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Dexlansoprazole (Oral route)

Pronunciation:

dex-lan-SOE-pra-zole

Brand Names:

  • Dexilant
  • Kapidex

Dosage Forms:

  • Capsule, Delayed Release

Classifications:

Therapeutic—

Gastric Acid Secretion Inhibitor

Pharmacologic—

Proton Pump Inhibitor

Uses of This Medicine:

Dexlansoprazole is used to treat certain conditions in which there is too much acid in the stomach. It is used to treat erosive esophagitis or "heartburn" caused by gastroesophageal reflux disease (GERD), a condition where the acid in the stomach washes back up into the esophagus.

Dexlansoprazole is a proton pump inhibitor (PPI). It works by decreasing the amount of acid produced by the stomach.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of dexlansoprazole in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of dexlansoprazole in the elderly.

Pregnancy—

Pregnancy CategoryExplanation
All TrimestersBAnimal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Atazanavir
  • Bosutinib
  • Dabrafenib
  • Erlotinib
  • Ketoconazole
  • Ledipasvir
  • Methotrexate
  • Mycophenolate Mofetil
  • Nilotinib
  • Pazopanib
  • Saquinavir
  • Vismodegib

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Cranberry
  • Levothyroxine
  • Warfarin

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Diarrhea or
  • Hypomagnesemia (low magnesium in the blood), history of or
  • Osteoporosis (bone problem) or
  • Seizures, history of—Use with caution. May make these conditions worse.
  • Liver disease, moderate—Use with caution. The effects may be increased because of slower removal from the body.

Proper Use of This Medicine:

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

This medicine comes with a Medication Guide. Read and follow the instructions carefully. Ask your doctor if you have any questions.

You may take this medicine with or without food.

Swallow the delayed-release capsule whole. If you cannot swallow the capsule whole, you may open it and pour the medicine into a tablespoon of applesauce. Swallow the mixture right away without chewing. Do not store the mixed medicine for later use.

If this medicine is given through an oral syringe:

  • Open the capsule and pour the medicine into a clean container with 20 milliliters (mL) of water.
  • Use an oral syringe to draw up the water and granule mixture.
  • Swirl the syringe gently to keep the granules from settling.
  • Give the mixture directly into the mouth right away. Do not store the mixed medicine for later use.
  • To rinse any leftover medicine in the syringe, refill the syringe with 10 mL of water, swirl gently and swallow the water. Repeat with an additional 10 mL of water.

If this medicine is given through a feeding tube:

  • Open the capsule and pour the medicine into a clean container with 20 mL of water.
  • Get the mixed medicine into a catheter-tip syringe.
  • Swirl the syringe gently to keep the granules from settling, and inject the medicine into the NG tube right away.
  • Refill the syringe with the 10 mL of water. Swirl it gently, and inject it into the tube to rinse any leftover medicine through the tube. Repeat with an additional 10 mL of water.

Use only the brand of this medicine that your doctor prescribed. Different brands may not work the same way.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For oral dosage form (delayed-release capsules):
    • For erosive esophagitis (EE):
      • Adults—60 milligrams (mg) once a day for up to 8 weeks. To prevent erosive esophagitis from coming back and for relief of heartburn, your doctor may want you to take 30 mg once a day for up to 6 months.
      • Children—Use and dose must be determined by your doctor.
    • For gastroesophageal reflux disease (GERD):
      • Adults—30 milligrams (mg) once a day for 4 weeks.
      • Children—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

It is important that your doctor check your progress at regular visits. This will allow your doctor to see if this medicine is working properly and to decide if you should continue to take it. Blood and other laboratory tests may be needed to check for unwanted effects.

This medicine may cause serious allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Check with your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are using this medicine.

Check with your doctor right away if you have watery stool that does not go away, stomach pain, and fever while taking this medicine.

Dexlansoprazole may increase your risk of having fractures of the hip, wrist, and spine. This is more likely if you are 50 years of age and older, if you receive high doses of this medicine, or use it for one year or more.

This medicine may cause hypomagnesemia (low magnesium in the blood). This is more likely to occur if you are taking this medicine for more than one year, or if you are taking this medicine together with digoxin (Lanoxin®) or certain diuretics (water pills). Check with your doctor right away if you have convulsions (seizures), fast, racing, or uneven heartbeat, muscle spasms (tetany), tremors, or unusual tiredness or weakness.

Do not stop taking this medicine without first checking with your doctor, or unless told to do so by your doctor.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription (eg, atazanavir, Reyataz®) or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common
Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
chest pain or discomfort
chest tightness or heaviness
confusion
continuing stomach pain
diarrhea
difficult or labored breathing
fast, irregular, pounding, or racing heartbeat or pulse
fever
headache
incoherent speech
joint pain, stiffness, or swelling
lightheadedness, dizziness, or fainting
mood changes
muscle pain, cramps, or weakness
nausea or vomiting
numbness or tingling in the hands, feet, or lips
pain or discomfort in the arms, jaw, leg, back, or neck
pounding in the ears
rash or hives
shakiness in the legs, arms, hands, or feet
sweating
swelling of the eyelids, face, lips, hands, or feet
swollen, painful, or tender lymph glands in the neck, armpit, or groin
unusual bleeding or bruising
vomiting of blood or material that looks like coffee grounds
watery or bloody diarrhea
Incidence not known
Drowsiness
muscle spasms (tetany) or twitching
seizures
trembling

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common
Abnormal dreams
burning or itching around the anus
change in taste or bad, unusual, or unpleasant (after) taste
chills
continuing ringing or buzzing or other unexplained noise in the ears
cough
difficult or painful urination
difficulty with moving
ear pain
falls
feeling of constant movement of self or surroundings
loss in sexual ability, desire, drive, or performance
loss of voice
metallic taste
muscle or bone pain
redness of the face, neck, arms, and occasionally, upper chest
sensation of spinning
sunburn
trouble sleeping

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.


Last Updated: 11/4/2014

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