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NIS - libdoc.who.int - World Health Organization

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Folium cum Flore Crataegi<br />

metabolic activation. The mutagenic activity appeared to be due to the<br />

quercetin content of the extract; however, the amount of quercetin ingested<br />

in a normal daily diet is higher than would be obtained from the<br />

extract (85). Intragastric administration of up to 1.6 g/kg body weight<br />

had no effect on the fertility of female and male rats or the F 1<br />

generation<br />

(86).<br />

Pregnancy: teratogenic effects<br />

Intragastric administration of up to 1.6 g/kg body weight of a standardized<br />

extract of Folium cum Flore Crataegi to rats and rabbits was not<br />

teratogenic (86).<br />

Pregnancy: non-teratogenic effects<br />

No peri- or postnatal toxicity was observed in rats treated <strong>int</strong>ragastrically<br />

with a standardized extract of Folium cum Flore Crataegi (1.6 g/kg body<br />

weight) (86).<br />

Other precautions<br />

No information available on general precautions or precautions concerning<br />

nursing mothers or paediatric use. Therefore, Folium cum Flore Crataegi<br />

should not be administered during lactation or to children without<br />

medical supervision.<br />

Adverse reactions<br />

None (84).<br />

Dosage forms<br />

Crude drug for infusion and hydroalcoholic extracts (35). Store in a wellclosed<br />

container, protected from light and moisture (1).<br />

Posology<br />

(Unless otherwise indicated)<br />

Daily dosage: 160–900 mg dried 45% ethanol or 70% methanol extract<br />

(drug:extract ratio 4–7:1) standardized to contain 18.75% oligomeric procyanidins<br />

(calculated as epi-catechin) or 2.2% flavonoids (calculated as<br />

hyperoside), respectively (26–29, 31–34, 84); 1.0–1.5 g comminuted crude<br />

drug as an infusion 3–4 times daily (35). Therapeutic effects may require<br />

4–6 weeks of continuous therapy (84).<br />

105

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