Esomeprazole Magnesium (Page 11 of 12)

14.7 Pathological Hypersecretory Conditions, Including Zollinger-Ellison Syndrome, in Adults

In a multicenter, open-label dose-escalation study of 21 adult patients (15 males and 6 females, 18 Caucasian and 3 Black, mean age of 56 years) with pathological hypersecretory conditions, such as Zollinger-Ellison Syndrome, esomeprazole magnesium significantly inhibited gastric acid secretion. The initial dosage of esomeprazole magnesium was 40 mg twice daily in 19 patients and 80 mg twice daily in 2 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 esomeprazole magnesium 40 mg twice daily, 13 (72%) had their BAO controlled with the original dosing regimen at the final visit. See Table 15.

Table 15: Adequate Acid Suppression at Final Visit by Dosage Regimen in Adult Patients with Pathological Hypersecretory Conditions

Esomeprazole Magnesium dose at the Month 12 visit

BAO under adequate control at the Month 12 visit (N=20)1

40 mg twice daily

13/15

80 mg twice daily

4/4

80 mg three times daily

1/1

1. One patient was not evaluated.

16 HOW SUPPLIED/STORAGE AND HANDLING

Product: 50090-5552

NDC: 50090-5552-1 90 CAPSULE, DELAYED RELEASE in a BOTTLE

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Medication Guide and Instructions for Use).

Acute Tubulointerstitial Nephritis
Advise the patient or caregiver to call the patient’s healthcare provider immediately if they experience signs and/or symptoms associated with suspected acute TIN [see Warnings and Precautions (5.2)].
Clostridium difficile-Associated Diarrhea
Advise the patient or caregiver to immediately call the patient’s healthcare provider if they experience diarrhea that does not improve [see Warnings and Precautions (5.3)].
Bone Fracture
Advise the patient or caregiver to report any fractures, especially of the hip, wrist or spine, to the patient’s healthcare provider [see Warnings and Precautions (5.4)].
Cutaneous and Systemic Lupus Erythematosus
Advise the patient or caregiver to immediately call the patient’s healthcare provider for any new or worsening of symptoms associated with cutaneous or systemic lupus erythematosus [see Warnings and Precautions (5.5)].
Cyanocobalamin (Vitamin B-12) Deficiency
Advise the patient or caregiver to report any clinical symptoms that may be associated with cyanocobalamin deficiency to the patient’s healthcare provider if they have been receiving esomeprazole magnesium delayed release capsules for longer than 3 years [see Warnings and Precautions (5.7)].
Hypomagnesemia
Advise the patient or caregiver to report any clinical symptoms that may be associated with hypomagnesemia to the patient’s healthcare provider, if they have been receiving esomeprazole magnesium delayed release capsules for at least 3 months [see Warnings and Precautions (5.8)].
Drug Interactions
Advise the patient or caregiver to report to their healthcare provider if starting treatment with rilpivirine-containing products, clopidogrel, St. John’s Wort or rifampin; or, if they take high-dose methotrexate [see Contraindications (4), Warnings and Precautions (5.6, 5.9, 5.11)].
Administration
Take esomeprazole magnesium delayed-release at least one hour before meals.
Antacids may be used concomitantly with esomeprazole magnesium delayed release capsules.
Swallow esomeprazole magnesium delayed-release capsules whole; do not chew or crush the capsules.
For patients who have difficulty swallowing capsules, esomeprazole magnesium delayed-release capsules can be opened, and the contents sprinkled on applesauce. Use with other foods is not recommended.
Add one tablespoon of applesauce to an empty bowl. The applesauce used should not be hot and should be soft enough to be swallowed without chewing.
Open the esomeprazole magnesium delayed-release capsule and carefully empty the granules inside the capsule onto the applesauce.
Mix the granules with the applesauce.
Administer the mixture immediately. Do not chew or crush the granules.
Discard any remaining mixture. Do not store the mixture for future use.
Esomeprazole magnesium delayed-release capsules can also be administered via a nasogastric tube, as described in the Instructions for Use.
Manufactured by:
Ohm Laboratories Inc.
New Brunswick, NJ 08901
Distributed by:
Sun Pharmaceutical Industries, Inc.
Cranbury, NJ 08512
September 2021 FDA-06

MEDICATION GUIDE

Esomeprazole Magnesium (ES-oh-MEP-ra-zole mag-NEE-zee-um) Delayed-Release Capsules, USP

Rx only

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

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

Esomeprazole magnesium delayed-release capsules, USP 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 delayed-release capsules, USP, may develop a kidney problem called acute tubulointerstitial nephritis that can happen at any time during treatment with esomeprazole magnesium delayed-release capsules, USP. 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.
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, USP, 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.

Talk to your doctor about your risk of these serious side effects. Esomeprazole magnesium delayed release capsules, USP can have other serious side effects. See “What are the possible side effects of esomeprazole magnesium delayed release capsules, USP?”

What are esomeprazole magnesium delayed-release capsules, USP?

A prescription medicine called a proton pump inhibitor (PPI) used to reduce the amount of acid in your stomach.

Esomeprazole magnesium delayed-release capsules, USP are 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 4-8 weeks of esomeprazole magnesium delayed-release capsules, USP 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).
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).
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 delayed-release capsules, USP are 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.

Esomeprazole magnesium delayed-release capsules, USP are used in children 1 to 11 years of age for:

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

It is not known if esomeprazole magnesium delayed-release capsules, USP are 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 delayed-release capsules, USP if you are:

allergic to esomeprazole magnesium or any of the ingredients in esomeprazole magnesium delayed-release capsules, USP. See the end of this Medication Guide for a complete list of ingredients in esomeprazole magnesium delayed-release capsules, USP.
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 delayed-release capsules, USP:
rash
throat tightness
face swelling
difficulty breathing
taking a medicine that contains rilpivirine (Edurant, Complera, Odefsey) used to treat HIV-1 (Human Immunodeficiency Virus).

Before taking esomeprazole magnesium delayed-release capsules, USP, tell your doctor about all of your medical conditions, including if 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, USP will harm your unborn baby.
are breastfeeding or planning to breastfeed. Esomeprazole 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, USP.

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 delayed-release capsules, USP?

Take esomeprazole magnesium delayed-release capsules, USP exactly as prescribed by your doctor.
Do not change your dose or stop esomeprazole magnesium delayed-release capsules, USP without talking to your doctor.
Take esomeprazole magnesium delayed-release capsules, USP at least 1 hour before a meal.
Antacids may be taken with esomeprazole magnesium delayed-release capsules, USP.
Swallow esomeprazole magnesium delayed-release capsules, USP whole. Never chew or crush esomeprazole magnesium delayed-release capsules, USP.
If you have difficulty swallowing esomeprazole magnesium delayed-release capsules, USP, 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 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 delayed-release capsules, USP, 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, USP, 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, USP, through a nasogastric tube.

What are the possible side effects of esomeprazole magnesium delayed-release capsules, USP?

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

See “What is the most important information I should know about esomeprazole magnesium delayed-release capsules, USP?”
Low vitamin B-12 levels in your body can happen in people who have taken esomeprazole magnesium delayed-release capsules, USP 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 delayed-release capsules, USP 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.

The most common side effects of esomeprazole magnesium delayed-release capsules, USP include:

headache
stomach (abdominal) pain
diarrhea
constipation
nausea
dry mouth
gas

These are not all the possible side effects of esomeprazole magnesium delayed-release capsules, USP.

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, USP?

Store esomeprazole magnesium delayed-release capsules, USP at 68 — 77° F (20 — 25° C).
Keep the container of esomeprazole magnesium delayed-release capsules, USP closed tightly.

Keep esomeprazole magnesium delayed-release capsules, USP and all medicines out of the reach of children.

General information about the safe and effective use of esomeprazole magnesium delayed-release capsules, USP

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use esomeprazole magnesium delayed-release capsules, USP for a condition for which it was not prescribed. Do not give esomeprazole magnesium delayed-release capsules, USP 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 delayed-release capsules, USP that is written for health professionals.

For more information, call 1-800-818-4555.

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

Active ingredient: esomeprazole magnesium (anhydrous)

Inactive ingredients in esomeprazole magnesium delayed-release capsules (including the capsule shells): D&C Red #28, FD&C Blue #1, FD&C Red #40, ferric oxide black, gelatin, hydroxypropyl cellulose, hypromellose, magnesium stearate, methacrylic acid copolymer dispersion, mono and di glycerides, polysorbate 80, potassium hydroxide, propylene glycol, shellac, sugar spheres (corn starch and sucrose), talc, titanium dioxide, and triethyl citrate.

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

Instructions for Use

Giving esomeprazole magnesium delayed release capsules, USP with water through a nasogastric tube (NG tube) or gastric tube

Esomeprazole magnesium delayed-release capsules, USP:

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, USP 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.

All trademarks are the property of their respective owners.

Manufactured by:

Ohm Laboratories Inc.

New Brunswick, NJ 08901

Distributed by:

Sun Pharmaceutical Industries, Inc.

Cranbury, NJ 08512

September 2021 FDA-06

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