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PRO-LANSOPRAZOLE is a brand name for Lansoprazole, supplied as a capsule (delayed release). The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: PRO-LANSOPRAZOLE (Lansoprazole delayed-release capsules) is indicated in the treatment of conditions where a reduction of gastric acid secretion is required, such as: • Duodenal ulcer • Gastric ulcer • Reflux esophagitis including patients with Barrett’s esophagus, and patients poorly responsive to an adequate course…
Verbatim from this product's HC label. Tap a section to expand.
and 14 CLINICAL TRIALS). 1 Pediatrics Pediatrics (1 to 17 years of age): Based on the data submitted and reviewed by Health Canada, the safety and efficacy of PRO-LANSOPRAZOLE in pediatric patients has been established. 3 Pediatrics).
PRO-LANSOPRAZOLE is indicated for treatment of erosive and non-erosive GERD in children, aged 1 to 17 years. The clinical trial treatment period did not extend beyond 12 weeks. 2 Geriatrics Geriatrics (>65 years of age): Evidence from clinical studies and experience suggests that use in the geriatric population is associated with differences in safety or effectiveness.
4 Geriatrics). PRO-LANSOPRAZOLE (Lansoprazole delayed-release capsules) Page 6 of 94 2 CONTRAINDICATIONS • PRO-LANSOPRAZOLE 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
). 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 When gastric ulcer is suspected, the possibility of malignancy should be excluded before therapy with PRO-LANSOPRAZOLE is instituted as treatment with these drugs may alleviate symptoms and delay diagnosis.
5 Post-Market 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 In the 24-month toxicology study in rats, after 18 months of treatment, Leydig cell hyperplasia increased above the concurrent and historical control level at dosages of 15 mg/kg/day or higher.
Testicular interstitial cell adenoma also occurred in 1 of 30 rats treated with 50 mg/kg/day (13 times the recommended human dose based on body surface area) in a 1-year toxicity study. These changes are associated with endocrine alterations which have not been, to date, observed in humans.
For further details, see 16 NON-CLINICAL TOXICOLOGY, Carcinogenicity.
Hepatic/Biliary/Pancreatic Use in Patients with Hepatic Impairment:
It is recommended that the initial dosing regimen need not be altered for patients with mild or moderate liver disease, but for patients with moderate impairment, doses higher than 30 mg per day should not be administered unless there are compelling clinical indications.
Dose reduction in patients with severe hepatic disease should be considered. PRO-LANSOPRAZOLE (Lansoprazole delayed-release capsules) Page 14 of 94 Immune Allergic reactions (including anaphylaxis) have been reported in patients receiving clarithromycin orally.
, Endocrine and Metabolism 11/2022 7 WARNINGS AND PRECAUTIONS, Gastrointestinal 11/2022 7 WARNINGS AND PRECAUTIONS, Immune 01/2024 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 .................................................................... 5 1 INDICATIONS ................................................................................................................
1 Pediatrics ...................................................................................................................... 2 Geriatrics ......................................................................................................................
5 2 CONTRAINDICATIONS ................................................................................................... 6 3 SERIOUS WARNINGS AND PRECAUTIONS BOX............................................................... 6 4 DOSAGE AND ADMINISTRATION ...................................................................................
1 Dosing Considerations ................................................................................................. 2 Recommended Dose and Dosage Adjustment ............................................................ 4 Administration .............................................................................................................
5 Missed Dose ................................................................................................................. 9 5 OVERDOSAGE ...............................................................................................................
• PRO-LANSOPRAZOLE 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.
• When PRO-LANSOPRAZOLE is used for the eradication of H. pylori infection and active duodenal ulcer disease, the contraindications for amoxicillin and clarithromycin, as found in their corresponding Product Monographs, should be considered.
• Co-administration with rilpivirine is contraindicated. 4 Drug-Drug Interactions.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Lansoprazole in Canada.
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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients on penicillin therapy. These reactions are more apt to occur in individuals with a history of penicillin hypersensitivity and/or a history of sensitivity to multiple allergens.
There have been well documented reports of individuals with a history of penicillin hypersensitivity reactions who have experienced severe hypersensitivity reactions when treated with a cephalosporin. Before initiating therapy with any penicillin, careful inquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins, and other allergens.
If an allergic reaction occurs, amoxicillin should be discontinued and the appropriate therapy instituted. Serious anaphylactic reactions require immediate emergency treatment with epinephrine, oxygen, corticosteroids, and airway management, including intubation, as indicated.
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.
Discontinue PRO-LANSOPRAZOLE 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 Adverse 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 PRO-LANSOPRAZOLE.
5 Post- Market Adverse 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.
7 Drug-Laboratory Test 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 PRO-LANSOPRAZOLE (Lansoprazole delayed-release capsules) Page 15 of 94 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).
Ophthalmologic Retinal atrophy:
In animal studies, retinal atrophy was observed in rats dosed orally for 2 years with PRO-LANSOPRAZOLE at doses of 15 mg/kg/day and above. These changes in rats are believed to be associated with the effects of taurine imbalance and phototoxicity in a susceptible animal model.
Clinical data available from long-term Lansoprazole delayed-release capsules studies are not suggestive of any drug-induced eye toxicity in humans. In humans, there are presently no concerns for ocular safety with short-term Lansoprazole delayed-release capsules treatment and the risks associated with long-term use for nearly 5 years appear to be negligible.
The finding of drug-induced retinal atrophy in the albino rat is considered to be species-specific with little relevance for humans. For further details, see 16 NON-CLINICAL TOXICOLOGY. Renal No […]
9 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING .................................. 10 7 WARNINGS AND PRECAUTIONS .................................................................................. 1 Special Populations ....................................................................................................
1 Pregnant Women ....................................................................................................... 2 Breast-feeding ............................................................................................................
3 Pediatrics .................................................................................................................... 4 Geriatrics ....................................................................................................................
17 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 ..........................................................
4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data ....................................................................................................... 5 Post-Market Adverse Reactions .................................................................................
29 9 DRUG INTERACTIONS .................................................................................................. 2 Drug Interactions Overview .......................................................................................
4 Drug-Drug Interactions .............................................................................................. 5 Drug-Food Interactions ..............................................................................................
6 Drug-Herb Interactions .............................................................................................. 7 Drug-Laboratory Test Interactions .............................................................................
35 10 CLINICAL PHARMACOLOGY ......................................................................................... 1 Mechanism of Action .................................................................................................
2 Pharmacodynamics .................................................................................................... 3 Pharmacokinetics .......................................................................................................
38 11 STORAGE, STABILITY AND DISPOSAL ........................................................................... 42 12 SPECIAL HANDLING INSTRUCTIONS ............................................................................. 42 PART II: SCIENTIFIC INFORMATION ......................................................................................
43 13 PHARMACEUTICAL INFORMATION .............................................................................. 43 14 CLINICAL TRIALS..........................................................................................................
1 Clinical Trials by Indication ......................................................................................... 1 Duodenal Ulcer .........................................................................................................
2 Helicobacter pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence 45 […]