Flupentixol decanoate 40mg/2ml solution for injection

  1. Name of the medicinal product

Flupentixol decanoate injection BP 20mg/ml Taj Pharma
Flupentixol decanoate injection BP 40mg/2ml Taj Pharma
Flupentixol decanoate injection BP 100mg/ml Taj Pharma

  1. Qualitative and quantitative composition

a) Each ml contains:
Flupentixol decanoate BP                     20mg
Medium-chain Triglycerides BP             q.s

b) Each ml contains:
Flupentixol decanoate BP                     40mg
Medium-chain Triglycerides BP             q.s

c) Each ml contains:
Flupentixol decanoate BP                     100mg
Medium-chain Triglycerides BP             q.s

For the full list of excipients, see section 6.1

  1. Pharmaceutical form

Solution for injection.

Flupentixol decanoate  Injection:

Clear, colourless to slightly yellowish oil, practically free from particles.

Flupentixol decanoate  Conc. Injection:

Clear, yellowish to yellow oil, practically free from particles.

Oily solution for deep intramuscular injection.

  1. Clinical particulars

4.1 Therapeutic indications

The treatment of schizophrenia and other psychoses.

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

4.2 Posology and method of administration

Posology

Adults

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. The maximum single dose at any one time is 400 mg. For example, 800 mg ever 2 weeks should not be given. 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.

Flupentixol decanoate  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 (Flupentixol decanoate  Conc Injection or Flupentixol decanoate  Low Volume Injection) should be used if doses greater than 3 ml (60 mg) are required.

The injection volumes selected for Flupentixol decanoate  Conc Injection or Flupentixol decanoate  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.

Older patients

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 older patients.

Children

Flupentixol decanoate  is not recommended for use in children due to lack of clinical experience.

Patients with 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).

Patients with 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). Flupentixol decanoate  should be initiated at low doses orally to check for tolerability before switching to the depot formulation.

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.

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in 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 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 Flupentixol decanoate  Injection and Conc. 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.

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 Flupentixol decanoate  and preventive measures undertaken.

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

Leukopenia, neutropenia and agranulocytosis have been reported with antipsychotics, including flupentixol decanoate.

Long-acting depot antipsychotics should be used with caution in combination with other medicines known to have a myelosuppressive potential, as these cannot rapidly be removed from the body in conditions where this may be required.

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.

Older people

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

Cerebrovascular

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.

Increased Mortality in Older people with Dementia

Data from two large observational studies showed that older 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.

Flupentixol decanoate  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 α-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 Fertility, pregnancy and lactation

Pregnancy

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.

Neonates exposed to antipsychotics (including Flupentixol decanoate ) during the third trimester of pregnancy are at risk of adverse reactions including extrapyramidal and/or withdrawal symptoms that may vary in severity and duration following delivery. There have been reports of agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, or feeding disorder. Consequently, newborns should be monitored carefully.

Animal studies have shown reproductive toxicity (see section 5.3).

Breast-feeding

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

Fertility

In humans, adverse events such as hyperprolactinaemia, galactorrhoea, amenorrhoea, libido decreased, erectile dysfunction and ejaculation failure have been reported (see section 4.8). These events may have a negative impact on female and/or male sexual function and fertility.

If clinical significant hyperprolactinaemia, galactorrhoea, amenorrhoea or sexual dysfunctions occur, a dose reduction (if possible) or discontinuation should be considered. The effects are reversible on discontinuation.

In preclinical fertility studies in rats, flupentixol slightly affected the pregnancy rate of female rats (see section 5.3).

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).

The majority of undesirable effects are 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.

Frequencies are taken from the literature and spontaneous reporting. Frequencies are defined as: very common (≤1/10), common (≤1/100 to <1/10), uncommon (≤1/1,000 to <1/100), rare (≤1/10,000 to <1/1,000), very rare (<1/10,000), or not known (can not be estimated from the available data).

Blood and lymphatic system disorders Rare Thrombocytopenia, neutropenia, leukopenia, agranulocytosis
Immune system disorders Rare Hypersensitivity, anaphylactic reaction.
Endocrine disorder Rare Hyperprolactinaemia.
Metabolism and nutrition disorders Common Increased appetite, weight increased.
Uncommon Decreased appetite.
Rare Hyperglycaemia, glucose tolerance abnormal.
Psychiatric disorders Common Insomnia, depression, nervousness, agitation, libido decreased.
Uncommon Confusional state.
Not known Suicidal ideation, suicidal Behaviour
Nervous system disorders Very common Somnolence, akathisia, hyperkinesia, hypokinesia.
Common Tremor, dystonia, dizziness, headache, disturbance in attention.
Uncommon to Rare Tardive dyskinesia, dyskinesia, parkinsonism, speech disorder, convulsion.
Very Rare Neuroleptic malignant syndrome.
Eye disorders Common Accommodation disorder, vision abnormal.
Uncommon Oculogyration.
Cardiac disorders Common Tachycardia, palpitations.
Rare Electrocardiogram QT prolonged.
Vascular disorders Uncommon Hypotension, hot flush.
Not known Venous thromboemoblism
Respiratory, thoracic and mediastinal disorders Common Dyspnoea.
Gastrointestinal disorders Very common Dry mouth.
Common Salivary hypersecretion, constipation, vomiting, dyspepsia, diarrhoea.
Uncommon Abdominal pain, nausea, flatulence.
Hepatobiliary disorders Uncommon Liver function test abnormal.
Very rare Jaundice
Skin and subcutaneous tissue disorders Common Hyperhidrosis, pruritus.
Uncommon Rash, photosensitivity reaction, dermatitis.
Musculoskeletal and connective tissue disorder Common Myalgia.
Uncommon Muscle rigidity.
Renal and urinary disorders common Micturition disorder, urinary retention.
Pregnancy, puerperium and perinatal conditions Not known Drug withdrawal syndrome neonatal (see 4.6)
Reproductive system and breast disorders Uncommon Ejaculation failure, erectile dysfunction.
Rare Gynaecomastia, galactorrhoea, amenorrhoea.
General disorders and administration site conditions Common Asthenia, fatigue.
Uncommon Injection site reaction1.

1 For 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.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important.

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.

  1. Pharmacological properties

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Neuroleptics (antipsychotics).

Mechanism of action

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. Flupentixol decanoate  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

Reproductive toxicity

In fertility studies in rats, flupentixol slightly affected the pregnancy rate of female rats. Animal reproduction studies in mice, rats and rabbits have not shown evidence of teratogenic effects. Embryotoxic effects in terms of increased post implantation loss/increased absorption rates or occasional abortions were seen in rats and rabbits at doses associated with maternal toxicity.

  1. 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 Flupentixol decanoate  Injection range. It should not be mixed with any other injection fluids.

6.3 Shelf life

Flupentixol decanoate  Injection:

Ampoules 1 ml and 2 ml : 4 years

Flupentixol decanoate  Conc Injection:

Ampoule 1 ml : 4 years

6.4 Special precautions for storage

Keep the ampoules in the outer carton in order to protect from light.

6.5 Nature and contents of container

Flupentixol decanoate  Injection:

Ampoules containing 1 ml and 2 ml of 20 mg/ml flupentixol decanoate in thin vegetable oil.

Pack size : 10 ampoules per carton.

Flupentixol decanoate  Conc Injection:

Ampoules containing 1 ml of 100 mg/ml flupentixol decanoate in thin vegetable oil. Pack size : 10 ampoules per carton.

6.6 Special precautions for disposal and other handling

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

 

7.Manufactured in India by:
TAJ PHARMACEUTICALS LTD.
Mumbai, India
Unit No. 214.Old Bake House,
Maharashtra chambers of Commerce Lane,
Fort, Mumbai – 400001
at:Gujarat, INDIA.
Customer Service and Product Inquiries:
1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
Monday through Saturday 9:00 a.m. to 7:00 p.m. EST
E-mail: tajgroup@tajpharma.com

Flupentixol decanoate injection BP 20mg/ml Taj Pharma
Flupentixol decanoate injection BP 40mg/2ml Taj Pharma
Flupentixol decanoate injection BP 100mg/ml Taj Pharma

Package leaflet: Information for the patient

Flupentixol decanoate injection BP 40mg/ml Taj Pharma

flupentixol decanoate

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

  • Keep this leaflet. You may need to read it again
  • If you have any further questions, ask your doctor, pharmacist or nurse
  • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours
  • If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

  1. What Flupentixol decanoate Injection is and what it is used for
    2. What you need to know before Flupentixol decanoate  Injection is given
    3. How Flupentixol decanoate  Injection is given
    4. Possible side effects
    5. How to store Flupentixol decanoate  Injection
    6. Contents of the pack and other information

 

  1. What Flupentixol decanoate Injection is and what it is used for

The name of your medicine is Flupentixol decanoate  40 mg/ml solution for injection (called Flupentixol decanoate  Injection in this leaflet).

Flupentixol decanoate  Injection contains the active substance flupentixol decanoate. Flupentixol decanoate  Injection belongs to a group of medicines known as antipsychotics (also called neuroleptics).

These medicines act on nerve pathways in specific areas of the brain and help to correct certain chemical imbalances in the brain that are causing the symptoms of your illness.

Flupentixol decanoate  Injection is used for the treatment of schizophrenia and other psychoses.

Your doctor, however, may prescribe Flupentixol decanoate  Injection for another purpose. Ask your doctor if you have any questions about why Flupentixol decanoate  Injection has been prescribed for you.

  1. What you need to know before Flupentixol decanoate Injection is given

Flupentixol decanoate  Injection is not given if you

  • are allergic (hypersensitive) to flupentixol, other thioxanthene drugs or antipsychotic drugs or any of the other ingredients of this medicine (listed in section 6)
  • are feeling less alert than usual or are drowsy or sleepy, or have serious problems with your blood circulation
  • are excited or agitated

Warnings and precautions

Talk to your doctor, pharmacist or nurse before Flupentixol decanoate  Injection is given if you:

  • have a heart condition, including an irregular heart beat (such as a slower heart beat); have had a recent heart attack or have problems that cause ankle swelling or shortness of breath
  • have severe breathing problems (such as asthma or bronchitis)
  • have liver, kidney or thyroid problems
  • suffer from epilepsy, or have been told that you are at risk of having fits (for example because of a brain injury or because of alcohol withdrawal)
  • suffer from Parkinson’s disease, or myasthenia gravis (a condition causing severe muscular weakness)
  • have an enlarged prostate or suffer from a condition known as phaeochromocytoma (a rare type of cancer of a gland near the kidney)
  • suffer from glaucoma (raised pressure within the eye)
  • have risk factors for stroke (e.g. smoking, hypertension)
  • have too little potassium or magnesium in your blood or a family history of irregular heart beats
  • use other antipsychotic medicines
  • suffer from diabetes
  • or someone else in your family has a history of blood clots, as medicines like these have been associated with formation of blood clots
  • are treated for cancer

Children and adolescents

Flupentixol decanoate  Injection is not recommended in these patients.

Thoughts of suicide and worsening of your depression or anxiety disorder

If you are depressed and/or have anxiety disorders you can sometimes have thoughts of harming or killing yourself. These may be increased when first starting antidepressants, since these medicines all take time to work, usually about two weeks but sometimes longer.

You may be more likely to think like this:

  • If you have previously had thoughts about killing or harming yourself
  • If you are a young adult. Information from clinical trials has shown an increased risk of suicidal behaviour in adults aged less than 25 years with psychiatric conditions who were treated with an antidepressant

If you have thoughts of harming or killing yourself at any time,contact your doctor or go to a hospital straight away.

You may find it helpful to tell a relative or close friend that you are depressed or have an anxiety disorder, and ask them to read this leaflet. You might ask them to tell you if they think your depression or anxiety is getting worse, or if they are worried about changes in your behaviour.

Other medicines and Flupentixol decanoate  Injection

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

The following medicines should not be taken at the same time as Flupentixol decanoate  Injection:

  • Medicines that change the heartbeat (quinidine, amiodarone, sotalol, dofetilide, erythromycin, moxifloxacin, cisapride, lithium)
  • Other antipsychotic medicines

Tell your doctor or pharmacist if you are taking any of the following medicines:

  • Tricyclic anti-depressants
  • Barbiturates or other medicines that make you feel drowsy
  • Anticoagulant drugs used to prevent blood clots (e.g. warfarin)
  • Anticholinergic drugs (contained in some cold, allergy or travel sickness remedies as well as other medicines)
  • Metoclopramide (used to treat nausea and other stomach conditions)
  • Piperazine (used to treat worm infections)
  • Levodopa or other medicines used to treat Parkinson’s disease
  • Sibutramine (used to reduce appetite)
  • Digoxin (to control heart rhythm)
  • Corticosteroids (e.g. prednisolone)
  • Medicines used to lower the blood pressure such as hydralazine, alpha blockers (e.g. doxazosin) betablockers, methyldopa, clonidine or guanethidine
  • Medicines that cause a disturbed water or salt balance (too little potassium or magnesium in your blood)
  • Medicines known to increase the concentration of flupentixol in your blood
  • Medicines used to treat epilepsy
  • Medicines used to treat diabetes

Flupentixol decanoate  Injection can reduce the effect of adrenaline (epinephrine) and similar drugs.

Tell your doctor, dentist, surgeon or anaesthetist before any operation as Flupentixol decanoate  Injection can increase the effects of general anaesthetics, muscle relaxing drugs and drugs used to prevent clots.

Flupentixol decanoate  Injection with alcohol

Flupentixol decanoate  Injection may increase the sedative effects of alcohol making you drowsier. It is recommended not to drink alcohol during treatment with Flupentixol decanoate  Injection.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you might be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

If you are pregnant or think you might be pregnant, tell your doctor. Flupentixol decanoate  Injection should not be used during pregnancy unless clearly necessary.

The following symptoms may occur in newborn babies, of mothers that have used Flupentixol decanoate  Injection in the last trimester (last three months of their pregnancy): shaking, muscle stiffness and/ or weakness, sleepiness, agitation, breathing problems, and difficulty in feeding. If your baby develops any of these symptoms you may need to contact your doctor.

Breast-feeding

If you are breast-feeding, ask your doctor for advice.

Flupentixol decanoate  Injection should not be used when breast-feeding, as small amounts of the medicine can pass into the breast milk.

Fertility

Flupentixol may decrease your sexual activity and fertility. These are not lasting effects. Please talk to your doctor about any problems.

Driving and using machines

There is a risk of feeling drowsy and dizzy when being treated with Flupentixol decanoate  Injection, especially at the start of your treatment. If this happens do not drive or use any tools or machines until you know you are not affected in this way.

Do not drive if you have blurred vision.

  1. How Flupentixol decanoate Injection is given

A small amount of Flupentixol decanoate  Injection is drawn up into a syringe and then injected into the muscle of your buttock or thigh.

Your doctor will decide on the correct amount of medicine to give, and how often to give it. The medicine is slowly released from the injection site so that a fairly constant amount of medicine gets into your blood during the period between each dose.

Adults

The usual dose lies between 50 mg every 4 weeks to 300 mg every 2 weeks but some patients require 400 mg every week. The maximum single dose at any one time is 400 mg. If you need more than 2 ml of medicine it will probably be divided between 2 injection sites.

If you haven’t received an injection like Flupentixol decanoate  Injection before, a small dose of 20 mg is usually given one week before your normal dose to test how well you tolerate the medicine.

If you have been treated with Flupentixol decanoate  tablets and you are being transferred to Flupentixol decanoate  Injection you may be asked to continue taking the tablets for several days after the first injection.

Your doctor may decide to adjust the amount given, or the interval between injections, from time to time.

If you have liver problems, the level of flupentixol in your blood may be checked.

Older patients (above 65 years)

Starting doses for older or frail patients are usually reduced to a quarter or a half of the dosage range.

Use in children

Flupentixol decanoate  Injection is not recommended for children.

Duration of treatment

It may take between four and six months before you feel better. Your doctor will decide the duration of treatment.

If you feel that the effect of Flupentixol decanoate  Injection is too strong or weak, talk to your doctor.

It is important that you continue to receive your medicine at regular intervals even if you are feeling completely well, because the underlying illness may persist for a long time. If you stop your treatment too soon your symptoms may return.

If you get more Flupentixol decanoate  Injection than you should

Your medicine will be given by your doctor or nurse.

In the unlikely event that you receive too much Flupentixol decanoate  Injection you may experience some symptoms.

Symptoms of overdose may include:

  • Drowsiness
  • Unconsciousness
  • Muscle movements or stiffness
  • Fits
  • Low blood pressure, weak pulse, fast heart rate, pale skin, restlessness
  • High or low body temperature
  • Changes in heart beat including irregular heart beat or slow heart rate

You will receive treatment for any of these symptoms from your doctor or nurse.

  1. Possible side effects

Like all medicines, Flupentixol decanoate  Injection can cause side effects, although not everybody gets them. Older patients tend to be more likely to suffer from some of these effects than younger patients and this may mean your treatment is supervised more closely.

Serious side effectsStop taking Flupentixol decanoate  and seek medical advice immediately if you have any of the following allergic reactions:

Not known: frequency cannot be estimated from the available data

  • Blood clots in the veins especially in the legs (symptoms include swelling, pain and redness in the leg), which may travel through blood vessels to the lungs causing chest pain and difficulty in breathing. If you notice any of these symptoms seek medical advice immediately.

If you get any of the following symptoms you should contact your doctor immediately as your dose may need to be reduced or stopped:

Very rare: may affect up to 1 in 10,000 people

  • High fever, unusual stiffness of the muscles and changes in consciousness, especially if occurring with sweating and fast heart rate. These symptoms may be signs of a rare but serious condition called neuroleptic malignant syndrome that has been reported with the use of Flupentixol decanoate Injection and similar medicines
  • Unusual movements of the mouth and tongue as these may early signs of a condition known as tardive dyskinesia
  • Unusual muscle movements (such as circular movements of the eyes), stiffness, tremor and restlessness (for example difficulty in sitting or standing still) as these may be signs of a so-called “extra pyramidal” reaction.
  • In rare cases irregular heart beats (arrhythmias) may have resulted in sudden death
  • Any yellowing of the skin and the white in the eyes (jaundice); your liver may be affected

Rare: may affect up to 1 in 1,000 people

  • Difficulty in breathing
  • Swelling of the face, lips, tongue or throat which causes difficulty in swallowing or breathing
  • Severe itching of the skin (with raised lumps)

Other side effects:

Side effects are most pronounced in the beginning of the treatment and most of them usually wear off during continued treatment.

Very common: may affect more than 1 in 10 people

  • Drowsiness
  • Dry mouth
  • Muscle spasm
  • Rigidity of the whole body

Common: may affect up to 1 in 10 people

  • Changes in appetite or weight
  • Insomnia
  • Depression
  • Nervousness or agitation
  • Dizziness
  • Headaches
  • Reduction in your sex drive
  • Poor concentration
  • Blurred or abnormal vision
  • Throbbing or fast heartbeats
  • Shortness of breath
  • Increase of saliva
  • Vomiting
  • Indigestion
  • Diarrhoea
  • Increased sweating or greasy skin
  • Itching
  • Muscle pain
  • Tremor
  • Abnormal urination (such as decrease in frequency or amount)
  • General weakness or pain, tiredness or feeling unwell

Uncommon: may affect up to 1 in 100 people

  • Confusion
  • Loss of co-ordination or altered muscle movements (including unusual movements of the mouth, tongue and eyeballs)
  • Speech problems
  • Fits
  • Low blood pressure
  • Hot flushes
  • Stomach pain
  • Feeling sick
  • Flatulence (wind) and constipation
  • Abnormal liver function tests
  • Rashes or skin reactions (including sensitivity to sunlight)
  • Stiff and floppy muscle
  • Problems with ejaculation or erections in male
  • Skin reactions at injection site

Rare: May affect up to 1 in 1,000 people

  • Difficulty in breathing
  • Swelling of the face, lips, tongue or throat which causes difficulty in swallowing or breathing
  • Severe itching of the skin (with raised lumps)
  • Reduction in blood platelets (which increases the risk of bleeding or bruising) and other blood cell changes
  • Raised blood levels of glucose or the hormone prolactin.
  • Loss of control of blood sugar levels
  • Breast enlargement in male
  • Unexpected excretion of breast milk
  • Women may experience an absence of menstrual periods

As with other medicines that work in a way similar to flupentixol decanoate (the active ingredient of Flupentixol decanoate  Injection), rare cases of the following side effects have been reported:

  • Slow heartbeat and abnormal ECG heart tracing.
  • Life threatening irregular heart beats.

In older people with dementia, a small increase in the number of deaths has been reported for patients taking antipsychotics compared with those not receiving antipsychotics.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse.

  1. How to store Flupentixol decanoate Injection

Usually your doctor or nurse will store the medicine for you. If you keep it at home:

  • Keep this medicine out of the sight and reach of children
  • Do not use this medicine after the expiry date that is printed on the label. The expiry date refers to the last day of that month
  • Keep the ampoules in the outer carton in order to protect from light.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

  1. Contents of the pack and other information

What Flupentixol decanoate  Injection contains

The active substance is flupentixol decanoate.

Each millilitre (ml) of Flupentixol decanoate  Injection contains 20 mg flupentixol decanoate.

The other ingredient is thin vegetable oil (purified from coconut oil).

What Flupentixol decanoate  Injection looks like and contents of the pack

Flupentixol decanoate  Injection is a clear, colourless or pale-yellow liquid.

Flupentixol decanoate  Injection is available in:

Glass ampoules containing 1 ml (20 mg), 2 ml (40 mg) and 1 ml (100mg) in cartons of 10 ampoules.

7.Manufactured in India by:
TAJ PHARMACEUTICALS LTD.
Mumbai, India
Unit No. 214.Old Bake House,
Maharashtra chambers of Commerce Lane,
Fort, Mumbai – 400001
at:Gujarat, INDIA.
Customer Service and Product Inquiries:
1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
Monday through Saturday 9:00 a.m. to 7:00 p.m. EST
E-mail: tajgroup@tajpharma.com

Related Products

Taj Generics (Taj Pharma) provides a wide range of products to the Indian market, including an extensive range of generics and specialty products; Our products cover a vast array of therapeutic categories, and we offer an extensive range of dosage forms and delivery systems including oral solids, controlled-release, steriles, injectables, topicals, liquids, transdermals, semi-solids and high-potency products. Our Generics portfolio offers over 1500 products in the major therapeutic areas of gastro-intestinal, cardiovascular, pain management, oncology, anti-infectives, paediatrics and dermatology.