Dexilant SoluTab

Generic name: Dexlansoprazole
Drug class: Proton pump inhibitors

Usage of Dexilant SoluTab

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.

On October 17, 2017, Dexilant Solutab® (delayed-release disintegrating tablets) was withdrawn from the US market. Dexilant® and Kapidex® (delayed-release capsules) are still available.

Dexilant SoluTab side effects

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, discomfort, 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

muscle pain, cramps, or weakness

nausea

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, 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

vomiting of blood or material that looks like coffee grounds

watery or bloody diarrhea

Incidence not known

Black, tarry stools

blistering, peeling, or loosening of the skin

blood in the urine

bloody nose

bone fracture

chills

confusion

cough

decreased urine output

drowsiness

dry mouth

heavier menstrual periods

increased thirst

itching

joint or muscle pain

loss of appetite

mood or mental changes

muscle cramps in the hands, arms, feet, legs, or face

muscle spasms (tetany) or twitching

numbness and tingling around the mouth, fingertips, or feet

painful or difficult urination

pinpoint red spots on the skin

red skin lesions, often with a purple center

red, irritated eyes

seizures

sore throat

sores, ulcers, or white spots in the mouth or on the lips

stomach cramps

swelling of the body, feet, or ankles

swollen glands

trembling

trouble speaking, thinking or walking

unusual tiredness or weakness

unusual weight gain

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

body aches or pain

bloated or full feeling

burning or itching around the anus

change in taste or bad, unusual, or unpleasant (after) taste

continuing ringing or buzzing or other unexplained noise in the ears

difficult or painful urination

difficulty with moving

ear congestion

ear pain

excess air or gas in the stomach or bowels

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

passing gas

redness of the face, neck, arms, and occasionally, upper chest

runny or stuffy nose

sensation of spinning

sneezing

sunburn

trouble sleeping

Incidence not known

Blurred vision

decreased interest in sexual intercourse

inability to have or keep an erection

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.

Before taking Dexilant SoluTab

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.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of dexlansoprazole in children younger than 12 years of age. Safety and efficacy have not been established. Dexilant is not recommended in children younger than 2 years of age and may increase the risk for heart problems (eg, heart valve thickening).

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of dexlansoprazole in the elderly. However, elderly patients are more sensitive to the effects of this medicine than younger adults.

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.

Interactions with 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 not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Rilpivirine

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.

Acalabrutinib

Amphetamine

Atazanavir

Atezolizumab

Cefuroxime Axetil

Dacomitinib

Dasatinib

Dextroamphetamine

Erlotinib

Fedratinib

Fluconazole

Gefitinib

Infigratinib

Ketoconazole

Ledipasvir

Levoketoconazole

Lisdexamfetamine

Mavacamten

Methamphetamine

Methotrexate

Methylphenidate

Mycophenolate Mofetil

Nelfinavir

Neratinib

Nilotinib

Octreotide

Palbociclib

Pazopanib

Pexidartinib

Saquinavir

Secretin Human

Selpercatinib

Sotorasib

Sparsentan

Sunitinib

Tocilizumab

Velpatasvir

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.

Levothyroxine

Warfarin

Interactions with Food/Tobacco/Alcohol

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. 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 may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

Cranberry

Relate drugs

How to use Dexilant SoluTab

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 and patient instructions. Read and follow the instructions carefully. Ask your doctor if you have any questions.

If you are taking the delayed-release capsule:

You may take this medicine with or without food.

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

If Dexilant® 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 Dexilant® 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 treatment of erosive esophagitis (EE):

Adults and children 12 years of age and older—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 younger than 12 years of age—Use and dose must be determined by your doctor.

Children younger than 2 years of age—Use of Dexilant is not recommended.

For treatment of gastroesophageal reflux disease (GERD):

Adults and children 12 years of age and older—30 milligrams (mg) once a day for 4 weeks.

Children younger than 12 years of age—Use and dose must be determined by your doctor.

Children younger than 2 years of age—Use of Dexilant is not recommended.

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.

Warnings

It is important that your doctor check your or your child's 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, urine, and other laboratory tests may be needed to check for unwanted effects.

Do not take this medicine if you are also using products that contain rilpivirine (Complera®, Edurant®). Using these medicines together may cause unwanted side effects.

This medicine may cause serious allergic reactions, including anaphylaxis, which 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 or your child has a change in frequency of urination or amount of urine, blood in the urine, fever, joint pain, loss of appetite, skin rash, swelling of the body, feet, or ankles, unusual tiredness or weakness, or unusual weight gain after receiving this medicine. These could be symptoms of a serious kidney problem called acute tubulointerstitial nephritis.

Taking this medicine for a long time may make it harder for your body to absorb vitamin B12. Tell your doctor if you have concerns about vitamin B12 deficiency.

Serious stomach conditions may occur while taking this medicine. Check with your doctor immediately if you or your child has stomach cramps, bloated feeling, watery and severe diarrhea which may also be bloody sometimes, fever, nausea or vomiting, or unusual tiredness or weakness.

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. Call your doctor right away if you have severe bone pain or are unable to walk or sit normally.

Cutaneous or systemic lupus erythematosus may occur or get worse in patients receiving a PPI. Call your doctor right away if you have joint pain or a skin rash on your cheeks or arms that gets worse when exposed to the sun.

This medicine may cause serious skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, acute generalized exanthematous pustulosis, and drug reaction with eosinophilia and systemic symptoms (DRESS). Check with your doctor right away if you have black, tarry stools, blistering, peeling, or loosening of the skin, chest pain, chills, cough, diarrhea, itching, joint or muscle pain, painful or difficult urination, red irritated eyes, red skin lesions, often with a purple center, sore throat, sores, ulcers, or white spots in the mouth or on the lips, swollen glands, unusual bleeding or bruising, or unusual tiredness or weakness.

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 1 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.

This medicine may increase your risk for fundic gland polyps (abnormal tissue growth in the upper part of your stomach). This is more likely if you are receiving this medicine for more than 1 year. Talk to your doctor if you have concerns.

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

Make sure any doctor or dentist who treats you knows that you are using this medicine. You may need to stop using this medicine several days before you have medical tests.

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

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