Kapidex

Dexlansoprazole is a prescription medication used to treat acid-related damage to the lining of the esophagus (erosive esophagitis, or EE) and heartburn related to gastroesophageal reflux disease (GERD) in adults. Dexlansoprazole belongs to a group of drugs called proton pump inhibitors (PPI), which reduce the amount of acid in the stomach.

This medication comes in capsule form and is taken once a day, with or without food.

Common side effects of dexlansoprazole include diarrhea, stomach pain, and nausea.

Dexlansoprazole may cause serious side effects, including:

• See “Drug Precautions”
• Low magnesium levels in your body. This problem can be serious. Low magnesium can happen in some people who take a proton pump inhibitor medicine for at least 3 months. If low magnesium levels happen, it is usually after a year of treatment. You may or may not have symptoms of low magnesium.

Tell your doctor right away if you develop any of these symptoms:

• seizures
• dizziness
• abnormal or fast heartbeat
• jitteriness
• jerking movements or shaking (tremors)
• muscle weakness
• spasms of the hands and feet
• cramps or muscle aches
• spasm of the voice box

Your doctor may check the level of magnesium in your body before you start taking dexlansoprazole, or during treatment, if you will be taking dexlansoprazole for a long period of time.

The most common side effects of dexlansoprazole include:

• diarrhea
• stomach pain
• nausea
• common cold
• vomiting
• gas

Serious allergic reactions may occur. Tell your doctor if you get any of the following symptoms with dexlansoprazole:

• rash
• face swelling
• throat tightness
• difficulty breathing

Your doctor may stop dexlansoprazole 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 dexlansoprazole. 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.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Dexlansoprazole may affect how other medicines work, and other medicines may affect how dexlansoprazole works.

Especially tell your doctor if you take:

• an antibiotic that contains ampicillin
• atazanavir (Reyataz)
• digoxin (Lanoxin)
• a product that contains iron
• ketoconazole (Nizoral)
• warfarin (Coumadin, Jantoven)
• tacrolimus (Prograf)
• methotrexate
• erlotinib
• medications that contain iron including Feosol, Ferra-TD, Fer-in-Sol, and ferrous sulfate

Ask your doctor or pharmacist for a list of these medicines, if you are not sure.

Know the medicines that you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.

Tell your doctor if you are breastfeeding or planning to breastfeed. It is not known if dexlansoprazole passes into your breast milk. You and your doctor should decide if you will take dexlansoprazole or breastfeed. You should not do both. Talk to your doctor about the best way to feed your baby if you take dexlansoprazole.

This section provides information on the proper use of a number of products that contain dexlansoprazole. It may not be specific to Kapidex. Please read with care.

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.

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 medicine 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.

If you are using the oral delayed-release disintegrating tablet:

• Take this medicine at least 30 minutes before a meal.
• Do not break or cut the tablet.
• Place the tablet on the tongue, allow to dissolve, and swallow it without water. Do not chew the microgranules. Or, you may swallow the tablet whole with water.
• Avoid drinking alcohol while taking this medicine.
• If Dexilant Solutab™ is given through an oral syringe: Place one tablet in an oral syringe and draw up 20 milliliters (mL) of water. 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 Solutab™ is given through a feeding tube: Place one tablet in a catheter-tip syringe and draw up 20 milliliters (mL) of water. Shake 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. Shake 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.
  • 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.
• For oral dosage form (oral disintegrating tablets):
  • For maintenance treatment of erosive esophagitis (EE):
    • Adults and children 12 years of age and older—30 milligrams (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.
  • 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.

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.

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, 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®).

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 a fever, joint pain, skin rash, swelling of the body, feet, or ankles, or unusual weight gain after taking this medicine. These could be symptoms of acute interstitial 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.

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.

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 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.

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

Before you have any medical tests, tell the medical doctor in charge that you are taking this medicine. The results of some tests may be affected by this medicine.

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 (eg, St. John's wort) or vitamin supplements.

Clinical Trials Experience

The safety of Kapidex 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 Kapidex 30 mg, 2218 patients on Kapidex 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 Kapidex 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 Kapidex 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 Kapidex 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 Kapidex, but occurring with the racemate lansoprazole can be found in the lansoprazole package insert, ADVERSE REACTIONS section.

The active ingredient in Kapidex (dexlansoprazole) delayed release capsules 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). Its empirical formula is: C16H14F3N3O2S, with a molecular weight of 369.36. The structural formula is:

Dexlansoprazole is a white to nearly white crystalline powder which melts with decomposition at 140°C. Dexlansoprazole is freely soluble in dimethylformamide, methanol, dichloromethane, ethanol, and ethyl acetate; and soluble in acetonitrile; slightly soluble in ether; and very slightly soluble in water; and practically insoluble in hexane.

Dexlansoprazole is stable when exposed to light. Dexlansoprazole is more stable in neutral and alkaline conditions than acidic conditions.

Kapidex is supplied as a dual delayed release formulation in capsules for oral administration. The capsules contain dexlansoprazole in a mixture of two types of enteric-coated granules with different pH-dependent dissolution profiles [see Clinical Pharmacology (12.3)].

Kapidex is available in two dosage strengths: 30 mg and 60 mg, per capsule. Each capsule contains enteric-coated granules consisting of dexlansoprazole (active ingredient) and the following 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 components of the capsule shell include the following inactive ingredients: hypromellose, carrageenan and potassium chloride. Based on the capsule shell color, blue contains FD&C Blue No. 2 and aluminum lake; gray contains ferric oxide and aluminum lake; and both contain titanium dioxide.

You should not use Kapidex if you are allergic to dexlansoprazole. Before taking Kapidex, tell your doctor if you are allergic to any drugs, or if you have liver disease. You may need a dose adjustment or special tests to safely take Kapidex.

FDA pregnancy category B. Kapidex is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether dexlansoprazole passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take extra medicine to make up the missed dose.