Depixol Injection and Conc Injection


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Depixol Injection and Conc Injection


1. Name Of The Medicinal Product

Depixol Injection

Depixol® Conc. Injection

2. Qualitative And Quantitative Composition

Depixol Injection:

20 mg/mL (2% w/v) cis(Z)-flupentixol decanoate in thin vegetable oil.

Ampoules 1mL and 2 mL, Syringes 1 mL and 2 mL and Vial 10 mL.

Depixol Conc Injection:

100 mg/mL (10%w/v) cis (Z)-flupentixol decanoate in thin vegetable oil.

Ampoules 0.5 mL and 1 mL and Vial 5 mL.

3. Pharmaceutical Form

Oily solution for deep intramuscular injection.

4. Clinical Particulars 4.1 Therapeutic Indications

The treatment of schizophrenia and other psychoses.

Use of Depixol should be restricted to those stabilised on oral therapy.

4.2 Posology And Method Of Administration

Route of administration

Deep intramuscular injection into the upper outer buttock or lateral thigh.

Dosage and dosage interval should be adjusted according to the patients' symptoms and response to treatment.

Note: As with all oil-based injections it is important to ensure, by aspiration before injection, that inadvertent intravascular entry does not occur.


The usual dosage of flupentixol decanoate lies between 50 mg every 4 weeks and 300 mg every 2 weeks, but some patients may require up to 400 mg weekly. Other patients may be adequately maintained on dosages of 20-40 mg flupentixol decanoate every 2-4 weeks. In patients who have not previously received depot antipsychotic, treatment is usually started with a small dose (e.g. 20 mg) to assess tolerability. An interval of at least one week should be allowed before the second injection is given at a dose consistent with the patients' condition.

Depixol Injection 20 mg/ml is not intended for use in patients requiring doses of greater than 60 mg (3 mL) of flupentixol. Injection volumes of 2 – 3 mL should be distributed between two injection sites.

More concentrated solutions of flupentixol decanoate (Depixol Conc Injection or Depixol Low Volume Injection) should be used if doses greater than 3 mL (60 mg) are required.

The injection volumes selected for Depixol Conc Injection or Depixol Low Volume Injection should not exceed 2 mL.

Adequate control of severe psychotic symptoms may take up to 4 to 6 months at high enough dosage. Once stabilised lower maintenance doses may be considered, but must be sufficient to prevent relapse.


In accordance with standard medical practice, initial dosage may need to be reduced to a quarter or half the normal starting dose in the frail or elderly.


Depixol is not indicated for children.

Reduced renal function

Flupentixol has not been studied in renal impairment. Increased cerebral sensitivity to antipsychotics has been noted in severe renal impairment (see section 4.4).

Reduced hepatic function

Flupentixol has not been studied in hepatic impairment. It is extensively metabolised by the liver and particular caution should be used in this situation and serum level monitoring is advised (see section 4.4). Depixol should be initiated at low doses orally to check for tolerability before switching to the depot formulation.

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients (see section 6.1). Circulatory collapse, depressed level of consciousness due to any cause (e.g. intoxication with alcohol, barbiturates or opiates), coma.

Not recommended for excitable or agitated patients.

4.4 Special Warnings And Precautions For Use

Caution should be exercised in patients having: liver disease; cardiac disease or arrhythmias; severe respiratory disease; renal failure; epilepsy (and conditions predisposing to epilepsy e.g. alcohol withdrawal or brain damage); Parkinson's disease; narrow angle glaucoma; prostatic hypertrophy; hypothyroidism; hyperthyroidism; myasthenia gravis; phaeochromocytoma and patients who have shown hypersensitivity to thioxanthenes or other antipsychotics.

The elderly require close supervision because they are specially prone to experience such adverse effects as sedation, hypotension, confusion and temperature changes.

The possibility of development of neuroleptic malignant syndrome (hyperthermia, muscle rigidity, fluctuating consciousness, instability of the autonomous nervous system) exists with any neuroleptic. The risk is possibly greater with the more potent agents. Patients with pre-existing organic brain syndrome, mental retardation, and opiate and alcohol abuse are overrepresented among fatal cases.

Treatment: Discontinuation of the neuroleptic. Symptomatic treatment and use of general supportive measures. Dantrolene and bromocriptine may be helpful.

Symptoms may persist for more than a week after oral neuroleptics are discontinued and somewhat longer when associated with the depot forms of the drugs.

Blood dyscrasias, including thrombocytopenia, have been reported rarely. Blood counts should be carried out if a patient develops signs of persistent infection.

As described for other psychotropics flupentixol may modify insulin and glucose responses calling for adjustment of the antidiabetic therapy in diabetic patients.

Acute withdrawal symptoms, including nausea, vomiting, sweating and insomnia have been described after abrupt cessation of antipsychotic drugs. Recurrence of psychotic symptoms may also occur, and the emergence of involuntary movement disorders (such as akathisia, dystonia and dyskinesia) has been reported. The plasma concentrations of the Depixol Injection gradually decrease over several weeks which makes gradual dosage tapering unnecessary.

When transferring patients from oral to depot antipsychotic treatment, the oral medication should not be discontinued immediately, but gradually withdrawn over a period of several days after administering the first injection.

An approximately 3-fold increased risk of cerebrovascular adverse events have been seen in randomised placebo controlled clinical trials in the dementia population with some atypical antipsychotics. The mechanism for this increased risk is not known. An increased risk cannot be excluded for other antipsychotics or other patient populations.

Flupentixol should be used with caution in patients with risk factors for stroke.

As with other drugs belonging to the therapeutic class of antipsychotics, flupentixol may cause QT prolongation. Persistently prolonged QT intervals may increase the risk of malignant arrhythmias. Therefore, flupentixol should be used with caution in susceptible individuals (with hypokalaemia, hypomagnesia or genetic predisposition) and in patients with a history of cardiovascular disorders, e.g. QT prolongation, significant bradycardia (<50 beats per minute), a recent acute myocardial infarction, uncompensated heart failure, or cardiac arrhythmia.

Cases of venous thromboembolism (VTE) have been reported with antipsychotic drugs. Since patients treated with antipsychotics often present with acquired risk factors for VTE, all possible risk factors for VTE should be identified before and during treatment with Depixol and preventive measures undertaken.

Concomitant treatment with other antipsychotics should be avoided (see section 4.5).

Suicide/suicidal thoughts or clinical worsening

Depression is associated with an increased risk of suicidal thoughts, self harm and suicide (suicide-related events). This risk persists until significant remission occurs. As improvement may not occur during the first few weeks or more of treatment, patients should be closely monitored until such improvement occurs.

It is general clinical experience that the risk of suicide may increase in the early stages of recovery. Other psychiatric conditions for which flupentixol is prescribed can also be associated with an increased risk of suicide-related events. In addition, these conditions may be co-morbid with major depressive disorder. The same precautions observed when treating patients with major depressive disorder should therefore be observed when treating patients with other psychiatric disorders. Patients with a history of suicide-related events, or those exhibiting a significant degree of suicidal ideation prior to commencement of treatment are known to be at greater risk of suicidal thoughts or suicide attempts, and should receive careful monitoring during treatment. A meta-analysis of placebo-controlled clinical trials of antidepressant drugs in adult patients with psychiatric disorders showed an increased risk of suicidal behaviour with antidepressants compared to placebo in patients less than 25 years old.

Close supervision of patients and in particular those at high risk should accompany drug therapy especially in early treatment and following dose changes. Patients (and caregivers of patients) should be alerted about the need to monitor for any clinical worsening, suicidal behaviour or thoughts and unusual changes in behaviour and to seek medical advice immediately if these symptoms present.

Increased Mortality in Elderly people with Dementia

Data from two large observational studies showed that elderly people with dementia who are treated with antipsychotics are at a small increased risk of death compared with those who are not treated. There are insufficient data to give a firm estimate of the precise magnitude of the risk and the cause of the increased risk is not known.

Depixol is not licensed for the treatment of dementia-related behavioural disturbances.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

In common with other antipsychotics, flupentixol enhances the response to alcohol the effects of barbiturates and other CNS depressants. Flupentixol may potentiate the effects of general anaesthetics and anticoagulants and prolong the action of neuromuscular blocking agents.

The anticholinergic effects of atropine or other drugs with anticholinergic properties may be increased. Concomitant use of drugs such as metoclopramide, piperazine or antiparkinson drugs may increase the risk of extrapyramidal effects such as tardive dyskinesia. Combined use of antipsychotics and lithium or sibutramine has been associated with an increased risk of neurotoxicity.

Antipsychotics may enhance the cardiac depressant effects of quinidine; the absorption of corticosteroids and digoxin. The hypotensive effect of vasodilator antihypertensive agents such as hydralazine and ?-blockers (e.g. doxazosin), or methyl-dopa may be enhanced.

Increases in the QT interval related to antipsychotic treatment may be exacerbated by the co-administration of other drugs known to significantly increase the QT interval.

Co-administration of such drugs should be avoided. Relevant classes include:

• class Ia and III antiarrhythmics (e.g. quinidine, amiodarone, sotalol, dofetilide)

• some antipsychotics (e.g. thioridazine)

• some macrolides (e.g. erythromycin)

• some antihistamines

• some quinolone antibiotics (e.g. moxifloxacin)

The above list is not exhaustive and other individual drugs known to significantly increase QT interval (e.g. cisapride, lithium) should be avoided.

Drugs known to cause electrolyte disturbances such as thiazide diuretics (hypokalaemia) and drugs known to increase the plasma concentration of flupentixol should also be used with caution as they may increase the risk of QT prolongation and malignant arrythmias (see section 4.4).

Antipsychotics may antagonise the effects of adrenaline and other sympathomimetic agents, and reverse the antihypertensive effects of guanethidine and similar adrenergic-blocking agents. Antipsychotics may also impair the effect of levodopa, adrenergic drugs and anticonvulsants.

The metabolism of tricyclic antidepressants may be inhibited and the control of diabetes may be impaired.

4.6 Pregnancy And Lactation

As the safety of this drug during pregnancy has not been established, use during pregnancy, especially the first and last trimesters, should be avoided, unless the expected benefit to the patient outweighs the potential risk to the foetus.

Flupentixol is excreted into the breast milk. If the use of Depixol is considered essential, nursing mothers should be advised to stop breast feeding.

The newborn of mothers treated with antipsychotics in late pregnancy, or labour, may show signs of intoxication such as lethargy, tremor and hyperexcitability, and have a low Apgar score.

4.7 Effects On Ability To Drive And Use Machines

Alertness may be impaired, especially at the start of treatment, or following the consumption of alcohol; patients should be warned of this risk and advised not to drive or operate machinery until their susceptibility is known. Patients should not drive if they have blurred vision.

4.8 Undesirable Effects

Cases of suicidal ideation and suicidal behaviours have been reported during flupentixol therapy or early after treatment discontinuation (see section 4.4).

Undesirable effects are for the majority dose dependent. The frequency and severity are most pronounced in the early phase of treatment and decline during continued treatment.

Extrapyramidal reactions may occur, especially in the early phase of treatment. In most cases these side effects can be satisfactorily controlled by reduction of dosage and/or use of antiparkinsonian drugs. The routine prophylactic use of antiparkinsonian drugs is not recommended. Antiparkinsonian drugs do not alleviate tardive dyskinesia and may aggravate them. Reduction in dosage or, if possible, discontinuation of flupentixol therapy is recommended. In persistent akathisia a benzodiazepine or propranolol may be useful.

Cardiac disorders

Tachycardia, palpitations.

Electrocardiogram QT prolonged.

Blood and lymphatic system disorders

Thrombocytopenia, neutropenia, leukopenia, agranulocytosis

Nervous system disorders

Somnolence, akathisia, hyperkinesia, hypokinesia.

Tremor, dystonia, dizziness, headache, disturbance in attention.

Tardive dyskinesia, dyskinesia, parkinsonism, speech disorder, convulsion.

Neuroleptic malignant syndrome.

Eye disorders

Accommodation disorder, vision abnormal.


Respiratory, thoracic and mediastinal disorders


Gastrointestinal disorders

Dry mouth.

Salivary hypersecretion, constipation, vomiting, dyspepsia, diarrhoea.

Abdominal pain, nausea, flatulence.

Renal and urinary disorders

Micturition disorder, urinary retention.

Skin and subcutaneous tissue disorders

Hyperhidrosis, pruritus.

Rash, photosensitivity reaction, dermatitis.

Musculoskeletal and connective tissue disorder


Muscle rigidity.

Endocrine disorder


Metabolism and nutrition disorders

Increased appetite, weight increased.

Decreased appetite.

Hyperglycaemia, glucose tolerance abnormal.

Vascular disorders

Hypotension, hot flush.

General disorders and administration site conditions

Asthenia, fatigue.

Injection site reaction1.

Immune system disorders

Hypersensitivity, anaphylactic reaction.

Hepatobiliary disorders

Liver function test abnormal.


Reproductive system and breast disorders

Ejaculation failure, erectile dysfunction.

Gynaecomastia, galactorrhoea, amenorrhoea.

Psychiatric disorders

Insomnia, depression, nervousness, agitation, libido decreased.

Confusional state.

1For injectable flupentixol presentations.

As with other drugs belonging to the therapeutic class of antipsychotics, rare cases of QT prolongation, ventricular arrhythmias - ventricular fibrillation, ventricular tachycardia, Torsade de Pointes and sudden unexplained death have been reported for flupentixol (see section 4.4).

Cases of venous thromboembolism, including cases of pulmonary embolism and cases of deep vein thrombosis have been reported with antipsychotic drugs- Frequency unknown.

Abrupt discontinuation of flupentixol may be accompanied by withdrawal symptoms. The most common symptoms are nausea, vomiting, anorexia, diarrhoea, rhinorrhoea, sweating, myalgias, paraesthesias, insomnia, restlessness, anxiety, and agitation. Patients may also experience vertigo, alternate feelings of warmth and coldness, and tremor. Symptoms generally begin within 1 to 4 days of withdrawal and abate within 7 to 14 days.

4.9 Overdose

Overdosage may cause somnolence or even coma, extrapyramidal symptoms, convulsions, hypotension, shock, hyper or hypothermia. ECG changes, QT prolongation, Torsade de Pointes, cardiac arrest and ventricular arrhythmias have been reported when administered in overdose together with drugs known to affect the heart.

Treatment is symptomatic and supportive, with measures aimed at supporting the respiratory and cardiovascular systems. The following specific measures may be employed if required.

- Anticholinergic antiparkinson drugs if extrapyramidal symptoms occur

- Sedation (with benzodiazepines) in the unlikely event of agitation or excitement or convulsions

- Noradrenaline in saline intravenous drip if the patient is in shock. Adrenaline must not be given.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Flupentixol is a non-sedating antipsychotic drug of the thioxanthene group. Its primary pharmacological action is dopamine blockade. Flupentixol has a high affinity for D1 and D2 receptors. Depixol Injection contains the deconoic ester of flupentixol in thin vegetable oil.

5.2 Pharmacokinetic Properties

After intramuscular injection, the ester is slowly released from the oil depot and is rapidly hydrolysed to release flupentixol. Flupentixol is widely distributed in the body and extensively metabolized in the liver. Peak circulating levels occur around 7 days after administration.

5.3 Preclinical Safety Data

Nil of relevance

6. Pharmaceutical Particulars 6.1 List Of Excipients

Thin vegetable oil "Viscoleo" (fractionated coconut oil).

6.2 Incompatibilities

This product may be mixed in the same syringe with other products in the Depixol Injection range. It should not be mixed with any other injection fluids.

6.3 Shelf Life

Depixol Injection:

Ampoules 1 mL and 2 mL : 4 years

Syringes 1 mL and 2 mL : 2 years

Vial 10 mL : 3 years (shelf-life after opening : 1 day)

Depixol Conc Injection:

Ampoule 0.5 mL : 2 years

Ampoule 1 mL : 4 years

Vial 5 mL : 3 years

6.4 Special Precautions For Storage

Store at or below 25°C. Protect from light.

6.5 Nature And Contents Of Container

Depixol Injection:

Ampoules containing 1 mL and 2 mL of 20 mg/mL (2% w/v) cis (Z)-flupentixol decanoate in thin vegetable oil. Pack size = 10 ampoules per box.

Syringes containing 1 mL and 2 mL of 20 mg/mL (2%w/v) cis (Z)-flupentixol decanoate in thin vegetable oil. Pack size = 5 syringes per box.

Vial containing 10 mL of 20 mg/mL (2%w/v) cis (Z)-flupentixol decanoate in thin vegetable oil. Pack size = 1 vial per box.

Depixol Conc Injection:

Ampoules containing 0.5 mL and 1 mL of 100 mg/ml (10% w/v) cis(Z)-flupentixol decanoate in thin vegetable oil. Pack size = 10 ampoules per box.

Vial containing 5 mL of 100 mg/ml (10%) cis(Z)- flupentixol decanoate in thin vegetable oil. Pack size = 1 vial per box.

6.6 Special Precautions For Disposal And Other Handling


7. Marketing Authorisation Holder

Lundbeck Ltd

Lundbeck House

Caldecotte Lake Business Park

Milton Keynes



United Kingdom

8. Marketing Authorisation Number(S)

Depxiol Injection - PL 0458/0007R

Depixol Conc Injection - PL 00458/0015R

9. Date Of First Authorisation/Renewal Of The Authorisation

28 January 1987 / 17 March 2002

10. Date Of Revision Of The Text


Depixol Injection and Conc Injection

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