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DEXILANT is a brand name for Dexlansoprazole, supplied as a capsule (delayed release). The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: DEXILANT (dexlansoprazole delayed release capsules) is indicated for: • healing of all grades of erosive esophagitis (EE) for up to 8 weeks in patients 12 years of age and older. • maintaining healing of erosive esophagitis for up to 4 months in adolescents 12 to 17 years of age and up to 6 months in adults. • the…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations • Patients should use the lowest dose and shortest duration of proton pump inhibitor (PPI) therapy appropriate to the condition being treated. • Withdrawal of long-term PPI therapy can lead to aggravation of acid related symptoms and may result in rebound acid hypersecretion.
2 Recommended Dose and Dosage Adjustment Indication Recommended Dose, Route of administration Frequency Healing of Erosive Esophagitis 60 mg, Oral or Nasogastric Once daily for up to 8 weeks Maintenance of Healed Erosive Esophagitis 30 mg a, Oral or Nasogastric Once daily for up to 6 months in adults and 4 months in adolescents (12 to 17 years)b Symptomatic Non-Erosive Gastroesophageal Reflux Disease (GERD) 30 mg, Oral or Nasogastric Once daily for 4 weeks a In patients who had moderate or severe erosive esophagitis, a maintenance dose of 60 mg may be used.
b Controlled studies did not extend beyond 6 months in adults, and beyond 4 months in adolescents 12 to 17 years of age. • No dosage 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). • No dosage adjustment is necessary for elderly patients or for patients with renal impairment.
• Health Canada has not authorized an indication for pediatric use in patients less than 12 years of age. 3 Pediatrics. 4 Administration DEXILANT can be taken without regard to food or the timing of food. DEXILANT should be swallowed whole with plenty of water.
• Alternatively, DEXILANT capsules can be opened and administered as follows: • Administration with Applesauce 1. Place one tablespoon of applesauce into a clean container 2. Open capsule 3. Sprinkle intact granules on applesauce; 4. Swallow applesauce and granules immediately.
Do not chew granules. Do not save the applesauce and granules for later use. • Administration with Water in an Oral Syringe 1. Open the capsule and empty the granules into a clean container with 20 mL of water. 2. Withdraw the entire mixture into a syringe.
3. Gently swirl the syringe in order to keep granules from settling. 4. Administer the mixture immediately into the mouth. Do not save the water and granule mixture for later use. 5. Refill the syringe with 10 mL of water, swirl gently, and administer.
In most patients, treatment of hypomagnesemia (and hypomagnesemia associated hypocalcemia and/or hypokalemia) required magnesium replacement and discontinuation of the PPI. , diuretics), health care professionals may consider monitoring magnesium levels prior to initiation of PPI treatment and periodically.
See 8 ADVERSE REACTIONS. The chronic use of PPIs may lead to hypomagnesemia.
Cyanocobalamin (Vitamin B12) Deficiency:
The prolonged use of PPIs may impair the absorption of protein-bound Vitamin B12 and may contribute to the development of cyanocobalamin (Vitamin B12) deficiency. Gastrointestinal Long-term use of DEXILANT is associated with an increased risk of fundic gland polyps, especially beyond one year.
See 8 ADVERSE REACTIONS. Most fundic gland polyps are asymptomatic. Use the lowest dose and shortest duration of PPI therapy appropriate to the condition being treated. Genitourinary Testicular interstitial cell adenoma occurred in 1 of 30 rats treated with 50 mg/kg/day of lansoprazole (13 times the recommended human dose based on body surface area) in a one-year toxicity study.
See 16 NON-CLINICAL TOXICOLOGY, Carcinogenicity. These changes are associated with endocrine alterations which have not been, to date, observed in humans. Hepatic/Biliary/Pancreatic No dosage adjustment is necessary for patients with mild hepatic impairment (Child-Pugh Class A).
A maximum daily dose of 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. 3 Pharmacokinetics, Special Populations and Conditions.
Immune Severe Cutaneous Adverse Reactions:
Severe cutaneous adverse reactions (SCARs), including Stevens- Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), acute generalized exanthematous pustulosis (AGEP) and erythema multiforme have been reported in association with the use of PPIs.
4 Drug-Drug Interactions. 1 Dosing Considerations • Patients should use the lowest dose and shortest duration of proton pump inhibitor (PPI) therapy appropriate to the condition being treated. • Withdrawal of long-term PPI therapy can lead to aggravation of acid related symptoms and may result in rebound acid hypersecretion.
2 Recommended Dose and Dosage Adjustment Indication Recommended Dose, Route of administration Frequency Healing of Erosive Esophagitis 60 mg, Oral or Nasogastric Once daily for up to 8 weeks Maintenance of Healed Erosive Esophagitis 30 mg a, Oral or Nasogastric Once daily for up to 6 months in adults and 4 months in adolescents (12 to 17 years)b Symptomatic Non-Erosive Gastroesophageal Reflux Disease (GERD) 30 mg, Oral or Nasogastric Once daily for 4 weeks a In patients who had moderate or severe erosive esophagitis, a maintenance dose of 60 mg may be used.
b Controlled studies did not extend beyond 6 months in adults, and beyond 4 months in adolescents 12 to 17 years of age. • No dosage 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). • No dosage adjustment is necessary for elderly patients or for patients with renal impairment.
• Health Canada has not authorized an indication for pediatric use in patients less than 12 years of age. 3 Pediatrics. 4 Administration DEXILANT can be taken without regard to food or the timing of food. DEXILANT should be swallowed whole with plenty of water.
• Alternatively, DEXILANT capsules can be opened and administered as follows: • Administration with Applesauce 1. Place one tablespoon of applesauce into a clean container 2. Open capsule 3. Sprinkle intact granules on applesauce; 4. Swallow applesauce and granules immediately.
• Dexlansoprazole is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
• Dexlansoprazole is contraindicated with co-administration of rilpivirine. 4 Drug-Drug Interactions.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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6. Repeat step 5. • Administration with Water via a Nasogastric Tube (≥16 French) 1. Open the capsule and empty the granules into a clean container with 20 mL of water. DEXILANT® (dexlansoprazole) Page 6 of 39 2. Withdraw the entire mixture into a catheter-tip syringe.
3. Swirl the syringe gently in order to keep the granules from settling, and immediately inject the mixture through the nasogastric tube into the stomach. Do not save the water and granule mixture for later use. 4. Refill the syringe with 10 mL of water, swirl gently, and flush the tube.
5. Repeat step 4. 5 Missed Dose If a capsule is missed at its usual time, it should be taken as soon as possible. But if it is too close to the time of the next dose, only the prescribed dose should be taken at the appointed time. A double dose should not be taken.
Discontinue dexlansoprazole at the first signs or symptoms of SCARs or other signs of hypersensitivity and consider further evaluation. At the time of prescription, patients should be informed of the signs and symptoms, and advised to monitor closely for skin reactions.
5 Post-Market Drug Reactions.
Subacute cutaneous lupus erythematosus:
Subacute cutaneous lupus erythematosus (SCLE) has been reported with the use of PPIs. If lesions occur, especially in sun-exposed areas of the skin, and if accompanied by arthralgia, the patient should seek medical help promptly and the health care professional should consider stopping DEXILANT.
The occurrence of SCLE with previous PPI treatment may increase the risk of SCLE with other PPIs. 5 Post-Market Adverse Drug Reactions. Monitoring and Laboratory Tests During treatment with antisecretory drugs, chromogranin A (CgA) increases due to decreased gastric acidity.
Increased CgA levels may interfere with investigations for neuroendocrine tumours. To avoid this interference, DEXILANT treatment should be stopped 14 days before CgA measurements. 4 Drug-Drug Interactions.
Musculoskeletal Bone Fracture:
Several published observational studies suggest that PPI therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist, or spine. The risk of fracture was increased in patients who received high-dose, defined as multiple daily doses, and long-term PPI therapy (a year or longer).
Patients should use the lowest dose and shortest duration of PPI therapy appropriate to the condition being treated. Patients at risk for osteoporosis-related fractures should be managed according to established treatment guidelines.
See 4 DOSAGE AND ADMINISTRATION and 8 ADVERSE REACTIONS. Renal No dosage adjustment is necessary for patients with renal impairment. 3 Pharmacokinetics, Special Populations and Conditions. 1 Pregnant Women There are no adequate or well-controlled studies in pregnant women with DEXILANT.
Exposure in clinical trials was very limited. DEXILANT should not be administered to pregnant women unless the expected benefits outweigh the potential risks. See 16 NON-CLINICAL TOXICOLOGY, Reproductive and Developmental Toxicology.
2 Breast-feeding It is not known whether DEXILANT (dexlansoprazole) is excreted in human milk. However, lansoprazole (the racemate) and its metabolites are excreted in the milk of rats. As many drugs are excreted in human milk, DEXILANT should not be given to nursing mothers unless its use is considered essential.
In this case, nursing should be avoided. 3 Pediatrics Pediatrics (<12 years of age): Based on the data submitted and reviewed by Health Canada, the safety and efficacy of DEXILANT in pediatric patients has not been established; therefore, Health Canada has not authorized an indication for pediatric use in children under 12 years of age.
DEXILANT should not be used in pediatric patients less than one year of age because lansoprazole (the racemic mixture) was not effective for the treatment of symptomatic GERD in a multicenter, double- blind controlled trial. In addition, toxicology studies with lansoprazole have shown heart valve thickening and bone changes in juvenile rats.
See 16 NON-CLINICAL TOXICOLOGY, Juvenile Animal Toxicity Data.
Pediatrics (12 to 17 years of age):
DEXILANT is indicated for adolescents 12 to 17 years of age, and is supported by evidence from adequate and well-controlled studies of dexlansoprazole in adults, and by additional efficacy, safety and pharmacokinetic data in adolescents 12 to 17 years of age for the treatment of heartburn associated with symptomatic non-erosive GERD, […]
Do not chew granules. Do not save the applesauce and granules for later use. • Administration with Water in an Oral Syringe 1. Open the capsule and empty the granules into a clean container with 20 mL of water. 2. Withdraw the entire mixture into a syringe.
3. Gently swirl the syringe in order to keep granules from settling. 4. Administer the mixture immediately into the mouth. Do not save the water and granule mixture for later use. 5. Refill the syringe with 10 mL of water, swirl gently, and administer.
6. Repeat step 5. • Administration with Water via a Nasogastric Tube (≥16 French) 1. Open the capsule and empty the granules into a clean container with 20 mL of water. DEXILANT® (dexlansoprazole) Page 6 of 39 2. Withdraw the entire mixture into a catheter-tip syringe.
3. Swirl the syringe gently in order to keep the granules from settling, and immediately inject the mixture through the nasogastric tube into the stomach. Do not save the water and granule mixture for later use. 4. Refill the syringe with 10 mL of water, swirl gently, and flush the tube.
5. Repeat step 4. 5 Missed Dose If a capsule is missed at its usual time, it should be taken as soon as possible. But if it is too close to the time of the next dose, only the prescribed dose should be taken at the appointed time. A double dose should not be taken.
5 OVERDOSAGE There have been no reports of significant overdose of DEXILANT. Dexlansoprazole is not expected to be removed from the circulation by hemodialysis. For management of a suspected drug overdose, contact your regional poison control centre.
6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING Dosage Forms, Strengths, Composition and Packaging DEXILANT is supplied as a dual delayed release formulation in capsules for oral administration using Dual Delayed Release technology.
The capsules contain dexlansoprazole in a mixture of two types of enteric-coated granules with different pH-dependent dissolution profiles. One type of granule is designed to release dexlansoprazole after the granules reach the proximal small intestine; the second type of granule is designed to release dexlansoprazole in the distal region of the small intestine, generally several hours later.
DEXILANT is provided in high-density polyethylene (HDPE) bottles in 90 count configurations. Each 30 mg capsule is opaque, blue and gray with TAP and “30” imprinted on the capsule and each 60 mg capsule is opaque, blue with TAP and “60” imprinted on the capsule.
Route of Administration Dosage Form / Strength/Composition Non-medicinal Ingredients Oral, Nasogastric Capsule (delayed release) 30 mg, 60 mg Dexlansoprazole Capsule: colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose 2910, low-substituted hydroxypropyl cellulose, magnesium carbonate, methacrylic acid copolymer, polyethylene glycol 8000, polysorbate 80, sucrose, sugar spheres, talc, titanium dioxide, and triethyl citrate.
Capsule shell: carrageenan, hypromellose 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. DEXILANT® (dexlansoprazole) Page 7 of 39 7 WARNINGS AND PRECAUTIONS General Symptomatic response with DEXILANT does not preclude the presence of gastric malignancy.
Antibiotic Combination Therapy:
Pseudomembranous colitis has been reported with nearly all antibacterial agents, including clarithromycin and amoxicillin, and may range in severity from mild to life threatening. Therefore, it is important to consider this diagnosis in patients who present with diarrhea subsequent to the administration of antibacterial agents.
Treatment with antibacterial agents alters the normal flora of the colon and may permit overgrowth of Clostridia. Studies indicate that a toxin produced by Clostridium difficile is a primary cause of “antibiotic-associated colitis”.
After the diagnosis of pseudomembranous colitis […]