DOSAGE AND ADMINISTRATION
The enzymatic activity of ULTRASE® MT (pancrelipase) Capsules is expressed in U.S.P. units. The smallest effective dose should be used. Dosage should be adjusted according to the severity of the exocrine pancreatic insufficiency. Begin therapy with one or two capsules with meals or snacks and adjust dosage according to symptoms. The number of capsules or capsule strength given with meals and/or snacks should be estimated by assessing which dose minimizes steatorrhea and maintains good nutritional status. Dosages should be adjusted according to the response of the patient. Where swallowing of capsules is difficult, they may be opened and the minitablets added to a small quantity of a soft food (e.g., applesauce, gelatin, etc.) that does not require chewing, and swallowed immediately. It is recommended that the total dose of pancrelipase being ingested for a meal or snack be dispersed equally (with fluids) before, during, and after the meal or snack.
Suggestions For The Use Of Pancreatic Enzymes In Cystic Fibrosis 13
- Patients should be receiving optimal diet for age and clinical status, recognizing
that those with failure to thrive or malnutrition require additional calories
and other nutrients for catch-up growth.
- Nutrition assessment should be a part of routine clinical evaluations.
- Initial dosing of pancreatic enzyme supplements should begin with 500 lipase
U/kg/meal using enteric-coated minitablet products.
- Patients should be reassessed 2-4 weeks after initiation of therapy. The
following items should be assessed:
- Clinical status, e.g., abdominal symptoms and exam;
- Nutritional intake and growth (height, weight, head circumference);
- Character of stools - greasy, oily (for information, not for decision
- Quantitative 72-hour fecal fat when indicated but not less than annually
(perform on a normal diet for age);
- Fat soluble vitamin measures.
- Corollaries to dosing suggestions:
- Dose may be altered in a stepwise fashion according to the response
of the patient (see 4. above).
- Dose approaching 2,000 lipase U/kg/meal would indicate the need
for further investigation (see below). Patients presently on higher
doses should be reevaluated; either immediately decrease the dose or titrate
down to a lower dose range at, or below, 2,000 lipase U/kg/meal. Doses
> 6,000 lipase U/kg/meal have been associated with colonic strictures.
- Pancreatic supplements mixed with applesauce or other acidic food substances
should be administered immediately, not stored.
- Enteric-coated minitablets should not be crushed.
- Enzyme doses (as lipase U/kg/meal) tend to decrease with advancing
- Patients should accept only product brands prescribed by their physician.
- Adjustment of dosage is the responsibility of the physician. Patients
should be advised not to adjust doses without consulting their physician.
Changes in product or dosage may require an adjustment period.
- Complaints transmitted by phone should be investigated thoroughly before
dose is adjusted. If indicated, this investigation should include 72-hour
fecal fat testing.
- Pancreatic supplements should be stored in a cool, dry place and checked
regularly for expiration date.
Call your doctor for medical advice about side effects. You may report side
effects to FDA at 1-800-FDA-1088.
ULTRASE® MT12 (pancrelipase) Capsules
Gelatin capsules (white and yellow), imprinted "ULTRASE MT (pancrelipase capsules) 12". Bottles
of 100 (NDC 58914-002-10).
ULTRASE® MT18 (pancrelipase) Capsules
Gelatin capsules (gray and white), imprinted "ULTRASE MT (pancrelipase capsules) 18". Bottles
of 100 (NDC 58914-018-10).
ULTRASE® MT20 (pancrelipase) Capsules
Gelatin capsules (light gray and yellow), imprinted "ULTRASE MT (pancrelipase capsules) 20".
Bottles of 100 (NDC 58914-004-10), and bottles of 500 (NDC 58914-004-50).
Store at controlled room temperature, between 15°C and 25°C (59°F and 77°F), in a dry place. Do not refrigerate.
1. Delchier JC, Vidon N, et al. Fate of orally ingested enzymes in pancreatic
insufficiency: comparison of two pancreatic enzyme preparations. Aliment
Pharmacol Therap. 1991;5:365-378.
2. Duhamel JP, Vidailhet M, et al. Ãtude multicentrique comparative d'une nouvelle
présentation de pancréatine en microgranules gastrorésistants dans I'insuffisance
pancréatique exocrine de la mucoviscidose chez l'enfant. Ann Pediatr.
3. Dutta SK, Tilley DK. The pH-sensitive enteric-coated pancreatic enzyme preparations:
an evaluation of therapeutic efficacy in adult patients with pancreatic insufficiency.
J Clin Gastroenterol. 1983;5:51-54.
4. Dutta SK, Rubin J, Harvey J. Comparative evaluation of the therapeutic efficacy
of a pH-sensitive enteric-coated pancreatic enzyme preparation with conventional
pancreatic enzyme therapy in the treatment of exocrine pancreatic insufficiency.
5. Gouerou H, Dain MP, et al. Alipase versus nonenteric-coated enzymes in pancreatic
insufficiency. Int J Pancreatol. 1989;5:45-50.
6. Mischler EH, Parrell S, et al. Comparison of effectiveness of pancreatic
enzyme preparations in cystic fibrosis. Am J Dis Child. 1982;136:1060-1063.
7. Salen G, Prakash A. Evaluation of enteric-coated microspheres for enzyme
replacement therapy in adults with pancreatic insufficiency. Cur Ther Res.
8. Schneider MU, Knoll-Ruzicka ML, et al. Pancreatic enzyme replacement therapy:
comparative effects of conventional and enteric-coated microspheric pancreatin
and acid-stable fungal enzyme preparations on steatorrhea in chronic pancreatitis.
9. Halgreen H, Thorsgaard Pedersen N, Worning H. Symptomatic
effect of pancreatic enzyme therapy in patients with chronic pancreatitis. Scand
J Gastroenterol. 1986;21:104-108.
13. Cystic Fibrosis Foundation Conference on Pancreatic Enzyme
Supplementation in the Context of Fibrosing Colonopathy; Washington, D.C., March
Marketed as ULTRASE® MT (pancrelipase capsules) by: AXCAN PHARMA US, INC. 22 Inverness
Center, Parkway, Birmingham, AL 35242 USA. www.axcan.com. ULTRASE® MT (pancrelipase capsules) is
manufactured by Eurand International, Milan, Italy using its EURAND MINITABS®
technology for Axcan Pharma US, Inc., 22 Inverness Center Parkway, Birmingham,
Alabama 35242 USA. FDA Rev date: n/a