Source: European Medicines Agency (EU) Publisher: Desma GmbH, Peter-Sander-Str. 41b, 55252, Mainz-Kastel, Germany, Tel: +49 (0) 6134 21079 0, Fax: +49 (0) 6134 21079 24
Biperiden has to be dosed individually.
At the beginning of treatment and in severe cases, 10-20 mg Biperiden Lactate (=2–4 ml solution for injection) can be administered intramuscularly or slowly intravenously, divided into several single doses over the day.
Inject 2.5-5 mg Biperiden Lactate (=0.5–1 ml solution for injection) as a single dose intramuscularly or slowly intravenously. If necessary, the same dose can be injected again after 30 minutes. The maximum daily dose amounts to 10–20 mg Biperiden Lactate (=2–4 ml solution for injection).
Intramuscular administration of 5–10 mg biperiden lactate (1–2 ml injection solution). In emergency cases in addition to the standard measures administration of 5 mg biperiden lactate (1 ml injection solution) intravenously is appropriate.
In the case of poisoning from organic phosphorous compounds biperiden is to be dosed individually. Depending on the toxic manifestation of the poisoning, repeated intravenous administration of 5 mg biperiden lactate could be given until disappearing of the poisoning.
If symptoms disappear during the injection, it should be discontinued.
Children up to 1 year: 1 mg biperiden lactate (corresponding to 0.2 ml).
Children up to 6 years: 2 mg biperiden lactate (corresponding to 0.4 ml).
Children up to 10 years: 3 mg biperiden lactate (corresponding to 0.6 ml).
Caution with dosing is necessary! The lowest possible dose should be used initially and the dose should then be slowly increased, depending on the response of the patient (see also section 5.2).
No pharmacokinetic data is available in patients with impaired liver or renal function. For this reason, caution is necessary when dosing. Start with the lowest possible dose and, depending upon the response of the patient, the dose should be increased slowly.
The solution for injection is to be injected intramuscularly or slowly intravenously in adults.
In children and adolescents (up to 18 years), the solution for injection can be administered slowly intravenously. If symptoms disappear during the injection, it should be discontinued.
Any residual solution is to be discarded after the ampoule has been opened.
The duration of treatment depends on the type and extent of the disease and can range from short-term administration to long-term medication or until treatment with an oral pharmaceutical form can be continued or ended.
Treatment with this medication should not be discontinued abruptly, but in steps.
Symptoms of an intoxication resemble in principle that of atropine poisoning with peripheral anticholinergic symptoms (wide, slow-reacting pupils; dryness of the membranes; redness of the face; increased cardiac rate; intestinal and bladder atony; raised temperature) and central nervous disturbances (such as excitation, delirium, confusion, clouding of consciousness and/or hallucinations). In severe intoxications, there is a risk of circulatory collapse and central respiratory paralysis.
Acetylcholinesterase inhibitors, particularly physostigmine, which can pass into the cerebrospinal fluid, are recommended as antidotes, which can also influence centrally triggered symptoms (and/or physostigmine salicylate, in case of a positive physostigmine test). If necessary, support of the cardiovascular and respiratory functions (artificial respiration with oxygen), heat dissipation in case of febrile temperatures and the application of a bladder catheter should be used, depending on the type of symptoms
Shelf life: 5 years.
This drug should no longer be used after the expiry date.
Do not store above 25°C.
Store ampoules in their outer carton, in order to protect the contents from light.
Residual amounts of solution are to be discarded, once the ampoule has been opened.
5 white-glass ampoules (type I) of 1 mlsolution for injection.
50 (10x5) white-glass ampoules (type I) of 1 ml solution for injection.
Not all pack sizes may be marketed.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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