ANTICHOLIUM Injection solution Ref.[8173] Active ingredients: Physostigmine

Revision Year: 2011  Publisher: DR. FRANZ KÖHLER CHEMIE GMBH, Werner-von-Siemens-Str. 22-28, D-64625 Bensheim, Telephone 0 62 51/1083-0, Telefax 0 62 51 / 1083-146, E-Mail: info@koehler-chemie.de

Therapeutic indications

For the treatment of postoperative disorders:

  • Central anticholinergic syndrome (CAS)
  • Delayed postoperative awakening
  • Shivering

As antidote and/or antagonist in case of intoxication with and/or overdose of:

  • Alcohol
  • Tropane alkaloids (hyoscyamine, atropine, scopolamine, e.g. in brugmansia, datura, atropa belladonna)
  • Amanita pantherina/amanita muscaria
  • Tricyclic antidepressants (amitriptyline, imipramine, trimipramine, clomipramine, doxepin)
  • Antiemetics/antihistamines (phenothiazine, thioridazine, chlorpromazine, promethazine, diphenhydramine, dimenhydrinate)
  • Neuroleptic drugs (especially butyrophenones)
  • Benzodiazepines
  • Antispasmodics (tolterodine, oxybutynine)
  • Parkinson disease medication (amantadine, diphenhydramine)
  • Baclofen, 4-hydroxybutyric acid (GHB)
  • Inhalation anaesthetics
  • Ketamine
  • 3-quinuclidinyl benzilate

Posology and method of administration

In case of intoxication:

Paediatric population

Infants: Start with a low dose of 0.5 mg of physostigmine salicylate administered intravenously or intramuscularly, repeat this dose every 5 minutes up to the overall dose of 2 mg, as long as the toxic, anticholinergic symptoms continue to persist and no cholinergic symptoms occur.

Adults

Slowly inject 0.04 mg/kg bodyweight (2 mg) of physostigmine salicylate either intravenously or intramuscularly and subsequently inject 1-4 mg every 20 minutes. Repeat the effective dose if the intoxication symptoms occur again, possibly also in the form of a continuous infusion.

For the treatment of postoperative awakening disorders

Slowly inject physostigmine intravenously at a dose of 0.04 mg/kg bodyweight (approx. 1 mg/min), the max. individual dose is 2 mg. In case of insufficient effect, make subsequent injections after 5 to 20 minutes at the earliest, after a positive evaluation of the effect of the first injection.

Intravenously, intramuscularly or as brief infusion in 50 ml physiological isotonic saline solution over 10-15 minutes. A general criterion for adequate physostigmine dosing is the recognizable recovery of mental abilities and responsiveness (e.g. specifying name, address, date).

Overdose

Overdose of Anticholium can cause bradycardia, hypersalivation, vomiting and generalized tonic-clonic seizures. Patients should be closely monitored by ECG. Intravenous administration of atropine up to normalization of the symptoms. Normally, half the amount of the administered physostigmine salicylate is sufficient. In case of intoxication, measures are to be started immediately to prevent absorption (such as gastric lavage, administration of activated charcoal and laxatives).

Shelf life

Shelf life in undamaged ampoules: 3 years.

The infusion solution should be used immediately after preparation.

Do not use the medicinal product after the expiry date stated on the pack.

Special precautions for storage

Do not store above 25°C, store in the outer packaging, protected from light.

Nature and contents of container

5 ml ampoules in packs containing 1 to 5 ampoules.

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