to have a safety profile similar to that of oral administration of Esoméprazole Arrow.
Pediatric
A randomized, open-label, multi-national study to evaluate the pharmacokinetics of repeated intravenous doses of once daily Esoméprazole Arrow in pediatric patients 1 month to 17 years old, inclusive was performed. The safety results are consistent with the known safety profile of Esoméprazole Arrow and no unexpected safety signals were identified.
Risk Reduction of Rebleeding of Gastric or Duodenal Ulcers in Adults
The data described below reflect exposure to Esoméprazole Arrow I.V. for Injection in 375 patients. Esoméprazole Arrow I.V. for Injection was studied in a placebo-controlled trial. Patients were randomized to receive Esoméprazole Arrow I.V. for Injection (n=375) or placebo (n=389). The population was 18 to 98 years old; 68% Male, 87% Caucasian, 1% Black, 7% Asian, 4% other, who presented with endoscopically confirmed gastric or duodenal ulcer bleeding. Following endoscopic hemostasis, patients received either 80 mg Esoméprazole Arrow as an intravenous infusion over 30 minutes followed by a continuous infusion of 8 mg per hour or placebo for a total treatment duration of 72 hours. After the initial 72-hour period, all patients received oral proton pump inhibitor (PPI) for 27 days.
Table 3 : Incidence (%) of adverse reactions that occurred in greater than 1% of patients within 72 hours after start of treatment*
Number(%)of patients
Esoméprazole Arrow
(n=375)
Placebo
(n=389)
Duodenal ulcer haemorrhage
16 (4.3%)
16 (4.1%)
Injection site reaction#
16 (4.3%)
2 (0.5)
Pyrexia
13 (3.5%)
11 (2.8%)
Cough
4 (1.1%)
1 (0.3%)
Dizziness
4 (1.1%)
3 (0.8%)
*Incidence ≥ 1% in the Esoméprazole Arrow group and greater than placebo group safety population
#Injection site reactions included erythema, swelling, inflammation, pruritus, phlebitis, thrombophlebitis and superficial phlebitis.
With the exception of injection site reactions described above, intravenous treatment with Esoméprazole Arrow administered as an injection or as an infusion was found to have a safety profile similar to that of oral administration of Esoméprazole Arrow.
Postmarketing Experience
The following adverse reactions have been identified during post-approval use of Esoméprazole Arrow. 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.
Postmarketing Reports - There have been spontaneous reports of adverse events with postmarketing use of Esoméprazole Arrow. These reports occurred rarely and are listed below by body system:
Blood And Lymphatic System Disorders: agranulocytosis, pancytopenia;
Renal and Urinary Disorders: interstitial nephritis;
Reproductive System and Breast Disorders: gynecomastia;
Respiratory, Thoracic and Mediastinal Disorders: bronchospasm;
Skin and Subcutaneous Tissue Disorders: alopecia, erythema multiforme, hyperhidrosis, photosensitivity, Stevens-Johnson syndrome, toxic epidermal necrolysis (TEN, some fatal).
Other adverse events not observed with Esoméprazole Arrow, but occurring with omeprazole can be found in the omeprazole package insert, ADVERSE REACTIONS section.
Esoméprazole Arrow is rapidly absorbed after oral doses, with peak plasma levels occurring after about 1-2 hrs. It is acid labile and an enteric-coated formulation has been developed. Bioavailability of Esoméprazole Arrow increases with both dose and repeated administration to about 68% and 89% for doses of 20 mg and 40 mg, respectively. Food delays and decreases the absorption of Esoméprazole Arrow, but this does not significantly change its effect of intragastric acidity. Esoméprazole Arrow is about 97% bound to plasma proteins. It is extensively metabolized in the liver by the cytochrome P450 (CYP450) isoenzyme CYP2C19 to hydroxy and desmethyl metabolites, which have no effect on gastric acid section. The remainder is metabolized by the CYP450 isoenzyme CYP3A4 to Esoméprazole Arrow sulfone. With repeated dosage, there is a decrease in first-pass metabolism and systemic clearance, probably caused by an inhibition of the CYP2C19 isoenzyme. However, there is no accumulation during once daily use. The plasma elimination half-life (t½) is about 1.3 hrs. Almost 80% of an oral dose is eliminated as metabolites in the urine, the remainder in the feces.
DailyMed. "ESOMEPRAZOLE STRONTIUM: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
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