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Ultresa

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Ultresa

ULTRESA
(pancrelipase) Capsules

DRUG 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 beads (1.7 mm in diameter and 1.9 mm thick for 4,000 USP lipase units, approximately 2.0 mm in diameter and 2.0 – 2.4 mm thick for 13,800, 20,700, and 23,000 USP lipase units).

The active ingredient evaluated 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.

4,000 USP units of lipase; 8,000 USP units of protease; 8,000 USP units of amylase. The hypromellose delayed-release capsules have a flesh opaque cap and blue opaque body, printed with “ULTRESA” on the cap and “4000” on the body in black ink. The capsule shell contains hypromellose, titanium dioxide, FD&C Blue 1, red iron oxide, and capsule imprint ink.

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 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 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 in capsule imprint ink.

The black radial imprinting on the capsule contains iron oxide black as colorant, shellac, and propylene glycol. It may also contain strong ammonia solution, and potassium hydroxide.

Last reviewed on RxList: 10/14/2014
This monograph has been modified to include the generic and brand name in many instances.

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