Pronunciation:

es-oh-MEP-ra-zole SOE-dee-um

Brand Names:

• NexIUM I.V.

Dosage Forms:

• Powder for Solution

Classifications:

Therapeutic—

Gastric Acid Secretion Inhibitor

Pharmacologic—

Esomeprazole

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 the 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 to be given only by or under the direct supervision of your doctor.

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 performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of esomeprazole injection in children 1 month of age and older. However, safety and efficacy have not been established in children younger than 1 month of age.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of esomeprazole injection in the elderly. However, elderly patients are more sensitive to the effects of this medicine than younger adults.

Breast-feeding—

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.

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 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.

• 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.

• Acalabrutinib
• Amphetamine
• Atazanavir
• Atezolizumab
• Belumosudil
• Belzutifan
• Benzphetamine
• Bosutinib
• Capecitabine
• Cefuroxime Axetil
• Cilostazol
• Citalopram
• Clopidogrel
• Dacomitinib
• Dasatinib
• Dextroamphetamine
• Erlotinib
• Escitalopram
• Eslicarbazepine Acetate
• Gefitinib
• Infigratinib
• Ketoconazole
• Ledipasvir
• Levoketoconazole
• Lisdexamfetamine
• Methamphetamine
• Methotrexate
• Mycophenolate Mofetil
• Nelfinavir
• Neratinib
• Nilotinib
• Octreotide
• Palbociclib
• Pazopanib
• Pexidartinib
• Phenobarbital
• Posaconazole
• Primidone
• Saquinavir
• Secretin Human
• Selpercatinib
• Sotorasib
• Sparsentan
• Sunitinib
• 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:

A nurse or other trained health professional will give you or your child this medicine in a medical facility. It is given through a needle placed into 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 very important that your doctor check your or your child's progress 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.

Do not use this medicine if you are also using it together with rilpivirine (Edurant®) or other products containing rilpivirine (eg, Complera®, Juluca®, Odefsey®). Using these medicines together may cause serious side effects.

This medicine may cause serious allergic reactions, including anaphylaxis and angioedema, which can be life-threatening and require immediate medical attention. Call your doctor right away if you have a rash, itching, trouble breathing or swallowing, or any swelling of your hands, face, or mouth while you are receiving this medicine.

Check with your doctor right away if you have a change in frequency of urination or amount of urine, blood in the urine, fever, joint pain, loss of appetite, nausea, skin rash, swelling of the body, feet, or ankles, unusual tiredness or weakness, or unusual weight gain after receiving this medicine. These could be symptoms of serious kidney problem called acute tubulointerstitial nephritis.

Serious stomach conditions may occur while taking this medicine. Check with your doctor immediately if you or your child has stomach cramps, bloated feeling, watery and severe diarrhea which may also be bloody sometimes, fever, nausea or vomiting, or unusual tiredness or weakness.

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 receive it for one year or more. Call your doctor right away if you have severe bone pain or are unable to walk or sit normally.

This medicine may cause serious skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, acute generalized exanthematous pustulosis, and drug reaction with eosinophilia and systemic symptoms (DRESS). Check with your doctor right away if you have black, tarry stools, blistering, peeling, or loosening of the skin, chest pain, chills, cough, diarrhea, itching, joint or muscle pain, painful or difficult urination, red irritated eyes, red skin lesions, often with a purple center, sore throat, sores, ulcers, or white spots in the mouth or on the lips, swollen glands, unusual bleeding or bruising, or unusual tiredness or weakness.

Cutaneous or systemic lupus erythematosus may occur or get worse in lupus patients receiving a PPI. Call your doctor right away if you or your child 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 it together with digoxin (Lanoxin®) or certain diuretics (water pills). Check with your doctor right away if you have convulsions (seizures), a fast, racing, or uneven heartbeat, muscle spasms (tetany), tremors, or unusual tiredness or weakness.

This medicine may increase your risk for fundic gland polyps (abnormal tissue growth in the upper part of your stomach). This is more likely if you are receiving this medicine for more than 1 year. Talk to your doctor if you have concerns.

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, 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 or nurse immediately if any of the following side effects occur:

Less common

Bloody, black, or tarry stools

diarrhea

fever

vomiting of blood or material that looks like coffee grounds

Rare

Drowsiness

loss of appetite

mood or mental changes

muscle spasms (tetany) or twitching

nausea

seizures

trembling

unusual tiredness or weakness

vomiting

Incidence not known

Agitation

back pain

blistering, peeling, or loosening of the skin

bloating

bloody or cloudy urine

blurred vision

bone fracture

chest pain or tightness

confusion

constipation

cough

darkened urine

decreased urine

difficulty breathing

difficulty with swallowing

dizziness

dry mouth

fast heartbeat

fever with or without chills

general feeling of discomfort or illness

greatly decreased frequency of urination or amount of urine

headache

high fever

hoarseness

indigestion

irritability

joint or muscle pain

light-colored stools

loss of consciousness

lower back or side pain

muscle aches, cramps, stiffness, or weakness

nausea

noisy breathing

numbness and tingling around the mouth, fingertips, or feet

painful or difficult urination

pains in the stomach, side, or abdomen, possibly radiating to the back

pale skin

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

stiff neck

stomach cramps

stomach pain, continuing

swelling of the feet or lower legs

swelling or inflammation of the mouth

swollen glands

tenderness

unusual bleeding or bruising

upper right stomach pain

watery or bloody diarrhea

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

Belching

heartburn

stomach discomfort or upset

Less common

Burning, itching, redness, skin rash, swelling, or soreness at the injection site

difficulty having a bowel movement

dryness of the mouth

feeling of constant movement of self or surroundings

gas

pain or tenderness around the eyes and cheekbones

sensation of spinning

sneezing

stuffy or runny nose

Incidence not known

Aggression

bad unusual or unpleasant (after) taste

change in taste

decreased interest in sexual intercourse

difficulty in moving

discouragement

feeling sad or empty

inability to have or keep an erection

increased sensitivity of the skin to sunlight

joint swelling

loss of interest or pleasure

loss in sexual ability, desire, drive, or performance

redness or discoloration of the skin

seeing, hearing, or feeling things that are not there

severe sunburn

swelling of the breasts or breast soreness in both females and males

thinning or loss of hair

trouble concentrating

trouble sleeping

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.