ESOMEPRAZOLE MAGNESIUM: Package Insert and Label Information (Page 8 of 8)

16 HOW SUPPLIED/STORAGE AND HANDLING

Esomeprazole Magnesium Delayed-Release Capsules, USP 20 mg, are size ‘4’ hard gelatin capsule having yellow cap and pink body imprinted as ’20 mg’ on the body with white ink and ‘1154’ on the cap with black ink, containing off white to cream colored granules.

NDC: 63629-5659-1: 30 Capsules in a BOTTLE

NDC: 63629-5659-2: 10 Capsules in a BOTTLE

NDC: 63629-5659-3: 60 Capsules in a BOTTLE

NDC: 63629-5659-4: 90 Capsules in a BOTTLE

NDC: 63629-5659-5: 42 Capsules in a BOTTLE

NDC: 63629-5659-6: 120 Capsules in a BOTTLE

NDC: 63629-5659-7: 180 Capsules in a BOTTLE

NDC: 63629-5659-8: 20 Capsules in a BOTTLE

17 PATIENT COUNSELING INFORMATION

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

Severe Cutaneous Adverse Reactions

Advise the patient or caregiver to discontinue esomeprazole magnesium and immediately call the patient’s healthcare provider for at first appearance of a severe cutaneous adverse reaction or other sign of hypersensitivity signs or symptoms associated with Severe Cutaneous Adverse Reactions [ see Warnings and Precautions ( 5.5) ].

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 ( 5.6)].

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 for longer than 3 years [see Warnings and Precautions ( 5.8)] .

Hypomagnesemia and Mineral Metabolism

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 for at least 3 months [see Warnings and Precautions ( 5.9) ].

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 ( 5.7, 5.10, 5.12)] .

Administration

  • Take esomeprazole magnesium delayed-release capsules 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.
  1. 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.
  2. Open the esomeprazole magnesium delayed-release capsule and carefully empty the granules inside the capsule onto the applesauce.
  3. Mix the granules with the applesauce.
  4. Administer the mixture immediately. Do not chew or crush the granules
  5. 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.
image description

Manufactured by:

TORRENT PHARMACEUTICALS LTD., INDIA.

Manufactured for:

TORRENT PHARMA INC., Levittown, PA 19057.

8087292 Revised: 04/2022

MEDICATION GUIDE

Esomeprazole Magnesium ( ee so MEP ra zol mag NEE zee um) Delayed-Release Capsules, USP

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 tubulointerstitial nephritis). Some people who take proton pump inhibitor (PPI) medicines, including esomeprazole magnesium delayed-release capsules, may develop a kidney problem called acute tubulointerstitial nephritis that can happen at any time during treatment with esomeprazole magnesium delayed-release capsules. 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 intestine . Call your doctor right away if you have watery stool 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 dose of PPI medicine 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, 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 capsulescan have other serious side effects. See “What are the possible side effects of e someprazole 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) used to reduce the amount of acid in your stomach.

Esomeprazole Magnesium Delayed-Release Capsules are used in adults for:

  • 4 to 8 weeks for the healing and symptoms relief of acid-related damage to the esophagus (erosive esophagitis or EE). Your doctor may prescribe another 4 to 8 weeks of esomeprazole magnesium delayed-release capsules 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).
  • 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 is 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.

It is not known if esomeprazole magnesium is 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 if you are:

  • allergic to esomeprazole magnesium, any other PPI medicine 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.

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:

o rash

o throat tightness

o face swelling

o 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, tell your doctor about all 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 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 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?

  • 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. The applesauce used should not be hot and should be soft enough to swallow without chewing. Do not mix the esomeprazole magnesium granules with any other food.
  • 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, 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 many esomeprazole magnesium delayed-release capsules, 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, through a nasogastric 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?”
  • Low Vitamin B-12 levels in your body can happen in people who have taken esomeprazole magnesium delayed-release capsules 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 some people who have taken esomeprazole magnesium delayed-release capsules 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.
  • Severe skin reactions. Esomeprazole magnesium delayed-release capsules can cause rare but severe skin reactions that may affect any part of your body. These serious skin reactions may need to be treated in a hospital and may be life threatening:

• Skin rash which may have blistering, peeling or bleeding on any part of your skin (including your lips, eyes, mouth, nose, genitals, hands or feet).
• You may also have fever, chills, body aches, shortness of breath, or enlarged lymph nodes. Stop taking esomeprazole magnesium delayed-release capsules and call your doctor right away. These symptoms may be the first sign of a severe skin reaction.

The most common side effects with esomeprazole magnesium delayed-release capsules may include:

  • headache
  • diarrhea
  • nausea
  • gas
  • abdominal pain
  • constipation
  • dry mouth
  • drowsiness

These are not all the possible side effects of 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 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°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 the safe and effective use of 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.

. 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 1-800-912-9561.

What are the ingredients in Esomeprazole Magnesium Delayed-Release Capsules?

Active ingredient: esomeprazole magnesium USP

Inactive ingredients in Esomeprazole Magnesium Delayed-Release Capsules (including the capsule shells):

20mg: D&C Red 28, ethyl cellulose, FD & C Red 40, gelatin, iron oxide yellow, magnesium oxide (light), magnesium stearate, methacrylic acid co-polymer, mono and diglycerides, polysorbate 80, povidone (K90D), sodium lauryl sulfate, sugar spheres, talc, titanium dioxide and triethyl citrate.

40mg: D&C Red 28, ethyl cellulose, FD & C Red 40, gelatin, magnesium oxide (light), magnesium stearate, methacrylic acid co-polymer, mono and diglycerides, polysorbate 80, povidone (K90D), sodium lauryl sulfate, sugar spheres, talc, titanium dioxide and triethyl citrate.

Capsules have pharmaceutical grade printing ink that contains black iron oxide, potassium hydroxide, povidone, propylene glycol, shellac, sodium hydroxide and titanium dioxide.

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), as prescribed by your doctor. Follow the instructions below:

Esomeprazole magnesium delayed-release capsules may be given through a nasogastric tube (NG tube) or gastric tube,

Esomeprazole magnesium delayed-release capsules:

  • 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.

Trademarks are the property of their respective owners.

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

image

Manufactured by:

TORRENT PHARMACEUTICALS LTD., INDIA.

Manufactured for:

TORRENT PHARMA INC., Levittown, PA 19057.

8087293 Revised: 04/2022

Esomeprazole Magnesium DR 20mg Cap.

Label
(click image for full-size original)
ESOMEPRAZOLE MAGNESIUM esomeprazole magnesium capsule, delayed release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63629-5659(NDC:13668-154)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ESOMEPRAZOLE MAGNESIUM (ESOMEPRAZOLE) ESOMEPRAZOLE 20 mg
Inactive Ingredients
Ingredient Name Strength
ETHYLCELLULOSE, UNSPECIFIED
GELATIN, UNSPECIFIED
GLYCERYL MONOSTEARATE
GLYCERYL STEARATE SE
MAGNESIUM OXIDE
MAGNESIUM STEARATE
METHACRYLIC ACID
POLYSORBATE 80
POTASSIUM HYDROXIDE
POVIDONE, UNSPECIFIED
POVIDONE K90
PROPYLENE GLYCOL
SHELLAC
SODIUM HYDROXIDE
SUCROSE
TALC
TITANIUM DIOXIDE
TRIETHYL CITRATE
Product Characteristics
Color yellow (yellow cap and pink body) Score no score
Shape CAPSULE (hard gelatin capsule) Size 14mm
Flavor Imprint Code 20;1154
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63629-5659-1 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE None
2 NDC:63629-5659-2 10 CAPSULE, DELAYED RELEASE in 1 BOTTLE None
3 NDC:63629-5659-3 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE None
4 NDC:63629-5659-4 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE None
5 NDC:63629-5659-5 42 CAPSULE, DELAYED RELEASE in 1 BOTTLE None
6 NDC:63629-5659-6 120 CAPSULE, DELAYED RELEASE in 1 BOTTLE None
7 NDC:63629-5659-7 180 CAPSULE, DELAYED RELEASE in 1 BOTTLE None
8 NDC:63629-5659-8 20 CAPSULE, DELAYED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203636 10/19/2015
Labeler — Bryant Ranch Prepack (171714327)
Registrant — Bryant Ranch Prepack (171714327)
Establishment
Name Address ID/FEI Operations
Bryant Ranch Prepack 171714327 REPACK (63629-5659), RELABEL (63629-5659)

Revised: 09/2022 Bryant Ranch Prepack

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