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Medically reviewed by Fedorchenko Olga Valeryevna, PharmD. Last updated on 25.04.2022
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Treatment Of Gastroesophageal Reflux Disease (GERD)
Healing Of Erosive Esophagitis
Esomeprazole 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 Esomeprazole may be considered.
In infants 1 month to less than 1 year, Esomeprazole is indicated for short-term treatment (up to 6 weeks) of erosive esophagitis due to acid-mediated GERD.
Maintenance Of Healing Of Erosive Esophagitis
Esomeprazole is indicated to maintain symptom resolution and healing of erosive esophagitis. Controlled studies do not extend beyond 6 months.
Symptomatic Gastroesophageal Reflux Disease
Esomeprazole 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.
Risk Reduction Of NSAID-Associated Gastric Ulcer
Esomeprazole 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.
H. pylori Eradication To Reduce The Risk Of Duodenal Ulcer Recurrence
Triple Therapy (Esomeprazole plus amoxicillin and clarithromycin): Esomeprazole, 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-Ellis On Syndrome
Esomeprazole is indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison Syndrome.
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.Sodium Bicarbonate (sodium bicarbonate 5% injection) Injection may be indicated in the treatment of metabolic acidosis which can occur in severe renal disease, uncontrolled diabetes, circulatory insufficiency due to shock, anoxia or severe dehydration, extracorporeal circulation of blood and severe primary lactic acidosis. Sodium Bicarbonate (sodium bicarbonate 5% injection) Injection is further indicated in the treatment of certain drug intoxications, including barbiturates, in poisoning by salicylates or methyl alcohol, and in hemolytic reactions requiring alkalinization of the urine to diminish nephrotoxicity of blood pigments. Sodium Bicarbonate (sodium bicarbonate 5% injection) Injection may also be indicated in severe diarrhea which is often accompanied by a significant loss of bicarbonate.
Esomeprazole 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. Esomeprazole is also used with antibiotics (eg, amoxicillin, clarithromycin) to treat ulcers that are caused by the H. pylori bacteria. Esomeprazole 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.
Esomeprazole is a proton pump inhibitor (PPI). It works by decreasing the amount of acid that is produced by the stomach.
Esomeprazole is available only with your doctor’s prescription.
Sodium bicarbonate, also known as baking soda, is used to relieve heartburn, sour stomach, or acid indigestion by neutralizing excess stomach acid. When used for this purpose, it is said to belong to the group of medicines called antacids. It may be used to treat the symptoms of stomach or duodenal ulcers. Sodium bicarbonate is also used to make the blood and urine more alkaline in certain conditions.
Antacids should not be given to young children (up to 6 years of age) unless prescribed by their doctor. Since children cannot usually describe their symptoms very well, a doctor should check the child before giving sodium bicarbonate. The child may have a condition that needs other treatment. If so, antacids will not help and may even cause unwanted effects or make the condition worse.
Sodium bicarbonate for oral use is available without a prescription.
Usual Adult Dose for Gastroesophageal Reflux Disease:
Esomeprazole Magnesium:
-20 mg orally once a day for 4 weeks
Esomeprazole:
-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:
Esomeprazole 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 esomeprazole 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:
-Esomeprazole Magnesium: 20 to 40 mg orally once a day for 4 to 8 weeks
-Esomeprazole: 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:
-Esomeprazole Magnesium: 20 mg orally once a day
-Esomeprazole: 24.65 mg orally once a daily
Comments:
-Esomeprazole 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:
Esomeprazole 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
Esomeprazole:
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 (esomeprazole 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:
Esomeprazole Magnesium:
-20 mg to 40 mg orally once daily for up to 6 months
Esomeprazole:
-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:
Esomeprazole Magnesium:
-40 mg orally twice a day
Esomeprazole:
-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:
Esomeprazole Magnesium:
-40 mg orally twice a day
Esomeprazole:
-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:
Esomeprazole 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:
Esomeprazole 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:
Esomeprazole 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
Esomeprazole 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
Esomeprazole: 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:
Esomeprazole 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
One vial (5 mL) of Sodium Bicarbonate added to a liter (1000 mL) of any of the following Hospira parenteral solutions will increase the pH to a more physiologic range. Specific pH may vary slightly from lot to lot.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. See PRECAUTIONS.
Addition of one vial of Sodium Bicarbonate to one-half liter (500 mL) is recommended to achieve a more physiologic pH of the following Hospira parenteral solutions:
Note: Some products, e.g., Amniosyn® solutions and those lonosol® and Normosol® formulas containing dextrose will NOT be brought to near physiologic pH by the addition of Sodium Bicarbonate. This is due to the relatively high buffer capacity of these fluids.
COMPATIBILITY & EFFECTIVNESS FO Sodium Bicarbonate WITH ADDITIVES TO 5% DEXTROSE INJECTION (D5-W)
When medications are added to intravenous solutions, the resultant admixtures may or may not be compatible in solutions containing Sodium Bicarbonate (4% sodium bicarbonate additive solution).
Following is a list of medications each added to one liter of 5% Dextrose Injection, USP (D5-W) classified according to their effect with Sodium Bicarbonate (4% sodium bicarbonate additive solution).
It should be noted that the admixtures were evaluated for physical compatibility, not for pharmacological compatibility. It, therefore, would be erroneous to circumvent medical judgment which must be involved in administering any solution that appears to be compatible on the basis of having no visible haze or precipitate. The inclusion of drugsin this study of their compatibility in solution does not imply their therapeutic usefulness or safety. This matter remains the judgment of the prescribing physician.
NOTE: The compatibility information contained herein in based on the studies involving Hospira dextrose only. Variationsin compativility could occur due to lot-to-lot variations or formula changes in the additivies or dextrose solutions of other manufacturers.
See also:
What is the most important information I should know about Esomeprazole?
Esomeprazole 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 esomeprazole 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 esomeprazole, but this does not significantly change its effect of intragastric acidity. Esomeprazole 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 esomeprazole 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.
See also:
What is the most important information I should know about Sodium Bicarbonate?
Sodium Bicarbonate (sodium bicarbonate 5% injection) Injection is contraindicated in patients with metabolic and respiratory alkalosis and in patients with hypocalcemia in which alkalosis may produce tetany.
Use Esomeprazole as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Esomeprazole comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Esomeprazole refilled.
- Take Esomeprazole by mouth on an empty stomach at least 1 hour before a meal.
- You will need to mix Esomeprazole in a small amount of water before taking your dose. You should use an oral syringe to measure the amount of water needed to mix your dose. Ask your pharmacist for an oral syringe. The recommended amount of water for the mixing of each dose is as follows:
- If your dose of Esomeprazole is 2.5 or 5 mg, add 1 teaspoon (5 mL) of water to a container.
- If your dose of Esomeprazole is 10, 20, or 40 mg, add 1 tablespoon (15 mL) of water to a container
- Tear open the medicine packet and add the contents of the packet to the container. Stir well. Allow the mixture to thicken for 2 to 3 minutes. Stir again. Drink the mixture within 30 minutes. If it is not used within 30 minutes, throw away this dose and mix a new dose. If any medicine remains in the glass after drinking, add more water. Stir and then drink right away.
- If the patient is taking Esomeprazole through a nasogastric (NG) tube or gastric tube, follow the instructions for use in the extra patient leaflet.
- If your doctor has instructed you to use more than 1 packet for your dose, follow the mixing instructions provided by your doctor or pharmacist.
- You may take antacids while you are using Esomeprazole if you are directed to do so by your doctor.
- Continue to take Esomeprazole even if you feel well. Do not miss any doses.
- If you miss a dose of Esomeprazole, 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 Esomeprazole.
Use sodium bicarbonate as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Sodium bicarbonate is usually administered as an injection at your doctor's office, hospital, or clinic. If you are using sodium bicarbonate at home, carefully follow the injection procedures taught to you by your health care provider.
- If sodium bicarbonate contains particles or is discolored, or if the vial is cracked or damaged in any way, do not use it.
- Keep this product, as well as syringes and needles, out of the reach of children and away from pets. Do not reuse needles, syringes, or other materials. Dispose of properly after use. Ask your doctor or pharmacist to explain local regulations for proper disposal.
- If you miss a dose of sodium bicarbonate, contact your doctor immediately.
Ask your health care provider any questions you may have about how to use sodium bicarbonate.
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.Use: Labeled Indications
Oral:
Esomeprazole magnesium and Esomeprazole:
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
Esomeprazole magnesium:
Heartburn (OTC labeling): Treatment of frequent heartburn (≥2 days per week).
IV: Esomeprazole 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.
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.Use: Labeled Indications
Management of metabolic acidosis; gastric hyperacidity; alkalinization of the urine; treatment of hyperkalemia; management of overdose of certain drugs, including tricyclic antidepressants and aspirin
Neutralizing additive (dental use): Improves onset of analgesia and reduces injection site pain by adjusting lidocaine with epinephrine solution to a more physiologic pH.
Off Label Uses
Contrast-induced nephropathy (CIN) (prevention)
Evidence from controlled trials supports the use of isotonic sodium bicarbonate as an effective option in the prevention of contrast-induced nephropathy (CIN), demonstrating reduced incidence compared to sodium chloride.
Kidney Disease Improving Global Outcomes (KDIGO) guidelines state that in patients at increased risk of contrast-induced acute kidney injury (CI-AKI), IV volume expansion with either isotonic sodium chloride or isotonic sodium bicarbonate solutions is recommended rather than no IV volume expansion. Isotonic sodium bicarbonate is not commercially available, and thus carries a risk for compounding error during preparation. Based on the potential for harm and additional burden of preparing bicarbonate solutions, no preference is given to one solution; either agent can be used, with ease of use recognized for isotonic saline (KDIGO 2012a). European Society of Urogenital Radiology (ESUR) Contrast Media Safety Committee guidelines state that IV isotonic sodium bicarbonate appears to provide protection equal or superior to IV isotonic saline, but either regimen may be used (ESUR [Stacul 2011]).
See also:
What other drugs will affect Esomeprazole?
Esomeprazole is extensively metabolized in the liver by CYP2C19 and CYP3A4.
In vitro and in vivo studies have shown that esomeprazole is not likely to inhibit CYPs 1A2, 2A6, 2C9, 206, 2E1 and 3A4. No clinically relevant interactions with drugs metabolized by these CYP enzymes would be expected. Drug interaction studies have shown that esomeprazole does not have any clinically significant interactions with phenytoin, warfarin, quinidine, clarithromycin or amoxicillin. Post-marketing reports of changes in prothrombin measures have been received among patients on concomitant warfarin and esomeprazole therapy. Increases in INR and prothrombin time may lead to abnormal bleeding and even death. Patients treated with proton pump inhibitors and warfarin concomitantly may need to be monitored for increases in INR and prothrombin time.
Esomeprazole may potentially interfere with CYP2C19, the major esomeprazole metabolizing enzyme. Coadministration of esomeprazole 30 mg and diazepam, a CYP2C19 substrate, resulted in a 45% decrease in clearance of diazepam. Increased plasma levels of diazepam were observed 12 hours after dosing and onwards. However, at that time, the plasma levels of diazepam were below the therapeutic interval, and thus this interaction is unlikely to be of clinical relevance.
Concomitant administration of esomeprazole and a combined inhibitor of CYP2C19 and CYP3A4, such as voriconazole, may result in more than doubling of the esomeprazole exposure. Dose adjustment of esomeprazole is not normally required for the recommended doses. However, in patients who may require higher doses, dose adjustment may be considered.
Esomeprazole acts as an inhibitor of CYP2C19. Esomeprazole given in doses of 40 mg daily for one week to 20 healthy subjects in cross-over study, increased Cmax and AUC of cilostazol by 18% and 26% respectively. Cmax and AUC of one of its active metabolites, 3,4-dihydro-cilostazol, which has 4-7 times the activity of cilostazol, were increased by 29% and 69% respectively. Co-administration of cilostazol with esomeprazole is expected to increase concentrations of cilostazol and its above mentioned active metabolite. Therefore a dose reduction of cilostazol from 100 mg b.i.d. to 50 mg b.i.d. should be considered.
Co-administration of' oral contraceptives, diazepam, phenytoin, or quinidine did not seen to change the pharmacokinetic profile of esomeprazole.
Antiretroviral Agents: Concomitant use of atazanavir and nelfinavir with proton pump inhibitors is not recommended. Co-administration of atazanavir with proton pump inhibitors is expected to substantially decrease atazanavir plasma concentrations and thereby reduce its therapeutic effect.
Esomeprazole has been reported to interact with some antiretroviral drugs. The clinical importance and the mechanisms behind these interactions are not always known. Increased gastric pH during esomeprazole treatment may change the absorption of the antiretroviral drug. Other possible interaction mechanisms are via CYP2C19. For some antiretroviral drugs, such as atazanavir and nelfinavir, decreased serum levels have been reported when given together with omeprazole. Following multiple doses of nelfinavir (1250 mg, bid) and esomeprazole (40 mg qd). AUC was decreased by 36% and 92%, Cmax by 37% and 89% and Cmin by 39% and 75% respectively for nelfinavir and M8. Following multiple doses of atazanavir (400 mg, qd) and esomeprazole (40 mg, qd, 2 hr before atazanavir), AUC was decreased by 94%, Cmax by 96%, and Cmin by 95%. Concomitant administration with esomeprazole and drugs such as atazanavir and nelfinavir is therefore not recommended. For other antiretroviral drugs, such as saquinavir, elevated serum levels have been reported with an increases in AUC by 82%, in Cmax by 75% and in Cmin by 106% following multiple dosing of saquinavir/ritonavir (1000/100 mg) bid for 15 days with esomeprazole 40 mg qd coadministered days 11 to 15. Therefore, clinical and laboratory monitoring for saquinavir toxicity is recommended during concurrent use with Esomeprazole.
Dose reduction of saquinavir should be considered from the safety perspective for individual patients. There are also some antiretroviral drugs of which unchanged serum levels have been reported when given with esomeprazole.
Studies evaluating concomitant administration of esomeprazole and either naproxen (non-selective NSAID) or rofecoxib (COX-2 selective NSAID) did not identify any clinically relevant changes in the pharmacokinetic profiles of esomeprazole or these NSAIDs.
Esomeprazole inhibits gastric acid secretion. Therefore, esomeprazole may interfere with the absorption of drugs where gastric pH is an important determinant of bioavailability (eg, ketoconazole, iron salts and digoxin).
See also:
What other drugs will affect Sodium Bicarbonate?
Acalabrutinib: Antacids may decrease the serum concentration of Acalabrutinib. Management: Separate administration of acalabrutinib from the administration of any antacids by at least 2 hours in order to minimize the potential for a significant interaction. Consider therapy modification
AcetaZOLAMIDE: May enhance the adverse/toxic effect of Sodium Bicarbonate. Specifically, the risk of renal calculus formation may be increased. Monitor therapy
Alpha-/Beta-Agonists (Indirect-Acting): Alkalinizing Agents may increase the serum concentration of Alpha-/Beta-Agonists (Indirect-Acting). Monitor therapy
Amantadine: Alkalinizing Agents may increase the serum concentration of Amantadine. Monitor therapy
Amphetamines: Alkalinizing Agents may decrease the excretion of Amphetamines. Management: Consider alternatives to using amphetamines and alkalinizing agents in combination. If these agents must be used together, patients should be monitored closely for excessive amphetamine effects. Consider therapy modification
Antipsychotic Agents (Phenothiazines): Antacids may decrease the absorption of Antipsychotic Agents (Phenothiazines). Monitor therapy
Atazanavir: Antacids may decrease the absorption of Atazanavir. Management: Administer antacids 1 hour before or 2 hours after atazanavir to minimize the risk of a clinically significant interaction. Consider therapy modification
Bisacodyl: Antacids may diminish the therapeutic effect of Bisacodyl. Antacids may cause the delayed-release bisacodyl tablets to release drug prior to reaching the large intestine. Gastric irritation and/or cramps may occur. Management: Antacids should not be used within 1 hour before bisacodyl administration. Consider therapy modification
Bismuth Subcitrate: Antacids may diminish the therapeutic effect of Bismuth Subcitrate. Management: Avoid administration of antacids within 30 minutes of bismuth subcitrate (tripotassium bismuth dicitrate) administration. Consider therapy modification
Bosutinib: Antacids may decrease the serum concentration of Bosutinib. Management: Administer antacids more than 2 hours before or after bosutinib. Consider therapy modification
Bromperidol: Antacids may decrease the absorption of Bromperidol. Monitor therapy
Calcium Polystyrene Sulfonate: Antacids may enhance the adverse/toxic effect of Calcium Polystyrene Sulfonate. The combined use of these two agents may result in metabolic alkalosis and/or loss of efficacy of the cation exchange resin. Management: To minimize this interaction, consider: a)separating doses by 2 or more hours; b)rectal administration of the exchange resin; or c)alternatives to antacids. Monitor for metabolic alkalosis and attenuation of CPS effects. Avoid magnesium hydroxide. Consider therapy modification
Captopril: Antacids may decrease the serum concentration of Captopril. Monitor therapy
Cefditoren: Antacids may decrease the serum concentration of Cefditoren. Management: Concomitant use of cefditoren with antacids is not recommended. Consider alternative methods to control acid reflux (eg, diet modification) or alternative antimicrobial therapy. If antacid therapy can not be avoided, separate dosing by several hours. Consider therapy modification
Cefpodoxime: Antacids may decrease the serum concentration of Cefpodoxime. Monitor therapy
Cefuroxime: Antacids may decrease the serum concentration of Cefuroxime. Management: Administer cefuroxime axetil at least 1 hour before or 2 hours after the administration of short-acting antacids. Consider therapy modification
Chloroquine: Antacids may decrease the serum concentration of Chloroquine. Management: Separate the administration of antacids and chloroquine by at least 4 hours to minimize any potential negative impact of antacids on chloroquine bioavailability. Consider therapy modification
Corticosteroids (Oral): Antacids may decrease the bioavailability of Corticosteroids (Oral). Management: Consider separating doses by 2 or more hours. Budesonide enteric coated tablets could dissolve prematurely if given with drugs that lower gastric acid, with unknown impact on budesonide therapeutic effects. Consider therapy modification
Cysteamine (Systemic): Antacids may diminish the therapeutic effect of Cysteamine (Systemic). Monitor therapy
Dabigatran Etexilate: Antacids may decrease the serum concentration of Dabigatran Etexilate. Management: Dabigatran etexilate Canadian product labeling recommends avoiding concomitant use with antacids for 24 hours after surgery. In other situations, administer dabigatran etexilate 2 hours prior to antacids. Monitor clinical response to dabigatran therapy. Consider therapy modification
Dasatinib: Antacids may decrease the serum concentration of Dasatinib. Management: Simultaneous administration of dasatinib and antacids should be avoided. Administer antacids 2 hours before or 2 hours after dasatinib. Consider therapy modification
Delavirdine: Antacids may decrease the serum concentration of Delavirdine. Management: Separate doses of delavirdine and antacids by at least 1 hour. Monitor for decreased delavirdine therapeutic effects with this combination. Consider therapy modification
Dexmethylphenidate: Antacids may increase the absorption of Dexmethylphenidate. Specifically, antacids may interfere with the normal release of drug from the extended-release capsules (Focalin XR brand), which could result in both increased absorption (early) and decreased delayed absorption. Monitor therapy
Erlotinib: Antacids may decrease the serum concentration of Erlotinib. Management: Separate the administration of erlotinib and any antacid by several hours in order to minimize the risk of a significant interaction. Consider therapy modification
Flecainide: Sodium Bicarbonate may diminish the arrhythmogenic effect of Flecainide. Sodium Bicarbonate may increase the serum concentration of Flecainide. Monitor therapy
Fosinopril: Antacids may decrease the serum concentration of Fosinopril. Management: The US and Canadian fosinopril manufacturer labels recommend separating the doses of antacids and fosinopril by 2 hours. Consider therapy modification
Gefitinib: Antacids may decrease the serum concentration of Gefitinib. Management: Administer gefitinib at least 6 hours before or after administration of an antacid, and closely monitor clinical response to gefitinib. Consider therapy modification
Hyoscyamine: Antacids may decrease the serum concentration of Hyoscyamine. Management: Administer immediate release hyoscyamine before meals and antacids after meals when these agents are given in combination. Consider therapy modification
Iron Preparations: Antacids may decrease the absorption of Iron Preparations. Management: Separate dosing of oral iron preparations and antacids as much as possible to avoid decreased efficacy of iron preparation. If coadministered with antacids, monitor for decreased therapeutic effects of iron preparations. Exceptions: Ferric Carboxymaltose; Ferric Citrate; Ferric Derisomaltose; Ferric Gluconate; Ferric Hydroxide Polymaltose Complex; Ferric Pyrophosphate Citrate; Ferumoxytol; Iron Dextran Complex; Iron Sucrose. Consider therapy modification
Itraconazole: Antacids may decrease the serum concentration of Itraconazole. Antacids may increase the serum concentration of Itraconazole. Management: Administer Sporanox brand itraconazole at least 2 hours before or 2 hours after administration of any antacids. Exposure to Tolsura brand itraconazole may be increased by antacids; consider itraconazole dose reduction. Consider therapy modification
Ketoconazole (Systemic): Antacids may decrease the serum concentration of Ketoconazole (Systemic). Management: Administer oral ketoconazole at least 2 hours prior to use of any antacid product. Monitor patients closely for signs of inadequate clinical response to ketoconazole. Consider therapy modification
Lanthanum: Antacids may diminish the therapeutic effect of Lanthanum. Consider therapy modification
Ledipasvir: Antacids may decrease the serum concentration of Ledipasvir. Management: Separate the administration of ledipasvir and antacids by 4 hours. Consider therapy modification
Lithium: Sodium Bicarbonate may increase the excretion of Lithium. Monitor therapy
Mecamylamine: Alkalinizing Agents may increase the serum concentration of Mecamylamine. Monitor therapy
Memantine: Alkalinizing Agents may increase the serum concentration of Memantine. Monitor therapy
Mesalamine: Antacids may diminish the therapeutic effect of Mesalamine. Antacid-mediated increases in gastrointestinal pH may cause the premature release of mesalamine from specific sustained-release mesalamine products. Management: Avoid concurrent administration of antacids with sustained-release mesalamine products. Separating antacid and mesalamine administration, and/or using lower antacid doses may be adequate means of avoiding this interaction. Consider therapy modification
Methenamine: Antacids may diminish the therapeutic effect of Methenamine. Management: Consider avoiding this combination if possible. Antacids may decrease the therapeutic effects of methenamine; sodium bicarbonate is of most concern. If coadministering methenamine and antacids, monitor for decreased methenamine efficacy. Consider therapy modification
Methylphenidate: Antacids may increase the absorption of Methylphenidate. Specifically, antacids may interfere with the normal release of drug from the extended-release capsules (Ritalin LA brand), which could result in both increased absorption (early) and decreased delayed absorption. Monitor therapy
Multivitamins/Minerals (with ADEK, Folate, Iron): Antacids may decrease the serum concentration of Multivitamins/Minerals (with ADEK, Folate, Iron). Specifically, antacids may decrease the absorption of orally administered iron. Management: Separate dosing of oral iron-containing multivitamin preparations and antacids by as much time as possible in order to minimize impact on therapeutic efficacy of the iron preparation. Consider therapy modification
Neratinib: Antacids may decrease the serum concentration of Neratinib. Specifically, antacids may reduce neratinib absorption. Management: Separate the administration of neratinib and antacids by giving neratinib at least 3 hours after the antacid. Consider therapy modification
Nilotinib: Antacids may decrease the serum concentration of Nilotinib. Management: Separate the administration of nilotinib and any antacid by at least 2 hours whenever possible in order to minimize the risk of a significant interaction. Consider therapy modification
PAZOPanib: Antacids may decrease the serum concentration of PAZOPanib. Management: Avoid the use of antacids in combination with pazopanib whenever possible. Separate doses by several hours if antacid treatment is considered necessary. The impact of dose separation has not been investigated. Consider therapy modification
Pexidartinib: Antacids may decrease the serum concentration of Pexidartinib. Management: Administer pexidartinib 2 hours before or after antacids. Consider therapy modification
Phosphate Supplements: Antacids may decrease the absorption of Phosphate Supplements. Management: This applies only to oral phosphate administration. Separating administer of oral phosphate supplements from antacid administration by as long as possible may minimize the interaction. Exceptions: Sodium Glycerophosphate Pentahydrate. Consider therapy modification
Potassium Phosphate: Antacids may decrease the serum concentration of Potassium Phosphate. Management: Consider separating administration of antacids and oral potassium phosphate by at least 2 hours to decrease risk of a significant interaction. Consider therapy modification
QuiNIDine: Antacids may decrease the excretion of QuiNIDine. Monitor therapy
QuiNINE: Alkalinizing Agents may increase the serum concentration of QuiNINE. Monitor therapy
Rilpivirine: Antacids may decrease the serum concentration of Rilpivirine. Management: Administer antacids at least 2 hours before or 4 hours after rilpivirine when used with most rilpivirine products. However, administer antacids at least 6 hours before or 4 hours after the rilpivirine/dolutegravir combination product. Consider therapy modification
Riociguat: Antacids may decrease the serum concentration of Riociguat. Management: Separate the administration of antacids and riociguat by at least 1 hour in order to minimize any potential interaction. Consider therapy modification
Rosuvastatin: Antacids may decrease the serum concentration of Rosuvastatin. Monitor therapy
Sotalol: Antacids may decrease the serum concentration of Sotalol. Management: Avoid simultaneous administration of sotalol and antacids. Administer antacids 2 hours after sotalol. Consider therapy modification
Sulpiride: Antacids may decrease the serum concentration of Sulpiride. Management: Separate administration of antacids and sulpiride by at least 2 hours in order to minimize the impact of antacids on sulpiride absorption. Consider therapy modification
Tetracyclines: Antacids may decrease the absorption of Tetracyclines. Management: Separate administration of antacids and oral tetracycline derivatives by several hours when possible to minimize the extent of this potential interaction. Exceptions: Eravacycline. Consider therapy modification
Velpatasvir: Antacids may decrease the serum concentration of Velpatasvir. Management: Separate administration of velpatasvir and antacids by at least 4 hours. Consider therapy modification
See also:
What are the possible side effects of Esomeprazole?
Clinical Trials Experience with
Intravenous Esomeprazole
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 esomeprazole 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 Esomeprazole I.V. for Injection in 359 patients. Esomeprazole 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 esomeprazole (n=359) in clinical trials are listed below:
Intravenous treatment with esomeprazole 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 esomeprazole.
Pediatric
A randomized, open-label, multi-national study to evaluate the pharmacokinetics of repeated intravenous doses of once daily esomeprazole in pediatric patients 1 month to 17 years old, inclusive was performed. The safety results are consistent with the known safety profile of esomeprazole and no unexpected safety signals were identified [seeClinical Pharmacology (12.3)].
Risk Reduction of Rebleeding of Gastric or Duodenal Ulcers in Adults
The data described below reflect exposure to Esomeprazole I.V. for Injection in 375 patients. Esomeprazole I.V. for Injection was studied in a placebo-controlled trial. Patients were randomized to receive Esomeprazole 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 esomeprazole 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.
With the exception of injection site reactions described above, intravenous treatment with esomeprazole administered as an injection or as an infusion was found to have a safety profile similar to that of oral administration of esomeprazole.
Postmarketing Experience
The following adverse reactions have been identified during post-approval use of Esomeprazole. 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 esomeprazole. These reports occurred rarely and are listed below by body system:
Blood And Lymphatic System Disorders: agranulocytosis, pancytopenia; Eye Disorders: blurred vision; Gastrointestinal Disorders: pancreatitis; stomatitis; microscopic colitis; Hepatobiliary Disorders: hepatic failure, hepatitis with or without jaundice; Immune System Disorders: anaphylactic reaction/shock; Infections and Infestations: GI candidiasis; Metabolism and nutritional disorders: hypomagnesemia with or without hypocalcemia and/or hypokalemia; Musculoskeletal And Connective Tissue Disorders: muscular weakness, myalgia, bone fracture; Nervous System Disorders: hepatic encephalopathy, taste disturbance; Psychiatric Disorders: aggression, agitation, depression, hallucination; 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 Esomeprazole, but occurring with omeprazole can be found in the omeprazole package insert, ADVERSE REACTIONS section.
See also:
What are the possible side effects of Sodium Bicarbonate?
Applies to sodium bicarbonate: capsule, granule, powder, solution, tablet
Along with its needed effects, sodium bicarbonate (the active ingredient contained in Sodium Bicarbonate) may cause some unwanted effects. Although the following side effects occur very rarely when this medicine is taken as recommended, they may be more likely to occur if it is taken: in large doses, for a long time, or by patients with kidney disease.
Severity: Moderate
If any of the following side effects occur while taking sodium bicarbonate, check with your doctor or nurse as soon as possible:
- Frequent urge to urinate
- headache (continuing)
- loss of appetite (continuing)
- mood or mental changes
- muscle pain or twitching
- nausea or vomiting
- nervousness or restlessness
- slow breathing
- swelling of feet or lower legs
- unpleasant taste
- unusual tiredness or weakness
Minor Side Effects
Some of the side effects that can occur with sodium bicarbonate may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:
Less common:
- Increased thirst
- stomach cramps
Each tablet contains 20 mg or 40 mg esomeprazole (as magnesium trihydrate).
Each tablet contains esomeprazole as enteric-coated pellets (MUPS).
Esomeprazole MUPS is a proton pump inhibitor. The active ingredient in Esomeprazole MUPS is esomeprazole magnesium trihydrate, a substituted benzimidazole. Esomeprazole 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.
Esomeprazole 20 mg: Sucrose 28 mg.
Esomeprazole 40 mg: Sucrose 30 mg.
Sodium bicarbonate is a white, crystalline powder that is commonly used as a pH buffering agent, an electrolyte replenisher, systemic alkalizer and in topical cleansing solutions.