Dexilant dexlansoprazole
Refer to the “Also Known As” section to reference different products that include the same medication as Dexilant.
Drug Basics
Brand Name: Dexilant
Generic Name: DEXLANSOPRAZOLE
Drug Type: HUMAN PRESCRIPTION DRUG
Route: ORAL
Dosage Form: CAPSULE, DELAYED RELEASE
Data Current As Of: 2019-11-18
| Warnings and Precautions | |
| Fundic Gland Polyps (5.10) | 06/2018 |
indications & usage
healing of erosive esophagitis
DEXILANT is indicated in patients 12 years of age and older for healing of all grades of erosive esophagitis (EE) for up to eight weeks.
maintenance of healed erosive esophagitis & relief of heartburn
DEXILANT is indicated in patients 12 years of age and older to maintain healing of EE and relief of heartburn for up to six months in adults and 16 weeks in patients 12 to 17 years of age.
treatment of symptomatic non-erosive gastroesophageal reflux disease
DEXILANT is indicated in patients 12 years of age and older for the treatment of heartburn associated with symptomatic non-erosive gastroesophageal reflux disease (GERD) for four weeks.
patient counseling information
Advise the patient to read the FDA-approved patient labeling (Medication Guide and Instructions for Use).
Adverse Reactions
Advise patients to report to their healthcare provider if they experience any signs or symptoms consistent with:
- Hypersensitivity Reactions [see Contraindications (4)]
- Acute Interstitial Nephritis [see Warnings and Precautions (5.2)]
- Clostridium difficile-Associated Diarrhea [see Warnings and Precautions (5.3)]
- Bone Fracture [see Warnings and Precautions (5.4)]
- Cutaneous and Systemic Lupus Erythematosus [see Warnings and Precautions (5.5)]
- Cyanocobalamin (Vitamin B12) Deficiency [see Warnings and Precautions (5.6)]
- Hypomagnesemia [see Warnings and Precautions (5.7)]
Drug Interactions
Advise patients to report to their healthcare provider if they are taking rilpivirine-containing products [see Contraindications (4)] or high-dose methotrexate [see Warnings and Precautions (5.9)].
Pregnancy
Advise a pregnant woman of the potential risk to a fetus. Advise females of reproductive potential to inform their healthcare provider of a known or suspected pregnancy [see Use in Specific Populations (8.1)].
Administration
- Take without regard to food.
- Missed doses: If a dose is missed, administer as soon as possible. However, if the next scheduled dose is due, do not take the missed dose, and take the next dose on time. Do not take two doses at one time to make up for a missed dose.
- Swallow whole; do not chew.
- Can be opened and sprinkled on applesauce for patients who have trouble swallowing the capsule.
- Alternatively, the capsule can be administered with water via oral syringe or NG tube, as described in the Instructions for Use.
| MEDICATION GUIDE DEXILANT (decks-i-launt) |
|---|
| Read this Medication Guide before you start taking DEXILANT and each time you get a refill. There may be new information. This information does not take the place of talking to your doctor about your medical condition or your treatment. |
| What is the most important information that I should know about DEXILANT? DEXILANT may help your acid-related symptoms, but you could still have serious stomach problems. Talk with your doctor. DEXILANT can cause serious side effects, including:
DEXILANT can have other serious side effects. See "What are the possible side effects of DEXILANT?" |
| What is DEXILANT? DEXILANT is a prescription medicine called a proton pump inhibitor (PPI). DEXILANT reduces the amount of acid in your stomach. DEXILANT is used in people 12 years of age and older:
GERD happens when acid from your stomach enters 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. It is not known if DEXILANT is safe and effective in children under 12 years of age. DEXILANT is not effective for symptoms of GERD in children under 1 year of age. |
| Who should not take DEXILANT? Do not take DEXILANT if you:
|
| What should I tell my doctor before taking DEXILANT? Before you take DEXILANT, tell your doctor if you:
Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. DEXILANT may affect how other medicines work, and other medicines may affect how DEXILANT works. Especially tell your doctor if you take methotrexate (Otrexup, Rasuvo, Trexall). Know the medicines that you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine. |
| How should I take DEXILANT?
|
| What are the possible side effects of DEXILANT? DEXILANT may cause serious side effects, including:
Your doctor may check the level of magnesium in your body before you start taking DEXILANT, or during treatment, if you will be taking DEXILANT for a long period of time.
The most common side effects of DEXILANT in adults include:
The most common side effects of DEXILANT in children 12 to 17 years of age include:
Other side effects: Serious allergic reactions. Tell your doctor if you get any of the following symptoms with DEXILANT:
Your doctor may stop DEXILANT if these symptoms happen. Tell your doctor if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of DEXILANT. For more information, ask your doctor or pharmacist. 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 DEXILANT?
Keep DEXILANT and all medicines out of the reach of children. |
| General information about the safe and effective use of DEXILANT Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use DEXILANT for a condition for which it was not prescribed. Do not give DEXILANT 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 DEXILANT. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about DEXILANT that is written for health professionals. For more information, go to www.DEXILANT.com or call 1-877-825-3327. |
| What are the ingredients in DEXILANT? Active ingredient: dexlansoprazole. Inactive ingredients: sugar spheres, magnesium carbonate, sucrose, low-substituted hydroxypropyl cellulose, titanium dioxide, hydroxypropyl cellulose, hypromellose 2910, talc, methacrylic acid copolymers, polyethylene glycol 8000, triethyl citrate, polysorbate 80, and colloidal silicon dioxide. The capsule shell is made of hypromellose, carrageenan and potassium chloride. Based on the capsule shell color, blue contains FD&C Blue No. 2 aluminum lake; gray contains black ferric oxide; and both contain titanium dioxide. |
instructions for use
DEXILANT (decks-i-launt)
(dexlansoprazole)
delayed-release capsules, for oral use
Taking DEXILANT with applesauce:
- 1.Place 1 tablespoon of applesauce into a clean container.
- 2.Carefully open the capsule and sprinkle the granules onto the applesauce.
- 3.Swallow the applesauce and granules right away. Do not chew the granules. Do not save the applesauce and granules for later use.
Giving DEXILANT with water using an oral syringe:
- 1.Place 20 mL of water into a clean container.
- 2.Carefully open the capsule and empty the granules into the container of water.
- 3.Use an oral syringe to draw up the water and granule mixture.
- 4.Gently swirl the oral syringe to keep the granules from settling.
- 5.Place the tip of the oral syringe in your mouth. Give the medicine right away. Do not save the water and granule mixture for later use.
- 6.Refill the syringe with 10 mL of water and swirl gently. Place the tip of the oral syringe in your mouth and give the medicine that is left in the syringe.
- 7.Repeat step 6.
Giving DEXILANT with water through a nasogastric tube (NG tube):
For people who have an NG tube that is size 16 French or larger, DEXILANT may be given as follows:
- 1.Place 20 mL of water into a clean container.
- 2.Carefully open the capsule and empty the granules into the container of water.
- 3.Use a 60 mL catheter-tip syringe to draw up the water and granule mixture.
- 4.Gently swirl the catheter-tip syringe to keep the granules from settling.
- 5.Connect the catheter-tip syringe to the NG tube.
- 6.Give the mixture right away through the NG tube that goes into the stomach. Do not save the water and granule mixture for later use.
- 7.Refill the catheter-tip syringe with 10 mL of water and swirl gently. Flush the NG tube with the water.
- 8.Repeat step 7.
How should I store DEXILANT?
- Store DEXILANT at room temperature between 68°F to 77°F (20°C to 25°C).
Keep DEXILANT and all medicines out of the reach of children.
This Medication Guide and Instructions for Use have been approved by the U.S. Food and Drug Administration.
Distributed by:
Takeda Pharmaceuticals America, Inc.
Deerfield, IL 60015
Distributed by:
Cardinal Health
Dublin, OH 43017
L71681019A
Revised: June 2018
DEXILANT is a trademark of Takeda Pharmaceuticals U.S.A., Inc. registered with the U.S. Patent and Trademark Office.
All other trademark names are the property of their respective owners.
©2009 – 2018 Takeda Pharmaceuticals America, Inc.
DEX006 R30
package / label display panel
Dexilant (dexlansoprazole) delayed release capsules
60 mg
Contains Approximately 1800 Capsules
