Clopixol Depot - instructions for use, dose, side effects, contraindications

Active substanceZuclopentixolZuclopentixol

Similar drugsTo uncover

Clopixol

pills inwards

H. Lundbeck A / S Denmark

Clopiksol Depot

solution w / m

H. Lundbeck A / S Denmark

Clopixol-Acuffase

solution w / m

H. Lundbeck A / S Denmark

Dosage form: & nbspsolution for intramuscular administration [oily]

Composition:

Active substance - zuclopentixola decanoate; Excipients triglycerides.

Description:

200 mg / ml - transparent, yellowish oil, practically free from particles;

500 mg / ml - transparent, yellow, oily liquid, practically free of particles.

Pharmacotherapeutic group:Antipsychotic (antipsychotic) remedy

ATX: & nbsp

N.05.A.F.05 Zuclopentixol

Pharmacodynamics:

CLOPIXOL DEPO is an antipsychotic agent (neuroleptic), a thioxanthene derivative.

CLOPIXOL DEPO has a pronounced antipsychotic and specific inhibitory effect. Nonspecific sedation weakens after several weeks of treatment.

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.

The specific inhibitory effect of CLOPIXOL DEPO is particularly beneficial in the treatment of psychotic patients with agitation, anxiety, hostility or aggression.The therapeutic effect of CLOPIXOL DEPOT is significantly more prolonged than that of 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 DEPO prevents the development of frequent relapses associated with arbitrary interruption by patients of oral medication.

Pharmacokinetics:

Pharmacokinetic and clinical trials of CLOPIXOL DEPO have shown that injections of CLOPIXOL DEPOT are most expediently carried out at intervals of 2-4 weeks. After the administration of zuclopentixol, the decanoate is subjected to enzymatic digestion to the active ingredient zuclopentixol and decanoic acid. The maximum concentration of zuclopentixol in serum is reached by the end of the first week after the injection. The concentration curve exponentially decreases with a half-life of 19 days, which reflects the rate of release from the depot. 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.

The pharmacokinetics of a dose of CLOPIXOL DEPO 200 mg 1 time and 2 weeks is equivalent to a daily oral dose of 25 mg of CLOPIXOL for 2 weeks.

Indications:

Acute and chronic schizophrenia and other psychotic disorders, especially with hallucinations, paranoid delusions and thinking disorders, as well as states of agitation, heightened anxiety, hostility or aggression.

Contraindications:

Acute poisoning with alcohol, barbiturates and opiates; comatose conditions.

CLOPIXOL DEPO is not recommended for use during pregnancy and lactation.

Carefully:

COLOPIXOL DEPO should be administered with caution to patients with convulsive syndrome, chronic hepatitis and cardiovascular diseases.

Dosing and Administration:

Clopixol Depot is injected deep intramuscularly into the upper outer quadrant of the gluteal region (local tolerability is good). Dosage and interval between injections are determined individually according to the patient's condition.

CLINAPOXOL DEPO 200 mg / ml: With maintenance treatment, the dosage range is usually 200-400 mg (1-2 ml) every 2-4 weeks. Some patients may require higher doses or shorter intervals between injections. If the volume of intramuscular injection (200 mg / ml) exceeds 2-3 ml, then a solution of a higher concentration (CLOPIXOL DEPO 500 mg / ml) is preferable.

CLOPIXOL DEPO 500 mg / ml: usually administered 250-750 mg (0.5-1.5 ml) every 1-4 weeks.

When switching from treatment with oral CLOPIXOL or CLOPIXOL-ACUFASE to maintenance treatment with CLOPIXOL DEPOT, the following scheme should be followed:

Transition from oral CLOPIXOL to CLOPIXOL DEPOT intramuscularly: Oral daily dose of Klopixol (mg) x 8 = CLOPIXOL DEPO (mg) intramuscularly after 2 weeks.

Patients should continue to take CLOXIXOL orally during the first week after the first injection, but in a reduced dose.

Transition from Klopixol-ACUFAZ intramuscularly to CLOPIXOL DEPOT intramuscularly:

Simultaneously with the last injection of Klopixol-ACUFASE, 200-400 mg (1-2 ml) of CLOPIXOL DEPOT should be administered intramuscularly. Repeated injections of CLOPIXOL DEPOT are performed once every 2 weeks.If necessary, higher doses or shorter intervals between injections may be used.

Side effects:

From the nervous system. At the initial stage of treatment, extrapyramidal symptoms may develop. In most cases, they are corrected by lowering dosages and / or prescribing antiparkinsonian drugs. However, regular prophylactic use of the latter is not recommended. With prolonged therapy, in some patients, tardive dyskinesia may very rarely occur. Antiparkinsonian medicines do not eliminate her symptoms. It is recommended to reduce the dosage or, if possible, discontinue therapy.

From the side of mental activity. Drowsiness at the initial stage.

From the autonomic nervous system and cardiovascular system. Dry mouth, disorder of accommodation, urinary retention, constipation, tachycardia, orthostatic hypotension and dizziness.

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 DEPO can enhance the sedative effect of alcohol, barbiturates and other inhibitors of the central nervous system. COLOPIXOL DEPO should not be administered together with guanethidine and similarly acting agents, Neuroleptics can block their hypotensive effect. CLOPIXOL DEPO can reduce the effectiveness of levodopa and other adrenergic agents, and the combination with metoclopramide and piperazine increases the risk of developing extrapyramidal symptoms.

CLIPIXOL DEPO can be mixed with CLOPIXOL-ACUFASE 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 symptoms of CNS are hyperthermia, muscle rigidity and impaired consciousness in combination 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.

With prolonged therapy, especially in large doses, careful monitoring is necessary, periodically assessing the condition of patients to decide whether to reduce the maintenance dosage.

Effect on the ability to drive transp. cf. and fur:Perhaps the influence of DEPOT CLOPIXOL is 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), 200 mg / ml, 500 mg / ml (ampoules) 1 ml.

Packaging:

CLOPIXOL DEPO 200 mg / ml:

1 ml per ampoule of colorless glass type 1 (Hebrew Pharm.). 1 or 10 ampoules with instructions for use in a cardboard pack with a perforated first opening (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.

CLOPIXOL DEPO 500 mg / ml:

1 ml per ampoule of colorless glass type 1 (Europe 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 25 ° C in a dark place.

Keep out of the reach of children.

Shelf life:

CLOPIXOL DEPO 200 mg / ml - 3 years.

CLOPIXOL DEPO 500 mg / ml - 4 years.

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

Terms of leave from pharmacies:On prescription

Registration number:П N014165 / 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

H.LUNDBECK, A / S Denmark

Representation: & nbspLUNDBEK EXPORT A / C LUNDBEK EXPORT A / C Denmark

Information update date: & nbsp29.01.2018

Illustrated instructions

Instructions

Clopiksol Depot (Clopixol Depot)