Trihexyphenidyl Organic - instructions for use, dose, side effects, contraindications

In 1 tablet of the drug contains: active substance: trihexyphenidyl hydrochloride 2 mg, Excipients: sucrose (white sugar) 78.4 mg, potato starch 18.6 mg, calcium stearate 1.0 mg.

Description:Round flat-cylindrical tablets of white or almost white color with a bevel.

Pharmacotherapeutic group:Holin block the central.

ATX: & nbsp

Trihexyphenidyl

Pharmacodynamics:

Trihexyphenidyl belongs to the list of potent substances. Trihexyphenidyl has a central and peripheral m-anticholinergic action. Stimulation of the central nervous system (CNS) is accompanied by depression. Has spasmolytic effect, has a direct inhibitory effect on the parasympathetic nervous system, as well as a miorelaksiruyuschee effect on smooth muscles and reduces the secretion of especially salivary and bronchial glands, reduces sweating.Has a minor effect on the secretion of the pancreas and bile.

Pharmacokinetics:

After oral intake quickly absorbed from the gastrointestinal tract, easily penetrates the blood-brain barrier. The effect of the drug occurs 1 hour after ingestion. The half-life period averages 6-10 hours. Quickly leaves the body, appears mostly unchanged. Even with prolonged use does not cumulate. There are no data on the distribution, binding to plasma proteins of blood, metabolism and clearance, changes in excretion of the drug for violations of liver and kidney function (including hemodialysis), penetration through the placenta and into breast milk.

Indications:

Parkinsonism; prevention and control of drug-induced extrapyramidal symptoms (with the exception of tardive dyskinesia).

Contraindications:Hypersensitivity to the drug components, mechanical stenosis of the gastrointestinal tract, megacolon, angle-closure glaucoma, urinary retention, prostatic hyperplasia (with residual urine), tachyarrhythmias, acute alcohol, drug or psychotropic drug poisoning, including opioids, tardive dyskinesia since trihexyphenidyl may provoke or aggravate the course of tardive dyskinesia), pregnancy and breastfeeding, child age, sugar / isomaltase deficiency, fructose intolerance, glucose-galactose malabsorption.

Carefully:

Tachycardia, hypertension, prostatic hyperplasia, psychotic and manic disorders, dementia syndrome, acute myocardial infarction, myasthenia gravis, glaucoma, elderly patients, patients with heart disease, decompensated kidney or liver disease, obstructive diseases of the gastrointestinal tract or genitourinary tract.

Pregnancy and lactation:

The use of trihexyphenidyl during pregnancy and breastfeeding is contraindicated in order to avoid the possible risk of toxic effects on the fetus and the newborn, and also due to the lack of reliable information on the use of the drug during pregnancy, its ability to penetrate the placental barrier, excretion in breast milk and the effect on the fetus and the newborn. Pre-clinical studies of trihexyphenidyl showed that in experiments on dogs and rats, the drug in doses,100 times higher than the therapeutic dose for humans, does not affect fertility within 15 weeks. Studies of the teratogenic and embryotoxic effects of trihexyphenidyl have not been conducted. If necessary, the use of the drug in women who are breastfeeding, breastfeeding should be discontinued.

Dosing and Administration:

Only adults. Inside. The intake of the drug does not depend on the time of eating. It is recommended to take a tablet with a sufficient amount of liquid (150-200 ml). When hypersalivation, if it was observed before the start of treatment, trihexyphenidyl should be taken after meals. With the development in the treatment of oral mucosal dryness administered before a meal (if it does not nausea).

The dose should be selected individually, starting from the lowest, increasing it to the minimum effective. With parkinsonism syndromes: the initial dose is 1 mg per day. Every 3-5 days the dose is gradually increased to 2.1 mg per day, dose is increased to 6-10 mg per day depending on the patient's reaction to obtain an optimal therapeutic effect. Some patients may require 12-15 mg per day or more.Patients with postencephalic parkinsonism may be resistant to the drug and require large doses. For the treatment of drug-induced extrapyramidal disorders, 5-10 mg of trihexyphenidyl per day is usually prescribed, depending on the severity of the symptoms. In some cases, 1 mg daily may be sufficient. Complete the treatment should be gradual, reducing the dose of trihexyphenidyl for 1 -2 weeks, until it is completely canceled. Abrupt cancellation of the drug may lead to a sudden deterioration in the patient's condition due to the worsening of the symptoms of the disease. The duration of treatment is determined by the doctor individually in each case.

Elderly patients over 65 years of age trihexyphenidyl prescribe in minimum doses of 1-2 mg under the control of cognitive functions and mental state.

With the combined use of trihexyphenidyl with other drugs used to treat parkinsonism, a dose reduction is necessary. With simultaneous administration together with levodopa, the dosage of both drugs should be reduced, usually 3-6 mg of trihexyphenidyl per day, divided into two doses.

The maximum single dose is 10 mg, the daily dose is 20 mg.

Side effects:

From the central nervous system: increased nervous excitability, euphoria, psychomotor agitation, agitation, headache, dizziness, irritability, delirium, hallucinations, increased fatigue, decreased ability to concentrate, psychoses, with increased doses or hypersensitivity may experience anxiety, impaired consciousness, memory, insomnia, involuntary movements in the form of dyskinesias (especially in patients who take levodopa preparations), worsening of the clinical parameters of myasthenia gravis.

Effects due to anticholinergic activity: dry mucosa mucous membrane of the oral cavity, paresis of accommodation, increased intraocular pressure, mydriasis, impaired vision; decreased sweating, constipation, urinary retention, difficulty urinating, tachycardia, bradycardia.

From the digestive system: nausea, vomiting.

Allergic reactions: rashes on the skin, photophobia.

Other: purulent parotitis (due to decreased saliva), skin hyperemia, decreased muscle tone, drug dependence.

Overdose:

Symptoms: the first manifestations of intoxication can be reddening of the skin, hyperemia of the face, dry skin and mucous membranes, dry mouth, swallowing, rapid breathing, tachycardia, high blood pressure, nausea, vomiting, fever, pupil dilated, rash on the face and upper part of the trunk. Manifestations from the side of the central nervous system: causeless euphoria, atactic gait. Excitation develops into a delirious state with pronounced visual hallucinations. In severe overdose: coma, cardiovascular and respiratory failure, death.

Treatment: it is necessary as soon as possible to wash the stomach and use other possible ways to reduce absorption of the drug, cold compresses, plentiful drink. Hemodialysis and hemoperfusion are shown only during the first hours after poisoning. There is no specific antidote. For the treatment of cardiac complications - sodium bicarbonate or sodium lactate, with convulsions - diazepam, with delirium - physostigmine.

Interaction:

Drugs that depress the central nervous system, with admission with triexyphenidyl increase inhibitory effects on the central nervous system.At simultaneous reception anticholinergics and drugs with anticholinergic activity, monoamine oxidase inhibitors (MAO) with triexyphenidyl, the anticholinergic effect of the latter increases, and possibly the occurrence of gastrointestinal disorders, fever, hyperthermia, up to a heat stroke.

Trihexyphenidyl weakens the effect metoclopramide and domperidone.

The simultaneous use of trihexyphenidyl with aantihistamines can lead to manifestations of undesirable reactions associated with increased anticholinergic action.

With simultaneous application quinidine and trihexyphenidyl is enhanced anticholinergic influence on cardiac activity (braking atrioventricular conduction).

With simultaneous application trihexyphenidyl reduces the effect of sublingual nitrates (due to dry mouth).

With the simultaneous use of trihexyphenidyl with nefopam and antimuscarinic drugs, including those used by inhalation, may increase the frequency and severity of anticholinergic side effects, such as dry mouth, constipation, drowsiness.

The action of trihexyphenidyl can increase with its combined use with drugs: amantadine, H1-histamine receptor blockers (diphenhydramine, promethazine, Clemastine), phenothiazine derivatives (chlorpromazine, alimamazine), tricyclic antidepressants (imipramine, amitriptyline, trimipramine).

When combined with chlorpromazine increases its metabolism, as a result of which it is possible to reduce its concentration in the plasma.

When combined with ketoconazole it is possible to reduce the absorption of the orally taken drug.

Influenced reserpine antiparkinsonian action trihexyphenidyl decreases, which leads to increased parkinsonian syndrome.

When used in combination with other antiparkinsonian drugs (eg, levodopa) trihexyphenidyl dose should be significantly reduced, since such a combination can enhance dyskinesias, especially at the beginning of treatment, reducing the absorption and C_max levodopa in the blood plasma.

Dyskinesia is increased with simultaneous admission tranquilizers and trihexyphenidyl.

Trihexyphenidyl and parasympathomimetic drugs (pilocarpine, carbachole, neostigmine) are antagonists, so they can not be used together due to an increase in antimuscarinic side effects.

Cannabinoids, barbiturates, opiates, alcohol - additive effects with trihexyphenidyl are possible.

Special instructions:

Since the use of trihexyphenidyl in some cases can last for a long time, the patient should be carefully monitored for a long time to avoid allergic or other undesirable reactions. Treatment can not be stopped suddenly. At the end of treatment or in the case of initiating an alternative treatment, the dose of trihexyphenidyl should be reduced gradually. The use of trihexyphenidyl can provoke early (starting) glaucoma. Periodically monitor the intraocular pressure. Patients with hypertension, impaired function of the heart, liver or kidney drug is not contraindicated, but these patients need careful monitoring. In patients with cardiovascular disease, impaired renal or hepatic function, the drug should be used with caution. As trihexyphenidyl may provoke or aggravate tardive dyskinesia, the drug is not recommended for patients with such a disease. Trihexyphenidyl should be used with caution in patients with glaucoma, obstructive diseases of the gastrointestinal tract or genitourinary tract, as well as in elderly men with possible prostatic hypertrophy. The use of trihexyphenidyl was associated with a clinical deterioration of myasthenia gravis, so the drug should be avoided or used with great care in patients with myasthenia gravis.

Although some psychiatric manifestations, such as confusion, delusions and hallucinations that may occur with atropine-like drugs, have been rare with trihexyphenidyl, the drug should be used with extreme caution in elderly patients. In addition, these patients may be impaired memory and thinking.

When using large doses of the drug or in the treatment of patients with predisposing factors (atherosclerosis, elderly age or patients who previously appeared idiosyncrasy for any drug), psychicdisturbances (mood changes, agitation, increased irritability), vomiting, or nausea. In these cases, it is necessary to stop treatment. Anticholinergic drugs, including trihexyphenidyl, should not be abruptly abolished in patients on prolonged therapy.

It should be borne in mind that it is possible to abuse the drug due to its euphoric or hallucinogenic properties.

If you receive dry mouth, it is advisable to take it before meals, as otherwise you may experience nausea.

In the course of long-term treatment, the severity of unwanted reactions caused by anticholinergic action decreases.

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 of 2 mg.

Packaging:

10 tablets per contour cell packaging made of polyvinylchloride film and aluminum foil. For 20 or 50 tablets in a jar of glass for storing medicines with a triangular aureole.

The bank or 2, or 5 contour mesh packages together with the instruction for use are placed in a cardboard box.

Storage conditions:

List of potent substances. In the dark place at a temperature of no higher than 30 0 С.

Keep out of the reach of children.

Shelf life:3 years.

Do not use after the expiration date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:LP-003535

Date of registration:29.03.2016

Expiration Date:29.03.2021

The owner of the registration certificate:ORGANICS, JSC ORGANICS, JSC Russia

Manufacturer: & nbsp

ORGANICS, JSC Russia

Information update date: & nbsp12.07.16

Illustrated instructions

Instructions

Trihexyphenidyl Organa (Trihexyphenidyl Organica)