MEDICATION GUIDE NEXIUM (nex-e-um)(esomeprazole magnesium)Delayed-Release Capsules NEXIUM (nex-e-um)(esomeprazole magnesium)For Delayed-Release Oral Suspension
Read the Medication Guide that comes with NEXIUM before
you start taking NEXIUM 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
What is the most important information I should know about NEXIUM? NEXIUM may help your acid-related symptoms, but you could still have serious stomach problems. Talk with your doctor. NEXIUM can cause serious side effects, including:
• Diarrhea. NEXIUM 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 Proton Pump Inhibitor 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 NEXIUM 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 NEXIUM. NEXIUM can have other serious side effects. See
“What are the possible side effects of NEXIUM?” What is NEXIUM? NEXIUM is a prescription medicine called a proton pump
inhibitor (PPI). NEXIUM reduces the amount of acid in your
• for 4 to 8 weeks to treat the symptoms of
gastroesophageal reflux disease (GERD). NEXIUM
may also be prescribed to heal acid-related damage
to the lining of the esophagus (erosive esophagitis),
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
• 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
For children and adolescents 1 year to 17 years of age,
NEXIUM may be prescribed for up to 8 weeks for short-term
In children ages 1 month to less than 1 year of age, NEXIUM
is only used to treat GERD with acid-related damage to the
esophagus (erosive esophagitis) for up to 6 weeks.
It is not known if NEXIUM is effective in children under 1
Who should not take NEXIUM? Do not take NEXIUM if you:
• are allergic to esomeprazole magnesium or any of the
ingredients in NEXIUM. See the end of this Medication
Guide for a complete list of ingredients in NEXIUM.
• are allergic to any other Proton Pump Inhibitor (PPI)
What should I tell my doctor before taking NEXIUM? Before you take NEXIUM, tell your doctor if you:
• have been told that you have low magnesium levels
• are pregnant or plan to become pregnant. It is not
known if NEXIUM can harm your unborn baby.
• are breastfeeding or planning to breastfeed. It is not
known if NEXIUM passes into your breastmilk. You
and your doctor should decide if you will take NEXIUM
or breastfeed. You should not do both. Talk to your
doctor about the best way to feed your baby if you
Tell your doctor about all of the medicines you take,
including prescription and non-prescription drugs, vitamins
and herbal supplements. NEXIUM may affect how other
medicines work, and other medicines may affect how
NEXIUM works. Especially tell your doctor if you take:
• St.John’s Wort (Hypericum perforatum)
• Rifampin (Rimactane, Rifater, Rifamate)
How should I take NEXIUM?
• Take NEXIUM exactly as prescribed by your doctor.
• Do not change your dose or stop NEXIUM without
• Take NEXIUM at least 1 hour before a meal.
• Swallow NEXIUM capsules whole. Never chew or crush NEXIUM.
• If you have difficulty swallowing NEXIUM 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
• If you forget to take a dose of NEXIUM, 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
• If you take too much NEXIUM, call your doctor or
local poison control center right away, or go to the
• See the “Instructions for Use” at the end of this
Medication Guide for instructions how to take NEXIUM
For Delayed-Release Oral Suspension, and how to mix
and give NEXIUM Delayed-Release Capsules and
NEXIUM For Delayed-Release Oral Suspension,
through a nasogastric tube or gastric tube.
What are the possible side effects of NEXIUM? NEXIUM can cause serious side effects, including:
• See “What is the most important information I should know about NEXIUM?”
• Chronic (lasting a long time) inflammation of the stomach lining (Atrophic Gastritis). Using
NEXIUM for a long period of time may increase the
risk of inflammation to your stomach lining. You may
or may not have symptoms. Tell your doctor if you
have stomach pain, nausea, vomiting, or weight loss.
• Low magnesium levels in your body. This
problem can be serious. Low magnesium can happen
in some people who take a proton pump inhibitor
medicine for at least 3 months. If low magnesium
levels happen, it is usually after a year of treatment.
Tel your doctor right away if you have any of these
• jerking movements or shaking (tremors)
Your doctor may check the level of magnesium in your body
before you start taking NEXIUM or during treatment if you
will be taking NEXIUM for a long period of time.
The most common side effects with NEXIUM may include:
Serious allergic reactions. Tell your doctor if you get any
Your doctor may stop NEXIUM if these symptoms happen.
Tel your doctor if you have any side effects that bother you
or that do not go away. These are not all the possible side
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 NEXIUM?
• Store NEXIUM at room temperature between 68°F to
• Keep the container of NEXIUM closed tightly.
Keep NEXIUM and all medicines out of the reach of children. General information about NEXIUM Medicines are sometimes prescribed for purposes other than
those listed in a Medication Guide. Do not use NEXIUM for a
condition for which it was not prescribed. Do not give
NEXIUM to other people, even if they have the same
This Medication Guide summarizes the most important
information about NEXIUM. If you would like more
information, talk with your doctor. You can ask your
pharmacist or doctor for information about NEXIUM that is
What are the ingredients in NEXIUM?
Active ingredient: esomeprazole magnesium trihydrate
Inactive ingredients in NEXIUM Delayed-Release Capsules (including the capsule shells): glyceryl
monostearate 40-55, hydroxypropyl cellulose, hypromellose,
magnesium stearate, methacrylic acid copolymer type C,
polysorbate 80, sugar spheres, talc, triethyl citrate, gelatin,
FD&C Blue #1, FD&C Red #40, D&C Red #28, titanium
dioxide, shellac, ethyl alcohol, isopropyl alcohol, n-butyl
alcohol, propylene glycol, sodium hydroxide, polyvinyl
Inactive granules in NEXIUM For Delayed-Release Oral Suspension: dextrose, xanthan gum, crospovidone,
citric acid, iron oxide, and hydroxypropyl cellulose.
Instructions for Use For instructions on taking Delayed-Release Capsules, see
the section of this leaflet called “How should I take NEXIUM?”
Take NEXIUM For Delayed-Release Oral Suspension as
• NEXIUM For Delayed-Release Oral Suspension comes
in foil packets containing 2.5 mg, 5 mg, 10 mg, 20
• You should use an oral syringe to measure the
amount of water needed to mix your dose. Ask your
• If your prescribed dose is 2.5 mg or 5 mg, add 5 mL
of water to a container, then add the contents of a foil
packet containing the dose prescribed by your doctor.
• If your prescribed dose is 10 mg, 20 mg, or 40 mg,
add 15 mL of water to a container, then add the
contents of a foil packet containing the dose
• If you or your child are instructed to use more than
one foil packet for the prescribed dose, follow the
mixing instructions provided by your pharmacist or
• Stir and take dose within 30 minutes. If not used
within 30 minutes, throw away this dose and mix a
• If any medicine remains after drinking, add more
• For young children, you can give the dose with an
oral syringe. Rinse the oral syringe with water after
NEXIUM Delayed-Release Capsules and NEXIUM For
Delayed-Release Oral Suspension 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 NEXIUM
• Replace the plunger and shake the syringe well for 15
seconds. Hold the syringe with the tip up and check
• Do not give the granules if they have dissolved or
• 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
NEXIUM For Delayed-Release Oral Suspension:
• NEXIUM For Delayed-Release Oral Suspension comes
in foil packets containing 2.5 mg, 5 mg, 10 mg, 20
• Use only a catheter tipped syringe to give NEXIUM
• If your prescribed dose is 2.5 mg or 5 mg, add 5 mL
of water to a catheter tipped syringe, then add the
contents of a foil packet containing the dose
• If your prescribed dose is 10 mg, 20 mg, or 40 mg,
add 15 mL of water to a catheter tipped syringe, then
add the contents of a foil packet containing the dose
• Shake the syringe right away and then leave it for 2
• Shake the syringe and give the medicine through the
NG or gastric tube (French size 6 or larger) into the
• Refill the syringe with the same amount of water
(either 5 mL or 15 mL of water depending on your
• Shake the syringe and flush any remaining medicine
from the NG tube or gastric tube into the stomach.
This Medication Guide has been approved by the U.S. Food
NEXIUM is a registered trademark of the AstraZeneca group
2012 AstraZeneca Pharmaceuticals LP. All rights reserved
Tekral Tablets NDC 64543-025-90 DESCRIPTION Each light yellow and light green bi-layered capsule shaped tablet that is scored on one side and debossed “TEKRAL” on the opposite side contains: Diphenhydramine Hydrochloride . 100 mg Pseudoephedrine Hydrochloride ………. 120 mg Tekral tablets are specially formulated to provide prolonged activity and contain active in
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