Clopixol-Acuffase (Clopixol-Acuphase)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceZuclopentixolZuclopentixol
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  • Clopixol
    pills inwards 
    H. Lundbeck A / S     Denmark
  • Clopiksol Depot
    solution w / m 
    X.Lundbeck A / S     Denmark
  • Clopixol-Acuffase
    solution w / m 
    H. Lundbeck A / S     Denmark
    • Dosage form: & nbsp

    solution for intramuscular administration (oily)

    Composition:

    Each ml of the preparation contains: active substance - Zuclopenthixol acetate 50 mg; Excipients triglycerides.

    Description:

    Transparent, yellowish oil, practically free of particles.

    Pharmacotherapeutic group:Antipsychotic (antipsychotic) remedy
    ATX: & nbsp

    N.05.A.F.05   Zuclopentixol

    Pharmacodynamics:

    Clopixol-ACUFAZ is an antipsychotic agent (neuroleptic), a derivative of thioxanthene.

    Antipsychotic action of neuroleptics is usually associated with blockade of dopamine receptors, which, apparently, causes a chain reaction in which other mediator systems are involved.

    Klopixol-ACUFAZ has a pronounced antipsychotic and specific inhibitory effect. Clopixol-ACUFAZ can have a transient, dose-dependent sedative effect. Rapid development of sedation at the beginning of therapy (before the onset of antipsychotic action) is an advantage in the treatment of acute and subacute psychosis.Nonspecific sedation occurs after 2 hours, reaches a maximum in about 8 hours, then significantly decreases and remains weak with repeated injections. Tolerance to the nonspecific sedative effect of the drug occurs quickly. The specific inhibitory effect of CLOXIXOL is particularly beneficial in the treatment of patients with agitation, anxiety, hostility or aggressiveness.

    CLOPIXOL-ACUFASE is used for the initial treatment of acute and chronic psychoses in the phase of exacerbation, as well as manic conditions. Single injection of Klopixol-ACUFAZ provides a pronounced and rapid relaxation of psychotic symptoms. The duration of the injection is 2-3 days. Usually one or two injections are sufficient, after which the patient can be transferred to treatment with oral medicines or depot forms.

    CLOPIXOL-ACUFASE is especially effective in the treatment of psychotic patients with agitation, anxiety, hostility or aggression.

    Pharmacokinetics:

    After the injection of zuclopentixol acetate is subjected to enzymatic digestion on the active ingredient zuclopentixol and acetic acid.The maximum concentration of zuclopentixol in the serum is reached after 24-48 hours (an average of 36 hours) after the injection. Then the concentration slowly decreases, reaching one-third of the maximum three days after the injection. Zuclopentixol slightly penetrates the placental barrier and in small amounts excreted in breast milk. Metabolites do not have neuroleptic activity and are excreted, mainly with faeces and, in part, with urine.

    Indications:

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

    Contraindications:

    Acute poisoning with alcohol, barbiturates and opiates; comatose conditions. CLOPIXOL-ACUFASE is not recommended for use during pregnancy and lactation.

    Carefully:

    Clopixol-ACUFAZ should be administered with caution to patients with convulsive syndrome, chronic hepatitis and cardiovascular diseases.

    Dosing and Administration:

    Clopixol-ACUFAZ is prescribed as a deep intramuscular injection in the upper outer quadrant of the gluteal region. Local tolerance is good.Dosage is selected individually depending on the patient's condition.

    The recommended volume of intramuscular 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 by CLOIPIXOL orally or CLOPIXOL DEPOT intramuscularly, guided by the following:

    When switching to treatment with CLOXYCOL peroral:

    2-3 days after the final injection of Klopixol-ACUFAZ (100 mg injections), the patient should be administered an oral daily dose of 40 mg, if possible in several divided doses. If necessary, the dose may increase by 10-20 mg every 2-3 days to 75 mg / day or more.

    When switching to treatment with CLOPIXOL DEPOT:

    Simultaneously with the final injection of Klopixol-ACUFAZ (100 mg), 200-400 mg (1-2 ml) of CLOPIXOL DEPO, 200 mg / ml, should be administered. Repeated injections of CLOPIXOL DEPO are performed every 2 weeks. If necessary, it is permissible to use higher doses of the drug or shorter intervals. CLOPIXOL-ACOFASE and CLOPIXOL DEPOS can be mixed in one syringe and administered as a single combined injection.Subsequent doses of CLOPIXOL and the intervals between injections should be determined depending on the patient's condition.

    Side effects:

    From the nervous system. Perhaps the development of extrapyramidal symptoms, especially at the initial stage of treatment. In most cases, they are corrected by lowering dosages and / or prescribing antiparkinsonian drugs. However, regular prophylactic use of the latter is not recommended.

    From the autonomic nervous system. Possible dry mouth and accommodation disorders. Violations of urination are rare.

    From the cardiovascular system. Orthostatic dizziness and tachycardia are possible. Orthostatic hypotension occurs rarely.

    From the side of the liver. Rarely transient changes in the level of "liver" transaminases and alkaline phosphatase are rare.

    Overdose:

    Symptoms: Drowsiness, hypo- or hyperthermia, hypotension, extrapyramidal symptoms, convulsions, shock, coma.

    Treatment: Symptomatic and supportive. Measures should be taken to maintain the respiratory and cardiovascular systems. Do not use epinephrine (adrenaline), tk. this can lead to a subsequent lowering of blood pressure. Seizures can be suppressed with diazepam, and extrapyramidal symptoms with biperidenum.

    Interaction:

    Clopixol-ACUFAZ can enhance the sedative effect of alcohol, barbiturates and other inhibitors of the central nervous system. Clopixol-ACUFAZ should not be administered together with guanethidine and similarly acting agents, Neuroleptics can block their hypotensive effect. CLOPIXOL-ACUFASE can reduce the effectiveness of levodopa and other adrenergic agents, and the combination with metoclopramide and piperazine increases the risk of developing extrapyramidal symptoms. CLOPIXOL-ACOUFFE can be mixed with a DEPOT CLOPIXOL, containing the same Viscoleo® oil.

    Special instructions:

    Malignant neuroleptic syndrome (CNS) is a rare, but possible complication with a fatal outcome with the use of neuroleptics. The main characteristics of the NSA are hyperthermia, muscle rigidity and impaired consciousness combined with dysfunction of the autonomic nervous system (labile arterial pressure, tachycardia, increased sweating).In addition to the immediate discontinuation of antipsychotics, the use of general supportive measures and symptomatic treatment is extremely important.

    Effect on the ability to drive transp. cf. and fur:

    Possible influence of CLOPIXOL-ACUFAZ on the ability to drive and other mechanisms. Therefore, at the beginning of therapy, caution should be exercised until the patient's response to treatment is determined.

    Form release / dosage:Solution for intramuscular administration (oily), 50 mg / ml (ampoule) 1 ml, 2 ml.
    Packaging:

    1 ml or 2 ml per ampoule of colorless glass type 1 (Hebrew Pharm.). 5 ampoules with instruction for use in a cardboard pack with perforated first opening control (tongue for opening) on ​​a cardboard substrate glued to the bottom of the pack.

    The ampoule is marked with a red dot indicating the fault location.

    Storage conditions:

    Store at a temperature of no higher than 30 ° C in a dark place.

    Keep out of the reach of children.

    Shelf life:

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

    Terms of leave from pharmacies:On prescription
    Registration number:P N014164 / 01-2002
    Date of registration:17.10.2008
    Expiration Date:Unlimited
    The owner of the registration certificate:H. Lundbeck A / SH. Lundbeck A / S Denmark
    Manufacturer: & nbsp
    Information update date: & nbsp29.01.2018
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