CREON 10000 CAPSULE, COATED PELLETS 150MG [SIN13945P]

Product Info

CREON 10000 CAPSULE, COATED PELLETS 150MG

[SIN13945P]

Indications
Creon 10 000 is indicated for the treatment of exocrine pancreatic insufficiency due to cystic fibrosis, chronic pancreatitis, pancreatectomy, or other conditions.

Dosage and administration
The posology aims at individual needs and depends on the severity of the disease and the composition of food.

It is recommended to take the enzymes during or immediately after the meals.
The capsules should be swallowed intact, without crushing or chewing, with enough fluid during or after each meal or snack. When swallowing of capsules is difficult (e.g. small children or elderly patients), the capsules may be carefully opened and the pellets may be added to acidic soft food [pH < 5.5] that does not require chewing, or the pellets can be taken with liquid [pH < 5.5]. This could be apple sauce or yogurt or fruit juice with a pH less than 5.5, e.g. apple, orange or pineapple juice. This mixture should not be stored.

Crushing and chewing of the pellets 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.

Care should be taken that no product is retained in the mouth.

It is important to ensure adequate hydration at all times, especially during periods of increased loss of fluids. Inadequate hydration may aggravate constipation. Any mixture of the pellets with food or liquids should be used immediately and should not be stored.

Posology in cystic fibrosis
Dosage recommendations for pancreatic enzyme replacement therapy were published following the Cystic Fibrosis Foundation Consensus Conferences. Creon 10 000 should be administered in a manner consistent with the recommendations of the Conferences provided in the following paragraphs. Patients may be dosed on a fat ingestion-based or actual body weight-based dosing scheme.

Additional recommendations for pancreatic enzyme therapy in patients with exocrine pancreatic insufficiency due to chronic pancreatitis or pancreatectomy are based on a clinical trial conducted in these populations.

Infants (up to 12 months)
Infants may be given 2,000 to 4,000 lipase units per 120 mL of formula or per breast-feeding. Do not mix Creon 10 000 capsule contents directly into formula or breast milk prior to administration.

Children Older than 12 Months and Younger than 4 Years
Enzyme dosing should begin with 1,000 lipase units/kg of body weight per meal for children less than age 4 years to a maximum of 2,500 lipase units/kg of body weight per meal (or less than or equal to 10,000 lipase units/kg of body weight per day), or less than 4,000 lipase units/g fat ingested per day.

Children 4 Years and Older and Adults
Enzyme dosing should begin with 500 lipase units/kg of body weight per meal for those older than age 4 years to a maximum of 2,500 lipase units/kg of body weight per meal (or less than or equal to 10,000 lipase units/kg of body weight per day), or less than 4,000 lipase units/g fat ingested per day.

Posology in other pancreatic exocrine insufficiency disorders
Dosage should be individualized by patient according to the degree of maldigestion and the fat content of the meal. The required dose for a meal ranges from about 25 000 to 80 000 Ph. Eur. units of lipase and half of the individual dose for snacks.

Limitations on Dosing
Dosing should not exceed the recommended maximum dosage set forth by the Cystic Fibrosis Foundation Consensus Conferences Guidelines. If symptoms and signs of steatorrhea persist, the dosage may be increased by the healthcare professional. Patients should be instructed not to increase the dosage on their own. There is great inter-individual variation in response to enzymes; thus, a range of doses is recommended. Changes in dosage may require an adjustment period of several days. If doses are to exceed 2,500 lipase units/kg of body weight per meal, further investigation is warranted. Doses greater than 2,500 lipase units/kg of body weight per meal (or greater than 10,000 lipase units/kg of body weight per day) should be used with caution and only if they are documented to be effective by 3-day fecal fat measures that indicate a significantly improved coefficient of fat absorption. Doses greater than 6,000 lipase units/kg of body weight per meal have been associated with colonic stricture, indicative of fibrosing colonopathy, in children less than 12 years of age. Patients currently receiving higher doses than 6,000 lipase units/kg of body weight per meal should be examined and the dosage either immediately decreased or titrated downward to a lower range.

Contraindications
Hypersensitivity to the active substance or to any of the excipients.