Sandoz-Esomerprazole

Brand Name

Sandoz-Esomerprazole

Common Name

esomeprazole

In this drug factsheet:

• How does this medication work? What will it do for me?
• How should I use this medication?
• What form(s) does this medication come in?
• Who should NOT take this medication?
• What side effects are possible with this medication?
• Are any nutrients depleted by this medication?
• Are there any other precautions or warnings for this medication?
• What other drugs could interact with this medication?

How does this medication work? What will it do for me?

Esomeprazole belongs to the family of medications known as proton pump inhibitors (PPIs). In adults and children, it is used to treat conditions such as reflux esophagitis (tissue damage caused by stomach contents flowing back up the esophagus) and symptoms of gastroesophageal reflux disease (GERD) in people with reflux esophagitis. It is also used to treat nonerosive reflux disease (NERD; heartburn and regurgitation not related to tissue damage) in children and adults. When combined with other medications, esomeprazole is used to treat duodenal ulcers that are caused by bacteria known as H. pylori.

Esomeprazole can be used to treat or reduce the risk of stomach ulcers due to medications known as NSAIDs (e.g., ibuprofen, naproxen, ketorolac) that irritate the stomach. It is also used to treat conditions associated with the overproduction of stomach acid, including Zollinger-Ellison syndrome.

Esomeprazole works by reducing the amount of acid the stomach produces.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

How should I use this medication?

The recommended dose of esomeprazole to treat reflux esophagitis and symptoms of GERD is 40 mg once daily for 4 to 8 weeks. After 8 weeks, treatment may be continued at a dose of 20 mg once daily.

To treat NERD or heartburn, the recommended dose is 20 mg taken once daily for 2 to 4 weeks. After this, esomeprazole may be taken at a dose of 20 mg once daily as needed to control symptoms.

To treat stomach ulcers associated with NSAID use, the dose is 20 mg once daily for 4 to 8 weeks. To prevent such ulcers, the dose is 20 mg once daily.

To treat duodenal ulcers caused by H. pylori in adults, the dose of esomeprazole is 20 mg twice daily taken with amoxicillin 1,000 mg twice daily and clarithromycin 500 mg twice daily–all for 7 days.

The initial dose to treat acid over-production with Zollinger-Ellison Syndrome, is 40 mg taken by mouth, twice a day. The dose that relieves the over-secretion of acid varies depending on the person.

For children 12 months to 11 years of age, the recommended dose of esomeprazole to treat reflux esophagitis is 10 mg to 20 mg (depending on the child's weight) once daily for 8 weeks. For NERD (heartburn and reflux), the recommended dose is 10 mg once daily for up to 8 weeks.

For children 11 to 17 years of age, the recommended dose of esomeprazole to treat reflux esophagitis is 20 mg to 40 mg once daily for 4 to 8 weeks. For NERD (heartburn and reflux), the recommended dose is 20 mg once daily for 2 to 4 weeks.

Many things can affect the dose of a medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

Esomeprazole tablets can be taken with or without food. They should be swallowed whole–do not crush or chew them. Alternatively, the tablet may be stirred into half a glass of noncarbonated water until it disintegrates. Drink the liquid containing the small pellets of medication immediately, or within 30 minutes. To ensure you get the full dose of the medication, rinse the glass with more water and drink it.

The sachets of esomeprazole contain granules for oral suspension. Pour all the granules of one sachet into a glass containing one tablespoon (15 mL) of water, stir, and leave for a few minutes to allow the mixture to thicken. Stir again and drink it within 30 minutes. To ensure you get the full dose of the medication, rinse the glass with more water and drink it.

It is important to take this medication exactly as prescribed by your doctor. If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is less than 12 hours until your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store this medication at room temperature, protect it from light and moisture, and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

What form(s) does this medication come in?

20 mg
Each light pink, elliptic, biconvex, film-coated tablet, engraved with "20" on one side, contains 20 mg of esomeprazole as esomeprazole magnesium dihydrate. Nonmedicinal ingredients: glyceryl monostearate, hydroxypropyl cellulose, hypromellose, magnesium stearate, methacrylic acid ethylacrylate copolymer, microcrystalline cellulose, polysorbate 80, stearoyl macrogolglycerides, sodium stearyl fumarate, sodium lauryl sulfate, sugar spheres (sucrose and maize starch), talc, triethyl citrate; film coating: hypromellose, iron oxide red, iron oxide yellow, polyethylene glycol, and titanium dioxide.

40 mg
Each light pink, elliptic, biconvex, film-coated tablet, engraved with "40" on one side, contains 40 mg of esomeprazole as esomeprazole magnesium dihydrate. Nonmedicinal ingredients: glyceryl monostearate, hydroxypropyl cellulose, hypromellose, magnesium stearate, methacrylic acid ethylacrylate copolymer, microcrystalline cellulose, polysorbate 80, stearoyl macrogolglycerides, sodium stearyl fumarate, sodium lauryl sulfate, sugar spheres (sucrose and maize starch), talc, triethyl citrate; film coating: hypromellose, iron oxide black, iron oxide red, polyethylene glycol, and titanium dioxide.

Who should NOT take this medication?

Do not take this medication if you:

• are allergic to esomeprazole or any ingredients of the medication
• are taking the medication rilpivirine

What side effects are possible with this medication?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• changed sense of taste
• diarrhea
• dizziness
• drowsiness
• dry mouth
• hair loss
• headache
• increased sweating
• nausea
• nervousness
• spinning sensation
• swelling ankles, feet, and hands
• trouble sleeping
• upset stomach

Although most of these side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• blurred vision
• breast enlargement
• confusion
• diarrhea (watery and severe; may also be bloody)
• feeling of burning or tingling
• hallucinations (seeing or hearing things that aren’t there)
• increased frequency of symptoms of infection (e.g., fever or chills, dizziness, headache, weight loss, stiff neck)
• rash on cheeks or the arms that worsens in the sun
• shortness of breath
• signs of clotting problems (e.g., unusual nosebleeds, bruising, blood in urine, coughing blood, bleeding gums, cuts that don’t stop bleeding)
• signs of depression (e.g., poor concentration, changes in weight, changes in sleep, decreased interest in activities, thoughts of suicide)
• signs of electrolyte imbalance (e.g., muscle pain or cramps, weakness, irregular heartbeat)
• signs of liver problems (e.g., nausea, vomiting, diarrhea, loss of appetite, weight loss, yellowing of the skin or whites of the eyes, dark urine, pale stools)
• skin reactions (such as rash, itching, or hives)
• sore joints
• symptoms of a fungal infection in the digestive system (e.g., diarrhea, vomiting, black stools, abdominal pain, fever)
• symptoms of kidney inflammation (e.g., decreased appetite, difficulty breathing, fatigue, frequent urination, itchiness, nausea, vomiting)

Stop taking the medication and seek immediate medical attention if any of the following occur:

• signs of a severe allergic reaction such as hives; difficulty breathing; or swelling of the tongue, face, mouth, or throat
• signs of a severe skin reaction such as blistering, peeling, a rash covering a large area of the body, a rash that spreads quickly, or a rash combined with fever or discomfort

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Are any nutrients depleted by this medication?

Some medications can affect vitamin and nutrient levels in the body. Below is a list of nutrient depletions associated with this medication. Talk to your doctor or pharmacist about whether taking a supplement is recommended or if you have any questions or concerns.

Are there any other precautions or warnings for this medication?

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Bone health:  Studies suggest that the use of esomeprazole, like other PPIs, may be related to an increased risk of fractures, particularly for people who take this medication for a year or longer. The lowest dose of this medication to control the symptoms, taken for the shortest period of time, is less likely to cause these problems.

Diarrhea: When gastric acid is decreased, the number of bacteria normally in the digestive system increases. Occasionally, this can cause serious infection in the digestive tract. If you experience watery, foul-smelling bowel movements after starting to take esomeprazole, contact your doctor as soon as possible.

Fluid and electrolyte balance: Esomeprazole may cause the levels of electrolytes such as potassium, magnesium, and calcium in the blood to change while taking this medication. If you experience symptoms of fluid and electrolyte imbalance such as muscle pains or cramps; dry mouth; numb hands, feet, or lips; or racing heartbeat, contact your doctor as soon as possible.

Liver function: The liver is partially responsible for removing esomeprazole from the body. Liver disease or reduced liver function may cause this medication to build up in the body, causing side effects. If you have liver problems, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. Your doctor may want to test your liver function regularly with blood tests while you are taking this medication.

Methotrexate interaction: Esomeprazole, like other medications in this group, may interact with methotrexate when the two medications are used at the same time. This combination may lead to higher-than-expected amounts of methotrexate in the body and can cause serious side effects, including kidney damage, irregular heartbeat, anemia, or infection. If you take esomeprazole and are also going to receive a dose of methotrexate, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

More serious conditions of the stomach and intestines: If you experience symptoms of a more serious condition of the stomach and intestines (e.g., trouble swallowing, unplanned weight loss, persistent vomiting, vomiting blood, or black stools) while taking this medication, contact your doctor immediately.

Subacute cutaneous lupus erythematosus (SCLE): Esomeprazole, like other PPIs, has been rarely associated with SCLE, an autoimmune disease. If you develop any skin lesions, especially in sun-exposed skin areas, and if accompanied by muscle aches or pains, contact your doctor immediately.

Vitamin B12: Long-term use of esomeprazole may lead to vitamin B12 deficiency. If you are a vegetarian or have low vitamin B12 levels, discuss with your doctor whether any special monitoring is required.

Pregnancy: This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately.

Breast-feeding: It is not known if esomeprazole passes into breast milk. If you are breast-feeding and are taking this medication, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using this medication have not been established for children less than 1 year of age.

What other drugs could interact with this medication?

There may be an interaction between esomeprazole and any of the following:

• amphetamines (e.g., dextroamphetamine, lisdexamfetamine)
• apalutamide
• "azole" antifungals (e.g., itraconazole, ketoconazole, voriconazole)
• bisphosphonates (e.g., alendronate, risedronate, zoledronic acid)
• capecitabine
• cefuroxime
• citalopram
• clobazam
• clopidogrel
• cysteamine
• digoxin
• doxycycline
• escitalopram
• hepatitis C antiviral medications (e.g., ledipasvir, sofosbuvir, velpatasvir)
• HIV protease inhibitors (e.g., atazanavir, tipranavir)
• lumacaftor and ivacaftor
• methotrexate
• monoclonal antibodies (e.g., atezolizumab, ipilimumab, pembrolizumab)
• multiple vitamins with minerals
• mycophenolate
• octreotide
• phenytoin
• pioglitazone
• other proton pump inhibitors (e.g., omeprazole, lansoprazole, pantoprazole)
• certain protein kinase inhibitors (e.g., bosutinib, dabrafenib, dasatinib, erlotinib, pazopanib)
• rifampin
• rilpivirine
• riociguat
• rosiglitazone
• St. John's wort
• tacrolimus
• warfarin

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

All material copyright MediResource Inc. 1996 – 2025. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Source: www.medbroadcast.com/drug/getdrug/Sandoz-Esomerprazole