ESOMEPRAZOLE MAGNESIUM- esomeprazole magnesium capsule, delayed release pellets
Medsource Pharmaceuticals
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Dispense with Medication Guide available at: www.lannett.com/med-guide/esomeprazole
Esomeprazole Magnesium ( es” oh mep’ ra zole mag nee’ zee um)
Delayed-release Capsules, USP
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:
Call your doctor right away if you have watery stool, stomach pain, and fever that does not go away.
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?
Esomeprazole Magnesium Delayed-release Capsules is a prescription medicine called a proton pump inhibitor (PPI).
Esomeprazole Magnesium Delayed-release Capsules reduces the amount of acid in your stomach.
Esomeprazole Magnesium Delayed-release Capsules is 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.
It is not known if Esomeprazole Magnesium Delayed-release Capsules is effective in children under 1 year of age.
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 Delayed-release Capsules 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 works.
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 pellets. 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 Delayed-release Capsules, 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 a 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 reduces 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
dizziness
abnormal or fast heart beat
jitteriness
jerking movements or shaking (tremors)
muscle weakness
spasms of the hands and feet
cramps or muscle aches
spasm of the voice box
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
diarrhea
nausea
gas
abdominal pain
constipation
dry mouth
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
face swelling
throat tightness
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 68°F to 77°F (20°C to 25°C).
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. It 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 1-844-834-0530.
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):
diglycerin, hypromellose, magnesium stearate, methacrylic acid and ethyl acrylate copolymer dispersion, monoglycerides, polysorbate 80, sugar spheres, talc, and triethyl citrate. The capsule shells have the following inactive ingredients: gelatin, FD&C Blue #1, sodium lauryl sulfate, and titanium dioxide. In addition, the 20 mg capsule shell contains FD & C Red #40 and the 40 mg capsule shell contains FD&C Red #3. The imprinting ink also contains ammonium hydroxide, butyl alcohol, black iron oxide, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol and shellac. The 20 mg ink also contains titanium dioxide. The 40 mg ink may also contain n-butyl alcohol.
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:
Esomeprazole Magnesium Delayed-release Capsules:
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Distributed by:
Lannett Company, Inc.
Philadelphia, PA 19136
CIA77978E
Rev. 12/2020
All brand names are the trademarks of their respective owners.