Ultrase MT (Lipase / Amylase / Protease) - Indications and Dosage

INDICATIONS AND USAGE

ULTRASE® MT (pancrelipase) Capsules are indicated for patients with partial or complete exocrine pancreatic insufficiency caused by:

• Cystic fibrosis (CF)
• Chronic pancreatitis due to alcohol use or other causes
• Surgery (pancreatico-duodenectomy or Whipple's procedure, with or without Wirsung duct injection, total pancreatectomy)
• Obstruction (pancreatic and biliary duct lithiasis, pancreatic and duodenal neoplasms, ductal stenosis)
• Other pancreatic disease (hereditary, post traumatic and allograft pancreatitis, hemochromatosis, Shwachman's Syndrome, lipomatosis, hyperparathyroidism)
• Poor mixing (Billroth II gastrectomy, other types of gastric bypass surgery, gastrinoma)

Pancrelipase capsules are effective in controlling steatorrhea.^1-9

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 FIBROSIS¹³

1. 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.
2. Nutrition assessment should be a part of routine clinical evaluations.
3. Initial dosing of pancreatic enzyme supplements should begin with 500 lipase U/kg/meal using enteric-coated minitablet products.
4. 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 making);
   • Quantitative 72-hour fecal fat when indicated but not less than annually (perform on a normal diet for age);
   • Fat soluble vitamin measures.
5. Corollaries to dosing suggestions:
   
   1. Dose may be altered in a stepwise fashion according to the response of the patient (see 4. above).
   2. 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.
   3. Pancreatic supplements mixed with applesauce or other acidic food substances should be administered immediately, not stored.
   4. Enteric-coated minitablets should not be crushed.
   5. Enzyme doses (as lipase U/kg/meal) tend to decrease with advancing age.
   6. Patient should accept only product brands prescribed by their physician.
   7. 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.
   8. Complaints transmitted by phone should be investigated thoroughly before dose is adjusted. If indicated, this investigation should include 72-hour fecal fat testing.
   9. Pancreatic supplements should be stored in a cool, dry place and checked regularly for expiration date.

HOW SUPPLIED

ULTRASE  ® MT12 (pancrelipase) Capsules

Gelatin capsules (white and yellow), imprinted "ULTRASE MT12". Bottles of 100 (NDC 58914-002-10).

ULTRASE  ® MT18 (pancrelipase) Capsules

Gelatin capsules (gray and white), imprinted "ULTRASE MT18". Bottles of 100 (NDC 58914-018-10).

ULTRASE  ® MT20 (pancrelipase) Capsules

Gelatin capsules (light gray and yellow), imprinted "ULTRASE MT20". 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.