CHYMOTRYPSIN

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This monograph is intended to serve as a guide to industry for the preparation of Product Licence Applications (PLAs) and labels for natural health product market authorization. It is not intended to be a comprehensive review of the medicinal ingredient.

Notes

Date

April 29, 2019

Proper name(s), Common name(s), Source material(s)

Table 1. Proper name(s), Common name(s), Source material(s)
Proper name(s) Common name(s) Source material(s)
Proper name(s) Part(s)

Chymotrypsin

  • alpha-Chymotrypsin
  • Chymotrypsin
  • Bos taurus
  • Sus scrofa

Pancreas

References: Proper name: IUBMB 1972; Common names: IUBMB 1972; Source materials: FCC 8 2012, USP 35 2102, Bisby et al. 2011.

Route of Administration

Oral

Dosage Form(s)

This monograph excludes foods or food-like dosage forms as indicated in the Compendium of Monographs Guidance Document.

Acceptable dosage forms for any age category listed in this monograph for the specified route of administration are listed in the Compendium of Monographs Guidance Document.

Use(s) or Purpose(s)

Digestive enzyme

Dose(s)

Subpopulation(s)

Adults 18 years and older

Quantity(ies)

Not to exceed 480,000 USP chymotrypsin units of enzymatic activity, per day; and 160,000 USP chymotrypsin units per single dose (USP 35 2012; Dörr and Herrmann 2007; Martin et al. 2002; Dale et al. 2001).

Notes

Direction(s) for use

All products

Take with food/meal.

Enteric-coated products

Swallow whole/do not crush or chew (CPS 2008).

Duration(s) of Use

Consult a health care practitioner/health care provider/health care professional/doctor/physician for prolonged use.

Risk Information

Caution(s) and warning(s)

Contraindication(s)

No statement required.

Known adverse reaction(s)

Stop use if hypersensitivity/allergy occurs (Martindale 2011).

Non-medicinal ingredients

Must be chosen from the current Natural Health Products Ingredients Database (NHPID) and must meet the limitations outlined in the database.

Storage conditions

Store in a tightly closed, light-resistant container in a cool, dry place (Ph.Eur. 2012; USP 35 2012).

Specifications

References Cited

References Reviewed