MEDICATION GUIDE

Esomeprazole Magnesium Delayed-Release Capsules, USP for oral use

(es ″ oh mep′ ra zole mag nee′ zee um)

 

What is the most important information I should know about esomeprazole magnesium delayed-release capsules, USP?

Esomeprazole magnesium delayed-release capsules may help your acid-related symptoms, but you could still have serious stomach problems. Talk with your doctor.

Esomeprazole magnesium delayed-release capsules can cause serious side effects, including:

•   A type of kidney problem (acute tubulointerstitial nephritis). Some people who take proton pump inhibitor (PPI) medicines, including Esomeprazole magnesium, may develop a kidney problem called acute tubulointerstitial nephritis that can happen at any time during treatment with Esomeprazole magnesium. Call your doctor right away if you have a decrease in the amount that you urinate or if you have blood in your urine.

   

• Diarrhea caused by an infection (Clostridium difficile) in your intestines. Call your doctor right away if you have watery stools or stomach pain that does not go away. You may or may not have a fever.
  
•   Bone fractures (hip, wrist, or spine). Bone fractures in the hip, wrist, or spine may happen in people who take multiple daily doses of PPI medicines and for a long period of time (a year or longer). Tell your doctor if you have a bone fracture, especially in the hip, wrist, or spine.
  
  

  Talk to your doctor about your risk of these serious side effects.

  
  

  Esomeprazole magnesium delayed-release capsules can have other serious side effects. See “What are the possible side effects of esomeprazole magnesium delayed-release capsules?”

  
  

  What is esomeprazole magnesium delayed-release capsules?

  
  

  A prescription medicine called a proton pump inhibitor (PPI) used to reduce the amount of acid in your stomach. Esomeprazole magnesium is used in adults for:

• 4 to 8 weeks for the healing and symptom relief of acid-related damage to the esophagus (erosive esophagitis or EE). Your doctor may prescribe another 4 to 8 weeks of esomeprazole magnesium in patients whose EE does not heal.
• maintaining healing of EE.
• 4 to 8 weeks to treat heartburn and other symptoms that happen with gastroesophageal reflux disease (GERD).
• up to 6 months to reduce the risk of stomach ulcers in some people taking pain medicines called non-steroidal anti-inflammatory drugs (NSAIDs).
• treating patients with a stomach infection (Helicobacter pylori) and a stomach ulcer, along with the antibiotics amoxicillin and clarithromycin.
• the long-term treatment of conditions where your stomach makes too much acid, including Zollinger-Ellison Syndrome. Zollinger-Ellison Syndrome is a rare condition in which the stomach produces a more than normal amount of acid.
  

  Esomeprazole magnesium is used in children and adolescents 12 to 17 years of age for:

• 4 to 8 weeks to heal EE.
• 4 weeks to treat heartburn and other symptoms that happen with GERD.

    

  It is not known if esomeprazole magnesium is safe and effective in children under 1 month of age for the treatment of GERD with EE. It is not known if esomeprazole magnesium is safe and effective in children less than 1 year of age for the treatment of GERD symptoms. It is not known if esomeprazole magnesium is safe and effective in children to reduce the risk of stomach ulcers in children who take medicines called NSAIDs, to treat Helicobacter pylori stomach infection to lower the risk of a stomach ulcer returning, and to treat conditions where your stomach makes too much acid.

  
  

  Do not take esomeprazole magnesium if you are:

• allergic to esomeprazole magnesium, any other PPI medicine, or any of the ingredients in esomeprazole magnesium. See the end of this Medication Guide for a complete list of ingredients in esomeprazole magnesium.

  Tell your doctor right away or get emergency medical help if you get any of the following symptoms of an allergic reaction with esomeprazole magnesium:

  
  

  o   rash

  o   throat tightness

  o   face swelling

  o   difficulty breathing

  
  
• taking a medicine that contains rilpivirine (EDURANT, COMPLERA, ODEFSEY) used to treat HIV-1 (Human Immunodeficiency Virus).

   

  Before taking esomeprazole magnesium, tell your doctor about all of your medical conditions, including if you:

• have low magnesium levels, low calcium levels and low potassium levels in your blood.
• have liver problems.
• are pregnant or plan to become pregnant. It is not known if esomeprazole magnesium will harm your unborn baby.
• are breastfeeding or planning to breastfeed. Esomeprazole magnesium may pass into your breast milk. Talk to your doctor about the best way to feed your baby if you take esomeprazole magnesium.

  Tell your doctor about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

  Especially tell your doctor if you take: clopidogrel (Plavix), methotrexate (Otrxup, Rasuvo, Trexall, XATMEP), digoxin (LANOXIN), rilpivirine (EDURANT), St. John’s Wort (Hypericum perforatum), or rifampin (Rimactane, Rifater, Rifamate).

  
  

  How should I take esomeprazole magnesium?

• Take esomeprazole magnesium exactly as prescribed by your doctor.
• Do not change your dose or stop esomeprazole magnesium without talking to your doctor.
• Take esomeprazole magnesium at least 1 hour before a meal.
• Antacids may be taken with esomeprazole magnesium.
• Swallow esomeprazole magnesium capsules whole. Never chew or crush esomeprazole magnesium.
• If you have difficulty swallowing esomeprazole magnesium capsules, you may open the capsule and empty the granules into 1 tablespoon of applesauce. The applesauce used should not be hot and should be soft enough to swallow without chewing. Do not mix the esomeprazole magnesium granules with any other food.
• Do not crush or chew the granules. Be sure to swallow the applesauce right away. Throw away any remaining mixture. Do not store it for later use.
• If you forget to take a dose of esomeprazole magnesium, take it as soon as you remember. If it is almost time for your next dose, do not take the missed dose. Take the next dose on time. Do not take a double dose to make up for a missed dose.
• If you take too much esomeprazole magnesium, call your doctor or local poison control center right away at 1-800-222-1222, or go to the nearest hospital emergency room.
• See the Instructions for Use at the end of this Medication Guide for instructions how to mix and give esomeprazole magnesium delayed-release capsules through a nasogastric tube or gastric tube.

  What are the possible side effects of esomeprazole magnesium?

  Esomeprazole magnesium can cause serious side effects, including:

• See “What is the most important information I should know about esomeprazole magnesium?”
• Low vitamin B-12 levels in your body can happen in people who have taken esomeprazole magnesium for a long time (more than 3 years). Tell your doctor if you have symptoms of low vitamin B-12 levels, including shortness of breath, lightheadedness, irregular heartbeat, muscle weakness, pale skin, feeling tired, mood changes, and tingling or numbness in the arms and legs.
• Low magnesium levels in your body can happen in people who have taken esomeprazole magnesium for at least 3 months. Tell your doctor right away if you have symptoms of low magnesium levels, including seizures, dizziness, irregular heartbeat, jitteriness, muscle aches or weakness, and spasms of hands, feet or voice.
• Stomach growths (fundic gland polyps). People who take PPI medicines for a long time have an increased risk of developing a certain type of stomach growths called fundic gland polyps, especially after taking PPI medicines for more than 1 year.
• Severe skin reactions. Esomeprazole magnesium can cause rare but severe skin reactions that may affect any part of your body. These serious skin reactions may need to be treated in a hospital and may be life threatening:
  • Skin rash which may have blistering, peeling or bleeding on any part of your skin (including your lips, eyes, mouth, nose, genitals, hands or feet).
  • You may also have fever, chills, body aches, shortness of breath, or enlarged lymph nodes.
  Stop taking esomeprazole magnesium and call your doctor right away. These symptoms may be the first sign of a severe skin reaction.

  The most common side effects of esomeprazole magnesium include:

  ·       headache

  ·       stomach (abdominal) pain

  ·       diarrhea

  ·       constipation

  ·       nausea

  ·       dry mouth

  ·       gas

  
  

  These are not all the possible side effects of esomeprazole magnesium. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

  
  

  How should I store esomeprazole magnesium?

• Store esomeprazole magnesium at room temperature between 68°F to 77°F (20°C to 25°C).
• Keep the container of esomeprazole magnesium closed tightly.

• Certain types of lupus erythematosus. Lupus erythematosus is an autoimmune disorder (the body’s immune cells attack other cells or organs in the body). Some people who take PPI medicines, including Esomeprazole magnesium, may develop certain types of lupus erythematosus or have worsening of the lupus they already have. Call your doctor right away if you have new or worsening joint pain or a rash on your cheeks or arms that gets worse in the sun.

Keep esomeprazole magnesium and all medicines out of the reach of children.

General information about the safe and effective use of esomeprazole magnesium. 

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use esomeprazole magnesium for a condition for which it was not prescribed. Do not give esomeprazole magnesium to other people, even if they have the same symptoms you have. It may harm them.

You can ask your pharmacist or doctor for information about esomeprazole magnesium that is written for health professionals.

What are the ingredients in esomeprazole magnesium delayed-release capsules, USP?

Active ingredient: esomeprazole magnesium dihydrate

Inactive ingredients in esomeprazole magnesium delayed-release capsules, USP:

Colloidal silicon dioxide, hypromellose, isopropyl alcohol, magnesium stearate, meglumine, methacrylic acid copolymer dispersion, methyl alcohol, methylene chloride, mono & diglycerides, poloxamer, Talc, triethyl citrate, and Sugar spheres (composed of sucrose, maize starch and purified water).

The capsule shells and Imprinting Ink have the following inactive ingredients: Capsule shell: FD & C Blue 1, FD & C Red 40, gelatin, sodium lauryl sulphate and titanium dioxide and Imprinting Ink: butyl alcohol, dehydrated alcohol, isopropyl alcohol, propylene glycol, Shellac, strong ammonia solution, and yellow iron oxide.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Manufactured by:

Alkem Laboratories Ltd.,

INDIA.

Distributed by:

Ascend Laboratories, LLC

Parsippany, NJ 07054

 Revised: November, 2023

 

Instructions for Use
Esomeprazole Magnesium Delayed-Release Capsules, USP
(es ″ oh mep′ ra zole mag nee′ zee um)

Giving esomeprazole magnesium delayed-release capsules with water through a nasogastric tube (NG tube) or gastric tube
 Esomeprazole magnesium delayed-release capsules:

• Open the capsule and empty the granules into a 60 mL catheter tipped syringe. Mix with 50 mL of water. Use only a catheter tipped syringe to give esomeprazole magnesium through a NG tube.
• Replace the plunger and shake the syringe well for 15 seconds. Hold the syringe with the tip up and check for granules in the tip.
• Do not give the granules if they have dissolved or have broken into pieces.
• Attach the syringe to the NG tube. Give the medicine right away in the syringe through the NG tube into the stomach.
• After giving the granules, flush the NG tube with more water.

This Instructions for Use has been approved by the U.S. Food and Drug Administration.

 

Manufactured by:

Alkem Laboratories Ltd.,

INDIA.

Distributed by:

Ascend Laboratories, LLC

Parsippany, NJ 07054

Revised: November, 2023

 

PT2444-06