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SANDOZ 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: Sandoz 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…
Verbatim from this product's HC label. Tap a section to expand.
and 14 CLINICAL TRIALS). 1 Pediatrics Pediatrics (6 to 17 years of age): Based on the data submitted and reviewed by Health Canada, the safety and efficacy of Sandoz Lansoprazole in pediatric patients has been established. 3 Pediatrics).
Sandoz Lansoprazole is indicated for treatment of erosive and non-erosive GERD in children, aged 6 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). 2 CONTRAINDICATIONS • 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 Sandoz Lansoprazole is instituted as treatment with these drug 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 Sandoz Lansoprazole (lansoprazole delayed-release capsules) Page 14 of 95 there are compelling clinical indications.
Dose reduction in patients with severe hepatic disease should be considered. Immune Allergic reactions (including anaphylaxis) have been reported in patients receiving clarithromycin orally. Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients on penicillin therapy.
, Hepatic/Biliary/Pancreatic). Patients with Renal Impairment • No dosage modification of Sandoz Lansoprazole is necessary (see 7 WARNINGS AND PRECAUTIONS, Renal). 4 Geriatrics). 4 Administration Sandoz Lansoprazole should be taken daily before breakfast.
Where the product may be used twice daily, it should be taken prior to breakfast and another meal. Sandoz Lansoprazole capsules should be swallowed whole with water. Sandoz Lansoprazole capsules SHOULD NOT BE CRUSHED, CHEWED, BROKEN OR CUT.
5 Missed Dose If a dose of this medication is missed, patients should be instructed to take it as soon as possible. However, if the next scheduled dose is due, the patient should not take the missed dose, and should be instructed to take the next dose on time.
Patients should be instructed not to take two doses at one time to make up for a missed dose. Sandoz Lansoprazole (lansoprazole delayed-release capsules) Page 10 of 95 5 OVERDOSAGE As in all cases where overdosing is suspected, treatment should be supportive and symptomatic.
Any unabsorbed material should be removed from the gastrointestinal tract, and the patient should be carefully monitored. Lansoprazole is not removed from the circulation by hemodialysis. In one reported case of overdose, the patient consumed 600 mg of lansoprazole with no adverse reaction.
7 times the recommended human dose based on body surface area) did not produce deaths or any clinical signs. 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING Table 1. Dosage Forms, Strengths, Composition and Packaging Route of Administration Dosage Form / Strength/Composition Non-medicinal Ingredients Oral Capsule (delayed-release) 15 mg, 30 mg D&C yellow No.
10, FD&C blue No. 1 (30 mg capsules only), FD&C green No. 3 (15 mg capsules only), FD&C red No. 3, gelatin, hydroxypropyl cellulose, hypromellose, macrogol, maize starch, magnesium carbonate, methacrylic acid-ethyl acrylate copolymer, polysorbate 80, silica colloidal anhydrous, sucrose, sugar spheres, talc, titanium dioxide.
• 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 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.
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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 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 Sandoz 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 Sandoz Lansoprazole (lansoprazole delayed-release capsules) Page 15 of 95 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).
Ophthalmologic Retinal atrophy:
In animal studies, retinal atrophy was observed in rats dosed orally for 2 years with 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 […]
Sandoz Lansoprazole (lansoprazole delayed-release capsules) Sandoz Lansoprazole is supplied in delayed-release capsules for oral administration. The delayed-release capsules contain the active ingredient, lansoprazole, in the form of enteric- coated granules and are available in two dosage strengths: 15 mg and 30 mg of lansoprazole per capsule.
Sandoz Lansoprazole is available as 15 mg, pink cap-green body capsules imprinted with “15” in white ink on the body and containing white to off white pellets. The capsules are available in bottles of 100. Sandoz Lansoprazole is available as 30 mg pink cap-black body capsules imprinted with “30” in white ink on the body and containing white to off white pellets.
The capsules are available in bottles of 100 and also approved in bottles of 500. For management of a suspected drug overdose, contact your regional poison control centre. Sandoz Lansoprazole (lansoprazole delayed-release capsules) Page 11 of 95 7 WARNINGS AND PRECAUTIONS Please see 3 SERIOUS WARNINGS AND PRECAUTIONS BOX.
General Gastric Malignancy:
Symptomatic response to therapy with lansoprazole delayed-release capsules does not preclude the presence of gastric malignancy.
Pseudomembranous Colitis:
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 has been established, therapeutic measures should be initiated. Mild cases of pseudomembranous colitis usually respond to discontinuation of the drug alone. In moderate to severe cases, consideration should be given to management with fluids and electrolytes, protein supplementation, and treatment with an antibacterial drug effective against Clostridium difficile colitis.
Clostridium Difficile-Associated Diarrhea:
Decreased gastric acidity due to any means, including proton pump inhibitors (PPIs), increases gastric counts of bacteria normally present in the gastrointestinal tract. Treatment with PPIs can lead to an increased risk of gastrointestinal infections such as Salmonella, Campylobacter and Clostridium difficile.
An increased risk for Clostridium difficile infection (CDI) and Clostridium difficile-associated diarrhea (CDAD) has been observed in association with PPI use in several observational studies. CDI/CDAD should be considered in the differential diagnosis for diarrhea that does not improve.
Additional risk factors for CDI and CDAD include recent hospitalization, the use of antibiotics, old age and the presence of co-morbidities. Patients should be prescribed PPIs at the lowest dose and for the shortest duration required for the condition being treated and be reassessed to ascertain whether continued PPI therapy remains beneficial.
Concomitant Use with Methotrexate:
Literature suggests that concomitant use of PPIs with methotrexate (primarily at high dose) may elevate and prolong serum levels of methotrexate and/or its metabolite, possibly leading to methotrexate toxicities. 4 Drug-Drug Interactions).
Sandoz Lansoprazole (lansoprazole delayed-release capsules) Page 12 of 95 H. pylori Eradication and Compliance: To avoid failure of the eradication treatment with a potential […]