NEXIUM (Page 11 of 11)

14.6 Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome

In a multicenter, open-label dose-escalation study of 21 patients (15 males and 6 females, 18 Caucasian and 3 Black, mean age of 55.5 years) with pathological hypersecretory conditions, such as Zollinger-Ellison Syndrome, NEXIUM significantly inhibited gastric acid secretion. Initial dose was 40 mg twice daily in 19/21 patients and 80 mg twice daily in 2/21 patients. Total daily doses ranging from 80 mg to 240 mg for 12 months maintained gastric acid output below the target levels of 10 mEq/h in patients without prior gastric acid-reducing surgery and below 5 mEq/hr in patients with prior gastric acid-reducing surgery. At the Month 12 final visit, 18/20 (90%) patients had Basal Acid Output (BAO) under satisfactory control (median BAO = 0.17 mmol/hr). Of the 18 patients evaluated with a starting dose of 40 mg twice daily, 13 (72%) had their BAO controlled with the original dosing regimen at the final visit. See Table 13.

Table 13: Adequate Acid Suppression at Final Visit by Dose Regimen
*
One patient was not evaluated.

NEXIUM dose at the Month 12 visit

BAO under adequate control at the Month 12 visit (N=20) *

40 mg twice daily

13/15

80 mg twice daily

4/4

80 mg three times daily

1/1

16 HOW SUPPLIED/STORAGE AND HANDLING

NEXIUM Delayed-Release Capsules, 40 mg, are opaque, hard gelatin, amethyst colored capsules with three radial bars in yellow on the cap and NEXIUM 40 mg in yellow on the body. They are supplied as follows:

NDC: 70518-2038-00

PACKAGING: 20 in 1 BOTTLE PLASTIC

Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F). [See USP Controlled Room Temperature]. Keep NEXIUM Delayed-Release Capsules container tightly closed. Dispense in a tight container if the NEXIUM Delayed-Release Capsules product package is subdivided.

Repackaged and Distributed By:

Remedy Repack, Inc.

625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Medication Guide).

Adverse Reactions

Advise patients to report to their healthcare provider if they experience any signs or symptoms consistent with:

Drug Interactions

  • Advise patients to let you know if they are taking, or begin taking, other medications, because NEXIUM can interfere with antiretroviral drugs and drugs that are affected by gastric pH changes [see Drug Interactions (7.1)].

Administration

  • Let patients know that antacids may be used while taking NEXIUM.
  • Advise patients to take NEXIUM at least one hour before a meal.
  • For patients who are prescribed NEXIUM Delayed-Release Capsules, advise them not to chew or crush the capsules.
  • Advise patients that, if they open NEXIUM Delayed-Release Capsules to mix the granules with food, the granules should only be mixed with applesauce. Use with other foods has not been evaluated and is not recommended.
  • For patients who are advised to open the NEXIUM Delayed-Release Capsules before taking them or who are prescribed NEXIUM For Delayed-Release Oral Suspension, instruct them in the proper technique for administration [see Dosage and Administration (2)] and tell them to follow the dosing instructions in the PATIENT INFORMATION insert included in the package. Instruct patients to rinse the syringe with water after each use.
  • For patients who are prescribed NEXIUM For Delayed-Release Oral Suspension and need to use more than one packet for their dose, instruct them regarding the correct amount of water to use when mixing their dose.

NEXIUM and the color purple as applied to the capsule are registered trademarks of the AstraZeneca group of companies.

©AstraZeneca 2020

Repackaged By / Distributed By: RemedyRepack Inc.

625 Kolter Drive, Indiana, PA 15701

(724) 465-8762

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 medical condition or your treatment.

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:

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

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 stomach.

NEXIUM is used in adults:

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), 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, NEXIUM may be prescribed for up to 8 weeks for short-term treatment of GERD.

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 month of age.

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 PPI medicine.

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 in your blood.
have liver problems.
are pregnant or plan to become pregnant. It is not known if NEXIUM can harm your unborn baby.
are breastfeeding or planning to breastfeed. NEXIUM may pass into your breast milk. Talk to your doctor about the best way to feed your baby if you take NEXIUM.

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:

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)

How should I take NEXIUM?

What are the possible side effects of NEXIUM?

NEXIUM can cause serious side effects, including:

seizures
dizziness
abnormal or fast heart beat
jitteriness
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:

headache
diarrhea
nausea
gas

Other side effects:

Serious allergic reactions. Tell your doctor if you get any of the following symptoms with NEXIUM:

rash
face swelling

Your doctor may stop NEXIUM 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 NEXIUM.

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?

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 symptoms you have. It may harm them.

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 written for health professionals.

For more information, go to www.purplepill.com or call 1-800-463-9486.

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 pyrrolidone, and D&C Yellow #10.

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 follows:

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:

NEXIUM Delayed-Release Capsules:

NEXIUM For Delayed-Release Oral Suspension:

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

NEXIUM is a registered trademark of the AstraZeneca group of companies.

©2020 AstraZeneca Pharmaceuticals LP. All rights reserved

Repackaged By / Distributed By: RemedyRepack Inc.

625 Kolter Drive, Indiana, PA 15701

(724) 465-8762

throat tightness
difficulty breathing

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

NEXIUM For Delayed-Release Oral Suspension comes in foil packets containing 2.5 mg, 5 mg, 10 mg, 20 mg, or 40 mg strengths.
You should use an oral syringe to measure the amount of water needed to mix your dose. Ask your pharmacist for an oral syringe.
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 prescribed by your doctor.
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 doctor.
Stir.
Leave 2 to 3 minutes to thicken.
Stir and take dose within 30 minutes. If not used within 30 minutes, throw away this dose and mix a new dose.
If any medicine remains after drinking, add more water, stir, and take dose right away.
For young children, you can give the dose with an oral syringe. Rinse the oral syringe with water after each use.

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 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.

NEXIUM For Delayed-Release Oral Suspension comes in foil packets containing 2.5 mg, 5 mg, 10 mg, 20 mg, or 40 mg strengths.
Use only a catheter tipped syringe to give NEXIUM through a NG tube or gastric tube.
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 prescribed by your doctor.
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 prescribed by your doctor.
Shake the syringe right away and then leave it for 2 to 3 minutes to thicken.
Shake the syringe and give the medicine through the NG or gastric tube (French size 6 or larger) into the stomach within 30 minutes.
Refill the syringe with the same amount of water (either 5 mL or 15 mL of water depending on your dose).
Shake the syringe and flush any remaining medicine from the NG tube or gastric tube into the stomach.

abdominal pain
constipation
dry mouth
drowsiness

muscle weakness
spasms of the hands and feet
cramps or muscle aches
spasm of the voice box

• 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.

Rifampin (Rimactane, Rifater, Rifamate)
cilostazol (Pletal)
diazepam (Valium)
tacrolimus (Prograf)
erlotinib (Tarceva)
methotrexate
clopidogrel (Plavix)
mycophenolate mofetil (Cellcept)

Take NEXIUM exactly as prescribed by your doctor.
Do not change your dose or stop NEXIUM without talking to your doctor.
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 away. Do not store it for later use.
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 make up for a missed dose.
If you take too much NEXIUM, 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 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.

See “What is the most important information I should know about NEXIUM?”
Vitamin B-12 deficiency. NEXIUM 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 NEXIUM 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:

DRUG: NEXIUM

GENERIC: Esomeprazole magnesium

DOSAGE: CAPSULE, DELAYED RELEASE

ADMINSTRATION: ORAL

NDC: 70518-2038-0

COLOR: purple

SHAPE: CAPSULE

SCORE: No score

SIZE: 14 mm

IMPRINT: NEXIUM40mg

PACKAGING: 20 in 1 BOTTLE, PLASTIC

ACTIVE INGREDIENT(S):

  • ESOMEPRAZOLE MAGNESIUM 40mg in 1

INACTIVE INGREDIENT(S):

  • GLYCERYL MONOSTEARATE
  • SODIUM HYDROXIDE
  • POLYETHYLENE GLYCOL, UNSPECIFIED
  • BUTYL ALCOHOL
  • ISOPROPYL ALCOHOL
  • ALCOHOL
  • TITANIUM DIOXIDE
  • D&C RED NO. 28
  • FD&C RED NO. 40
  • FD&C BLUE NO. 1
  • GELATIN, UNSPECIFIED
  • POLYSORBATE 80
  • TRIETHYL CITRATE
  • TALC
  • METHACRYLIC ACID
  • MAGNESIUM STEARATE
  • HYPROMELLOSE, UNSPECIFIED
  • HYDROXYPROPYL CELLULOSE (1600000 WAMW)
  • POVIDONE, UNSPECIFIED
  • D&C YELLOW NO. 10
Remedy_Label
(click image for full-size original)
NEXIUM esomeprazole magnesium capsule, delayed release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70518-2038(NDC:0186-5040)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ESOMEPRAZOLE MAGNESIUM (ESOMEPRAZOLE) ESOMEPRAZOLE 40 mg
Inactive Ingredients
Ingredient Name Strength
GLYCERYL MONOSTEARATE
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
HYPROMELLOSE, UNSPECIFIED
MAGNESIUM STEARATE
METHACRYLIC ACID
TALC
TRIETHYL CITRATE
POLYSORBATE 80
GELATIN, UNSPECIFIED
FD&C BLUE NO. 1
FD&C RED NO. 40
D&C RED NO. 28
TITANIUM DIOXIDE
ALCOHOL
ISOPROPYL ALCOHOL
BUTYL ALCOHOL
POLYETHYLENE GLYCOL, UNSPECIFIED
SODIUM HYDROXIDE
POVIDONE, UNSPECIFIED
D&C YELLOW NO. 10
Product Characteristics
Color purple (Amethyst) Score no score
Shape CAPSULE Size 14mm
Flavor Imprint Code NEXIUM40mg
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70518-2038-0 20 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021153 04/26/2019
Labeler — REMEDYREPACK INC. (829572556)

Revised: 06/2021 REMEDYREPACK INC.

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