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Esomeprazole strontium (Oral route)

Pronunciation:

es-oh-MEP-ra-zole STRON-shee-um

Dosage Forms:

  • Capsule, Delayed Release

Classifications:

Therapeutic—

Gastric Acid Secretion Inhibitor

Pharmacologic—

Esomeprazole

Uses of This Medicine:

Esomeprazole 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. Esomeprazole is also used with antibiotics (eg, amoxicillin, clarithromycin) to treat ulcers that are caused by the H. pylori bacteria. This medicine 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 strontium is a proton pump inhibitor (PPI). It works by decreasing the amount of acid that is produced by the stomach.

This medicine is available only with your doctor’s prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of esomeprazole strontium in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of esomeprazole strontium in the elderly.

Pregnancy—

Pregnancy CategoryExplanation
All TrimestersCAnimal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast-feeding—

Studies suggest that this medication may alter milk production or composition. If an alternative to this medication is not prescribed, you should monitor the infant for side effects and adequate milk intake.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

  • Rilpivirine

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Atazanavir
  • Bosutinib
  • Cilostazol
  • Citalopram
  • Clopidogrel
  • Dasatinib
  • Erlotinib
  • Escitalopram
  • Eslicarbazepine Acetate
  • Gefitinib
  • Ketoconazole
  • Ledipasvir
  • Methotrexate
  • Mycophenolate Mofetil
  • Nelfinavir
  • Nilotinib
  • Pazopanib
  • Posaconazole
  • Saquinavir
  • Tacrolimus
  • Thiopental
  • Velpatasvir
  • Vismodegib

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Levothyroxine
  • Risedronate
  • Voriconazole
  • Warfarin

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

  • Cranberry

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Diarrhea or
  • Hypomagnesemia (low magnesium in the blood), history of or
  • Osteoporosis (thinning of the bones) or
  • Systemic lupus erythematosus (SLE)—Use with caution. May make these conditions worse.
  • Liver disease, severe—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of This Medicine:

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

This medicine comes with a Medication Guide. Read and follow the instructions carefully. Ask your doctor if you have any questions.

It may take several days before this medicine begins to relieve stomach pain. To help relieve this pain, antacids may be taken with esomeprazole strontium, unless your doctor has told you not to use them.

Take this medicine at least 1 hour before a meal and for the full time of treatment, even if you begin to feel better after a few days.

If you are taking this medicine to treat an ulcer with an H. pylori infection, take it together with the antibiotics (eg, amoxicillin, clarithromycin).

To use the capsule:

  • Swallow the capsule whole. Do not crush or chew it.
  • If the capsule cannot be swallowed, open it and sprinkle the contents on one tablespoonful of applesauce. Do not heat the applesauce. Swallow the mixture right away. Do not chew or crush the granules. Throw away any remaining mixture.

To use the capsule with a nasogastric (NG) tube:

  • Open the capsule and empty the granules into a 60 mL catheter-tipped syringe and mix it with 50 mL of water.
  • Shake the syringe well for 15 seconds. Hold the syringe with the tip up and check the granules in the tip.
  • Deliver the mixture into the nasogastric tube.
  • Do not inject the granules if they have dissolved or have broken into pieces.
  • Flush the tube with more water to rinse all of the medicine into the stomach.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For oral dosage form (delayed-release capsules):
    • To prevent NSAID-associated gastric ulcer:
      • Adults—24.65 or 49.3 milligrams (mg) once a day for up to 6 months. Your doctor may adjust your dose if needed.
      • Children—Use and dose must be determined by your doctor.
    • To treat duodenal ulcers with H. pylori infection:
      • Adults—49.3 milligrams (mg) once a day for 10 days. The dose is usually taken together with amoxicillin and clarithromycin. Your doctor may adjust your dose if needed.
      • Children—Use and dose must be determined by your doctor.
    • To treat erosive esophagitis:
      • Adults—24.65 or 49.3 milligrams (mg) once a day for 4 to 8 weeks. Your doctor may adjust your dose if needed.
      • Children—Use and dose must be determined by your doctor.
    • To treat gastroesophageal reflux disease (GERD):
      • Adults—24.65 milligrams (mg) once a day for 4 to 8 weeks. Your doctor may adjust your dose if needed.
      • Children—Use and dose must be determined by your doctor.
    • To treat Zollinger-Ellison syndrome:
      • Adults—49.3 milligrams (mg) two times a day. Your doctor may adjust your dose if needed.
      • Children—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. Blood and urine tests may be needed to check for unwanted effects. If your condition does not improve, or if it becomes worse, check with your doctor.

This medicine is sometimes given together with amoxicillin (Amoxil®) and clarithromycin (Biaxin®) to treat ulcers. Be sure you understand about the risks and proper use of any other medicines your doctor prescribes together with esomeprazole strontium.

Check with your doctor right away if you have a fever, joint pain, skin rash, swelling of the body, feet, or ankles, or unusual weight gain after taking this medicine. These could be symptoms of acute interstitial nephritis.

Taking this medicine for a long time may make it harder for your body to absorb vitamin B12. Tell your doctor if you have concerns about vitamin B12 deficiency.

Check with your doctor right away if you have watery stool that does not go away, stomach pain, and fever while taking this medicine.

This medicine may increase your risk of having fractures of the hip, wrist, and spine. This is more likely if you use high doses or use it for one year or more.

Cutaneous or systemic lupus erythematosus may occur or get worse in patients receiving a PPI. Call your doctor right away if you have joint pain or a skin rash on your cheeks or arms that gets worse when exposed to the sun.

This medicine may cause hypomagnesemia (low magnesium in the blood). This is more likely to occur if you are taking this medicine for more than one year, or if you are taking this medicine together with digoxin (Lanoxin®) or certain diuretics (water pills). Check with your doctor right away if you have convulsions (seizures), fast, racing, or uneven heartbeat, muscle spasms (tetany), tremors, or unusual tiredness or weakness.

Make sure any doctor or dentist who treats you knows that you are using this medicine. This medicine may affect the results of certain medical tests.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription (eg, atazanavir, clopidogrel, nelfinavir, Plavix®, Reyataz®, Viracept®) or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, St. John's wort) or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Rare
Bloody, black, or tarry stools
chest pain or chest tightness
cough
difficulty with swallowing
dizziness
excess air or gas in the stomach
fast heartbeat
large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
pain or discomfort in the chest, upper stomach, or throat
puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
shortness of breath
skin rash, hives, or itching
unusual tiredness or weakness
vomiting of blood or material that looks like coffee grounds
Incidence not known
Blistering, peeling, or loosening of the skin
chills
dark-colored urine
diarrhea
drowsiness
headache
high fever
joint or muscle pain
light-colored stools
loss of appetite
mood or mental changes
muscle spasms (tetany) or twitching
nausea or vomiting
seizures
sore throat
trembling
unexplained bleeding or bruising
watery and severe diarrhea, which may also be bloody
yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
Difficulty having a bowel movement (stool)
dry mouth
passing gas
Rare
Back pain
change in taste
changes in vision
continuing ringing or buzzing or other unexplained noise in the ears
fast, pounding, or irregular heartbeat or pulse
hearing loss
hiccup
slow heartbeat
Incidence not known
Hair loss or thinning of the hair
swelling of the breasts or breast soreness in both females and males

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.


Last Updated: 7/4/2017
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