Esomeprazole (Intravenous route)
- NexIUM I.V.
- Powder for Solution
Gastric Acid Secretion Inhibitor
Uses of This Medicine:
Esomeprazole injection is used to treat conditions where there is too much acid in the stomach. It is used for the short-term treatment (up to 10 days) of gastroesophageal reflux disease (GERD) with erosive esophagitis in adults and children 1 month of age and older. GERD is a condition where the acid in the stomach washes back up into the esophagus. This medicine is also used to lower risk of rebleeding in patients with acute gastric or duodenal ulcer after endoscopy.
Esomeprazole 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:
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.
Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of esomeprazole injection in children. However, safety and efficacy have not been established in children younger than 1 month of age.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of esomeprazole injection in the elderly.
|All Trimesters||C||Animal 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.|
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
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 receiving 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.
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.
- Eslicarbazepine Acetate
- Mycophenolate Mofetil
- Secretin Human
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.
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.
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:
A nurse or other trained health professional will give you or your child this medicine in a clinic or hospital. This medicine is given through a needle placed in one of your veins.
It may take several days before this medicine begins to relieve stomach pain. To help relieve this pain, antacids may be taken with esomeprazole, unless your doctor has told you not to use them.
Your doctor will give you a few doses of this medicine until your condition improves, and then switch you to an oral medicine that works the same way. If you have any concerns about this, talk to your doctor.
Precautions While Using This Medicine:
It is important that your doctor check the progress of you or your child at regular visits. Blood and urine tests may be needed to check for unwanted effects. If your or your child's condition does not improve, or if it becomes worse, check with your doctor.
This medicine may cause serious allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash, itching, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are using this medicine.
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 receiving this medicine. These could be symptoms of acute interstitial nephritis.
Check with your doctor right away if you have watery diarrhea that does not go away, stomach pain, and a fever while receiving this medicine.
Esomeprazole injection may increase your risk of having fractures of the hip, wrist, and spine. This is more likely if you are 50 years of age and older, if you receive high doses of this medicine, 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 using this medicine for more than 1 year, or if you are using 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 or your child 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, Plavix®, Reyataz®) or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, St. John's wort) or vitamin supplements.
Side Effects of This Medicine:
- Less common
- Black, tarry stools
- bloody stools
- vomiting of blood or material that looks like coffee grounds
- loss of appetite
- mood or mental changes
- muscle spasms (tetany) or twitching
- nausea or vomiting
- unusual tiredness or weakness
- Incidence not known
- Blistering, peeling, or loosening of the skin
- darkened urine
- difficulty with swallowing
- fast heartbeat
- joint or muscle pain
- pains in the stomach, side, or abdomen, possibly radiating to the back
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- red skin lesions, often with a purple center
- red, irritated eyes
- skin rash, hives, or itching
- sore throat
- sores, ulcers, or white spots in the mouth or on the lips
- tightness in the chest
- yellow eyes or skin
- More common
- Acid or sour stomach
- stomach discomfort or upset
- Less common
- Burning, itching, redness, skin rash, swelling, or soreness at the injection site
- difficulty having a bowel movement (stool)
- dryness of the mouth
- feeling of constant movement of self or surroundings
- pain or tenderness around the eyes and cheekbones
- sensation of spinning
- stuffy or runny nose
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 or nurse immediately if any of the following side effects occur:
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:
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: 9/4/2017