Generic name
Isoflavone phytoestrogens.
Description
Dry concentrated herbal ethanol extract of Trifolium pratense (Red clover)
Composition
Active: Diphenolic Isoflavones: biochanin A (4’,methoxy-5,7-dihydroxyisoflavone)
formononetin (4’-methoxy-7-hydroxyisoflavone) genistein (4’,5,7-trihydroxyisoflavone) daidzein (4’,7-dihydroxyisoflavone) FREE OF sugar, yeast, milk derivatives, wheat, cornstarch, gluten, preservatives, and artificial flavours.
Actions
Natural dietary supplement containing isoflavones for correction of dietary deficiency in diets, which have low levels of isoflavonoid phytoestrogens as a result of low consumption of legumes (pulses). The actions of the isoflavonoid phytoestrogens include anti-oxidation, inhibition of various enzyme systems, and modulation of the formation, transport and action of reproductive hormones.
Indications
Promensil is a natural dietary supplement based on active isoflavones extracted from red clover. Promensil has been proven effective in the management of symptoms associated with menopause, including hot flushes.
Contraindications and interactions
In the absence of definitive research data, it is recommended that the diet should not be supplemented with isoflavonoid phytoestrogens during therapy with reproductive hormones including estrogen, progestogen and androgen because of the potential risk of competitive inhibition.
Precautions
Use in Lactation: Isoflavones are secreted in breast milk, but the clinical significance has not been fully evaluated. Until evidence of the effect (adverse or beneficial) of phytoestrogen supplementation has been established their use during lactation cannot be recommended.
Use in Pregnancy Promensil is not recommended for use during pregnancy.
Use in the neonate No studies have been performed on children.
Adverse reactions
No adverse reactions are known at the recommended dosage. No weight
gain was seen in a double blind placebo controlled 12 week study.
Overdosage
The effects of overdose in humans are unknown
Pharmacology
Note. Current knowledge of the full range of biological functions of plant flavonoids and isoflavonoid phytoestrogens is incomplete. The isoflavonoid phytoestrogens are heterocyclic phenols with a similar structure to estrogens. The various biological effects of the isoflavonoid phytoestrogens at the cellular level include the following:
– anti-oxidation binding to type II nuclear estrogen receptors
– competitive inhibition of the cellular effects of estradiol
– inhibition of protein-tyrosine kinase
– inhibition of topoisomerase and protein histidine kinase activities
– surrogate estrogen effect through estrogen receptor binding
– stimulate differentiation of leukaemic and other malignant cells
– stimulate synthesis of sex hormone binding globulin in liver cells
– inhibition of bFGF-stimulated endothelial cell proliferation and
in vitro angiogenesis
– Inhibition of estrogen-dependant growth of human breast cancer cells.
Pharmacokinetics
Following oral administration, peak plasma levels are achieved in 5 hours.
All four isoflavones are present in plasma post-challenge. After oral administration, the terminal half-life is at least 9 to 12 hours. The kinetics of plasma levels for all 4 isoflavones are similar. Almost all (approximately 99%) of the plasma isoflavones are conjugated (glucuronides and sulphonates).
Absorption, bioavailability: The estrogenic isoflavones are either absorbed intact or undergo fermentation by gut flora. The relative importance of these two processes varies between individuals. The fermentation process largely converts biochanin A to genistein and formononetin to daidzein; the genistein and daidzein then either are absorbed intact or undergo further degradation to various metabolites, the principal ones of which are the isoflavans, equol (7-hydroxy-3-(4’-hydroxyphenol) chroman) and 0-desmethylangolensin, and which then are absorbed.
Excretion: The isoflavones and isoflavans are excreted largely in the urine with lesser amounts in the bile.
Directions for use
Adults one-two tablets daily.
Presentation
Coated 500mg tablets. Each tablet contains 40mg of standardised isoflavones.
Pack
40mg [30].
Formulation USA
Promensil 40mg (30) tablets - red
Promensil 40mg (30) tablets and 40mg (60) tablets - clear
Formulation Canada
Promensil 40mg (30) tablets - red
Storage
Store tablets at room temperature out of direct sunlight in a sealed
container. Shelf life is greater than 2 years.
Poisons schedule
None. Trifolium pratense is an approved human foodstuff and a traditional
human herb for therapeutic use.
Appendix: Data sheet |
