What is CREON MINIMICROSPHERES 35?

CREON MINIMICROSPHERES 35 35700 UNIT contains AMYLASE : 35700 UNIT PROTEASE : 2240 UNIT LIPASE : 35000 UNIT. It is listed in the Health Canada Drug Product Database under DIN 02494639, held by BGP PHARMA ULC, supplied as CAPSULE (DELAYED RELEASE) for ORAL administration. Health Canada currently lists it as marketed, status dated 26-Jan-2021. Nexara Health is a licensed Canadian wholesale distributor (DEL 3-002896-A) and can source this product for hospitals, pharmacies and clinics. Availability and lead time are confirmed per order.

What is CREON MINIMICROSPHERES 35 used for?

CREON MINIMICROSPHERES® (pancreatin) is indicated in pediatric and adult patients for: treatment of pancreatic exocrine insufficiency (PEI) attributed to cystic fibrosis, chronic pancreatitis, or any other medically defined pancreatic disease that might require pancreatic enzyme therapy including, but not limited to: cystic fibrosis, chronic pancreatitis, pancreatic surgery, gastrectomy, pancreatic cancer, gastrointestinal bypass surgery (e.g. Billroth II gastroenterostomy), ductal obstruction of the pancreas or common bile duct (e.g. from neoplasm), Shwachman-Diamond Syndrome, status after an attack of acute pancreatitis and initiation of enteral or oral feeding.

Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.

Product details and regulatory record

How is it administered?

Dosage should be adjusted according to the severity of the pancreatic exocrine 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. It is important to ensure adequate hydration at all times. Any mixture of the minimicrospheres with food or liquids should be used immediately and should not be stored. Cystic Fibrosis: Infants: Initiate at 2,000 to 5,000 lipase units for each feeding (usually 120 mL), adjusted up to a dose no greater than 2,500 lipase units per kilogram per feeding with a maximum daily dose of 10,000 lipase units per kilogram per day. Children Younger Than 4 Years of Age: Initiate with 1,000 lipase units per kilogram body weight per meal. Half the standard dose is given with snacks. Do not exceed 10,000 lipase units per kilogram body weight per day or 4,000 lipase units/gram fat intake. Children Older Than 4 Years of Age and Adults: Initiate with 500 lipase units per kilogram body weight per meal. Half the standard dose is given with snacks. Do not exceed 10,000 lipase units per kilogram body weight per day or 4,000 lipase units/gram fat intake. Other Conditions Associated With Pancreatic Exocrine Insufficiency (Adults): The required dose for a meal ranges from about 25,000 to 80,000 units of lipase and half of the required dose for snacks. Dosage should be individualized according to the degree of maldigestion and the fat content of the meal. In certain conditions, such as with acute pancreatitis, CREON MINIMICROSPHERES® should be taken when food intake has started again. Administration: CREON MINIMICROSPHERES® MICRO is available as gastro-resistant granules (minimicrospheres) dosed with a spoon. CREON MINIMICROSPHERES® 10, 20, 25 and 35 are available as capsules filled with gastro-resistant granules (minimicrospheres). The capsules should be swallowed intact, without crushing or chewing, with enough fluid during or after each meal or snack. It is recommended to take the enzymes during or immediately after the meals. When swallowing of capsules is difficult, they may be opened. The minimicrospheres can be added to small amounts of acidic soft food (pH < 5.5) that do not require chewing such as apple sauce or yogurt, or be taken with acidic liquid (pH < 5.5) such as apple, orange or pineapple juice. This mixture should not be stored. Alternatively, the minimicrospheres can be mixed with a small amount of milk on a (weaning) spoon and administered to the infant immediately. The minimicrospheres should not be added to a baby's bottle. The soft food or fluid mixture should be swallowed immediately without crushing, chewing or holding in the mouth, and followed with water or juice to ensure complete ingestion. Mixtures with food or liquids should be used immediately and not stored, otherwise the protective enteric coating may dissolve. Care should be taken to ensure that no product is retained in the mouth. Crushing and chewing of the minimicrospheres or mixing with food or fluid with a pH greater than 5.5 can disrupt the protective enteric coating. This can result in early release of enzymes in the oral cavity and may lead to reduced efficacy and irritation of the mucous membranes. Missed Dose: If a dose is missed, the patient should take their next dose as usual with their next meal. The patient should not double the dose.

Included because it drives pack selection and wastage. Consult the monograph.

How is it stored and handled?

Store CREON MINIMICROSPHERES® at temperatures not exceeding 25°C in a tightly-closed container to protect from moisture. Once opened, store at temperatures not exceeding 25°C, keep the container tightly-closed to protect from moisture and use within 6 months. Keep out of reach and sight of children.

How is it supplied?

CREON MINIMICROSPHERES® MICRO is available as round, light brown gastro-resistant granules (minimicrospheres) in glass bottles of 20 grams. The bottle comes in a carton box with a polystyrene dosing spoon. One spoonful (100 mg) contains minimicrospheres corresponding to (Ph.Eur. units): 5,000 units of lipase, 5,100 units of amylase, and 320 units of protease. CREON MINIMICROSPHERES® 10 is available as capsules with a brown opaque cap and a transparent body, filled with brownish granules. It is available in HDPE bottles of 100 capsules. One capsule contains minimicrospheres corresponding to (Ph. Eur. units) 10,000 units of lipase, 11,200 units of amylase, and 730 units of protease. CREON MINIMICROSPHERES® 20 is available as capsules with a brown opaque cap and a transparent body, filled with brownish granules. It is available in HDPE bottles of 100 capsules. One capsule contains minimicrospheres corresponding to (Ph. Eur. units) 20,000 units of lipase, 22,400 units of amylase, and 1,460 units of protease. CREON MINIMICROSPHERES® 25 is available as capsules with a Swedish orange opaque cap and a transparent body, filled with brownish granules. It is available in HDPE bottles of 100 capsules. One capsule contains minimicrospheres corresponding to (Ph. Eur. units) 25,000 units of lipase, 25,500 units of amylase, and 1,600 units of protease. CREON MINIMICROSPHERES® 35 is available as capsules with a burnt orange cap and a transparent body, filled with brownish granules. It is available in HDPE bottles of 100 capsules. One capsule contains minimicrospheres corresponding to (Ph. Eur. units) 35,000 units of lipase, 35,700 units of amylase, and 2,240 units of protease.

Contraindications

CREON MINIMICROSPHERES® is contraindicated in patients who are hypersensitive to this drug (porcine protein or pancreatic enzymes) or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.

Warnings and precautions

Pancreatic enzyme products, including CREON MINIMICROSPHERES®, 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. Unusual abdominal symptoms should be reviewed to exclude the possibility of colonic damage, especially if the patient is taking in excess of 10,000 units of lipase/kg body weight/day or more than 4,000 units of lipase/gram fat intake. CREON MINIMICROSPHERES® 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. 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. Potential Viral Exposure from the Product Source: As with all currently marketed porcine pancreatin products, CREON MINIMICROSPHERES® is sourced from pancreatic tissue from swine used for food consumption. Although the risk that CREON MINIMICROSPHERES® 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. CREON MINIMICROSPHERES® may cause hyperuricosuria and hyperuricemia with extremely high doses.

What can be used instead?

Other Canadian products sharing ATC code A09AA02 MULTIENZYMES (LIPASE, PROTEASE ETC). 14 of 65 DINs in this group are currently marketed — marketed products are listed first, because that is what can actually be bought. These tables describe supply, not clinical equivalence: substitution rests with the prescriber or pharmacist, and interchangeability is determined provincially.