Our comprehensive guide hospitals information helps you quickly locate a hospital anywhere in the world. Our database contains in excess of 16,000 hospitals, making it one of the best places to find information on the hospital you are searching for. To assist you with locating a hospital, you can refine your search by selecting the country in which the hospital is located and choose to search by either hospital name, city/town or state/county.

 Home>> Ultresa (pancrelipase) delayed-release capsules

Ultresa (pancrelipase) delayed-release capsules

General Information

Ultresa (pancrelipase) delayed-release capsules is a pancreatic enzyme preparation consisting of pancrelipase, an extract derived from porcine pancreatic glands. Pancrelipase contains multiple enzyme classes, including porcine-derived lipases, amylases, and proteases. The pancreatic enzymes in Ultresa act like digestive enzymes physiologically secreted by the pancreas.

Ultresa is specifically indicated for the treatment of exocrine pancreatic insufficiency due to cystic fibrosis or other conditions.

Ultresa is supplied as a tablet for oral administration. The initial dose of Ultresa should begin at the lowest recommended dose and gradually increased. The dosage of Ultresa should be individualized based on clinical symptoms, the degree of steatorrhea present, and the fat content of the diet.


Additional Information

For additional information regarding Viokace or exocrine pancreatic insufficiency due to cystic fibrosis or other conditions, please visit the AptalisPharma web page.


Clinical Results

FDA Approval
The FDA approval of Ultresa was based on two clinical trials conducted in 40 subjects, ages 7 to 37 years, with exocrine pancreatic insufficiency associated with cystic fibrosis.
Study One
This randomized, double-blind, placebo-controlled, crossover study enrolled 31 subjects ages 8 to 37 years. The subjects were randomized to receive Ultresa at a dose not to exceed 2,500 lipase units per kilogram per meal or snack or matching placebo for 6 to 7 days of treatment followed by crossover to the alternate treatment for an additional 6 to 7 days. All subjects consumed a high-fat diet (2 grams of fat per kilogram of body weight per day) during the treatment periods. The final analysis population was limited to 24 subjects who completed both treatment periods and had stool results available for each treatment period.The primary endpoints were the coefficient of fat absorption (CFA) and the coefficient of nitrogen absorption (CNA), both determined by a 72-hour stool collection during both treatments. The Mean CFA was 89% with Ultresa treatment compared to 56% with placebo treatment. The mean difference in CFA was 35 percentage points in favor of Ultresa (p<0.0001). The mean CNA was 84% with Ultresa treatment compared to 59% with placebo treatment. The mean difference in CNA was 26 percentage points in favor of Ultresa treatment (p<0.0001).
Study Two
This open-label study enrolled 9 subjects, ages 7 years to 11 years. After a 15 day screening period on individually-titrated doses of Ultresa not exceeding 2,500 lipase units per kilogram per meal, the subjects entered a 7-day washout phase before returning to a 12-day treatment phase on the same individually-titrated dose of Ultresa. The mean daily dose of Ultresa during the treatment phase was 6,846 lipase units per kilogram body weight per day. All subjects consumed a high-fat diet (2 grams of fat per kilogram of body weight per day) during both the washout phase and the treatment phase. The final analysis was limited to 7 subjects who completed both the washout and treatment phases of the study. The mean CFA was 35% during the washout phase and was 83% during the Ultresa treatment phase.


Mechanism of Action

Ultresa (pancrelipase) delayed-release capsules is a pancreatic enzyme preparation consisting of pancrelipase, an extract derived from porcine pancreatic glands. The pancreatic enzymes in Ultresa catalyze the hydrolysis of fats to monoglycerides, glycerol and free fatty acids, proteins into peptides and amino acids, and starches into dextrins and short chain sugars such as maltose and maltotriose in the duodenum and proximal small intestine, thereby acting like digestive enzymes physiologically secreted by the pancreas.


Side effects

Adverse reactions associated with the use of Ultresa may include, but are not limited to, the following:

  • headache
  • pharyngolaryngeal pain
  • epistaxis


Treatment

exocrine pancreatic insufficiency

Select an option ICD-9 and ICD-10 ICD-9CM ICD-10CM Back News | Share | Print Otezla (apremilast) Select an option ICD-9 and ICD-10 ICD-9CM ICD-10CM Back News | Share | Print Peg-Intron (peginterferon alfa-2b) Select an option ICD-9 and ICD-10 ICD-9CM ICD-10CM Back News | Share | Print Belbuca (buprenorphine) Select an option ICD-9 and ICD-10 ICD-9CM ICD-10CM Back News | Share | Print Bridion (sugammadex) Select an option ICD-9 and ICD-10 ICD-9CM ICD-10CM Back News | Share | Print Ozurdex (dexamethasone) Select an option ICD-9 and ICD-10 ICD-9CM ICD-10CM Back News | Share | Print Alinia (nitazoxanide) Select an option ICD-9 and ICD-10 ICD-9CM ICD-10CM Back News | Share | Print Portrazza (necitumumab) Select an option ICD-9 and ICD-10 ICD-9CM ICD-10CM Back News | Share | Print Rayaldee (calcifediol) Select an option ICD-9 and ICD-10 ICD-9CM ICD-10CM Back News | Share | Print Ameluz (aminolevulinic acid hydrochloride) Select an option ICD-9 and ICD-10 ICD-9CM ICD-10CM Back News | Share | Print Caduet (amlodipine/atorvastatin) Select an option ICD-9 and ICD-10 ICD-9CM ICD-10CM Back News | Share | Print Ultracet (acetaminophen and tramadol HCl) Select an option ICD-9 and ICD-10 ICD-9CM ICD-10CM Back News | Share | Print Cefazolin and Dextrose USP Select an option ICD-9 and ICD-10 ICD-9CM ICD-10CM Back News | Share | Print Betapace AF Tablet Select an option ICD-9 and ICD-10 ICD-9CM ICD-10CM Back News | Share | Print Chloraprep (chlorhexidine gluconate) Select an option ICD-9 and ICD-10 ICD-9CM ICD-10CM Back News | Share | Print Prolia (denosumab) Select an option ICD-9 and ICD-10 ICD-9CM ICD-10CM Back News | Share | Print Cinqair (reslizumab) Select an option ICD-9 and ICD-10 ICD-9CM ICD-10CM Back News | Share | Print Astelin nasal spray Select an option ICD-9 and ICD-10 ICD-9CM ICD-10CM Back News | Share | Print Prevnar 13 (Pneumococcal 13-valent Conjugate Vaccine) Select an option ICD-9 and ICD-10 ICD-9CM ICD-10CM Back News | Share | Print Prilosec (omeprazole) Select an option ICD-9 and ICD-10 ICD-9CM ICD-10CM Back News | Share | Print Trovan Select an option ICD-9 and ICD-10 ICD-9CM ICD-10CM Back News | Share | Print Prozac Weekly (fluoxetine HCl) Select an option ICD-9 and ICD-10 ICD-9CM ICD-10CM Back News | Share | Print INFERGEN (interferon alfacon-1) Select an option ICD-9 and ICD-10 ICD-9CM ICD-10CM Back News | Share | Print Pramipexole Select an option ICD-9 and ICD-10 ICD-9CM ICD-10CM Back News | Share | Print Ranitidine Capsules Select an option ICD-9 and ICD-10 ICD-9CM ICD-10CM Back News | Share | Print Dynabac Select an option ICD-9 and ICD-10 ICD-9CM ICD-10CM Back News | Share | Print Atryn (antithrombin recombinant lyophilized powder for reconstitution) Select an option ICD-9 and ICD-10 ICD-9CM ICD-10CM Back News | Share | Print Rexulti (brexpiprazole) Select an option ICD-9 and ICD-10 ICD-9CM ICD-10CM Back News | Share | Print Kadcyla (ado-trastuzumab emtansine) Select an option ICD-9 and ICD-10 ICD-9CM ICD-10CM Back News | Share | Print Exelon (rivastigmine tartrate) Select an option ICD-9 and ICD-10 ICD-9CM ICD-10CM Back News | Share | Print Tykerb (lapatinib) Select an option ICD-9 and ICD-10 ICD-9CM ICD-10CM Back News | Share | Print Cipro (ciprofloxacin HCl) Select an option ICD-9 and ICD-10 ICD-9CM ICD-10CM Back News | Share | Print Arixtra Select an option ICD-9 and ICD-10 ICD-9CM ICD-10CM Back News | Share | Print Lyrica (pregabalin) Select an option ICD-9 and ICD-10 ICD-9CM ICD-10CM Back News | Share | Print Oravig (miconazole) Select an option ICD-9 and ICD-10 ICD-9CM ICD-10CM Back News | Share | Print MERIDIA Select an option ICD-9 and ICD-10 ICD-9CM ICD-10CM Back News | Share | Print Qsymia (phentermine + topiramate extended-release) Select an option ICD-9 and ICD-10 ICD-9CM ICD-10CM Back News | Share | Print Keppra Select an option ICD-9 and ICD-10 ICD-9CM ICD-10CM Back News | Share | Print Opsumit (macitentan) Select an option ICD-9 and ICD-10 ICD-9CM ICD-10CM Back News | Share | Print Krystexxa (pegloticase) Select an option ICD-9 and ICD-10 ICD-9CM ICD-10CM Back News | Share | Print Livalo (pitavastatin)