Amylasedrug info

amylase 24600 UNT / lipase 4200 UNT / protease 14200 UNT Delayed Release Oral Capsule [Pancreaze]

What it is used for

PANCREAZE is indicated for the treatment of exocrine pancreatic insufficiency in adult and pediatric patients. PANCREAZE ® is indicated for the treatment of exocrine pancreatic insufficiency in adult and pediatric patients.

Text above is quoted in full from the FDA-approved drug label published by openFDA, effective June 6, 2025. Matched to this product by RxNorm code. Cross-references to other sections of the full prescribing information have been removed, since they point to a document not shown here. Nothing else is changed: no sentence is shortened, reworded or summarised.

Description

Pancrelipase is a pancreatic enzyme product consisting of a mixture of enzymes including lipases, proteases, and amylases and is an extract derived from porcine pancreatic glands. The enteric-coated microtablets in PANCREAZE are formulated to release pancreatic enzymes at an approximate pH of 5.5 or greater. PANCREAZE (pancrelipase) delayed-release capsules are for oral administration and include a two-piece shell containing enteric-coated microtablets that are each approximately 2 mm in diameter and are available as follows: 2,600 USP units of lipase; 8,800 USP units of protease; and 15,200 USP units of amylase; delayed-release capsules have a light orange opaque body and clear cap imprinted with "VIVUS" and "MT 2". The shells contain hypromellose, titanium dioxide, yellow iron oxide, red iron oxide and imprint ink contains black iron oxide, shellac, propylene glycol, strong ammonia solution, potassium hydroxide. 4,200 USP units of lipase; 14,200 USP units of protease; and 24,600 USP units of amylase; delayed-release capsules have a yellow opaque body and clear cap imprinted with "VIVUS" and "MT 4". The shells contain hypromellose, titanium dioxide, yellow iron oxide, and imprint ink contains black iron oxide, shellac-glaze-45%, ammonium hydroxide, propylene glycol. 10,500 USP units of lipase; 35,500 USP units of protease; and 61,500 USP units of amylase; delayed-release capsules have a flesh opaque body and clear cap imprinted with "VIVUS" and "MT 10". The shells contain hypromellose, titanium dioxide, red iron oxide, and imprint ink contains black iron oxide, shellac-glaze-45%, ammonium hydroxide, propylene glycol. 16,800 USP units of lipase; 56,800 USP units of protease; 98,400 USP units of amylase; delayed-release capsules have a flesh opaque body and clear cap imprinted with "VIVUS" and "MT 16". The shells contain hypromellose, titanium dioxide, red iron oxide, yellow iron oxide, and imprint ink contains black iron oxide, shellac-glaze-45%, ammonium hydroxide, propylene glycol. 21,000 USP units of lipase; 54,700 USP units of protease; and 83,900 USP units of amylase; delayed-release capsules have a white opaque body and cap imprinted with "VIVUS" and "MT 20". The shells contain hypromellose, titanium dioxide, and imprint ink contains yellow iron oxide, shellac, strong ammonia solution, propylene glycol. 37,000 USP units of lipase; 97,300 USP units of protease; and 149,900 USP units of amylase; delayed-release capsules have an iron grey opaque body and white opaque cap imprinted with "VIVUS" and "MT 37". The shells contain hypromellose, titanium dioxide, black iron oxide and imprint ink contains black iron oxide, shellac-glaze-45%, ammonium hydroxide, propylene glycol. PANCREAZE (pancrelipase) delayed-release capsules include the following inactive ingredients: colloidal silicon dioxide, crospovidone, magnesium stearate, methacrylic acid ethyl acrylate copolymer, microcrystalline cellulose, montan glycol wax, simethicone emulsion, talc and triethyl citrate.

Text above is quoted in full from the FDA-approved drug label published by openFDA, effective June 6, 2025. Matched to this product by RxNorm code. Cross-references to other sections of the full prescribing information have been removed, since they point to a document not shown here. Nothing else is changed: no sentence is shortened, reworded or summarised.

This page reproduces regulatory text for reference. It is not medical advice, and KenyRx is not a pharmacy or a prescriber. Talk to a doctor or pharmacist about whether a medicine is right for you.

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