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APO-DEXLANSOPRAZOLE 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: APO-DEXLANSOPRAZOLE (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…
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 mga, 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 APO-DEXLANSOPRAZOLE is necessary for patients with mild hepatic impairment (Child- Pugh Class A).
APO-DEXLANSOPRAZOLE 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 APO-DEXLANSOPRAZOLE can be taken without regard to food or the timing of food. APO-DEXLANSOPRAZOLE should be swallowed whole with plenty of water.
• Alternatively, APO-DEXLANSOPRAZOLE capsules can be opened and administered as follows: • Administration with Applesauce 1. Place one tablespoon of applesauce into a clean container APO-DEXLANSOPRAZOLE (Dexlansoprazole Delayed-Release Capsules) Page 6 of 48 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 dexlansoprazole delayed-release capsules 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 APO-DEXLANSOPRAZOLE (Dexlansoprazole Delayed-Release Capsules) Page 10 of 48 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:
, Immune 06/2023 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES .................................................................................................
2 TABLE OF CONTENTS.................................................................................................................... 2 PART I: HEALTH PROFESSIONAL INFORMATION...........................................................................
4 1 INDICATIONS .................................................................................................................... 1 Pediatrics .....................................................................................................................
2 Geriatrics ..................................................................................................................... 4 2 CONTRAINDICATIONS ......................................................................................................
4 4 DOSAGE AND ADMINISTRATION ...................................................................................... 1 Dosing Considerations .................................................................................................
2 Recommended Dose and Dosage Adjustment ............................................................ 4 Administration ............................................................................................................ 5 Missed Dose ................................................................................................................
6 5 OVERDOSAGE................................................................................................................... 6 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ...................................... 7 7 WARNINGS AND PRECAUTIONS .......................................................................................
• APO-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.
• APO-DEXLANSOPRAZOLE is contraindicated with co-administration of rilpivirine. 4 Drug-Drug Interactions. APO-DEXLANSOPRAZOLE (Dexlansoprazole Delayed-Release Capsules) Page 5 of 48
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. 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.
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.
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 APO-DEXLANSOPRAZOLE.
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, APO-DEXLANSOPRAZOLE 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.
APO-DEXLANSOPRAZOLE (Dexlansoprazole Delayed-Release Capsules) Page 11 of 48 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 dexlansoprazole delayed-release capsules. Exposure in clinical trials was very limited. APO-DEXLANSOPRAZOLE 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 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, APO-DEXLANSOPRAZOLE 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 dexlansoprazole delayed-release capsules 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.
APO-DEXLANSOPRAZOLE 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):
APO-DEXLANSOPRAZOLE is indicated for adolescents 12 to 17 years of age, and is supported by evidence from adequate and […]
1 Special Populations ................................................................................................... 1 Pregnant Women ......................................................................................................
2 Breast-feeding ........................................................................................................... 3 Pediatrics ...................................................................................................................
4 Geriatrics ................................................................................................................... 12 8 ADVERSE REACTIONS .....................................................................................................
1 Adverse Reaction Overview....................................................................................... 2 Clinical Trial Adverse Reactions ................................................................................. 1 Clinical Trial Adverse Reactions – Pediatrics..............................................................
3 Less Common Clinical Trial Adverse Reactions .......................................................... 5 Post-Market Adverse Reactions ................................................................................ 16 9 DRUG INTERACTIONS .....................................................................................................
2 Drug Interactions Overview....................................................................................... 4 Drug-Drug Interactions ..............................................................................................
5 Drug-Food Interactions ............................................................................................. 6 Drug-Herb Interactions..............................................................................................
7 Drug-Laboratory Test Interactions ............................................................................ 22 10 CLINICAL PHARMACOLOGY ............................................................................................
1 Mechanism of Action ................................................................................................ 2 Pharmacodynamics ...................................................................................................
3 Pharmacokinetics ...................................................................................................... 24 11 STORAGE, STABILITY AND DISPOSAL ..............................................................................
28 12 SPECIAL HANDLING INSTRUCTIONS ................................................................................ 28 PART II: SCIENTIFIC INFORMATION ............................................................................................
29 13 PHARMACEUTICAL INFORMATION ................................................................................. 29 14 CLINICAL TRIALS .............................................................................................................
1 Clinical Trials by Indication ........................................................................................ 29 Healing of Erosive Esophagitis in Adult Patients ..................................................................
29 Maintenance of Healed Erosive Esophagitis in Adult Patients ............................................ 32 Symptomatic GERD in Adult Patients .................................................................................. 34 Healing of EE, Maintenance of Healed EE: Adolescents 12 to 17 Years of Age ....................
35 Symptomatic Non-Erosive GERD: Adolescents 12 to 17 Years of Age ................................. 2 Comparative Bioavailability Studies […]