Dexilant

The pharmacokinetics of dexlansoprazole are highly variable, with percent coefficient of variation (CV%) values for C_max, AUC, and CL/F of greater than 30% (see Table 4).

Absorption

After oral administration of DEXILANT 30 mg or 60 mg to healthy subjects and symptomatic GERD patients, mean C_max and AUC values of dexlansoprazole increased approximately dose proportionally (see Figure 1).

When granules of DEXILANT 60 mg are mixed with water and dosed via NG tube or orally via syringe, the bioavailability (C_max and AUC) of dexlansoprazole was similar to that when DEXILANT 60 mg was administered as an intact capsule.

Distribution

Plasma protein binding of dexlansoprazole ranged from 96.1% to 98.8% in healthy subjects and was independent of concentration from 0.01 to 20 mcg/mL. The apparent volume of distribution (V_z/F) after multiple doses in symptomatic GERD patients was 40.3 L.

Metabolism

Dexlansoprazole is extensively metabolized in the liver by oxidation, reduction, and subsequent formation of sulfate, glucuronide and glutathione conjugates to inactive metabolites. Oxidative metabolites are formed by the cytochrome P450 (CYP) enzyme system including hydroxylation mainly by CYP2C19, and oxidation to the sulfone by CYP3A4.

CYP2C19 is a polymorphic liver enzyme which exhibits three phenotypes in the metabolism of CYP2C19 substrates; extensive metabolizers (*1/*1), intermediate metabolizers (*1/mutant) and poor metabolizers (mutant/mutant). Dexlansoprazole is the major circulating component in plasma regardless of CYP2C19 metabolizer status. In CYP2C19 intermediate and extensive metabolizers, the major plasma metabolites are 5-hydroxy dexlansoprazole and its glucuronide conjugate, while in CYP2C19 poor metabolizers dexlansoprazole sulfone is the major plasma metabolite.

Elimination

Following the administration of DEXILANT, no unchanged dexlansoprazole is excreted in urine. Following the administration of [¹⁴C] dexlansoprazole to six healthy male subjects, approximately 50.7% (standard deviation (SD): 9.0%) of the administered radioactivity was excreted in urine and 47.6% (SD: 7.3%) in the feces. Apparent clearance (CL/F) in healthy subjects was 11.4 to 11.6 L/h, respectively, after five days of 30 or 60 mg once daily administration.

Effect of Food on Pharmacokinetics and Pharmacodynamics

In food-effect studies in healthy subjects receiving DEXILANT under various fed conditions compared to fasting, increases in C_max ranged from 12% to 55%, increases in AUC ranged from 9% to 37%, and t_max varied (ranging from a decrease of 0.7 hours to an increase of three hours). No significant differences in mean intragastric pH were observed between fasted and various fed conditions. However, the percentage of time intragastric pH exceeded four over the 24 hour dosing interval decreased slightly when DEXILANT was administered after a meal (57%) relative to fasting (64%), primarily due to a decreased response in intragastric pH during the first four hours after dosing. Because of this, while DEXILANT can be taken without regard to food, some patients may benefit from administering the dose prior to a meal if post-meal symptoms do not resolve under post-fed conditions.

Special Populations

Pediatric Use

The pharmacokinetics of dexlansoprazole in patients under the age of 18 years have not been studied.

Geriatric Use

The terminal elimination half-life of dexlansoprazole is significantly increased in geriatric subjects compared to younger subjects (2.23 and 1.5 hours, respectively); this difference is not clinically relevant. Dexlansoprazole exhibited higher systemic exposure (AUC) in geriatric subjects (34.5% higher) than younger subjects. No dosage adjustment is needed in geriatric patients [see Use in Specific Populations (8.5)].

Renal Impairment

Dexlansoprazole is extensively metabolized in the liver to inactive metabolites, and no parent drug is recovered in the urine following an oral dose of dexlansoprazole. Therefore, the pharmacokinetics of dexlansoprazole are not expected to be altered in patients with renal impairment, and no studies were conducted in subjects with renal impairment [see Use in Specific Populations (8.6)]. In addition, the pharmacokinetics of lansoprazole were studied in patients with mild, moderate or severe renal impairment; results demonstrated no need for a dose adjustment for this patient population.

Hepatic Impairment

In a study of 12 patients with moderately impaired hepatic function who received a single oral dose of DEXILANT 60 mg, plasma exposure (AUC) of bound and unbound dexlansoprazole in the hepatic impairment group was approximately two times greater compared to subjects with normal hepatic function. This difference in exposure was not due to a difference in protein binding between the two liver function groups. No adjustment for DEXILANT is necessary for patients with mild hepatic impairment (Child-Pugh Class A). DEXILANT 30 mg should be considered 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) [see Use in Specific Populations (8.7)].

Gender

In a study of 12 male and 12 female healthy subjects who received a single oral dose of DEXILANT 60 mg, females had higher systemic exposure (AUC) (42.8% higher) than males. No dosage adjustment is necessary in patients based on gender.

Drug-Drug Interactions

Warfarin

In a study of 20 healthy subjects, co-administration of DEXILANT 90 mg once daily for 11 days with a single 25 mg oral dose of warfarin on Day 6 did not result in any significant differences in the pharmacokinetics of warfarin or INR compared to administration of warfarin with placebo. However, there have been reports of increased INR and prothrombin time in patients receiving PPIs and warfarin concomitantly [see Drug Interactions (7.2)].

Cytochrome P 450 Interactions

Dexlansoprazole is metabolized, in part, by CYP2C19 and CYP3A4 [see Clinical Pharmacology (12.3)].

In vitro studies have shown that dexlansoprazole is not likely to inhibit CYP isoforms 1A1, 1A2, 2A6, 2B6, 2C8, 2C9, 2D6, 2E1 or 3A4. As such, no clinically relevant interactions with drugs metabolized by these CYP enzymes would be expected. Furthermore, in vivo studies showed that DEXILANT did not have an impact on the pharmacokinetics of coadministered phenytoin (CYP2C9 substrate) or theophylline (CYP1A2 substrate). The subjects' CYP1A2 genotypes in the drug-drug interaction study with theophylline were not determined. Although in vitro studies indicated that DEXILANT has the potential to inhibit CYP2C19 in vivo, an in vivo drug-drug interaction study in mainly CYP2C19 extensive and intermediate metabolizers has shown that DEXILANT does not affect the pharmacokinetics of diazepam (CYP2C19 substrate).

Clopidogrel

Clopidogrel is metabolized to its active metabolite in part by CYP2C19. A study of healthy subjects who were CYP2C19 extensive metabolizers, receiving once daily administration of clopidogrel 75 mg alone or concomitantly with DEXILANT 60 mg (n=40), for nine days was conducted. The mean AUC of the active metabolite of clopidogrel was reduced by approximately 9% (mean AUC ratio was 91%, with 90% CI of 86-97%) when DEXILANT was coadministered compared to administration of clopidogrel alone. Pharmacodynamic parameters were also measured and demonstrated that the change in inhibition of platelet aggregation (induced by 5 mcM ADP) was related to the change in the exposure to clopidogrel active metabolite. The clinical significance of this finding is not clear.

12.5 Pharmacogenomics

Effect of CYP2C19 Polymorphism on Systemic Exposure of Dexlansoprazole

Systemic exposure of dexlansoprazole is generally higher in intermediate and poor metabolizers. In male Japanese subjects who received a single dose of DEXILANT 30 mg or 60 mg (N=2 to 6 subjects/group), mean dexlansoprazole C_max and AUC values were up to two times higher in intermediate compared to extensive metabolizers; in poor metabolizers, mean C_max was up to four times higher and mean AUC was up to 12 times higher compared to extensive metabolizers. Though such study was not conducted in Caucasians and African Americans, it is expected dexlansoprazole exposure in these races will be affected by CYP2C19 phenotypes as well.

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

The carcinogenic potential of dexlansoprazole was assessed using lansoprazole studies. In two 24-month carcinogenicity studies, Sprague-Dawley rats were treated orally with lansoprazole at doses of 5 to 150 mg/kg/day, about one to 40 times the exposure on a body surface (mg/m²) basis of a 50 kg person of average height [1.46 m² body surface area (BSA)] given the recommended human dose of lansoprazole 30 mg/day.

Lansoprazole produced dose-related gastric ECL cell hyperplasia and ECL cell carcinoids in both male and female rats [see Clinical Pharmacology (12.2)].

In rats, lansoprazole also increased the incidence of intestinal metaplasia of the gastric epithelium in both sexes. In male rats, lansoprazole produced a dose-related increase of testicular interstitial cell adenomas. The incidence of these adenomas in rats receiving doses of 15 to 150 mg/kg/day (4 to 40 times the recommended human lansoprazole dose based on BSA) exceeded the low background incidence (range = 1.4 to 10%) for this strain of rat.

In a 24 month carcinogenicity study, CD-1 mice were treated orally with lansoprazole doses of 15 to 600 mg/kg/day, two to 80 times the recommended human lansoprazole dose based on BSA. Lansoprazole produced a dose-related increased incidence of gastric ECL cell hyperplasia. It also produced an increased incidence of liver tumors (hepatocellular adenoma plus carcinoma). The tumor incidences in male mice treated with 300 and 600 mg lansoprazole/kg/day (40 to 80 times the recommended human lansoprazole dose based on BSA) and female mice treated with 150 to 600 mg lansoprazole/kg/day (20 to 80 times the recommended human lansoprazole dose based on BSA) exceeded the ranges of background incidences in historical controls for this strain of mice. Lansoprazole treatment produced adenoma of rete testis in male mice receiving 75 to 600 mg/kg/day (10 to 80 times the recommended human lansoprazole dose based on BSA).

A 26 week p53 (+/-) transgenic mouse carcinogenicity study of lansoprazole was not positive.

Lansoprazole was positive in the Ames test and the in vitro human lymphocyte chromosomal aberration assay. Lansoprazole was not genotoxic in the ex vivo rat hepatocyte unscheduled DNA synthesis (UDS) test, the in vivo mouse micronucleus test or the rat bone marrow cell chromosomal aberration test.

Dexlansoprazole was positive in the Ames test and in the in vitro chromosome aberration test using Chinese hamster lung cells. Dexlansoprazole was negative in the in vivo mouse micronucleus test.

The potential effects of dexlansoprazole on fertility and reproductive performance were assessed using lansoprazole studies. Lansoprazole at oral doses up to 150 mg/kg/day (40 times the recommended human lansoprazole dose based on BSA) was found to have no effect on fertility and reproductive performance of male and female rats.

13.2 Animal Toxicology and/or Pharmacology

Reproductive Toxicology Studies

A reproduction study conducted in rabbits at oral dexlansoprazole doses up to 30 mg/kg/day (approximately nine times the maximum recommended human dexlansoprazole dose [60 mg/day] based on BSA) revealed no evidence of impaired fertility or harm to the fetus due to dexlansoprazole. In addition, reproduction studies performed in pregnant rats with oral lansoprazole at doses up to 150 mg/kg/day (40 times the recommended human lansoprazole dose based on BSA) and in pregnant rabbits at oral lansoprazole doses up to 30 mg/kg/day (16 times the recommended human lansoprazole dose based on BSA) revealed no evidence of impaired fertility or harm to the fetus due to lansoprazole.

14 CLINICAL STUDIES

14.1 Healing of Erosive Esophagitis

Two multi-center, double-blind, active-controlled, randomized, eight week studies were conducted in patients with endoscopically confirmed EE. Severity of the disease was classified based on the Los Angeles Classification Grading System (Grades A-D). Patients were randomized to one of the following three treatment groups: DEXILANT 60 mg daily, DEXILANT 90 mg daily or lansoprazole 30 mg daily. Patients who were H. pylori positive or who had Barrett's Esophagus and/or definite dysplastic changes at baseline were excluded from these studies. A total of 4092 patients were enrolled and ranged in age from 18 to 90 years (median age 48 years) with 54% male. Race was distributed as follows: 87% Caucasian, 5% Black and 8% other. Based on the Los Angeles Classification, 71% of patients had mild EE (Grades A and B) and 29% of patients had moderate to severe EE (Grades C and D) before treatment.

The studies were designed to test non-inferiority. If non-inferiority was demonstrated then superiority would be tested. Although non-inferiority was demonstrated in both studies, the finding of superiority in one study was not replicated in the other.

The proportion of patients with healed EE at Week 4 or 8 is presented below in Table 5.

DEXILANT 90 mg was studied and did not provide additional clinical benefit over DEXILANT 60 mg.

14.2 Maintenance of Healed Erosive Esophagitis

A multi-center, double-blind, placebo-controlled, randomized study was conducted in patients who successfully completed an EE study and showed endoscopically confirmed healed EE. Maintenance of healing and symptom resolution over a six month period were evaluated with DEXILANT 30 mg or 60 mg once daily compared to placebo. A total of 445 patients were enrolled and ranged in age from 18 to 85 years (median age 49 years), with 52% female. Race was distributed as follows: 90% Caucasian, 5% Black and 5% other.

Sixty-six percent of patients treated with 30 mg of DEXILANT remained healed over the six-month time period as confirmed by endoscopy (see Table 6).

DEXILANT 60 mg was studied and did not provide additional clinical benefit over DEXILANT 30 mg.

The effect of DEXILANT 30 mg on maintenance of relief of heartburn was also evaluated. Upon entry into the maintenance study, a majority of patients' baseline heartburn severity was rated as none. DEXILANT 30 mg demonstrated a statistically significantly higher percent of 24 hour heartburn-free periods compared to placebo over the six month treatment period (see Table 7). The majority of patients treated with placebo discontinued due to relapse of EE between month two and month six.

14.3 Symptomatic Non-Erosive GERD

A multi-center, double-blind, placebo-controlled, randomized, four week study was conducted in patients with a diagnosis of symptomatic non-erosive GERD made primarily by presentation of symptoms. These patients who identified heartburn as their primary symptom, had a history of heartburn for 6 months or longer, had heartburn on at least four of seven days immediately prior to randomization and had no esophageal erosions as confirmed by endoscopy. However, patients with symptoms which were not acid-related may not have been excluded using these inclusion criteria. Patients were randomized to one of the following treatment groups: DEXILANT 30 mg daily, 60 mg daily, or placebo. A total of 947 patients were enrolled and ranged in age from 18 to 86 years (median age 48 years) with 71% female. Race was distributed as follows: 82% Caucasian, 14% Black and 4% other.

DEXILANT 30 mg provided statistically significantly greater percent of days with heartburn-free 24 hour periods over placebo as assessed by daily diary over four weeks (see Table 8). DEXILANT 60 mg was studied and provided no additional clinical benefit over DEXILANT 30 mg.

A higher percentage of patients on DEXILANT 30 mg had heartburn-free 24 hour periods compared to placebo as early as the first three days of treatment and this was sustained throughout the treatment period (percentage of patients on Day 3: DEXILANT 38% versus placebo 15%; on Day 28: DEXILANT 63% versus placebo 40%).

16 HOW SUPPLIED/STORAGE AND HANDLING

DEXILANT delayed-release capsules, 30 mg, are opaque, blue and gray with TAP and "30" imprinted on the capsule and supplied as:

DEXILANT 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 to 30°C (59 to 86°F) [see USP Controlled Room Temperature].

17 PATIENT COUNSELING INFORMATION

See FDA-approved patient labeling (Medication Guide and Instructions for Use)

To ensure the safe and effective use of DEXILANT, this information and instructions provided in the FDA-Approved Medication Guide should be discussed with the patient.

Inform the patient to watch for signs of an allergic reaction as these could be serious and may require that DEXILANT be discontinued.

Advise patients to immediately report and seek care for diarrhea that does not improve. This may be a sign of Clostridium difficile associated diarrhea [see Warnings and Precautions (5.2)].

Advise the patient to immediately report and seek care for any cardiovascular or neurological symptoms including palpitations, dizziness, seizures, and tetany as these may be signs of hypomagnesemia [see Warnings and Precautions (5.4)].

Advise the patient to tell their health care provider if they take atazanavir, tacrolimus, warfarin, methotrexate and drugs that are affected by gastric pH changes [see Drug Interactions (7)].

Advise the patient to follow the dosing instructions in the Medication Guide and inform the patient of the following administration options:

• •DEXILANT is available as a delayed-release capsule.
• •DEXILANT can be taken without regard to food.
• •DEXILANT should be swallowed whole.
• •DEXILANT should not be chewed.

Counsel patients who have difficulty swallowing capsules according to instructions provided in Dosage and Administration (2.3). Advise patients to follow the Instructions for Use that comes with the product.

MEDICATION GUIDE

DEXILANT (decks-i-launt)
(dexlansoprazole)
delayed-release capsules

Read this Medication Guide before you start taking DEXILANT and each time you get a refill. There may be new information. This information does not take the place of talking to your doctor about your medical condition or your treatment.

What is the most important information that I should know about DEXILANT?

DEXILANT may help your acid-related symptoms, but you could still have serious stomach problems. Talk with your doctor.

DEXILANT can cause serious side effects, including:

• • Diarrhea. DEXILANT may increase your risk of getting severe diarrhea. This diarrhea may be caused by an infection (Clostridium difficile) in your intestines.

  Call your doctor right away if you have watery stool, stomach pain, and fever that does not go away.

  Bone fractures. People who take multiple daily doses of proton pump inhibitor medicines for a long period of time (a year or longer) may have an increased risk of fractures of the hip, wrist or spine. You should take DEXILANT exactly as prescribed, at the lowest dose possible for your treatment and for the shortest time needed. Talk to your doctor about your risk of bone fracture if you take DEXILANT.

• • Bone fractures. People who take multiple daily doses of proton pump inhibitor medicines for a long period of time (a year or longer) may have an increased risk of fractures of the hip, wrist or spine. You should take DEXILANT exactly as prescribed, at the lowest dose possible for your treatment and for the shortest time needed. Talk to your doctor about your risk of bone fracture if you take DEXILANT.

DEXILANT can have other serious side effects. See “What are the possible side effects of DEXILANT?”

What is DEXILANT?

DEXILANT is a prescription medicine called a proton pump inhibitor (PPI). DEXILANT reduces the amount of acid in your stomach.

DEXILANT is used in adults:

• •for up to 8 weeks to heal acid-related damage to the lining of the esophagus (called erosive esophagitis or EE).
• •for up to 6 months to continue healing of erosive esophagitis and relief of heartburn.
• •for 4 weeks to treat heartburn related to gastroesophageal reflux disease (GERD).

GERD happens when acid from your stomach enters the tube (esophagus) that connects your mouth to your stomach. This may cause a burning feeling in your chest or throat, sour taste or burping.

It is not known if DEXILANT is safe and effective in children under 18 years of age.

Who should not take DEXILANT?

Do not take DEXILANT if you are allergic to dexlansoprazole or any of the other ingredients in DEXILANT. See the end of this Medication Guide for a complete list of ingredients in DEXILANT.

What should I tell my doctor before taking DEXILANT?

Before you take DEXILANT, tell your doctor if you:

• •have been told that you have low magnesium levels in your blood
• •have liver problems
• •have any other medical conditions
• •are pregnant or plan to become pregnant. It is not known if DEXILANT will harm your unborn baby.
• •are breastfeeding or planning to breastfeed. It is not known if DEXILANT passes into your breast milk. You and your doctor should decide if you will take DEXILANT or breastfeed. You should not do both. Talk to your doctor about the best way to feed your baby if you take DEXILANT.

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

Especially tell your doctor if you take:

• •an antibiotic that contains ampicillin
• •atazanavir (Reyataz)
• •erlotinib (Tarceva)
• •digoxin (Lanoxin)
• •a product that contains iron
• •ketoconazole (Nizoral)
• •warfarin (Coumadin, Jantoven)
• •tacrolimus (Prograf)
• •methotrexate

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.

How should I take DEXILANT?

• •Take DEXILANT exactly as prescribed by your doctor.
• •Do not change your dose or stop taking DEXILANT without talking to your doctor first.
• •You can take DEXILANT with or without food.
• •Swallow DEXILANT capsules whole. Do not chew DEXILANT capsules or the granules that are in the capsules.
• •If you have trouble swallowing DEXILANT capsules whole, you can open the capsules and sprinkle the contents on a tablespoon of applesauce.

  See the “Instructions for Use” at the end of this Medication Guide for instructions about how to take DEXILANT capsules with applesauce, and how to give DEXILANT capsules using an oral syringe or through a nasogastric tube.

  If you forget to take a dose of DEXILANT, take it as soon as you remember. If it is almost time for your next dose, do not take the missed dose. Take the next dose on time. Do not take 2 doses at the same time to make up for the missed dose.

• •If you forget to take a dose of DEXILANT, take it as soon as you remember. If it is almost time for your next dose, do not take the missed dose. Take the next dose on time. Do not take 2 doses at the same time to make up for the missed dose.
• •If you take too much DEXILANT, call your doctor right away or go to the nearest hospital emergency room.

What are the possible side effects of DEXILANT?

DEXILANT may cause serious side effects, including:

• • See “What is the most important information I should know about DEXILANT?”
• • 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 DEXILANT, or during treatment, if you will be taking DEXILANT for a long period of time.

The most common side effects of DEXILANT include:

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

Other side effects:

• • Serious allergic reactions. Tell your doctor if you get any of the following symptoms with DEXILANT:
  • •rash
  • •face swelling
  • •throat tightness
  • •difficulty breathing

Your doctor may stop DEXILANT 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 DEXILANT. 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.

How should I store DEXILANT?

• •Store DEXILANT at room temperature between 68°F to 77°F (20°C to 25°C).

Keep DEXILANT and all medicines out of the reach of children.

General information about DEXILANT

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use DEXILANT for a condition for which it was not prescribed. Do not give DEXILANT to other people, even if they have the same symptoms you have. It may harm them.

This Medication Guide summarizes the most important information about DEXILANT. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about DEXILANT that is written for healthcare professionals.

For more information, go to www.DEXILANT.com or call 1-877-825-3327.

What are the ingredients in DEXILANT?

Active ingredient: dexlansoprazole.

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 capsule shell is made of hypromellose, carrageenan and potassium chloride. Based on the capsule shell color, blue contains FD&C Blue No. 2 aluminum lake; gray contains black ferric oxide; and both contain titanium dioxide.

Instructions for Use

• •DEXILANT may be taken with or without food.
• •Swallow DEXILANT capsules whole.
• •Do not chew DEXILANT capsules or the granules that are in the capsules.

If you have trouble swallowing DEXILANT capsules whole, you may take or give them as follows:

Taking DEXILANT with applesauce:

• 1.Place 1 tablespoon of applesauce into a clean container.
• 2.Carefully open the capsule and sprinkle the granules onto the applesauce.
• 3.Swallow the applesauce and granules right away. Do not chew the granules. Do not save the applesauce and granules for later use.

Giving DEXILANT with water using an oral syringe:

• 1.Place 20 mL of water into a clean container.
• 2.Carefully open the capsule and empty the granules into the container of water.
• 3.Use an oral syringe to draw up the water and granule mixture.
• 4.Gently swirl the syringe to keep the granules from settling.
• 5.Give the mixture into the mouth right away. Do not save the water and granule mixture for later use.
• 6.Refill the syringe with 10 mL of water and swirl gently. Give the water into the mouth.
• 7.Repeat step 6 above.

Giving DEXILANT with water through a nasogastric tube (NG tube):

For people who have a nasogastric (NG) tube that is size 16 French or larger, DEXILANT may be given as follows:

• 1.Place 20 mL of water into a clean container.
• 2.Carefully open the capsule and empty the granules into the container of water.
• 3.Use a 60 mL catheter-tip syringe to draw up the water and granule mixture.
• 4.Gently swirl the syringe to keep the granules from settling.
• 5.Connect the catheter-tip syringe to the nasogastric tube.
• 6.Give the mixture right away through the nasogastric tube into the stomach. Do not save the water and granule mixture for later use.
• 7.Refill the syringe with 10 mL of water and swirl gently. Flush the nasogastric tube with the water.
• 8.Repeat step 7 above.

This Medication Guide and Instructions for Use have been approved by the U.S. Food and Drug Administration.

Distributed by:

Takeda Pharmaceuticals America, Inc.

Deerfield, IL 60015

Revised: August 2013

DEXILANT is a trademark of Takeda Pharmaceuticals U.S.A., Inc. registered with the U. S. Patent and Trademark Office and used under license by Takeda Pharmaceuticals America, Inc.

All other trademark names are the property of their respective owners.

©2009-2013 Takeda Pharmaceuticals America, Inc.

DEX006 R20

Package/Label Display Panel

Dexilant (dexlansoprazole) delayed release capsules

60 mg

Contains Approximately 1800 Capsules