d colonic strictures in children less than 12 years of age [see Warnings and Precautions (5.1)].
8.5 Geriatric UseClinical studies of ULTRESA did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
10 OVERDOSAGEThere have been no reports of overdose in clinical trials or postmarketing surveillance with ULTRESA. Chronic high doses of pancreatic enzyme products have been associated with fibrosing colonopathy and colonic strictures [see Dosage and Administration (2) and Warnings and Precautions (5.1)]. High doses of pancreatic enzyme products have been associated with hyperuricosuria and hyperuricemia, and should be used with caution in patients with a history of hyperuricemia, gout, or renal impairment [see Warnings and Precautions (5.3) ].
11 DESCRIPTION
ULTRESA 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.
Pancrelipase is a beige-white amorphous powder. It is miscible in water and practically insoluble or insoluble in alcohol and ether.
Each delayed-release capsule for oral administration contains enteric-coated minitablets that are approximately 2.0 mm in diameter and 2.0 – 2.4 mm thick.
The active ingredient eva luated in clinical trials is lipase. ULTRESA is dosed by lipase units. Other active ingredients include protease and amylase.
ULTRESA contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hydrogenated castor oil, hypromellose phthalate, magnesium stearate, microcrystalline cellulose, talc, and triethyl citrate.
13,800 USP units of lipase; 27,600 USP units of protease; 27,600 USP units of amylase. The hard gelatin delayed-release capsules have a white cap and yellow body printed with “13800UL” on cap and “AXCA” on the body in black ink. The capsule shell contains gelatin, titanium dioxide, yellow iron oxide, and gelatin capsule imprint ink.
20,700 USP units of lipase; 41,400 USP units of protease; 41,400 USP units of amylase. The hard gelatin delayed-release capsules have a gray cap and white body printed with “20700UL” on cap and “AXCA” on the body in black ink. The capsule shell contains gelatin, titanium dioxide, black iron oxide, and gelatin capsule imprint ink.
23,000 USP units of lipase; 46,000 USP units of protease; 46,000 USP units of amylase. The hard gelatin delayed-release capsules have a light gray cap and yellow body printed with “23000UL” on cap and “AXCA” on the body in black ink. The capsule shell contains gelatin, titanium dioxide, yellow iron oxide, black iron oxide, and gelatin capsule imprint ink.
12 CLINICAL PHARMACOLOGY12.1 Mechanism of ActionThe pancreatic enzymes in ULTRESA catalyze the hydrolysis of fats to monoglycerides, glycerol and free fatty acids, proteins into peptides and amino acids, and starches
