Dexlansoprazole

Healing of Erosive Esophagitis

​Dexlansoprazole delayed-release capsules (Dexlansoprazole capsules) are indicated in adults for healing of all grades of erosive esophagitis (EE) for up to eight weeks.

Maintenance of Healed Erosive Esophagitis

​Dexlansoprazole capsules and Dexlansoprazole SoluTab delayed-release orally disintegrating tablets (Dexlansoprazole SoluTab) are indicated in adults to maintain healing of EE and relief of heartburn for up to six months.

Symptomatic Non-Erosive Gastroesophageal Reflux Disease

​Dexlansoprazole capsules and Dexlansoprazole SoluTab are indicated in adults for the treatment of heartburn associated with symptomatic non-erosive gastroesophageal reflux disease (GERD) for four weeks.

Dexlansoprazole is in a group of drugs called proton pump inhibitors. Dexlansoprazole decreases the amount of acid produced in the stomach.

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.

Recommended Dose

Dexlansoprazole (Dexlansoprazole delayed release capsules) is available as capsules in 30 mg and 60 mg strengths for adult use. Directions for use in each indication are summarized in Table 1.

Table 1: Dexlansoprazole (Dexlansoprazole delayed release capsules) Dosing Recommendations

Special Populations

No adjustment for Dexlansoprazole (Dexlansoprazole delayed release capsules) is necessary for patients with mild hepatic impairment (Child-Pugh Class A). Consider a maximum daily dose of 30 mg for patients with moderate hepatic impairment (Child-Pugh Class B). No studies have been conducted in patients with severe hepatic impairment (Child-Pugh Class C).

No dosage adjustment is necessary for elderly patients or for patients with renal impairment.

Important Administration Information

Dexlansoprazole (Dexlansoprazole delayed release capsules) can be taken without regard to food. Dexlansoprazole (Dexlansoprazole delayed release capsules) should be swallowed whole.

• Alternatively, Dexlansoprazole (Dexlansoprazole delayed release capsules) capsules can be opened and administered as follows:
  • Open capsule;
  • Sprinkle intact granules on one tablespoon of applesauce;
  • Swallow immediately.

How supplied

Dosage Forms And Strengths

• 30 mg capsules are opaque, blue and gray with TAP and “30” imprinted on the capsule.
• 60 mg capsules are opaque, blue with TAP and “60” imprinted on the capsule.

Storage And Handling

Dexlansoprazole (Dexlansoprazole delayed release capsules) delayed release capsules, 30 mg, are opaque, blue and gray with TAP and “30” imprinted on the capsule and supplied as:

Dexlansoprazole (Dexlansoprazole delayed release capsules) delayed release capsules, 60 mg, are opaque, blue with TAP and “60” imprinted on the capsule and supplied as:

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F).

Distributed by : Takeda Pharmaceuticals America, Inc., Deerfield, IL 60015. Rev March 2010

See also:
What is the most important information I should know about Dexlansoprazole?

Heartburn is often confused with the first symptoms of a heart attack. Seek emergency medical attention if you have chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, and a general ill feeling.

You should not take Dexlansoprazole if you are allergic to it.

Before you take Dexlansoprazole, tell your doctor if you have liver disease or low levels of magnesium in your blood.

Take this medication for the full prescribed length of time. Your symptoms may improve before the condition is fully treated.

When treating heartburn, Dexlansoprazole is usually given for 4 weeks. To best heal erosive esophagitis, you may need to take Dexlansoprazole for several months. Follow your doctor's instructions.

Use Dexlansoprazole delayed-release capsules as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Dexlansoprazole delayed-release capsules comes with an extra patient information sheet called a Medication Guide. It also comes with instructions for use. Read them carefully. Read them again each time you get Dexlansoprazole delayed-release capsules refilled.
• Take Dexlansoprazole delayed-release capsules by mouth with or without food.
• Swallow Dexlansoprazole delayed-release capsules whole. Do not break, crush, or chew before swallowing. If you cannot swallow the capsule whole, you may open it and sprinkle the contents over 1 tablespoon (15 mL) of applesauce. Swallow the entire mixture right away. Do not crush or chew the medicine before swallowing. Do not store the mixture for future use. Read the instructions for use for more information.
• You may also open the capsule and sprinkle the contents into 20 mL of water. Use an oral syringe to draw up the mixture. Swirl the mixture and swallow right away. Do not store the mixture for future use. Refill the syringe with water and take to be sure you have taken all the medicine. Follow the instructions for use in the extra patient leaflet.
• If the patient is taking Dexlansoprazole delayed-release capsules through a nasogastric tube, follow the instructions for use in the extra patient leaflet.
• Continue to take Dexlansoprazole delayed-release capsules even if you feel well. Do not miss any doses.
• If you miss a dose of Dexlansoprazole delayed-release capsules, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Dexlansoprazole delayed-release capsules.

Dexlansoprazole is used to treat certain stomach and esophagus problems (such as acid reflux). It works by decreasing the amount of acid your stomach makes. It relieves symptoms such as heartburn, difficulty swallowing, and persistent cough. This medication helps heal acid damage to the stomach and esophagus, helps prevent ulcers, and may help prevent cancer of the esophagus. Dexlansoprazole belongs to a class of drugs known as proton pump inhibitors (PPIs).

OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.

Dexlansoprazole may also be used to treat stomach ulcers.

How to use Dexlansoprazole

Read the Medication Guide and the Patient Information Leaflet if available from your pharmacist before you start taking Dexlansoprazole and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth as directed by your doctor, usually once daily with or without food. If your symptoms usually occur after a meal, your doctor may direct you to take your dose every day before the same meal for best results. Dosage and length of treatment are based on your medical condition and response to treatment.

Do not crush or chew the capsules. Swallow this medication whole. If you have trouble swallowing this medication whole, you may open the capsule and sprinkle the contents onto 1 tablespoon (15 milliliters) of applesauce. Swallow all of the drug/food mixture right away without chewing it. Do not prepare the mixture ahead of time for later use. Doing so may destroy the drug.

If you are giving this drug with a liquid medication measuring device/syringe, or through a tube into the stomach (nasogastric or gastric tube), ask your health care professional for detailed instructions on how to properly mix and give it.

If needed, antacids may be taken along with this medication. If you are also taking sucralfate, take Dexlansoprazole at least 30 minutes before sucralfate.

Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day. Continue to take this medication for the prescribed length of treatment even if you are feeling better.

Tell your doctor if your condition persists or worsens. The risk of side effects goes up over time. Ask your doctor how long you should take this medication.

See also:
What other drugs will affect Dexlansoprazole?

Drugs with pH-Dependent Absorption Pharmacokinetics

Dexlansoprazole (Dexlansoprazole delayed release capsules) causes inhibition of gastric acid secretion. Dexlansoprazole (Dexlansoprazole delayed release capsules) is likely to substantially decrease the systemic concentrations of the HIV protease inhibitor atazanavir, which is dependent upon the presence of gastric acid for absorption, and may result in a loss of therapeutic effect of atazanavir and the development of HIV resistance. Therefore, Dexlansoprazole (Dexlansoprazole delayed release capsules) should not be co-administered with atazanavir.

It is theoretically possible that Dexlansoprazole (Dexlansoprazole delayed release capsules) may interfere with the absorption of other drugs where gastric pH is an important determinant of oral bioavailability (e.g., ampicillin esters, digoxin, iron salts, ketoconazole).

Warfarin

Co-administration of Dexlansoprazole (Dexlansoprazole delayed release capsules) 90 mg and warfarin 25 mg did not affect the pharmacokinetics of warfarin or INR. However, there have been reports of increased INR and prothrombin time in patients receiving PPIs and warfarin concomitantly. Increases in INR and prothrombin time may lead to abnormal bleeding and even death. Patients treated with Dexlansoprazole (Dexlansoprazole delayed release capsules) and warfarin concomitantly may need to be monitored for increases in INR and prothrombin time.

See also:
What are the possible side effects of Dexlansoprazole?

Clinical Trials Experience

The safety of Dexlansoprazole was evaluated in 4548 patients in controlled and uncontrolled clinical studies, including 863 patients treated for at least 6 months and 203 patients treated for one year. Patients ranged in age from 18 to 90 years (median age 48 years), with 54% female, 85% Caucasian, 8% Black, 4% Asian, and 3% other races. Six randomized controlled clinical trials were conducted for the treatment of EE, maintenance of healed EE, and symptomatic GERD, which included 896 patients on placebo, 455 patients on Dexlansoprazole 30 mg, 2218 patients on Dexlansoprazole 60 mg, and 1363 patients on lansoprazole 30 mg once daily.

As clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Most Commonly Reported Adverse Reactions

The most common adverse reactions (≥2%) that occurred at a higher incidence for Dexlansoprazole than placebo in the controlled studies are presented in Table 2.

Adverse Reactions Resulting in Discontinuation

In controlled clinical studies, the most common adverse reaction leading to discontinuation from Dexlansoprazole therapy was diarrhea (0.7%).

Other Adverse Reactions

Other adverse reactions that were reported in controlled studies at an incidence of less than 2% are listed below by body system:

Blood and Lymphatic System Disorders: anemia, lymphadenopathy

Cardiac Disorders: angina, arrhythmia, bradycardia, chest pain, edema, myocardial infarction, palpitation, tachycardia

Ear and Labyrinth Disorders: ear pain, tinnitus, vertigo

Endocrine Disorders: goiter

Eye Disorders: eye irritation, eye swelling

Gastrointestinal Disorders: abdominal discomfort, abdominal tenderness, abnormal feces, anal discomfort, Barrett's esophagus, bezoar, bowel sounds abnormal, breath odor, colitis microscopic, colonic polyp, constipation, dry mouth, duodenitis, dyspepsia, dysphagia, enteritis, eructation, esophagitis, gastric polyp, gastritis, gastroenteritis, gastrointestinal disorders, gastrointestinal hypermotility disorders, GERD, GI ulcers and perforation, hematemesis, hematochezia, hemorrhoids, impaired gastric emptying, irritable bowel syndrome, mucus stools, nausea and vomiting, oral mucosal blistering, painful defecation, proctitis, paresthesia oral, rectal hemorrhage

General Disorders and Administration Site Conditions: adverse drug reaction, asthenia, chest pain, chills, feeling abnormal, inflammation, mucosal inflammation, nodule, pain, pyrexia

Hepatobiliary Disorders: biliary colic, cholelithiasis, hepatomegaly

Immune System Disorders: hypersensitivity

Infections and Infestations: candida infections, influenza, nasopharyngitis, oral herpes, pharyngitis, sinusitis, viral infection, vulvo-vaginal infection

Injury, Poisoning and Procedural Complications: falls, fractures, joint sprains, overdose, procedural pain, sunburn

Laboratory Investigations: ALP increased, ALT increased, AST increased, bilirubin decreased/increased, blood creatinine increased, blood gastrin increased, blood glucose increased, blood potassium increased, liver function test abnormal, platelet count decreased, total protein increased, weight increase

Metabolism and Nutrition Disorders: appetite changes, hypercalcemia, hypokalemia

Musculoskeletal and Connective Tissue Disorders: arthralgia, arthritis, muscle cramps, musculoskeletal pain, myalgia

Nervous System Disorders: altered taste, convulsion, dizziness, headaches, migraine, memory impairment, paresthesia, psychomotor hyperactivity, tremor, trigeminal neuralgia

Psychiatric Disorders: abnormal dreams, anxiety, depression, insomnia, libido changes

Renal and Urinary Disorders: dysuria, micturition urgency

Reproductive System and Breast Disorders: dysmenorrhea, dyspareunia, menorrhagia, menstrual disorder

Respiratory, Thoracic and Mediastinal Disorders: aspiration, asthma, bronchitis, cough, dyspnoea, hiccups, hyperventilation, respiratory tract congestion, sore throat

Skin and Subcutaneous Tissue Disorders: acne, dermatitis, erythema, pruritis, rash, skin lesion, urticaria

Vascular Disorders: deep vein thrombosis, hot flush, hypertension

Additional adverse reactions that were reported in a long-term uncontrolled study and were considered related to Dexlansoprazole by the treating physician included: anaphylaxis, auditory hallucination, B-cell lymphoma, bursitis, central obesity, cholecystitis acute, decreased hemoglobin, dehydration, diabetes mellitus, dysphonia, epistaxis, folliculitis, gastrointestinal pain, gout, herpes zoster, hyperglycemia, hyperlipidemia, hypothyroidism, increased neutrophils, MCHC decrease, neutropenia, oral soft tissue disorder, polydipsia, polyuria, rectal tenesmus, restless legs syndrome, somnolence, thrombocythemia, tonsillitis.

Other adverse reactions not observed with Dexlansoprazole, but occurring with the racemate lansoprazole can be found in the lansoprazole package insert, ADVERSE REACTIONS section.

Dexlansoprazole, a proton-pump inhibitor (PPI), is (+)-2-[(R)-{[3-methyl-4-(2,2,2-trifluoroethoxy)pyridin-2-yl]methyl}sulfinyl]-1H-benzimidazole, a compound that inhibits gastric acid secretion. Dexlansoprazole is the R-enantiomer of lansoprazole (a racemic mixture of the R- and S-enantiomers).