Dexlansoprazole is used to treat heartburn caused by gastroesophageal reflux disease (GERD), and to heal erosive esophagitis (damage to the esophagus from stomach acid).

Dexlansoprazole may also be used for purposes not listed in this medication guide.

Dexlansoprazole can cause kidney problems. Tell your doctor if you are urinating less than usual, or if you have blood in your urine.

Diarrhea may be a sign of a new infection. Call your doctor if you have diarrhea that is watery or has blood in it.

Dexlansoprazole may cause new or worsening symptoms of lupus. Tell your doctor if you have joint pain and a skin rash on your cheeks or arms that worsens in sunlight.

You may be more likely to have a broken bone while taking dexlansoprazole long term or more than once per day.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Take dexlansoprazole with a full glass of water.

Dexlansoprazole may be taken with or without food.

Swallow the capsule whole and do not crush, chew, break, or open it.

If you cannot swallow a capsule whole, open it and sprinkle the medicine into a spoonful of applesauce. Swallow the mixture right away without chewing. Do not save it for later use.

To heal erosive esophagitis and relieve heartburn, dexlansoprazole is usually given for up to 6 months in adults, and for 4 to 16 weeks in children ages 12 through 17. Follow your doctor's dosing instructions very carefully.

Use this medicine for the full prescribed length of time, even if your symptoms quickly improve.

Call your doctor if your symptoms do not improve, or if they get worse while using dexlansoprazole.

This medicine can affect the results of certain medical tests. Tell any doctor who treats you that you are using dexlansoprazole.

Dexlansoprazole may also affect a drug-screening urine test and you may have false results. Tell the laboratory staff that you use dexlansoprazole.

Store at room temperature away from moisture and heat.

Usual Adult Dose for Erosive Esophagitis:

Healing of Erosive Esophagitis (EE): 60 mg orally once a day
-Duration of therapy: Up to 8 weeks

Maintenance dose: 30 mg orally once a day
-Duration of therapy: Up to 6 months

Comments:
-Patients may be given maintenance doses for the relief of heartburn.
-Controlled studies for maintenance therapy did not extend beyond 6 months.

Uses:
-Healing of all grades of EE
-Maintenance of healed EE
-Relief of heartburn

Usual Adult Dose for Gastroesophageal Reflux Disease:

30 mg orally once a day
-Duration of therapy: 4 weeks

Use: Treatment of heartburn associated with symptomatic non-erosive gastroesophageal reflux disease (GERD)

Usual Pediatric Dose for Erosive Esophagitis:

12 years and older:
Healing of EE: 60 mg orally once a day
-Duration of therapy: Up to 8 weeks

Maintenance dose: 30 mg orally once a day
-Duration of therapy: Up to 6 months

Comments:
-Patients may be given maintenance doses for the relief of heartburn.
-Controlled studies of maintenance therapy did not extend beyond 16 weeks.

Uses:
-Healing of all grades of EE
-Maintenance of healed EE
-Relief of heartburn

Usual Pediatric Dose for Gastroesophageal Reflux Disease:

12 years and older: 30 mg orally once a day
-Duration of therapy: 4 weeks

Use: Treatment of heartburn associated with symptomatic non-erosive GERD

Heartburn can mimic early symptoms of a heart attack. Get emergency medical help if you have chest pain that spreads to your jaw or shoulder and you feel anxious or light-headed.

You should not take this medicine if you are allergic to dexlansoprazole, or if:

• you had breathing problems, kidney problems, or a severe allergic reaction after taking this medicine in the past; or

• you also take a medicine that contains rilpivirine (Complera, Edurant, Odefsey).

Tell your doctor if you have ever had:

• severe liver disease;

• osteoporosis;

• low bone mineral density (osteopenia); or

• low levels of magnesium in your blood.

You may be more likely to have a broken bone in your hip, wrist, or spine while taking a proton pump inhibitor long-term or more than once per day. Talk with your doctor about ways to keep your bones healthy.

Dexlansoprazole may harm an unborn baby. Use effective birth control to prevent pregnancy, and tell your doctor if you become pregnant.

It may not be safe to breastfeed while using this medicine. Ask your doctor about any risk.

Dexlansoprazole is not approved for use by anyone younger than 12 years old.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

Unless your doctor tells you otherwise, continue your normal diet.

dexlansoprazole can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or bloody, call your doctor. Do not use anti-diarrhea medicine unless your doctor tells you to.

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Dexlansoprazole may cause serious side effects. Call your doctor at once if you have:

• severe stomach pain, diarrhea that is watery or bloody;

• a seizure (convulsions);

• sudden pain or trouble moving your hip, wrist, or back;

• kidney problems-- fever, rash, nausea, loss of appetite, joint pain, urinating less than usual, blood in your urine, weight gain;

• low magnesium--dizziness, fast or irregular heart rate, tremors (shaking) or jerking muscle movements, feeling jittery, muscle cramps, muscle spasms in your hands and feet, cough or choking feeling; or

• new or worsening symptoms of lupus--joint pain, and a skin rash on your cheeks or arms that worsens in sunlight.

Taking dexlansoprazole long-term may cause you to develop stomach growths called fundic gland polyps. Talk with your doctor about this risk.

If you use dexlansoprazole for longer than 3 years, you could develop a vitamin B-12 deficiency. Talk to your doctor about how to manage this condition if you develop it.

Common side effects of dexlansoprazole may include:

• nausea, vomiting, stomach pain, gas;

• diarrhea;

• headache;

• mouth pain, sore throat; or

• stuffy nose, sinus pain, or other cold symptoms.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tell your doctor about all your current medicines. Many drugs can affect dexlansoprazole, especially:

• methotrexate;

• rifampin;

• St. John's wort; or

• warfarin (Coumadin, Jantoven).

This list is not complete and many other drugs may affect dexlansoprazole. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Keep all appointments with your doctor and the laboratory. Your doctor may order certain laboratory tests before and during your treatment.

Before having any laboratory test, tell your doctor and the laboratory personnel that you are taking dexlansoprazole.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.