FDA Label for Esomeprazole Magnesium DR
View Indications, Usage & Precautions
Esomeprazole Magnesium DR Product Label
The following document was submitted to the FDA by the labeler of this product Advanced Rx Pharmacy Of Tennessee, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Medication Guide Section
MEDICATION GUIDE
Esomeprazole Magnesium Delayed-Release Capsules USP
(es'' oh mep' ra zole mag nee' zee um)
Read the Medication Guide that comes with esomeprazole magnesium delayed-release capsules before you start taking esomeprazole magnesium delayed-release capsules and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or your treatment.
What is the most important information I should know about esomeprazole magnesium delayed-release capsules?
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 interstitial nephritis). Some people who take proton pump inhibitor (PPI) medicines, including esomeprazole magnesium delayed-release capsules, may develop a kidney problem called acute interstitial nephritis that can happen at any time during treatment with esomeprazole magnesium delayed-release capsules. Call your doctor if you have a decrease in the amount that you urinate or if you have blood in your urine.
Diarrhea. Esomeprazole magnesium delayed-release capsules may increase your risk of getting severe diarrhea. This diarrhea may be caused by an infection (Clostridium difficile) in your intestines.
Call your doctor right away if you have watery stool, stomach pain, and fever that does not go away.
Bone fractures. People who take multiple daily doses of PPI medicines for a long period of time (a year or longer) may have an increased risk of fractures of the hip, wrist, or spine. You should take esomeprazole magnesium delayed-release capsules exactly as prescribed, at the lowest dose possible for your treatment and for the shortest time needed. Talk to your doctor about your risk of bone fracture if you take esomeprazole magnesium delayed-release capsules.
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 delayed-release capsules, 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.
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 are esomeprazole magnesium delayed-release capsules?
Esomeprazole magnesium delayed-release capsules are a prescription medicine called a proton pump inhibitor (PPI). Esomeprazole magnesium delayed-release capsules reduce the amount of acid in your stomach.
Esomeprazole magnesium delayed-release capsules are used in adults:
for 4 to 8 weeks to treat the symptoms of gastroesophageal reflux disease (GERD). Esomeprazole magnesium delayed-release capsules may also be prescribed to heal acid-related damage to the lining of the esophagus (erosive esophagitis), and to help continue this healing.
GERD happens when acid in your stomach backs up into the tube (esophagus) that connects your mouth to your stomach. This may cause a burning feeling in your chest or throat, sour taste, or burping.
for up to 6 months to reduce the risk of stomach ulcers in some people taking pain medicines called non-steroidal anti-inflammatory drugs (NSAIDs).
to treat patients with a stomach infection (Helicobacter pylori), along with the antibiotics amoxicillin and clarithromycin.
for 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.
For children and adolescents 1 year to 17 years of age, esomeprazole magnesium delayed-release capsules may be prescribed for up to 8 weeks for short-term treatment of GERD.
Who should not take esomeprazole magnesium delayed-release capsules?
Do not take esomeprazole magnesium delayed-release capsules if you:
are allergic to esomeprazole magnesium or any of the ingredients in esomeprazole magnesium delayed-release capsules. See the end of this Medication Guide for a complete list of ingredients in esomeprazole magnesium delayed-release capsules.
are allergic to any other PPI medicine.
What should I tell my doctor before taking esomeprazole magnesium delayed-release capsules?
Before you take esomeprazole magnesium delayed-release capsules, tell your doctor if you:
have been told that you have low magnesium levels in your blood.
have liver problems.
are pregnant or plan to become pregnant. It is not known if esomeprazole magnesium delayed-release capsules can 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 delayed-release capsules.
Tell your doctor about all of the medicines you take, including prescription and non-prescription drugs, vitamins and herbal supplements. Esomeprazole magnesium delayed-release capsules may affect how other medicines work, and other medicines may affect how esomeprazole magnesium delayed-release capsules work.
Especially tell your doctor if you take:
warfarin (Coumadin, Jantoven)
ketoconazole (Nizoral)
voriconazole (Vfend)
atazanavir (Reyataz)
nelfinavir (Viracept)
saquinavir (Fortovase)
products that contain iron
digoxin (Lanoxin)
St.John’s Wort (Hypericum perforatum)
Rifampin (Rimactane, Rifater, Rifamate)
cilostazol (Pletal)
diazepam (Valium)
tacrolimus (Prograf)
erlotinib (Tarceva)
methotrexate
clopidogrel (Plavix)
mycophenolate mofetil (Cellcept)
How should I take esomeprazole magnesium delayed-release capsules?
Take esomeprazole magnesium delayed-release capsules exactly as prescribed by your doctor.
Do not change your dose or stop esomeprazole magnesium delayed-release capsules without talking to your doctor.
Take esomeprazole magnesium delayed-release capsules at least 1 hour before a meal.
Swallow esomeprazole magnesium delayed-release capsules whole. Never chew or crush esomeprazole magnesium delayed-release capsules.
If you have difficulty swallowing esomeprazole magnesium delayed-release capsules, you may open the capsule and empty the contents into a tablespoon of applesauce. Do not crush or chew the granules. Be sure to swallow the applesauce right away. Do not store it for later use.
If you forget to take a dose of esomeprazole magnesium delayed-release capsules, 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, 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 delayed-release capsules?
Esomeprazole magnesium delayed-release capsules can cause serious side effects, including:
See “What is the most important information I should know about esomeprazole magnesium delayed-release capsules?”
Vitamin B-12 deficiency. Esomeprazole magnesium delayed-release capsules reduce the amount of acid in your stomach. Stomach acid is needed to absorb vitamin B-12 properly. Talk with your doctor about the possibility of vitamin B-12 deficiency if you have been on esomeprazole magnesium delayed-release capsules for a long time (more than 3 years).
Low magnesium levels in your body. Low magnesium can happen in some people who take a PPI medicine for at least 3 months. If low magnesium levels happen, it is usually after a year of treatment.
You may or may not have symptoms of low magnesium. Tell your doctor right away if you have any of these symptoms:
seizures
muscle weakness
dizziness
spasms of the hands and feet
abnormal or fast heart beat
cramps or muscle aches
jitteriness
spasm of the voice box
jerking movements or shaking (tremors)
Your doctor may check the level of magnesium in your body before you start taking esomeprazole magnesium delayed-release capsules or during treatment if you will be taking esomeprazole magnesium delayed-release capsules for a long period of time.
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.
The most common side effects with esomeprazole magnesium delayed-release capsules may include:
headache
abdominal pain
diarrhea
constipation
nausea
dry mouth
gas
drowsiness
Other side effects:
Serious allergic reactions. Tell your doctor if you get any of the following symptoms with esomeprazole magnesium delayed-release capsules:
rash
throat tightness
face swelling
difficulty breathing
Your doctor may stop esomeprazole magnesium delayed-release capsules if these symptoms happen.
Tell your doctor if you have any side effects that bother you or that do not go away. These are not all the possible side effects with esomeprazole magnesium delayed-release capsules.
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 delayed-release capsules?
Store esomeprazole magnesium delayed-release capsules at room temperature between 20° to 25°C (68° to 77°F).
Keep the container of esomeprazole magnesium delayed-release capsules closed tightly.
Keep esomeprazole magnesium delayed-release capsules and all medicines out of the reach of children.
General information about esomeprazole magnesium delayed-release capsules
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use esomeprazole magnesium delayed-release capsules for a condition for which it was not prescribed. Do not give esomeprazole magnesium delayed-release capsules to other people, even if they have the same symptoms you have. They may harm them.
This Medication Guide summarizes the most important information about esomeprazole magnesium delayed-release capsules. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about esomeprazole magnesium delayed-release capsules that is written for health professionals.
For more information, call Aurobindo Pharma USA, Inc. at 1-866-850-2876.
What are the ingredients in esomeprazole magnesium delayed-release capsules?
Active ingredient: esomeprazole magnesium dihydrate
Inactive ingredients in esomeprazole magnesium delayed-release capsules (including the capsule shells): colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, magnesium carbonate, magnesium oxide, methacrylic acid and ethyl acrylate copolymer dispersion, mono and di glycerides, polysorbate 80, sugar spheres (which contains liquid glucose, starch (maize) and sucrose), talc, titanium dioxide, triethyl citrate, gelatin, sodium lauryl sulfate, shellac, yellow iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, propylene glycol and strong ammonia solution.
Instructions for Use
For instructions on taking Delayed-Release Capsules, see the section of this leaflet called “How should I take esomeprazole magnesium delayed-release capsules?”
Esomeprazole magnesium delayed-release capsules may be given through a nasogastric tube (NG tube) or gastric tube, as prescribed by your doctor. Follow the instructions below:
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 delayed-release capsules 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.
Give the medicine right away.
Do not give the granules if they have dissolved or have broken into pieces.
Attach the syringe to the NG tube. Give the medicine in the syringe through the NG tube into the stomach.
After giving the granules, flush the NG tube with more water.
This Medication Guide has been approved by the U.S. Food and Drug Administration.
The brands listed are trademarks of their respective owners and are not trademarks of Aurobindo Pharma Limited.
Dispense with Medication Guide available at: www.aurobindousa.com/medication-guides
Distributed by:
Aurobindo Pharma USA, Inc.
279 Princeton-Hightstown Road
East Windsor, NJ 08520
Manufactured by:
Aurobindo Pharma Limited
Hyderabad-500 038, India
Revised: 07/2020
Dosage And Administration Section
2 DOSAGE AND ADMINISTRATION
Esomeprazole magnesium is supplied as delayed-release capsules for oral administration. The recommended dosages are outlined in Table 1. Esomeprazole magnesium delayed-release capsules should be taken at least one hour before meals.
The duration of proton pump inhibitor administration should be based on available safety and efficacy data specific to the defined indication and dosing frequency, as described in the prescribing information, and individual patient medical needs. Proton pump inhibitor treatment should only be initiated and continued if the benefits outweigh the risks of treatment.
Table 1: Recommended Dosage Schedule for Esomeprazole Magnesium Delayed-Release Capsules
Indication
Dose
Frequency
Gastroesophageal Reflux Disease (GERD)
Healing of Erosive Esophagitis
20 mg or 40 mg
Once Daily for 4 to 8 Weeks1
Maintenance of Healing of Erosive Esophagitis
20 mg
Once Daily2
Symptomatic Gastroesophageal Reflux Disease
20 mg
Once Daily for 4 Weeks3
Pediatric GERD
12 to 17 Year Olds
Healing of Erosive Esophagitis
20 mg or 40 mg
Once Daily for 4 to 8 Weeks
Symptomatic GERD
20 mg
Once Daily for 4 Weeks
1 to 11 Year Olds4
Short-term Treatment of Symptomatic GERD
10 mg
Once Daily for up to 8 Weeks
Healing of Erosive Esophagitis
weight < 20 kg
10 mg
Once Daily for 8 Weeks
weight > 20 kg
10 mg or 20 mg
Once Daily for 8 Weeks
Risk Reduction of NSAID-Associated Gastric Ulcer
20 mg or 40 mg
Once Daily for up to 6 months2
H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence
Triple Therapy:
Esomeprazole Magnesium Delayed-Release Capsules
40 mg
Once Daily for 10 Days
Amoxicillin
1000 mg
Twice Daily for 10 Days
Clarithromycin
500 mg
Twice Daily for 10 Days
Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome
40 mg6
Twice Daily7
1.[See CLINICAL STUDIES (14.1).] The majority of patients are healed within 4 to 8 weeks. For patients who do not heal after 4 to 8 weeks, an additional 4 to 8 weeks of treatment may be considered.
2. Controlled studies did not extend beyond six months.
3. If symptoms do not resolve completely after 4 weeks, an additional 4 weeks of treatment may be considered.
4. Doses over 1 mg/kg/day have not been studied.
6. The dosage of esomeprazole magnesium delayed-release capsules in patients with pathological hypersecretory conditions varies with the individual patient. Dosage regimens should be adjusted to individual patient needs.
7. Doses up to 240 mg daily have been administered [see DRUG INTERACTIONS (7)].
Please refer to amoxicillin and clarithromycin prescribing information for Contraindications, Warnings, and dosing in elderly and renally-impaired patients.
Specific Populations
Hepatic Insufficiency
In patients with mild to moderate liver impairment (Child-Pugh Classes A and B), no dosage adjustment is necessary. For patients with severe liver impairment (Child-Pugh Class C), a dose of 20 mg of esomeprazole magnesium delayed-release capsules should not be exceeded [see CLINICAL PHARMACOLOGY (12.3)].
Directions for use specific to the route and available methods of administration for each of these dosage forms are presented in Table 2.
Table 2: Administration Options
Administration Options
(See text following table for additional instructions.)
Dosage Form
Route
Options
Delayed-Release Capsules
Oral
Capsule can be swallowed whole.
-or-
Capsule can be opened and mixed with applesauce.
Delayed-Release Capsules
Nasogastric Tube
Capsule can be opened and the intact granules emptied into a syringe and delivered through the nasogastric tube.
Esomeprazole magnesium delayed-release capsules should be swallowed whole.
Alternatively, for patients who have difficulty swallowing capsules, one tablespoon of applesauce can be added to an empty bowl and the esomeprazole magnesium delayed-release capsule can be opened, and the granules inside the capsule carefully emptied onto the applesauce. The granules should be mixed with the applesauce and then swallowed immediately: do not store for future use. The applesauce used should not be hot and should be soft enough to be swallowed without chewing. The granules should not be chewed or crushed. If the granules/applesauce mixture is not used in its entirety, the remaining mixture should be discarded immediately.
For patients who have a nasogastric tube in place, esomeprazole magnesium delayed-release capsules can be opened and the intact granules emptied into a 60 mL catheter tipped syringe and mixed with 50 mL of water. It is important to only use a catheter tipped syringe when administering esomeprazole magnesium delayed-release capsules through a nasogastric tube. Replace the plunger and shake the syringe vigorously for 15 seconds. Hold the syringe with the tip up and check for granules remaining in the tip. Attach the syringe to a nasogastric tube and deliver the contents of the syringe through the nasogastric tube into the stomach. After administering the granules, the nasogastric tube should be flushed with additional water. Do not administer the granules if they have dissolved or disintegrated.
The mixture must be used immediately after preparation.
Indications And Usage Section
1 INDICATIONS AND USAGE
1.1 Treatment of Gastroesophageal Reflux Disease (GERD)
Healing of Erosive Esophagitis
Esomeprazole magnesium delayed-release capsules are indicated for the short-term treatment (4 to 8 weeks) in the healing and symptomatic resolution of diagnostically confirmed erosive esophagitis. For those patients who have not healed after 4 to 8 weeks of treatment, an additional 4 to 8 week course of esomeprazole magnesium delayed-release capsules may be considered.
Maintenance of Healing of Erosive Esophagitis
Esomeprazole magnesium delayed-release capsules are indicated to maintain symptom resolution and healing of erosive esophagitis. Controlled studies do not extend beyond 6 months.
Symptomatic Gastroesophageal Reflux Disease
Esomeprazole magnesium delayed-release capsules are indicated for short-term treatment (4 to 8 weeks) of heartburn and other symptoms associated with GERD in adults and children 1 year or older.
1.2 Risk Reduction of NSAID-Associated Gastric Ulcer
Esomeprazole magnesium delayed-release capsules are indicated for the reduction in the occurrence of gastric ulcers associated with continuous NSAID therapy in patients at risk for developing gastric ulcers. Patients are considered to be at risk due to their age (≥ 60) and/or documented history of gastric ulcers. Controlled studies do not extend beyond 6 months.
1.3 H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence
Triple Therapy (esomeprazole magnesium delayed-release capsules plus amoxicillin and clarithromycin): Esomeprazole magnesium delayed-release capsules, in combination with amoxicillin and clarithromycin, is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or history of within the past 5 years) to eradicate H. pylori. Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence [see DOSAGE AND ADMINISTRATION (2) and CLINICAL STUDIES (14)].
In patients who fail therapy, susceptibility testing should be done. If resistance to clarithromycin is demonstrated or susceptibility testing is not possible, alternative antimicrobial therapy should be instituted [see CLINICAL PHARMACOLOGY (12.4) and the prescribing information for clarithromycin].
1.4 Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome
Esomeprazole magnesium delayed-release capsules are indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison Syndrome.
* Please review the disclaimer below.