PYGEUM - PRUNUS AFRICANA

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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

August 5, 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) Preparation

Prunus africana

  • Pygeum
  • Red stinkwood

Prunus africana

  • Stem bark
  • Trunk bark

Dried

References: Proper name: USDA 2019; Common names: USDA 2019, Godfrey et al. 2010; Source materials: Godfrey et al. 2010, Mills and Bone 2005.

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)

Standardized extracts

Helps reduce the urologic symptoms (such as weak urine flow, incomplete voiding, frequent daytime and nighttime urination) associated with benign prostatic hyperplasia (Wilt et al. 2002; Ishani et al. 2000; Chatelain et al. 1999; Breza et al. 1998; Carani et al. 1991; Barlet et al. 1990).

Non-standardized preparations

No claim (safety only)

Dose(s)

Subpopulation(s)

Standardized extracts making a claim for symptoms of benign prostatic hyperplasia

Adult Males 18 years and older

Non-standardized preparations

Adults 18 years and older

Quantity(ies)

Symptoms of benign prostatic hyperplasia

Methods of preparation: Standardized extracts

75 - 200 milligrams of extract per day, standardized to 12-14% of phytosterols (Wilt et al. 2002; Ishani et al. 2000; Chatelain et al. 1999; Breza et al. 1998; Carani et al. 1991; Barlet et al. 1990).

No claim (safety only)

Methods of preparation: Dry, Powder, Non-Standardized Extracts (Dry extract, Tincture, Fluid extract, Decoction, Infusion)

Not to exceed 4 grams of dried stem bark and/or trunk bark, per day.1

1Note
Maximum daily dose of the crude material is based on a conservative extrapolation of the dose supported in the available evidence.

Direction(s) for use

No statement required.

Duration(s) of Use

No statement required.

Risk Information

Caution(s) and warning(s)

Standardized extracts making a claim for symptoms of benign prostatic hyperplasia (adult males)

Non-standardized preparations for adults (i.e. including women) (safety only)

Consult a health care practitioner/health care provider/health care professional/doctor/physician prior to use if you are pregnant or breastfeeding.

Contraindication(s)

No statement required.

Known adverse reaction(s)

No statement required.

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