Anticholium Drug Information

• Dosage and Administration: Use in adults: 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 maximum individual dose is 2 mg. In case of insufficient effect, give subsequent injections after 5 to 20 minutes at the earliest, after a positive evaluation of the effect of the first injection.
• In cases of intoxication: Adults: Slowly inject 0.04 mg/kg bodyweight (2 mg) of physostigmine salicylate intravenously and subsequently inject 1-4 mg every 20 minutes. Repeat the effective dose if the intoxication symptoms recur, also in the form of a continuous infusion if deemed useful.
• Use in children and adolescents: In cases of intoxication: Infants: Start with a low dose of 0.5 mg of physostigmine salicylate administered intravenously, 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.
• Method of administration: Intravenously slowly or as brief infusion in 50 ml physiological 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).

• Adverse Reactions: Like all medicines, ANTICHOLIUM ® can cause side effects, although not everybody gets them.
• System organ class Frequency: Unknown Immune system disorders Hypersensitivity reactions Endocrine disorders Hypersalivation Heart diseases Changes of the heart rate (both bradycardia and tachycardia), sinoatrial block Vascular diseases Low blood pressure (hypotension) Respiratory, thoracic and mediastinal disorders Spasms of the respiratory tract (broncho spasms) Gastrointestinal disorders Nausea, vomiting Skin and subcutaneous tissue disorders Sweating

Interactions: Tell your doctor or pharmacist if you are taking/ using, have recently taken/used or intend to take/ use any other medicines. In case of simultaneous administration of other cholinesterase inhibitors (e.g. medicines for the treatment of dementia), caution should be exercised because of the potentiating effect. In intoxication with depolarizing muscle relaxants of the suxamethonium type, ANTICHOLIUM ® is contraindicated!

Pregnancy: There is no experience with the use of ANTICHOLIUM ® in pregnant women. Physostigmine, the active substance contained in ANTICHOLIUM ®, passes into the placenta. Animal studies are insufficient with respect to effects on pregnancy, embryonal/foetal development, birth and postnatal development.

The potential risk for humans is unknown. For this reason, ANTICHOLIUM ® may only be administered to pregnant women if deemed absolutely necessary by the attending doctor.

Contraindications: ANTICHOLIUM ® should not be used in the presence of hypersensitivity to physostigmine salicylate, bronchial asthma, ulcers associated with tissue destruction (gangrene), coronary heart disease, constipation (mechanical obstipation), mechanical ischuria (urinary retention), hereditary form of muscle atrophy (myotonic dystrophy), closed traumatic brain injuries, intestinal obstruction, spasms in the urinary tract collection system, inactivation of nerve and muscle cells after administration of drugs to relax the muscles (depolarization block after depolarizing muscle relaxants), in case of intoxication due to “irreversibly acting” cholinesterase inhibitors (drugs used to treat dementia), intoxication with phosphoric acid esters or barbiturates.

Overdosage: 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 to prevent absorption are to be started immediately (such as gastric lavage, administration of medicinal charcoal and laxatives). The following information is intended for healthcare professionals: Overdose emergency measures, symptoms, antidotes In cases of intoxication, measures to prevent absorption such as gastric lavage, administration of medicinal charcoal and laxatives are to be started immediately.

An overdose of ANTICHOLIUM ® can cause bradycardia, hypersalivation, vomiting, and generalized tonic-clonic seizures. Patients should be closely monitored by ECG.