Universal reference book for medicines
Name of the preparation: CLOPIXOL-ACUFASE (CLOPIXOL-ACUPHASEВ® )

Active substance: zuclopenthixol

Type: Antipsychotic drug (antipsychotic)

Manufacturer: H.LUNDBECK (Denmark)
Composition, form of production and packaging
Clopixol

Tablets covered with a film membrane of pale pink color, round, biconcave;
on a cross-section of white color.
1 tab.

Zuclopenthixol dihydrochloride 2.364 mg,

which corresponds to the content of zuclopentixol 2 mg

Auxiliary substances: potato starch - 22.2 mg, lactose monohydrate 17.4 mg, microcrystalline cellulose 9 mg, copovidone 3 mg, glycerol 85% 1.2 mg, talc 4.2 mg, hydrogenated castor oil 0.48 mg, magnesium stearate 0.42 mg .

The composition of the membrane: hypromellose 5 - 1.37 mg, macrogol 6000 - 0.274 mg, titanium dioxide (E171) - 0.445 mg, iron oxide red (E172) 0.011 mg.

50 pcs.
- plastic containers (1) - packs cardboard.
100 pieces.
- plastic containers (1) - packs cardboard.
Clopixol

The tablets covered with a film membrane of a pinkish-brown color, round, biconcave;
on a cross-section of white color.
1 tab.

zuclopentixole dihydrochloride 11.82 mg,

which corresponds to the content of zuclopentixol 10 mg

Auxiliary substances: potato starch - 29.2 mg, lactose monohydrate - 21.6 mg, microcrystalline cellulose - 13.5 mg, kapovidone - 4.5 mg, glycerol 85% - 1.8 mg, talc - 6.3 mg, castor oil hydrogenated - 0.72 mg, magnesium stearate - 0.63 mg .

The composition of the membrane: hypromellose 5-2.05 mg, macrogol 6000 - 0.411 mg, titanium dioxide (E171) - 0.479 mg, iron oxide red (E172) - 0.205 mg.

50 pcs.
- plastic containers (1) - packs cardboard.
100 pieces.
- plastic containers (1) - packs cardboard.
Clopixol

Tablets covered with a film membrane of red-brown color, round, biconcave;
on a cross-section of white color.
1 tab.

zuclopentixole dihydrochloride 29.55 mg,

which corresponds to the content of zuclopentixol 25 mg

Auxiliary substances: potato starch - 31.6 mg, lactose monohydrate - 22 mg, microcrystalline cellulose - 18 mg, copovidone - 6 mg, glycerol 85% - 2.4 mg, talc - 8.4 mg, hydrogenated castor oil - 0.96 mg, magnesium stearate - 0.84 mg .

The composition of the membrane: hypromellose 5 - 2.74 mg, macrogol 6000 - 0.548 mg, titanium dioxide (E171) - 0.091 mg, iron oxide red (E172) - 0.822 mg.

50 pcs.
- plastic containers (1) - packs cardboard.
100 pieces.
- plastic containers (1) - packs cardboard.
Clopixol-Acuphase

Solution for the / m introduction (oily) yellowish color, transparent, virtually free of particles.

1 ml

ZuClopentixol acetate 50 mg

Excipients: triglycerides.

1 ml - ampoules of colorless glass (5) - packs cardboard.

Clopixol Depot

Solution for the / m introduction (oily) yellowish color, transparent, virtually free of particles.

1 ml

Zuclopenthixol Decanoate 200 mg

Excipients: triglycerides.

1 ml - ampoules of colorless glass (1) - packs of cardboard.

1 ml - ampoules of colorless glass (10) - packs cardboard.

INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2008.

PHARMACHOLOGIC EFFECT

An antipsychotic agent (neuroleptic), a derivative of thioxanthene.
Clopixol has a pronounced antipsychotic and specific inhibitory effect. Clopixol may also have a transient, dose-dependent sedative effect, the rapid development of which at the beginning of therapy (before the onset of antipsychotic action) is an advantage in the treatment of acute and subacute psychosis. Tolerance to the nonspecific sedative effect of the drug occurs quickly. Due to a specific inhibitory effect, the drug is especially indicated in agitation, anxiety, hostility or aggression.
A single injection of Clopixol-Acuphase provides a pronounced and rapid relaxation of psychotic symptoms.
The duration of the antipsychotic effect of the drug after one injection is 2-3 days. Nonspecific sedation occurs after 2 hours, reaches a maximum in about 8 hours, then significantly decreases and weakly manifested with repeated injections.
The therapeutic effect of Clopixol Depot is significantly more prolonged than Clopixol.
This allows confidently to conduct continuous antipsychotic treatment with Clopixol Depot, which is especially important for patients who do not perform medical appointments. Clopixol Depot prevents the development of frequent relapses associated with arbitrary interruption of oral medication by patients.
PHARMACOKINETICS

Pharmacokinetic and clinical trials of Clopixol Depot showed that injection of the drug is most expedient to spend at intervals of 2-4 weeks.

The pharmacokinetic dose of Clopixol Depot 200 mg once every 2 weeks is equivalent to a dose of Clopixol for oral administration of 25 mg / day for 2 weeks.

Suction

After taking Klopiksola inside C max zuclopentixola in blood plasma is achieved after 4 hours. Bioavailability of zuclopentixol when ingested - about 44%.

After the / m injection of Clopixol-acupase, zuclopentixol acetate is subjected to enzymatic cleavage into the active component of zuclopenthixol and acetic acid.
Cmax of zuclopentixol in the blood serum is achieved after 24-48 hours (an average of 36 hours) after the injection. Then the concentration slowly decreases, reaching 1/3 of C max 3 days after the injection.
After IM injection of Clopixol, the depot of zuclopentixol decanoate undergoes enzymatic cleavage into the active component of zuclopenthixol and decanoic acid.
Cmax of zuclopentixol in the serum is reached by the end of the first week after the injection.
Distribution

Zuclopentixol in small amounts penetrates through the placental barrier, in small amounts is excreted in breast milk.

Metabolism and excretion

When ingested, T 1/2 is approximately 20 hours.

After IM injection of Clopixol Depot, the curve of the concentration of zuclopentixol decreases exponentially, with T 1/2 being 19 days, which reflects the rate of release of the active substance from the depot.

Metabolites do not have neuroleptic activity;
are excreted mainly with feces and partly with urine.
INDICATIONS

Clopixol

- Acute and chronic schizophrenia and other psychotic disorders, especially with hallucinations, paranoid delusions and mental disorders;

- states of agitation, heightened anxiety, hostility, aggression;

- manic phase of manic-depressive psychosis;

- Mental retardation, combined with psychomotor agitation, agitation and other behavioral disorders;

- senile dementia with paranoid ideas, disorientation, behavioral disorders, confusion.

Clopixol-Acuphase

- initial treatment of acute psychoses, including manic conditions, and chronic psychoses in the phase of exacerbation.

Clopixol Depot

- Acute and chronic schizophrenia and other psychotic disorders, especially with hallucinations, paranoid delusions and mental disorders;

- states of agitation, heightened anxiety, hostility, aggression.

DOSING MODE

Clopixol

The drug is taken orally, the daily dose can be divided into several doses.
The dose is selected individually depending on the patient's condition. At the beginning of treatment it is recommended to use the drug in low doses, which then, depending on the patient's response to treatment, is rapidly increased to achieve the optimal clinical effect.
With an acute attack of schizophrenia and other acute psychotic disorders, severe agitation and mania, the dose of the drug is usually 10-50 mg / day.

With moderate and severe psychotic disorders, the initial dose is 20 mg / day and, if necessary, can be increased by 10-20 mg at 2-3 day intervals to 75 mg / day or more.

In chronic psychotic conditions in schizophrenia and other chronic psychoses, the maintenance dose is 20-40 mg / day.

When agitating in patients with oligophrenia, the dose is 6-20 mg / day, if necessary, the dose can be increased to 25-40 mg / day.

In senile disorders, accompanied by agitation and confusion , the drug is prescribed in a dose of 2-6 mg / day, if necessary, an increase in the dose to 10-20 mg / day;it is more preferable to take the drug in the evening.

Clopixol-Acuphase

The drug is administered in the form of a deep intravenous injection into the upper outer quadrant of the gluteal region.

The recommended volume of IM injection is 1-3 ml (50-150 mg).
If necessary, repeated injections are carried out with an interval of 2-3 days. In some patients, an additional injection can be administered 24-48 hours after the first injection.
Supportive therapy should be continued with Clopixol for oral administration or Clopixol Depot IM in accordance with the recommendations below.

Clopixol Depot

The drug is administered in the form of a deep intravenous injection into the upper outer quadrant of the gluteal region.

The dose and interval between injections are determined individually, depending on the patient's condition.

Clopixol Depot (200 mg / ml) with maintenance treatment is administered in doses of 200-400 mg (1-2 ml) every 2-4 weeks.
In some cases, higher doses or shorter intervals between injections may be required.
Transition from Clopixol for oral administration to the / m introduction of Clopixol Depot

The daily dose (mg) Clopixol for oral administration x 8 = dose (mg) Clopixol Depot for intravenous administration once every 2 weeks.

Clopixol intake should be continued within the first week after the first injection, but in a reduced dose.

Transition c / m of the introduction of Clopixol-acupase to Clopixol administration inside

2-3 days after the final injection of Clopixol-acupase (100 mg) Clopixol should be administered orally at a daily dose of 40 mg, if possible in several divided doses.
If necessary, the dose can be increased by 10-20 mg every 2-3 days to 75 mg / day or more.
Transition from the / m introduction of Clopixol-acuphase to the / m introduction of Klopiksola Depot

Simultaneously with the final injection of Clopixol-Acupase (100 mg), 200-400 mg (1-2 ml) of Clopixol Depot (200 mg / ml) should be administered.
Repeated injections of Clopixol Depot are performed every 2 weeks. If necessary, it is permissible to use the drug at higher doses or to shorten the intervals between injections.Clopixol-acupase and Clopixol depot can be mixed in one syringe and administered as a single injected injection. Subsequent doses of Clopixol Depot and the intervals between injections should be determined depending on the patient's condition.
SIDE EFFECT

From the side of the central nervous system and the peripheral nervous system: at the initial stage of treatment, extrapyramidal symptoms may develop (in most cases they are corrected by lowering the dose and / or administration of antiparkinsonian drugs, however, regular prophylactic action of the latter is not recommended), drowsiness;
possibly also a violation of accommodation.
With prolonged therapy, in some patients, tardive dyskinesia rarely occurs.
Antiparkinsonian drugs do not eliminate the symptoms of this condition. It is recommended to reduce the dose or, if possible, discontinue therapy.
From the cardiovascular system: orthostatic dizziness, tachycardia;
rarely - orthostatic hypotension.
On the part of the digestive system: dry mouth, constipation;
rarely - minor transient changes in hepatic samples.
From the urinary system: urinary retention.

CONTRAINDICATIONS

acute alcohol intoxication;

- acute intoxication with barbiturates;

- acute intoxication with opioid analgesics;

- Comatose conditions.

PREGNANCY AND LACTATION

Clopixol is not recommended for use during pregnancy and lactation (breastfeeding).

APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS

Be wary appoint patients with chronic hepatitis.

SPECIAL INSTRUCTIONS

Be wary appoint patients with chronic hepatitis, heart disease (including with arrhythmias), convulsive syndrome, as well as with increased sensitivity to the components of the drug.

With prolonged therapy, it is necessary to periodically conduct a thorough clinical control to assess the condition of patients in order to decide on reducing the maintenance dose.

It should be borne in mind that when using neuroleptics, incl.
zuclopentixol, in rare cases, the development of malignant neuroleptic syndrome (CSF) with a fatal outcome is possible. The main symptoms of CNS are: hyperthermia, muscle rigidity and impaired consciousness in combination with dysfunction of the autonomic nervous system (labile blood pressure, tachycardia, increased sweating). When these symptoms appear, Clopixol is urgently needed and symptomatic and maintenance therapy is prescribed.
Clopixol-acupase can be mixed with Clopixol Depot containing the same Viscoleo oil.

Impact on the ability to drive vehicles and manage mechanisms

Perhaps the effect of the drug on the ability to manage motor vehicles and other mechanisms.
When using the drug, especially at the beginning of treatment, care is required until an individual reaction to the therapy is determined.
OVERDOSE

Symptoms: drowsiness, coma, extrapyramidal disorders, convulsions, arterial hypotension, shock, hyper- or hypothermia are possible.

Treatment: in case of taking the drug inside it is necessary to rinse the stomach as soon as possible, the use of sorbent is recommended.
In the future, symptomatic and supportive therapy is performed. Steps should be taken to maintain the respiratory and cardiovascular systems. Do not use epinephrine (adrenaline), tk. this can lead to a further decrease in blood pressure. Seizures can be suppressed with diazepam, and extrapyramidal symptoms with biperidenum.
DRUG INTERACTION

With the simultaneous use of Clopixol can enhance the sedative effect of ethanol, barbiturates and other drugs that have a depressing effect on the central nervous system.

Clopixol should not be used concurrently with guanethidine and agents with a similar effect (because antipsychotics can block their hypotensive effect).

With the simultaneous use of Clopixol may reduce the effectiveness of levodopa and other adrenergic agents.

With the simultaneous use of clopixol with metoclopramide and piperazine, the risk of developing extrapyramidal symptoms increases.

Pharmaceutical incompatibility is not established.

TERMS OF RELEASE FROM PHARMACY

The drug is released by prescription.

TERMS AND CONDITIONS OF STORAGE

The drug Klopiksol should be stored at a temperature of no higher than 25 В° C.
Each package shows the expiry date.
The drug Klopiksol Depot should be stored in a dark place at a temperature of no higher than 25 В° C.
Shelf life - 3 years.
The drug Klopixol-acupase should be stored in a dark place at a temperature of no higher than 30 В° C.
Shelf life - 2 years.
The drug should be stored out of the reach of children.

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