Chlorprothixen – composition, dosage, indications, contraindications, side effects

Chlorprothixen Zentiva is a film-coated tablet formulation of neuroleptics. It contains the substance chloroprotixene and is indicated in the treatment of endogenous and organic psychoses (with states of motor agitation). Chlorprothixen works by blocking the receptors that are responsible for transmitting information with the help of dopamine, blocking the adrenaline-dependent alpha receptors, and inhibiting the release of hormones from the pituitary and hypothalamus.

Chlorprothixene — what kind of drug is it?

Chlorprothixen Hasco is a drug that has a strong sedative effect, has a weak antiproductive and antioxidant effect, and has a slight antidepressant effect. It also has an antihistamine and antiemetic effect. It has an anxiolytic effect in small doses. It does not cause fatigue and drowsiness. It enhances the effects of alcohol, sleeping pills and inducers. It lowers body temperature.

Chlorprothixen is available as 15 mg and 50 mg. The active substance is chloroprotixene hydrochloride.

Chlorprothixen Hasco, 15 mg

One film-coated tablet contains 15 mg of chloroprotixene hydrochloride (Chlorprothixeni hydrochloridum).

Excipients with known effect: One film-coated tablet contains 39,27 mg of lactose monohydrate and sunset yellow, aluminum lake (E 110).

Chlorprothixen Hasco, 50 mg

One film-coated tablet contains 50 mg of chloroprotixene hydrochloride (Chlorprothixeni hydrochloridum).

Excipients with known effect: One coated tablet contains 130,90 mg of lactose monohydrate and cochineal red, aluminum lake (E 124).

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Chlorprothixen – action

Chloroprotixene is a thioxanthene derivative with a structure similar to phenothiazine derivatives. Its antipsychotic activity is based on blocking postsynaptic dopaminergic receptors in the brainand by blocking alpha-adrenergic receptors and inhibiting the release of most hormones in the hypothalamus and pituitary gland.

Chloroprotixene increases prolactin levels by blocking prolactinostatin, a factor that inhibits the release of prolactin (PIF) from the pituitary gland. Unlike other thioxanthene derivatives, it exhibits a clear sedative effect, as it inhibits the stimuli flowing to the reticular system of the brainstem, and also acts as an antiemetic by inhibiting chemoreceptors in the spinal cord.

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Chlorprothixen – indications

Indications for the use of Chlorprothixen is the treatment of endogenous and organic psychoses with states of motor agitation and aggressiveness, anxiety and insomnia in neuroses and psychosomatic disorders, alcohol psychoses. In surgery – premedication to calm the patient down and reduce neurovegetative reactions and to prevent postoperative vomiting.

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Chlorprothixen – dosage

The dosage should be adjusted individually depending on the indications and the patient’s tolerance to the drug.

Dosage of Chlorprothixen in case of neuroses:

1. usually 15 mg one to three times a day.

Dosage of Chlorprothixen in case of psychosomatic disorders:

1. usually 50 mg to 100 mg two to four times a day. The daily dose should be divided so that the larger dose is administered at bedtime.

Dosage of Chlorprothixen for premedication:

1. the dosage is determined by the doctor individually for each patient.

Dosage of Chlorprothixen for children and adolescents:

1. The use of chloroprotixen in children and adolescents is not recommended due to the lack of well-controlled studies.

How to administer Chlorprothixen:

1. The film-coated tablets should be taken with a meal and swallowed whole with a glass of water or milk to avoid stomach irritation.

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Chlorprothixen – contraindications

The main contraindication to taking Chlorprothixen is hypersensitivity to the active substance, thioxanthene derivatives or to any of the excipients. In addition, the contraindication to the use of the product is:

1. circulatory collapse, disturbance of consciousness regardless of etiology (e.g. intoxication with alcohol, barbiturates or opioids), coma,
2. history of cardiovascular disorders of clinical significance (e.g. significant bradycardia (<50 beats / minute), recent acute myocardial infarction, decompensated heart failure, myocardial hypertrophy, arrhythmias treated with class IA and III antiarrhythmic drugs), History of tachycardia with torsade de pointes,
3. congenital long QT syndrome or known acquired QT prolongation (QTc interval over 450 ms in men and over 470 ms in women),
4. use of drugs that prolong the QT interval,
5. diagnosed decompensated hypokalemia and known, decompensated magnesium deficiency.

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Chlorprothixen – precautions

Talk to your doctor or pharmacist before using Chlorprothixen. In some disease states, special care should be taken when taking the drug. For this reason, please inform your doctor about any illnesses you have.

Particular caution should be exercised when using the drug by patients with:

1. pheochromocytoma,
2. a prolactin-dependent tumor,
3. severe orthostatic hypotension (when you stand upright)
4. Parkinson’s disease,
5. cardiovascular diseases,
6. an overactive thyroid gland,
7. urination disorders, urinary retention,
8. pyloric stenosis, intestinal obstruction,
9. suffering from alcoholism or abuse of opioids or drugs with a sedative (sedative) effect on the central nervous system,
10. severe respiratory disorders (e.g. pneumonia, asthma, emphysema),
11. risk factors for stroke (for the elderly)
12. exposed to extreme temperatures and during electroconvulsive treatment,
13. history of cardiovascular disease or a history of prolonged QT interval.

As with the use of other neuroleptics, chloroprotixen should be used with caution in patients with:

1. organic brain damage,
2. mental retardation,
3. epilepsy,
4. severely impaired liver, kidney and / or heart function,
5. myasthenia gravis (a disease characterized by muscle weakness)
6. benign prostatic hyperplasia,
7. diabetes (chloroprotixene may have an influence on the level of insulin and glucose in the blood, which requires correction of antidiabetic treatment).

Precautions for Neuroleptic Malignant Syndrome:

With the use of any neuroleptic drug, there is a possibility of neuroleptic malignant syndrome, the symptoms of which are: high fever, muscle stiffness, impaired consciousness, instability of the autonomic nervous system.

Precautions for glaucoma:

in people with a rare disease – a shallow anterior chamber and a narrow angle, attacks of acute glaucoma caused by dilated pupils may occur.

Precautions in case of venous thromboembolism:

be especially careful if you or someone in your family have a history of blood clots, as blood clots have been associated with the use of antipsychotics (drugs to treat behavioral disorders).

Precautions for priapism:

Cases of priapism (prolonged, usually painful erection that may require surgery) have been reported with the use of antipsychotics. Chlorprothixen Hasco belongs to the group of antipsychotics and therefore the risk of priapism following its use cannot be ruled out. Tell your doctor immediately if you experience prolonged or painful erection. You may need immediate medical attention.

Chloroprotixene may cause a false-positive urine pregnancy immunoassay, urine test for bilirubin.

Chloroprotixen should be used with caution in the elderly population. Elderly people are especially prone to developing hypotension associated with standing upright body positions. Chloroprotixene is not intended for the treatment of dementia-related behavioral disorders. An increase in cerebrovascular adverse events has been observed in the elderly with dementia.

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Chlorprothixen – interactions with other drugs

Tell your doctor or pharmacist about all the drugs you are taking or have recently taken, as well as about the drugs you plan to use.

In particular, tell your doctor if you are taking any of the following medicines:

1. blood pressure lowering drugs (e.g. guanethidine and similar drugs);
2. antidepressants (e.g. tricyclics);
3. inducing sleepiness (barbiturates and similar medicines);
4. used to treat epilepsy (neuroleptics and lithium compounds);
5. used to treat Parkinson’s disease (levodopa and similar drugs);
6. used to treat galactorrhea (e.g. bromocriptine) – your doctor will change the dosage if necessary.

The following drugs should not be taken simultaneously with Chlorprothixen Hasco:

1. drugs that alter the heartbeat (e.g. quinidine, amiodarone, sotalol, dofetilide, erythromycin, terfenadine, astemizole, gatifloxacin, moxifloxacin, cisapride, lithium);
2. other antipsychotics (e.g. thioridazine).

Avoid using:

1. medications that disrupt the fluid and electrolyte balance (e.g. thiazide diuretics);
2. medicines known to increase the blood levels of chloroprotixen (e.g. paroxetine, fluoxetine, chloramphenicol, disulfiram, isoniazid, MAO inhibitors, oral contraceptives, buspirone, sertraline, citalopram).

The risk of extrapyramidal symptoms (e.g., slowness of movement, disturbed facial expressions, stiffness resulting from increased muscle tone, tremors) increases if you take:

1. metoclopramide (an antiemetic);
2. phenothiazine, haloperidol or reserpine derivatives (antipsychotics);
3. piperazine (an antiparasitic drug that works against human pinworms and roundworms).

Chlorprothixen – pregnancy and breastfeeding

Chloroprotixen should not be administered during pregnancy unless the expected benefit to the mother outweighs the risk to the fetus. Newborns from mothers exposed to antipsychotics (including chloroprotixen) during the third trimester of pregnancy are at risk of adverse reactions including extrapyramidal and / or withdrawal symptoms which may vary in severity and duration after birth.

Agitation, hypertonia, hypotension, tremor, somnolence, respiratory distress syndrome, or feeding disorders have been observed. Therefore, newborns should be carefully monitored.

Chloroprotixen is excreted in human milk in low concentrations and therapeutic doses are not expected to have any effect on the infant. The dose taken by the infant is approximately 2% of the dose taken by the mother. Breast-feeding may be continued during treatment with chloroprotixen if clinically relevant, but observation of the infant is recommended, especially in the first 4 weeks after birth.

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Chlorprothixen – effects on the ability to drive and use machines

Chloroprotixene is a sedative drug. It may adversely affect the performance of activities requiring increased attention, precise coordination of movements and quick decision-making (e.g. driving vehicles, operating machinery, working at high altitudes, etc.), especially at the beginning of treatment. Patients should be informed of the possibility of impaired ability to drive or operate machinery.

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Chlorprothixen – side effects

Most of the side effects are dose dependent. Incidence and severity are greatest early in treatment and decline with continued treatment. The blockade of dopaminergic receptors in the central nervous system can cause acute neurological complications – dystonia, and also akathisia or extrapyramidal symptoms.

Very common side effects (may affect more than 1 in 10 people):

1. drowsiness, dizziness, dry mouth, increased drooling.

Common side effects (may affect up to 1 in 10 people):

1. increased appetite, insomnia, nervousness, agitation, decreased libido, headache, dystonia (involuntary movements that make parts of the body twist or flex), disturbed eye accommodation, abnormal vision, rapid heartbeat (especially when stopping treatment suddenly), palpitations (palpitations) ), postural hypotension (including dizziness which usually occurs when you stand up suddenly), constipation, indigestion, nausea, increased sweating, muscle pain, chronic weakness, fatigue, weight gain.

Uncommon side effects (may affect up to 1 in 100 people):

1. decreased appetite, akathisia (inability to keep a steady position), tardive dyskinesia (involuntary, uncoordinated muscle movement, especially of the face), parkinsonism, seizures, seizures of compulsive looking with eye rotation, hypotension, hot flushes, vomiting, diarrhea, rash, itching, photosensitivity, skin inflammation, muscle stiffness, micturition disorder, urinary retention, ejaculation failure, erectile dysfunction, weight loss, liver function test abnormal.

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Chlorprothixen – overdose

Symptoms of overdose with Chlorprothixen include drowsiness, coma, convulsions, shock, movement disorders, hyperthermia or hypothermia, respiratory depression, and hypotension (may take several hours and last for 2-3 days). In severe cases, kidney damage.

Seizures, hyperactivity and haematuria may occur as soon as the symptoms of overdose have resolved. ECG changes, QT prolongation, torsades de pointes, cardiac arrest and ventricular arrhythmias have been reported when the drug has been overdosed with other medicines known to have cardiac effects.

Treatment of overdose with Chlorprothixen is symptomatic and supportive. Gastric lavage should be performed as soon as possible after oral ingestion, administration of activated charcoal may be considered. Treatment that supports respiratory and cardiovascular function should be instituted.

Epinephrine (adrenaline) should not be administered as this may further reduce blood pressure. If convulsions occur, diazepam can be used, and in case of extrapyramidal disorders – biperiden.

In the event of neuroleptic malignant syndrome (hyperthermia, muscle stiffness, impaired consciousness, instability of the autonomic nervous system), the neuroleptic drug should be discontinued. Treatment is symptomatic and supportive. Administration of dantrolene and bromocriptine may be helpful. Symptoms may persist for more than one week after discontinuation of oral neuroleptic drugs.

Doses in the range of 2,5 g to 4 g (adults) and 4 mg / kg (children) can be fatal. The survival of adult patients after taking 10 g of the drug and the survival of a 3-year-old child after consuming 1000 mg.