PRODUCT MONOGRAPH COTAZYM. Pancrelipase Preparations

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PRODUCT MONOGRAPH COTAZYM Pancrelipase Preparations Cotazym Capsules: 10,000 USP units (Lipase activity) / 40,000 USP units (amylase activity) / 35,000 USP units (protease activity) Cotazym ECS 8 Capsules:
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PRODUCT MONOGRAPH COTAZYM Pancrelipase Preparations Cotazym Capsules: 10,000 USP units (Lipase activity) / 40,000 USP units (amylase activity) / 35,000 USP units (protease activity) Cotazym ECS 8 Capsules: 10,800 USP units (Lipase activity) / 42,000 USP units (amylase activity) / 45,000 USP units (protease activity) Cotazym ECS 20 Capsules: 25,000 USP units (Lipase activity) / 100,000 USP units (amylase activity) / 100,000 USP units (protease activity) USP Enzymes Digestant Merck Canada Inc route Transcanadienne Kirkland QC Canada H9H 4M7 Date of Approval: February 13, 2015 Submission Control No: Cotazym (Pancrelipase) Page 1 of 14 Table of Contents PART I: HEALTH PROFESSIONAL INFORMATION... 3 SUMMARY PRODUCT INFORMATION... 3 DESCRIPTION... 3 INDICATIONS AND CLINICAL USE... 3 CONTRAINDICATIONS... 3 WARNINGS AND PRECAUTIONS... 4 ADVERSE REACTIONS... 6 DRUG INTERACTIONS... 7 DOSAGE AND ADMINISTRATION... 7 OVERDOSAGE... 8 ACTION AND CLINICAL PHARMACOLOGY... 8 STORAGE AND STABILITY... 8 SPECIAL HANDLING INSTRUCTIONS... 8 DOSAGE FORMS, COMPOSITION AND PACKAGING... 8 PART II: SCIENTIFIC INFORMATION PHARMACEUTICAL INFORMATION CLINICAL TRIALS DETAILED PHARMACOLOGY MICROBIOLOGY TOXICOLOGY REFERENCES PART III: CONSUMER INFORMATION Cotazym (Pancrelipase) Page 2 of 14 COTAZYM (Pancrelipase Preparations) PART I: HEALTH PROFESSIONAL INFORMATION SUMMARY PRODUCT INFORMATION Route of Administration oral Dosage Form / Strength Cotazym Capsule/ 10,000/40,000/35,000 USP units (lipase/amylase/protease) Cotazym ECS 8 Enteric coated capsule/ 10,800/42,000/45,000 USP units (lipase/amylase/protease) Cotazym ECS 20 Enteric coated capsule/ 25,000/100,000/100,000 USP units (lipase/amylase/protease) Clinically Relevant Nonmedicinal Ingredients Cornstarch, pregelatinized starch, sucrose. For a complete listing see Dosage Forms, Composition and Packaging section. DESCRIPTION COTAZYM is a pancreatic enzyme preparation consisting of pancrelipase, an extract derived from porcine pancreatic glands. Pancrelipase contains multiple enzyme classes, including porcine-derived lipases, proteases, and amylases. INDICATIONS AND CLINICAL USE COTAZYM (pancreatic enzymes) is indicated for the treatment of pancreatic insufficiency attributed to cystic fibrosis, chronic pancreatitis, or any other medically defined pancreatic disease that might require pancreatic enzyme therapy. Geriatrics ( 65 years of age): Clinical studies of COTAZYM in geriatric patients have not been conducted. Pediatrics ( 18 years of age): Post approval, several clinical studies have been conducted supporting the safe and effective use of COTAZYM in pediatric patients with established pancreatic insufficiency. CONTRAINDICATIONS Patients who have known hypersensitivity to porcine protein, pancreatic enzymes or any excipients. Cotazym (Pancrelipase) Page 3 of 14 During acute pancreatitis or the acute exacerbation of chronic pancreatitis. WARNINGS AND PRECAUTIONS Serious Warnings and Precautions Pancreatic enzyme products, including COTAZYM have been associated with fibrosing colonopathy (strictures of the ileo-caecum and large intestine) if given at high doses chronically to patients with cystic fibrosis. It is not clear whether this complication is caused by high dosages of pancreatic enzymes, or whether the underlying disease is responsible. Unusual abdominal symptoms should be reviewed to exclude the possibility of colonic damage. COTAZYM cannot be substituted (unit for unit) with other pancreatic enzyme products because they are biological products and, therefore, differ in their manufacturing processes, formulations, exact composition, enzymatic activities, stability and bioactivity in the small intestine, so the response of the patient to the estimated dose must be monitored and adjusted as necessary. Special attention to the response of the patient is required during any change in treatment from one pancreatic enzyme product to another. General Should hypersensitivity develop, discontinue medication and treat the patient symptomatically. It is important to ensure adequate hydration in patients at all times during therapy with pancreatic enzymes. The capsules should not be chewed or crushed because the coating (that is formulated to deliver the enzymes to the correct place in the intestines) will be destroyed. If the capsules are opened and the contents shaken onto soft food, it should not have an alkaline ph (e.g., milk, custard, ice cream, other dairy products) because the enteric coating will dissolve prematurely and limit absorption (see DOSAGE and ADMINISTRATION). To avoid irritation of the mouth, lips and tongue, opened capsules should be swallowed immediately before meals or snacks to minimize the probability of retaining some of the drug in the mouth. Proteolytic enzymes present in COTAZYM, when retained in the mouth, may begin to digest the mucous membranes and cause ulcerations. Therefore, in the event that capsules are opened for sprinkling the powder on food or drink or for any other reason, care should be taken so that powder is not spilled on hands or inhaled since it may prove irritating to the skin or mucous membranes. A proper balance between fat, protein and starch intake must be maintained to avoid temporary indigestion. Cotazym (Pancrelipase) Page 4 of 14 Any change in pancreatic enzyme replacement therapy (e.g., dose or brand of medication) should be made cautiously and only under medical supervision. Pancreatic extracts can form insoluble complexes with folic acid, resulting in folic acid deficiency. Pancreatic enzyme replacement therapy, in patients in whom both the exocrine and endocrine pancreas are not functioning, may interact with insulin therapy of diabetes. High-dose pancreatin mini-microspheres improve but do not fully normalize fat absorption, possibly because of the residual influence of diabetes and malnutrition on absorptive function. Since control of blood glucose may be brittle in malnourished, insulin-dependent patients, enzyme adjustment should be carefully supervised in-hospital to avoid exacerbation of pancreatic dysfunction. Potential Viral Exposure from the Product Source As with all currently marketed porcine pancreatin products, COTAZYM is sourced from pancreatic tissue from swine used for food consumption. Although the risk that COTAZYM will transmit an infectious agent to humans has been reduced by the testing and inactivation of certain viruses during manufacturing, there is a theoretical risk for transmission of viral disease, including diseases caused by novel or unidentified viruses. The presence of porcine viruses that might infect humans cannot be definitely excluded. However, no cases of transmission of an infectious illness associated with the use of porcine pancreatic extracts have been reported, whereas they have been used for a long time. Carcinogenesis and Mutagenesis Long-term studies in animals have not been performed to evaluate carcinogenic potential. Hepatic/Biliary/Pancreas COTAZYM (or pancreatic enzyme products) may cause hyperuricosuria and hyperuricemia with very high doses. Also at very high doses, perianal irritation and inflammation may occur. Special Populations Pregnant Women: There is insufficient data from the use of COTAZYM in pregnant women. Although some animal studies have been conducted, no adequate, well controlled studies have been conducted in pregnant women. COTAZYM should only be used during pregnancy if, in the opinion of the physician, the potential benefits outweigh the potential risks. Nursing Women: There is insufficient data to assess the risks. Pancreatic enzymes act locally in the gastrointestinal tract, and cannot be absorbed in their intact state systemically. Some of the constituent amino acids and nucleic acids are probably absorbed with dietary protein. However, the possibility of protein constituents being secreted into breast milk cannot be excluded. COTAZYM should be used only if, in the opinion of the physician, the potential benefits outweigh the potential risks. Pediatrics ( 18 years of age) Post approval, several clinical studies have been conducted supporting the safe and effective use of COTAZYM in pediatric patients with established pancreatic insufficiency. Cotazym (Pancrelipase) Page 5 of 14 Geriatrics ( 65 years of age): Clinical studies of COTAZYM in geriatric patients have not been conducted. ADVERSE REACTIONS Adverse Drug Reaction Overview The most common adverse reactions are abdomenal discomfort and pain. Other gastrointestinal reactions are less common and include abnormal stool and diarrhea. Nausea and vomiting have been reported, but these are not common. With high doses, perianal irritation and inflammation have been reported (see WARNINGS and PRECAUTIONS). At extremely high doses, hyperuricosuria and hyperuricaemia have been reported. Fibrosing colonopathy have been reported in cystic fibrosis patients (see WARNINGS and PRECAUTIONS). Allergic or hypersensitivity reactions of the skin have been reported. Clinical Trial Adverse Drug Reactions Because clinical trials are conducted under very specific conditions the adverse reaction rates observed in the clinical trials may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug. Adverse drug reaction information from clinical trials is useful for identifying drug-related adverse events and for approximating rates. The following adverse reactions have been observed for pancreatic enzyme products during clinical trials with the below indicated frequencies. Gastrointestinal Disorders: Very common ( 1/10): abdominal pain Common ( 1/100 to 1/10): abdominal distention, constipation, diarrhea, nausea, vomiting. Gastrointestinal disorders are mainly associated with the underlying disease. Similar or lower incidences compared to placebo were reported for diarrhea and for abdominal pain. Skin and Subcutaneous Tissue Disorders: Uncommon ( 1/1,000 to 1/100): rash Post-Market Adverse Drug Reactions The following adverse events have been reported during post-marketing use for pancreatic enzyme products. Because these reactions are reported voluntarily from a population of unknown size, it is not possible to reliably estimate their frequency. Cotazym (Pancrelipase) Page 6 of 14 Gastrointestinal Disorders: Immune System Disorders: Strictures of the ileo-caecum and large bowel (fibrosing colonopathy) have been reported in patients with cystic fibrosis taking high doses of pancreatin preparations. Hypersensitivity (anaphylactic reactions) Allergic reactions mainly but not exclusively limited to the skin have been observed and additionally identified as adverse reactions during post-approval use. Skin and Subcutaneous Tissue Disorders: Pruritus, urticaria DRUG INTERACTIONS There have been no reports of interactions with other drugs or other forms of interaction. DOSAGE AND ADMINISTRATION Dosing Considerations Patients with pancreatic insufficiency should consume a high-calorie, unrestricted fat diet appropriate for their age and clinical status. A nutritional assessment should be performed regularly as a component of routine care, and additionally when the dosage of pancreatic enzyme replacement is made. Dosage should be adjusted according to the severity of the exocrine pancreatic enzyme deficiency. The number of capsules, or dosage strength given with meals and/or snacks should be estimated by assessing at which dose steatorrhea is minimized and good nutritional status is maintained. The capsules should be taken orally with each meal or snack. They can either be swallowed whole, preferably with some fluid, or can be opened and the contents sprinkled on food or drink. If the capsules are opened and the contents shaken onto soft food, it should not have an alkaline ph (e.g., milk, custard, ice cream, other dairy products) because the enteric coating will dissolve prematurely and limit absorption (see WARNINGS and PRECAUTIONS). Take the medication immediately. Do not store it to be taken later. Recommended Dose and Dosage Adjustment Average dose: 1 to 3 capsules with each meal and 1 capsule with each snack as directed by physician. Cotazym (Pancrelipase) Page 7 of 14 OVERDOSAGE For management of a suspected drug overdose, contact your regional Poison Control Centre. Extremely high dosages of pancreatic enzymes have been reported to cause hyperuricosuria and hyperuricaemia. Most cases responded to supportive measures, including discontinuation of the enzyme therapy and ensuring adequate hydration. ACTION AND CLINICAL PHARMACOLOGY Mechanism of Action COTAZYM delivers predictable biologically active pancreatic enzymes (lipase, amylase and protease) into the duodenum. The enzymes catalyze the breakdown of fats into glycerol and fatty acids, proteins into proteases and derivatives, and starch into dextrins and sugars. STORAGE AND STABILITY Store in a tightly closed container at a temperature not exceeding 25 o C. Do not freeze. SPECIAL HANDLING INSTRUCTIONS Not applicable for COTAZYM DOSAGE FORMS, COMPOSITION AND PACKAGING COTAZYM : Each clear capsule contains: lipase activity of 10,000 USP units, amylase activity of 40,000 USP units and protease activity of 35,000 USP units. Nonmedicinal ingredients: gelatin, magnesium stearate, opacode S (print ink), precipitated calcium carbonate, pregelatinized starch, silicon dioxide, sodium lauryl sulphate and talc. Tartrazine-free. Bottles of 100 and 1,000. COTAZYM ECS 8: Each clear capsule with enteric coated microspheres contains: lipase activity of 10,800 USP units, amylase activity of 42,000 USP units and protease activity of 45,000 USP units. Nonmedicinal ingredients: cellulose acetate phthalate, colloidal silicon dioxide, cornstarch, diethyl phthalate, gelatin, opacode S (print ink), propylene glycol, propylene glycol monostearate, povidone, silicon dioxide, sodium lauryl sulphate, sucrose and talc. Tartrazine-free. Bottles of 100 and 500. COTAZYM ECS 20: Each clear orange capsule with enteric coated microspheres contains: lipase activity of 25,000 USP units, amylase activity of 100,000 USP units and protease activity of 100,000 USP units. Nonmedicinal ingredients: cellulose acetate phthalate, colloidal silicon dioxide, cornstarch, D&C Yellow No. 10, diethyl phthalate, FD&C Red No. 40, gelatin, opacode Cotazym (Pancrelipase) Page 8 of 14 S (print ink), propylene glycol, propylene glycol monostearate, povidone, silicon dioxide, sodium lauryl sulphate, sucrose and talc. Tartrazine-free. Bottles of 100. Cotazym (Pancrelipase) Page 9 of 14 PART II: SCIENTIFIC INFORMATION PHARMACEUTICAL INFORMATION Drug Substance Proper name: Pancrelipase Chemical name: Molecular formula and molecular mass: Structural formula: Not Applicable Not Applicable Not Applicable Physicochemical properties: COTAZYM is a pancreatic enzyme preparation consisting of pancrelipase, an extract derived from porcine pancreatic glands. Pancrelipase contains multiple enzyme classes, including porcine-derived lipases, proteases, and amylases. Pancreatin is a cream colored granular powder with a faint, characteristic meaty odor. CLINICAL TRIALS Information not available for COTAZYM. DETAILED PHARMACOLOGY Information not available for COTAZYM. MICROBIOLOGY Information not available for COTAZYM. TOXICOLOGY Information not available for COTAZYM. Cotazym (Pancrelipase) Page 10 of 14 REFERENCES Cotazym (Pancrelipase) Page 11 of 14 IMPORTANT: PLEASE READ PART III: CONSUMER INFORMATION COTAZYM (Pancrelipase Preparations) This leaflet is part III of a three-part Product Monograph published when COTAZYM was approved for sale in Canada and is designed specifically for Consumers. This leaflet is a summary and will not tell you everything about COTAZYM. Contact your doctor or pharmacist if you have any questions about the drug. ABOUT THIS MEDICATION What the medication is used for: COTAZYM is used for the treatment of pancreatic insufficiency attributed to cystic fibrosis, chronic pancreatitis, or any other medically defined pancreatic disease that might require pancreatic enzyme therapy, as determined by the doctor. What it does: COTAZYM is a prescription medicine used to treat people who cannot digest food normally because their pancreas does not make enough enzymes due to cystic fibrosis, swelling of the pancreas that lasts a long time (chronic pancreatitis), removal of some or all of the pancreas (pancreatectomy), or other conditions. COTAZYM may help your body use fats, proteins, and sugars from food. It contains a mixture of digestive enzymes including lipases, proteases, and amylases from pig pancreas. When it should not be used: COTAZYM should not be used if you: have known hypersensitivity to porcine protein, pancreatic enzymes or any excipients; and/or during acute pancreatitis or the acute exacerbation of chronic pancreatitis What the medicinal ingredient is: Lipase, amylase, protease, mixed conjugated bile salts and cellulose. What the important nonmedicinal ingredients are: Capsule print ink, cellulose acetate phthalate, colloidal silicon dioxide, cornstarch, diethyl phthalate, gelatin, magnesium stearate, povidone, precipitated calcium carbonate, pregelatinized starch, propylene glycol, silicon dioxide, sodium lauryl sulphate, sucrose, talc, titanium dioxide, red food dye (FD&C Red No. 40), yellow food dye (D&C Yellow No. 10). What dosage forms it comes in: Capsules containing 10,000 units of lipase, 40,000 units of amylase and 35,000 units of protease (Cotazym ). Enteric coated capsules containing 10,800 units of lipase, 42,000 units of amylase and 45,000 units of protease (Cotazym ECS 8). Enteric coated capsules containing 25,000 units of lipase, 100,000 units of amylase and 100,000 units of protease (Cotazym ECS 20). WARNINGS AND PRECAUTIONS NG Serious Warnings and Precautions COTAZYM may increase your chance of having a rare bowel disorder called fibrosing colonopathy. This condition is serious and may require surgery. The risk of having this condition may be reduced by following the dosing instructions that your doctor gave you. Talk to your doctor about all the drugs you are taking before taking COTAZYM. BEFORE you use COTAZYM talk to your doctor or pharmacist if you: Are allergic to pork (pig) products Have a history of intestinal blockage or scarring or thickening of your bowel wall (fibrosing colonopathy) Have gout, kidney disease, or high blood uric acid (hyperuricemia or hyperuricosuria) Have trouble swallowing capsules Have any other medical condition Are pregnant, plan to become pregnant, are breastfeeding or plan to breast-feed. It is not known if COTAZYM will harm your unborn baby or if COTAZYM passes into your breast milk. Enzymes such as COTAZYM are broken down in your gastrointestinal tract, and thus are not absorbed into the body as intact enzymes. Tell your doctor all the medications that you take, including prescription and nonprescription drugs, natural health products, vitamins and herbs. Talk to your doctor if the following occurs while taking COTAZYM : stomach area (abdominal) pain bloating trouble passing stool (having bowel movements) nausea, vomiting, or diarrhea Take COTAZYM exactly as prescribed. Do not take more or less COTAZYM than directed by your doctor. INTERACTIONS WITH THIS MEDICATION As with all other pancrelipase lipase preparations, interactions with COTAZYM is possible. Therefore, tell your doctor all Cotazym (Pancrelipase) Page 12 of 14 IMPORTANT: PLEASE READ the medications that you take, including prescription and nonprescription drugs, natural health products, vitamins and herbs. PROPER USE OF THIS MEDICATION Take COTAZYM exactly as prescribed by your healthcare provider. You should not switch COTAZYM with any other pancreatic enzyme product without first talking to your doctor. Do not take more capsules in a day than the number your doctor tells you to take (total daily dose). Always take COTAZYM with a meal or snack a
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