Evaluation of Blood Alcohol Concentrations after Oral Administration of a Fixed Combination of Thyme Herb and Primrose Root Fluid Extract to Children with Acute Bronchitis

Abstract

In conclusion, oral administration of the drug containing 4.9% ethanol to children (age 1-12 years) demonstrated a favourable risk/benefit ratio of the drug.

The role of alcoholic extract of Zataria multiflora Boiss in controlling opium withdrawal symptoms: a randomized, double-blind study

“…A combination of thyme extract with methadone was generally well tolerated. All adverse events were mild or moderate in severity and complied with the known safety profile of thyme extract [30,31].…”

Ethanol in herbal medicinal products for children

“…This also applies to the case of a study in which single doses corresponding to 142 mg ethanol were applied to children between 6 and 12 years up to 12 times per day [ 12 ], as this single dose of ethanol is eliminated within 3 min [ 4 ] so that an accumulation is not to be expected. That relevant blood ethanol levels are not achieved has recently also been confirmed by a pharmacokinetic study with one of the medicinal products included in this review, Bronchicum® Elixir [ 11 ], where children of 1–12 years of age were included. Therefore, there is no specific risk to be assigned to the ethanol content of these medicines.…”

“…Liquid dosage forms have an advantage for use in children, as it is possible to adapt doses to the respective age groups. Ethanol is specified as the extraction solvent for herbal medicinal products in all relevant pharmacopeias, and replacement by other solvents like glycerol or propylene glycol and by the addition of preservatives is not generally applicable, as the toxicological proof of safety for these substances is not equally convincing [ 4 , 11 ]. Therefore these medicines are rated as safe for use in children by regulatory agencies and are also perceived as safe by health professionals and consumers [ 2 ].…”

Kombination aus Thymiankraut und Primelwurzel zur Behandlung der Bronchitis – eine Übersicht

“…Die Europäische Aufsichtsbehörde European Medicines Agency (EMA) hat aus diesem Grund als Grenzwert der Alkoholkonzentration 0,125 ‰ im Vollblut festgesetzt, der nach Verabreichung einer einzelnen Dosis eines Arzneimittels nicht überschritten werden soll. In einer Studie wurde an Kindern mit akuter Bronchitis im Alter von 1-12 Jahren untersucht, ob bei Behandlung mit einer Saftzubereitung (Bronchicum ® Elixir), die 4,9 % Alkohol enthält, dieser Grenzwert eingehalten wird [12]. Alle gemessenen Blutalkoholkonzentrationen lagen deutlich unter dem EMA-Grenzwert (im Mittel bei 0,0051 ± 0,0078 ‰).…”