Dexilant: Uses, Side Effects and Dosage

What is DEXILANT used for?

DEXILANT is used in people 12 years of age and older to:

• help heal the throat:

  • damaged by acid backing up from the stomach to the throat (erosive reflux esophagitis).
  • help maintain the healed throat.

• relieve symptoms of non-erosive gastroesophageal reflux disease (GERD) such as:

  • heartburn during the day and night.
  • the burning, burping and sour taste.

How does DEXILANT work?

DEXILANT is a medicine called a proton pump inhibitor (PPI). PPIs reduce the amount of acid your stomach makes.

DEXILANT capsules contain two different types of granules, tiny dissolving beads that release medicine. The first granule begins releasing medicine within 1 hour. The rest of the medicine is released 4-5 hours later, so the medicine continues to work later in the day.

What are the ingredients in DEXILANT?

Medicinal ingredients: dexlansoprazole.

Non-medicinal ingredients:

Capsule granules: colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose 2910, low-substituted hydroxypropyl cellulose, magnesium carbonate, methacrylic acid copolymer, polyethylene glycol 8000, polysorbate 80, sucrose, sugar spheres, talc, titanium dioxide, and triethyl citrate.

Capsule shell: carrageenan, hypromellose, and potassium chloride.

Capsule shell color: blue contains FD&C Blue No.2 aluminum lake; gray contains black ferric oxide; and both contain titanium dioxide.

DEXILANT comes in the following dosage forms:

• Capsules, 30 mg or 60 mg.

Do not use DEXILANT if:

• you are allergic to DEXILANT or any of its ingredients. (See What are the ingredients in DEXILANT?).
• you are currently taking a medication called rilpivirine.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take DEXILANT. Talk about any health conditions or problems you may have, including if you:

• are taking other medications. (See The following may interact with DEXILANT).
• have liver problems.

• are pregnant or planning to become pregnant.

• are breastfeeding or planning to breastfeed.

• have signs of low magnesium in the body (hypomagnesemia) with symptoms such as:

  • rapid or irregular heartbeat (palpitations).
  • brain symptoms such as dizziness, seizures.
  • muscle symptoms such as twitching, cramps, spasms (tetany).
• are due to have a specific blood test (Chromogranin A).

Other warnings you should know about:

Tell your doctor if you experience the following symptoms before taking DEXILANT:

• unexplained weight loss.
• severe or persistent diarrhea.
• repeated vomiting.
• vomiting blood.
• dark stools.
• tiredness (anemia).
• difficulty in swallowing.

DEXILANT may help your acid-related symptoms. However, you could still have serious stomach problems. Talk to your doctor if your symptoms continue.

You should take DEXILANT exactly as prescribed. You will use the lowest dose and shortest time suitable for your condition. Talk to your doctor if you have any concerns about your treatment.

Depending on your condition, your doctor may tell you to use this type of medicine (proton pump inhibitors) for a longer period.

Using proton pump inhibitors for a long time (every day for a year or longer) may increase risks of broken bones of the hip, wrist or spine. Talk to your doctor about this risk.

Long term use of proton pump inhibitors may interfere with the absorption of Vitamin B12 from the diet. This may cause a shortage of Vitamin B12 in your body. Talk to your doctor.

Using DEXILANT for a long period of time may cause a growth in your stomach (polyp), especially after one year.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

The following may interact with DEXILANT:

How to take DEXILANT:

• Do not crush or chew capsules or granules.

• Take DEXILANT at any time of day, with or without food. By either:

  • Swallowing capsule whole, with water.
  • Or, if you have trouble swallowing capsules, the capsules can be opened and taken with applesauce or water, as follows:

Applesauce:

DEXILANT capsules can be opened and the contents sprinkled on a tablespoon of applesauce. Swallow immediately. Granules should not be chewed.

Water with an Oral Syringe:

1. 1. Open the capsule and empty the granules into a clean container with 20 mL of water.
2. 2. Draw up the water and granules mixture into an oral syringe.
3. 3. Swirl the syringe gently, and give the mixture into the mouth right away. Do not save the water and granule mixture for later use.
4. 4. Refill the syringe with 10 mL of water, and swirl gently. Give the water into the mouth.
5. 5. Repeat step 4.

Water through a Nasogastric Tube: If you have a nasogastric tube (size 16 French or larger)

1. 1. Open the capsule and empty the granules into a clean container with 20 mL of water.
2. 2. Draw up the water and granules mixture into a catheter-tip syringe.
3. 3. Swirl the syringe gently and connect the syringe to the nasogastric tube. Right away, give the mixture through the nasogastric tube into the stomach. Do not save the water and granule mixture for later use.
4. 4. Refill the syringe with 10 mL of water, swirl gently, and flush the nasogastric tube with water.
5. 5. Repeat step 4.

Usual dose:

The recommended dose is not the same for all conditions. Your doctor will have told you what dose to take for your condition. Follow your doctor’s directions carefully.

Overdose:

Missed Dose:

If you miss a dose, take it as soon as you remember. If it is almost time for the next dose, skip the missed dose. Take the next dose at your regular time. Do not double doses.

What are possible side effects from using DEXILANT?

Like all medications, DEXILANT can cause side effects. Serious side effects are uncommon. These are not all the possible side effects you may feel when taking DEXILANT. If you experience any side effects not listed here, tell your healthcare professional.

The most common side effects are:

• constipation.
• diarrhea.
• gas.
• headache.
• nausea.
• stomach pain.

Tell your doctor right away if you have any of these symptoms:

• New or worsening joint pain.
• Rash on your cheeks or arms that gets worse in the sun.

Your symptoms may get worse after stopping your medication. This may occur as your stomach may increase the production of acid.

Serious side effects and what to do about them

Serious side effects and what to do about them

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.

Reporting Side Effects

Storage:

Store DEXILANT at room temperature, 15°- 30°C.

Keep out of reach and sight of children.

If you want more information about DEXILANT:

• Talk to your healthcare professional

• Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website: https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html; the manufacturer’s website www.takeda.com/en-ca, or by calling

  1-800-268-2772.

Takeda Canada Inc.

22 Adelaide Street West, Suite 3800

Toronto, Ontario M5H 4E3

DEXILANT® and the DEXILANT Logo® are registered trademarks of Takeda Pharmaceuticals U.S.A., Inc. TAKEDA® and the TAKEDA Logo® are registered trademarks of Takeda Pharmaceutical Company Limited, used under license.

Last Revised: 30 March 2023