Duedom

Healing of Erosive Esophagitis

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

Dyspeptic symptom complex often associated with delayed gastric emptying, gastroesophageal reflux disease (GERD) or esophagitis: Epigastric sense of fullness, feeling of abdominal distention, upper abdominal pain, flatulence (gassiness), eructation (belching), and heartburn.

Short-term treatment of nausea and vomiting of various origins including functional, organic, infectious, diabetic origin, or induced by radiotherapy or medicine therapy. (It is not considered suitable for chronic nausea and vomiting, nor for the routine prophylaxis of postoperative vomiting.)

Treatment of nausea and vomiting induced by dopamine agonists ie, L-dopa and bromocriptine used in Parkinson's disease.

Domperidone (Duedom) may also be given as needed, together with paracetamol for the symptomatic treatment of nausea and vomiting associated with migraine.

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

Dexlansoprazole (Duedom) is used to treat heartburn caused by gastroesophageal reflux disease (GERD), and to heal erosive esophagitis (damage to the esophagus from stomach acid).

Dexlansoprazole (Duedom) may also be used for purposes not listed in this medication guide.

Domperidone (Duedom) is a medicine that increases the movements or contractions of the stomach and bowel. Domperidone (Duedom) is also used to treat nausea and vomiting caused by other drugs used to treat Parkinson's Disease.

Domperidone (Duedom) is to be given only by or under the immediate supervision of your doctor.

Recommended Dose

Dexlansoprazole (Duedom) (Dexlansoprazole (Duedom) 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 (Duedom) (Dexlansoprazole (Duedom) delayed release capsules) Dosing Recommendations

Special Populations

No adjustment for Dexlansoprazole (Duedom) (Dexlansoprazole (Duedom) 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 (Duedom) (Dexlansoprazole (Duedom) delayed release capsules) can be taken without regard to food. Dexlansoprazole (Duedom) (Dexlansoprazole (Duedom) delayed release capsules) should be swallowed whole.

• Alternatively, Dexlansoprazole (Duedom) (Dexlansoprazole (Duedom) 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 (Duedom) (Dexlansoprazole (Duedom) 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 (Duedom) (Dexlansoprazole (Duedom) 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

Domperidone (Duedom) is injected submucosally in the urinary bladder in close proximity to the ureteral orifice. The injection of Domperidone (Duedom) creates increased tissue bulk thereby providing coaptation of the distal ureter during filling and contraction of the bladder. The dextranomer microspheres are gradually surrounded by host connective tissue.

Directions For Use

Domperidone (Duedom) is to be administered only by qualified surgeons experienced in the use of a cystoscope and trained in the technique of subureteric and/or intraureteric injections injections (with Domperidone (Duedom) or other materials).

It is recommended to use the Domperidone (Duedom) metal needle (3.7F x 23G tip x 350 mm) for safe and accurate administration of Domperidone (Duedom). To assist the physician in positioning the needle, the Domperidone (Duedom) metal needle has a circular mark 6 mm from the needle tip. To show the position of the needle bevel, there is a square mark 8 mm from the needle tip. The marks are for reference only.

Domperidone (Duedom) can be injected with any common pediatric cystoscope with a minimum 4 French working channel. A type of cystoscope witha straight working channel is also well adapted for this type of procedure. The child is placed in a lithotomy position under general anesthesia and cystoscopy is performed to localize the ureteral orifices.

Before injecting Domperidone (Duedom) the following is recommended:

• Flush physiological saline solution through the needle.
• Fasten the needle tightly to the syringe.
• Remove the air from the needle by injecting the gel into the needle up to a point where a droplet is visible at the tip.

Please note that the luer lock adapter is snapped onto the syringe and held in place with friction only. It can rotate freely or be pulled off should enough force be applied. Because of this, it is recommended that the thumb and forefinger are held firmly around both the glass syringe barrel and the luer lock adapter when assembling the needle and syringe. To facilitate proper threading/fastening of needle hub and luer lock adapter, please both push and rotate them firmly together.

To avoid any interruption in patient treatment or the need to repeat a procedure because of leakage or breakage of a syringe, it is recommended that extra syringes be kept in inventory.

Domperidone (Duedom) is easily injected by finger pressure on a normal syringe with any commonly used pediatric cystoscope. Due to its viscoelastic properties, Domperidone (Duedom) can be injected through a fine needle – no special injection device is necessary.

Injection Techniques

Several techniques have been described for the endoscopic treatment of VUR including a subureteric injection (STING procedure), a single intra-ureteric injection (HIT procedure) and a double (proximal and distal) intra-ureteric injection (Double-HIT procedure). The Double-HIT procedure is a refinement of the original STING and HIT procedures and has been reported to result in greater clinical success rates.

In general, the bladder is semi-filled to allow for good visualization of the ureteral orifice(s) and to avoid tension within the submucosal layer of the ureter secondary to overdistension. For the HIT procedure, hydrodistention of the ureteral orifice is initiated to define the site of injection within the submucosa of the intramural ureter. The needle is inserted approximately 4 mm in the submucosa of the mid- to distal ureteral tunnel at the 6 o

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What is the most important information I should know about Dexlansoprazole (Duedom)?

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 (Duedom) if you are allergic to it.

Before you take Dexlansoprazole (Duedom), 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 (Duedom) is usually given for 4 weeks. To best heal erosive esophagitis, you may need to take Dexlansoprazole (Duedom) for several months. Follow your doctor's instructions.

Hypersensitivity to Domperidone (Duedom) or any ingredient of Domperidone (Duedom).

If patients are taking oral ketoconazole, fluconazole, voriconazole, erythromycin, clarithromycin, telithromycin, amiodarone, selective serotonin reuptake inhibitors, HIV protease inhibitors, calcium antagonists which can increase plasma concentrations of Domperidone (Duedom), leading to a prolonged QTc interval. These medicines can increase plasma concentrations of Domperidone (Duedom) leading to a prolonged QTc interval. Patients with long QT syndrome develop a very fast heart rhythm disturbance leading to a sudden loss of consciousness.

Gastrointestinal hemorrhage (bleeding), obstruction, perforation or conditions where gastrointestinal stimulation or movements may be dangerous.

Prolactin-releasing pituitary tumor (prolactinoma).

Use Dexlansoprazole (Duedom) as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Dexlansoprazole (Duedom) 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 (Duedom) refilled.
• Take Dexlansoprazole (Duedom) by mouth with or without food.
• Swallow Dexlansoprazole (Duedom) 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 (Duedom) through a nasogastric tube, follow the instructions for use in the extra patient leaflet.
• Continue to take Dexlansoprazole (Duedom) even if you feel well. Do not miss any doses.
• If you miss a dose of Dexlansoprazole (Duedom), 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 (Duedom).

Dexlansoprazole (Duedom) 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 (Duedom) 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 (Duedom) may also be used to treat stomach ulcers.

How to use Dexlansoprazole (Duedom)

Read the Medication Guide and the Patient Information Leaflet if available from your pharmacist before you start taking Dexlansoprazole (Duedom) 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 (Duedom) 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.

Domperidone (Duedom) is used to treat vomiting or nausea caused due to indigestion, diseases or drugs. It is also used to relieve fullness of stomach, belching and heavy bloating, gas and heartburn for a longer period up to 2 weeks.

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What other drugs will affect Dexlansoprazole (Duedom)?

Drugs with pH-Dependent Absorption Pharmacokinetics

Dexlansoprazole (Duedom) (Dexlansoprazole (Duedom) delayed release capsules) causes inhibition of gastric acid secretion. Dexlansoprazole (Duedom) (Dexlansoprazole (Duedom) 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 (Duedom) (Dexlansoprazole (Duedom) delayed release capsules) should not be co-administered with atazanavir.

It is theoretically possible that Dexlansoprazole (Duedom) (Dexlansoprazole (Duedom) 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 (Duedom) (Dexlansoprazole (Duedom) 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 (Duedom) (Dexlansoprazole (Duedom) delayed release capsules) and warfarin concomitantly may need to be monitored for increases in INR and prothrombin time.

Concomitant administration of anticholinergic drugs may antagonise the antidyspeptic effect of Domperidone (Duedom).

Antacids and antisecretory drugs should not be given simultaneously with oral formulations of Domperidone (Duedom) as they lower its oral bioavailability.

The main metabolic pathway of Domperidone (Duedom) is through CYP3A4. In vitro and human data show that the concomitant use of drugs that significantly inhibit this enzyme may result in increased plasma levels of Domperidone (Duedom). Examples of potent CYP3A4 inhibitors include: Azole antifungals eg, fluconazole*, itraconazole, ketoconazole* and voriconazole*; macrolide antibiotics eg, clarithromycin* and erythromycin*; HIV protease inhibitors eg, amprenavir, atazanavir, fosamprenavir, indinavir, nelfinavir, ritonavir and saquinavir; calcium antagonists eg, diltiazem and verapamil; amiodarone*; aprepitant; nefazodone; telithromycin*.

(*Also prolong the QTc interval; see Contraindications.)

Separate pharmacokinetic/pharmacodynamic interaction studies with oral ketoconazole or oral erythromycin in healthy subjects confirmed a marked inhibition of Domperidone (Duedom)'s CYP3A4 mediated first-pass metabolism by these drugs.

With the combination of Domperidone (Duedom) 10 mg 4 times daily and ketoconazole 200 mg twice daily, a mean QTc prolongation of 9.8 msec was seen over the observation period, with changes at individual time points ranging from 1.2-17.5 msec. With the combination of Domperidone (Duedom) 10 mg 4 times daily and erythromycin 500 mg 3 times daily, mean QTc over the observation period was prolonged by 9.9 msec, with changes at individual time points ranging from 1.6-14.3 msec. Both the C_max and AUC of Domperidone (Duedom) at steady-state were increased approximately 3-fold in each of these interaction studies.

The contribution of increased plasma concentrations of Domperidone (Duedom) to the observed effect on QTc is not known.

In these studies, Domperidone (Duedom) monotherapy at 10 mg 4 times daily resulted in increases in mean QTc of 1.6 msec (ketoconazole study) and 2.5 msec (erythromycin study), while ketoconazole monotherapy (200 mg twice daily) and erythromycin monotherapy (500 mg 3 times daily) led to increases in mean QTc of 3.8 and 4.9 msec, respectively, over the observation period.

In another multiple-dose study in healthy subjects, no significant increases in QTc were noted during steady-state treatment with Domperidone (Duedom) monotherapy at 40 mg 4 times daily (total daily dose of 160 mg, which is double the maximum daily dose) at plasma concentrations of Domperidone (Duedom) that were at least similar to those found in the combination arms of the interaction studies.

Theoretically, since Domperidone (Duedom) has gastrokinetic effects, it could influence the absorption of concomitantly orally administered drugs, particularly those with sustained release or enteric-coated formulations. However, in patients already stabilised on digoxin or paracetamol, concomitant administration of Domperidone (Duedom) did not influence the blood levels of these drugs.

Domperidone (Duedom) may also be given with neuroleptics, the action of which it does not potentiate; dopaminergic agonists (bromocriptine, L-dopa), whose unwanted peripheral effects eg, digestive disorders, nausea and vomiting, it suppresses without counteracting their central properties.

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What are the possible side effects of Dexlansoprazole (Duedom)?

Clinical Trials Experience

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

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What are the possible side effects of Domperidone (Duedom)?

Adverse Events

The safety of Domperidone (Duedom) in the treatment of VUR is based on a pivotal randomized study in which 39 children were treated with Domperidone (Duedom), two nonrandomized supportive studies in which 170 children were treated with Domperidone (Duedom), and a nonrandomized post-approval study in which 165 children were treated with Domperidone (Duedom). Follow-up for the pivotal and supportive studies was 12 months; follow-up for the post-approval study was 5 years (5-year data available for 31 of the 165 enrolled subjects (18.8%) ). No patients died during the course of these studies.

A list of the treatment -related adverse events occurring in > 1% of patients in all four studies is presented in Table 1.

Table 1: List of Treatment-Related Adverse Events Occurring in > 1% of Patients in the Pivitol, Supportive and Post-Approval Studies

The following adverse events were associated with the use of Domperidone (Duedom) from spontaneous post-marketing surveillance reporting or from clinical studies (occurring ≤ 1%) and include but are not limited to: ureteral obstruction with or without hydronephrosis (some cases requiring temporary placement of a ureteric stent, and rare cases of ureteral re-implant procedures), hematuria, urgency, frequency, pyelonephritis, foreign body reaction, calcification, pyrexia, hypertonic bladder, bladder irritation, and Henoch-Schonlein purpura.

Adverse events should be reported to:

Salix Product Information Call Center, Phone: 1-800-508-0024, Fax: 1-510-595-8183, E-mail: [email protected]

Dexlansoprazole (Duedom), 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 (Duedom) is the R-enantiomer of lansoprazole (a racemic mixture of the R- and S-enantiomers).

Domperidone (Duedom) is a synthetic anticoagulant and an indanedione derivative. It prevents the formation of active procoagulation factors II, VII, IX, and X, as well as the anticoagulant proteins C and S, in the liver by inhibiting the vitamin K mediated gamma-carboxylation of precursor proteins.