Cyclodol® (Cyclodol®)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceTrihexyphenidylTrihexyphenidyl
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    • Dosage form: & nbspPills.
    Composition:
    active substance: trihexyphenidyl hydrochloride - 2 mg;
    Excipients: sucrose 78.6 mg, potato starch 11.8 mg, microcrystalline cellulose 7.0 mg, calcium stearate 0.6 mg.
    Description:Round flat cylindrical tablets of white color, with a bevel.
    Pharmacotherapeutic group:An antiparkinsonian remedy.
    ATX: & nbsp

    N.04.A.A.01   Trihexyphenidyl

    Pharmacodynamics:Trihexyphenidyl has central and peripheral m-holinoblokiruyuschee, as well as muscle relaxant effect on smooth muscle. The mechanism of action is based on competition with acetylcholine on the postsynaptic membrane. Reduces tremor, to a lesser extent affects rigidity and bradykinesia. In connection with peripheral m-holinoblokiruyuschim action reduces saliva and, to a lesser extent, sweating.
    Pharmacokinetics:When administered orally trihexyphenidyl quickly and completely absorbed from the digestive tract; due to high lipotropy it passes well through the blood-brain and placental barrier. The effect of the drug occurs 1 hour after ingestion, at the maximum level lasts 2-3 hours and ends after 6-12 hours. The half-life period is 5-10 hours. In tissues, under the influence of nonspecific esterases, it hydrolyzes with the formation of alcohol and organic acids, in unchanged the form is excreted in small amounts through the kidneys. Even with prolonged use does not cumulate.
    Indications:
    Parkinsonism (all types, including Parkinson's disease): motor disorders associated with extrapyramidal system damage.
    Contraindications:Hypersensitivity to any of the components of the drug, mechanical stenosis of the gastrointestinal tract, megacolon, zakratougolnaya glaucoma, urinary retention, prostatic hyperplasia (with the presence of residual urine), pulmonary edema, dementia, children under 18 years of age, pregnancy and lactation, a shortage of sugar / isomaltase, fructose intolerance, glucose-galactose malabsorption.
    Carefully:
    Decompensated heart, kidney or liver diseases, tachycardia, tachyarrhythmia, arterial hypertension, acute myocardial infarction, psychosis, myasthenia gravis, tardive dyskinesia (repetitive unconscious movements).
    Elderly patients and patients with impaired health, with organic diseases of the brain and heart, as well as with violations of kidney and liver, the drug should be used with extreme caution, in smaller doses.
    In case of malicious use (for causing hallucinations and euphoria), therapy can not be stopped suddenly, the doses are reduced gradually (to avoid the development of withdrawal symptoms).
    Pregnancy and lactation:
    In connection with the ability of trihexyphenidyl to penetrate the placental barrier, its use during pregnancy is contraindicated in order to exclude the possible risk of toxic effects on the fetus.
    Trihexyphenidyl is excreted in breast milk, so its use during breastfeeding is contraindicated.
    Dosing and Administration:
    The drug is used inside while eating or between meals, with enough water.With the initial hypersalivation, the drug is taken after a meal, if there is a dryness in the oral mucosa during treatment, before eating (see section "Special instructions").
    Doses prescribed individually, at the beginning of therapy increase gradually. The initial dose is 0.5-1 mg / day. If necessary, every 3-5 days the dose is increased by 1-2 mg. Multiplicity of destination - 3-4 times a day. The maximum single dose is 10 mg, the daily dose is 16 mg.
    The duration of treatment is determined by the doctor individually; with prolonged treatment of Parkinsonism (more than 1 month), the application should be discontinued gradually (within 1-2 weeks) in order to avoid the possible development of withdrawal syndrome (neurosis, anxiety, tachycardia, orthostatic hypotension, sleep disturbances).
    Side effects:

    From the nervous system: dizziness, irritability, fatigue, insomnia, memory impairment, mydriasis, headache, delirium, hallucinations, decreased ability to concentrate, psychoses.

    Effects due to m-cholinoblocking activity: dryness of the oral mucosa, disruption of accommodation, constipation, urinary retention (incl.with hypertrophy of the prostate gland), tachycardia, increased intraocular pressure, decreased sweating.

    From the digestive system: nausea, vomiting, abdominal pain.

    Allergic reactions: skin rash, photophobia, hypersensitivity.

    Other: Purulent parotitis (due to decreased saliva), skin hyperemia, decreased muscle tone, it is possible to develop drug dependence.

    Overdose:Large doses of trihexyphenidyl cause blockade of postganglionic endings of the parasympathetic nervous system, the poisoning pattern corresponds to atropine poisoning (mydriasis, dryness of the oral mucosa, tachycardia, intestinal and biliary tractions, fever, etc.). Disturbances from the central nervous system are expressed by the symptoms of mental and motor excitement, coma or paralysis of the respiratory center may develop.
    On psychotic patients, the drug may have a hallucinogenic and euphoric effect, which leads to frequent abuse. Cases of death due to drug overdose were noted.
    Treatment of poisoning: there is no specific antidote.
    First aid: gastric lavage, reception of activated carbon. Treatment is symptomatic. To eliminate delirium, cholinesterase inhibitors (physiostigmine) are used. To eliminate complications associated with cardiac dysfunction, apply sodium hydrogen carbonate or sodium lactate; in case of seizures apply diazepam. Hemodialysis and hemoperfusion are prescribed only in the first hours after poisoning.
    Interaction:
    The action of trihexyphenidyl can increase with its joint application with other drugs: amantadine, H1-histamine receptor blockers (diphenhydramine, promethazine, Clemastine), phenothiazine derivatives (chlorpromazine, trimeprazine), tricyclic antidepressants (imipramine, amitriptyline, trimipramine), MAO inhibitors.
    Levodopa increases the antiparkinsonian activity of trihexyphenidyl, so when combined, the dosage of both drugs should be reduced. Usually in this case, enough 3-6 mg of trihexyphenidyl per day, divided into two doses. Under the influence of reserpine, the antiparkinsonian action of trihexyphenidyl decreases (depletion of dopamine reserves in the central nervous system, activation of cholinergic neurons).
    Due to the development of dryness in the mouth under the influence of trihexyphenidyl, the effect of drugs used sublingually (nitrates) decreases; because of the ability of trihexyphenidyl to reduce intestinal motility, the absorption of drugs from the gastrointestinal tract decreases. Trihexyphenidyl reduces the effect on the digestive tract of drugs that depress the gag reflex (metoclopramide and domperidone).
    The depressive effects of alcohol and drugs that affect the central nervous system may be exacerbated when used with trihexyphenidyl.
    Trihexyphenidyl and parasympatomimetic drugs (pilocarpine, carbachole, neostigmine) are antagonists, so they can not be used together.
    Antiarrhythmic drugs (quinidine) increase the possible side effects of trihexyphenidyl on cardiac activity.

    Special instructions:
    Preclinical studies of trihexyphenidyl showed that in trials on dogs and rats, the drug at doses 100 times higher than the therapeutic dose for a human does not affect fertility for 15 weeks.Studies of teratogenic, embryotoxic and carcinogenic effects of trihexyphenidyl were not conducted.
    The drug does not have a mutagenic effect.
    Symptoms of acute toxicity are described in the section "Overdose".
    With prolonged treatment of Parkinsonism (more than 1 month), use should be discontinued gradually (within 1-2 weeks) in order to avoid the possible development of withdrawal syndrome (neurosis, anxiety, tachycardia, orthostatic hypotension, sleep disturbances).
    If there is dryness in the mouth when taking the drug, it is advisable to take it before meals, tk. otherwise, nausea may appear (see section "Dosing and Administration").
    Patients over 60 years of age are prescribed with extreme caution because of hypersensitivity to the drug, the possibility of memory impairment and thinking. When using large doses of the drug or in the treatment of patients with predisposing factors (atherosclerosis, advanced age, or patients who have previously developed idiosyncrasy for a drug), mental disorders (unnatural mood increase, agitation, increased irritability), vomiting, or nausea may occur .In these cases, it is necessary to stop treatment.
    In the course of long-term treatment, the severity of side effects due to anticholinergic action decreases.
    Regular monitoring of intraocular pressure (the risk of closed-angle glaucoma) should be monitored.
    The drug may worsen the condition of patients with tardive dyskinesia. When used simultaneously with other drugs with m-cholinoblocking activity, the side effects of trihexyphenidil may be increased, the risk of developing tardive dyskinesia is increased.
    In the treatment with neuroleptics, the use of trihexyphenidyl does not prevent the development of a malignant neuroleptic syndrome.
    There are cases of abuse of trihexyphenidyl, especially in psychiatric patients (due to hallucinating and euphorizing effects).
    Perhaps the development of drug dependence. To avoid the development of possible withdrawal symptoms (withdrawal syndrome) - neurosis, anxiety, tachycardia, orthostatic hypotension, sleep disorders - therapy should be discontinued gradually (within 1-2 weeks).
    Effect on the ability to drive transp. cf. and fur:During the treatment period, care must be taken when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.
    Form release / dosage:
    Tablets 2 mg.


    Packaging:
    25 tablets in a planar cell packaging made of polyvinylchloride film and aluminum foil.
    2 contour mesh packages with instructions for use are placed in a pack of cardboard.
    Storage conditions:Store in a dark place at a temperature of no higher than 25 ° C. Keep out of the reach of children.
    Shelf life:
    5 years.
    Do not use after the expiry date printed on the package.
    Terms of leave from pharmacies:On prescription
    Registration number:П N014767 / 01
    Date of registration:15.12.2008
    The owner of the registration certificate:GRINDEX, JSC GRINDEX, JSC Latvia
    Manufacturer: & nbsp
    Representation: & nbspGrindeks Rus, Open CompanyGrindeks Rus, Open CompanyRussia
    Information update date: & nbsp25.09.2015
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