Papain

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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)

Papain

Papain

Carica papaya

  • Fruit
  • Leaf

References: Proper name: IUBMB 2000; Common name: IUBMB 2000; Source material: Merck 2012, USDA 2011, Morton 1987.

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 the age category listed in this monograph and specified route of administration are indicated in the Compendium of Monographs Guidance Document.

Use(s) or Purpose(s)

Digestive enzyme (Merck 2012)

Dose(s)

Subpopulation(s)

Adults 18 years and older

Quantity(ies)

Not to exceed 7,200,000 FCC PU of enzymatic activity, per day; and 2,400,000 FCC PU per single dose (Martin et al. 2002; Dale et al. 2001).

Direction(s) for use

Take with food/a meal.

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 (HC 2011; Martindale 2011; US FDA 2008).

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

No statement required.

Specifications

References Cited

References Reviewed