Composition, form of production and packaging
The solution for intravenous and / or injection is clear, colorless.
1 ml
biperidene lactate 5 mg
Excipients: sodium lactate - 14 mg, water d / and - 989 mg.
1 ml - ampoules of colorless glass (5) - a film of deep drawing (1) - packs cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2016.
PHARMACHOLOGIC EFFECT
The anticholinergic drug of the central action reduces the activity of the cholinergic neurons of the striatum (the structural component of the extrapyramidal system).Peripheral anticholinergic action is less pronounced. Reduces tremors and stiffness. Biperiden causes psychomotor agitation, vegetative disorders.
PHARMACOKINETICS
Distribution
Binding to plasma proteins is 91-94%. Plasma clearance is 11.6 В± 0.8 ml / min / kg. Excreted in breast milk.
Metabolism
Biperiden is completely metabolized. The main metabolites are bicycloheptane and piperidine.
Excretion
It is excreted in the form of metabolites with urine and feces. Excretion is carried out in two phases. T 1/2 of the first phase is 1.5 h, T 1/2 of the second phase is 24 h.
Pharmacokinetics in special clinical cases
In elderly patients, T 1/2 may increase.
INDICATIONS
- Parkinsonism syndrome in adults;
- extrapyramidal symptoms in children and adults caused by neuroleptics or similarly acting drugs;
- poisoning with nicotine or phosphorus-containing organic substances in adults.
DOSING MODE
In Parkinson's syndrome in adults in severe cases, the drug is given in / m or IV slowly in a dose of 10-20 mg (2-4 ml), divided into 2-4 injections.
For motor disorders caused by the action of drugs, to quickly achieve a therapeutic response to adults, the drug is administered IM or IV slowly in a dose of 2.5-5 mg (0.5-1 ml) once. If necessary, the same dose can be re-entered after 30 minutes. The maximum daily dose is 10-20 mg (2-4 ml).
Children under the age of 1 year are prescribed IV slowly in a dose of 1 mg (0.2 ml), at the age of 6 years - 2 mg (0.4 ml) and at the age of 10 years - 3 mg (0.6 ml). If necessary, this dose can be re-entered after 30 minutes. The drug should be discontinued if side effects develop during administration.
The experience of using the drug Akineton В® with drug dystonia in children is limited to short courses of treatment with the drug.
In case of nicotine poisoning in adults, in addition to standard therapy, the drug is given in / m at a dose of 5-10 mg (1-2 ml) and IV in a dose of 5 mg when the patient's life is at risk.
In case of poisoning with an organic phosphoric mixture , individual dosing of biperidene is carried out, depending on the degree of poisoning. The drug is administered iv in a dose of 5 mg with repeated administration until the symptoms of poisoning disappear.
SIDE EFFECT
From the side of the central nervous system: dizziness, drowsiness, weakness, fatigue, anxiety, confusion, euphoria, memory impairment and in some cases hallucinations, delirious disorders; nervousness, headache, insomnia, dyskinesia, ataxia, muscle cramps and speech impairment. With increased excitation of the nervous system, especially in patients with impaired cerebral function, it is necessary to reduce the dose of the drug.
On the part of the digestive system: dry mouth, increased salivary glands, constipation, epigastric discomfort, nausea.
From the side of the organ of vision: paresis of accommodation, mydriasis, accompanied by photophobia, angle-closure glaucoma (the intraocular pressure should be regularly monitored).
From the cardiovascular system: tachycardia and bradycardia, lowering blood pressure.
From the urinary system: difficulty urinating, especially in patients with prostatic hyperplasia (in this case, it is recommended to reduce the dose); more rarely - urinary retention.
Other : decreased sweating, allergic reactions, drug dependence.
CONTRAINDICATIONS
- an angle-closure glaucoma;
- stenosis of the gastrointestinal tract;
- megacolon;
- obstruction of the digestive tract;
- increased individual sensitivity to any of the components of the drug.
With caution should prescribe the drug for prostatic hyperplasia, urinary retention, heart rhythm disorders, elderly patients (especially in the presence of organic brain symptoms) and patients predisposed to epileptic seizures.
PREGNANCY AND LACTATION
Since the experience of using the drug Akineton В® in pregnancy is limited, it should be prescribed after a thorough assessment of the potential benefits of therapy for the mother and the possible risk to the fetus, especially in the first trimester.
Biperiden is excreted in breast milk, in which its concentrations can reach the concentrations observed in the blood plasma, therefore, during the treatment period, breastfeeding should be stopped.
APPLICATION FOR CHILDREN
The experience of using the drug Akineton В® with drug dystonia in children is limited to short courses of treatment with the drug.
Children under the age of 1 year are prescribed IV slowly in a dose of 1 mg (0.2 ml), at the age of 6 years - 2 mg (0.4 ml) and at the age of 10 years - 3 mg (0.6 ml). If necessary, this dose can be re-entered after 30 minutes. The drug should be discontinued if side effects develop during administration.
The experience of using the drug Akineton В® with drug dystonia in children is limited to short courses of treatment with the drug.
APPLICATION IN ELDERLY PATIENTS
Caution should be given to the drug in elderly patients (especially in the presence of organic cerebral symptoms).
SPECIAL INSTRUCTIONS
Side effects are observed, especially in the early stages of treatment and with too rapid a rise in the dose.
Except for life-threatening complications, abrupt withdrawal should be avoided.
In elderly patients, especially those having cerebral vascular or degenerative disorders, an increased sensitivity to the drug may often appear.
Anticholinergic drugs of central action, similar to the drug Akineton В® , may increase the predisposition to epileptic seizures. Therefore, doctors should take this fact into consideration when treating patients with this predisposition.
Late dyskinesia caused by neuroleptics may be intensified by the drug Akineton В® .
Parkinsonian symptoms in the case of advanced tardive dyskinesia in some cases are so severe that they prevent the continuation of treatment with anticholinergic drugs.
Abuse of the drug Akineton В® was noted. This phenomenon is possibly associated with improved mood and temporary euphoric effects of this drug, which are occasionally observed.
During prolonged therapy with the drug Akineton В® , intraocular pressure should be checked regularly.
Impact on the ability to drive vehicles and manage mechanisms
The administration of the drug Akineton В® , especially in combination with other central-action drugs, with anticholinergics, may impair the ability to drive and work with machinery.
OVERDOSE
Symptoms: dilated, slowly reacting to light pupils (mydriasis), dry mucous membranes, reddening of the skin, rapid heartbeat, atony of the bladder and intestines, hyperthermia, especially in children, agitation, confusion, delirium, collapse.
Treatment: antidote - inhibitors of acetylcholinesterase and, above all, physostigmine, if necessary - catheterization of the bladder. Conduction of symptomatic therapy.
DRUG INTERACTION
The use of the drug Akineton В® in combination with other anticholinergic psychotropic drugs, with antihistamine, antiparkinsonian and antiepileptic medicines can contribute to the strengthening of central and peripheral side effects.
Simultaneous administration of quinidine can cause an increase in anticholinergic cardiovascular effects (especially AV violation).
Simultaneous administration with levodopa may increase dyskinesia.
Anticholinergics can increase the central side effects of pethidine.
When treating the drug, the oppressive effect of ethanol on the central nervous system increases.
Akineton В® weakens the effect of metoclopramide and similarly acting remedies on the digestive tract.
TERMS OF RELEASE FROM PHARMACY
The drug is released by prescription.
TERMS AND CONDITIONS OF STORAGE
List A. The drug should be stored out of the reach of children at a temperature of no higher than 25 В° C. Shelf life - 5 years.
