Fluphenazine Decanoate Injection USP 125mg/5ml Taj Pharma

  1. NAME OF THE MEDICINAL PRODUCT

Fluphenazine Decanoate Injection USP 125mg/5ml Taj Pharma

  1. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each ml of ampoule contains:
Fluphenazine Decanoate……………25mg

Also contains sesame oil (q.s.).

Benzyl alcohol 15mg/ml.

For full list of excipients, see section 6.1.

  1. PHARMACEUTICAL FORM

Solution for Injection

Pale yellow clear, oily liquid.

  1. CLINICAL PARTICULARS

4.1 Therapeutic indications

For the treatment and maintenance of schizophrenic patients and those with paranoid psychoses.

While Fluphenazine Decanoate Injection USP 125mg/5ml Taj Pharma Injection has been shown to be effective in acute states, it is particularly useful in the maintenance treatment of chronic patients who are unreliable at taking their oral medication, and also of those who do not absorb their oral phenothiazine adequately.

4.2 Posology and method of administration

Dosage and Administration

Adults

It is recommended that patients be stabilised on the injection in hospital.

Recommended dosage regimes for all indications:

  1. Patients without previous exposure to a depot fluphenazine formulation:

Initially 0.125ml ie. 12.5mg (0.0625ml ie 6.25mg for patients over 60) by deep intramuscular injection into the gluteal region.

The onset of action generally appears between 24 and 72 hours after injection and the effects of the drug on psychotic symptoms become significant within 48 to 96 hours. Subsequent injections and the dosage interval are determined in accordance with the patient’s response. When administered as maintenance therapy, a single injection may be effective in controlling schizophrenic symptoms for up to four weeks or longer.

It is desirable to maintain as much flexibility in the dose as possible to achieve the best therapeutic response with the least side-effects; most patients are successfully maintained within the dose range 0.125ml (12.5mg) to 1ml (100mg) given at a dose interval of 2 to 5 weeks.

Patients previously maintained on oral fluphenazine:

It is not possible to predict the equivalent dose of depot formulation in view of the wide variability of individual response.

  1. Patients previously maintained on depot fluphenazine:

Patients who have suffered a relapse following cessation of depot fluphenazine therapy may be restarted on the same dose (as they were receiving formerly), although the frequency of injections may need to be increased in the early weeks of treatment until satisfactory control is obtained.

Elderly:

Elderly patients may be particularly susceptible to extrapyramidal reactions. Therefore reduced maintenance dosage may be required and a smaller initial dose (See above).

Children:

Not recommended for children.

*Where a very small volume/low concentration of fluphenazine is required patients may be transferred to the equivalent dose of Fluphenazine Decanoate Injection USP 125mg/5ml Taj Pharma Injection 25mg/ml on the basis that 1ml Fluphenazine Decanoate Injection USP 125mg/5ml Taj Pharma Concentrate (100mg/ml) is equivalent to 4ml Fluphenazine Decanoate Injection USP 125mg/5ml Taj Pharma Injection.

Note

The dosage should not be increased without close supervision and it should be noted that there is a variability in individual response.

The response to antipsychotic drug treatment may be delayed. If drugs are withdrawn, recurrence of symptoms may not become apparent for several weeks or months.

Route of administration: Intramuscular.

4.3 Contraindications

The product is contraindicated in the following cases:

Comatose states

Marked cerebral atherosclerosis

Phaeochromocytoma

Renal failure

Liver failure

Severe cardiac insufficiency

Severely depressed states

Existing blood dyscrasias

Hypersensitivity to Fluphenazine Decanoate or to any of the excipients

Because of the content of benzyl alcohol Fluphenazine Decanoate Injection USP 125mg/5ml Taj Pharma injection must not be given to newborns or premature neonates.

4.4 Special warnings and precautions for use

Caution should be exercised with the following:

Liver disease

Renal impairment

Cardiac arrhythmias, cardiac disease

Thyrotoxicosis

Severe respiratory disease

Epilepsy, conditions predisposing to epilepsy (eg. alcohol withdrawal or brain damage)

Parkinson’s disease

Patients who have shown hypersensitivity to other phenothiazines

Personal or family history of narrow angle glaucoma

In very hot weather

The elderly, particularly if frail or at risk of hypothermia

Hypothyroidism

Myasthenia gravis

Prostatic hypertrophy

Patients with known or with a family history of cardiovascular disease should receive ECG screening, and monitoring and correction of electrolyte balance prior to treatment with fluphenazine.

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 fluphenazinenad preventative measures undertaken.

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. Therefore, gradual withdrawal is advisable.

Psychotic patients on large doses of phenothiazines who are undergoing surgery should be watched carefully for hypotension. Reduced amounts of anaesthetics or central nervous system depressants may be necessary.

Fluphenazine should be used with caution in patients exposed to organophosphorus insecticides

Neuroleptic drugs elevate prolactin levels, and an increase in mammary neoplasms has been found in rodents after chronic administration. However, studies to date have not shown an association between chronic administration of these drugs and human mammary tumours.

As with any phenothiazine, the physician should be alert to the possibility of “silent pneumonias” in patients receiving long-term fluphenazine.

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 risk is not known.

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

Fluphenazine Decanoate Injection USP 125mg/5ml Taj Pharma Concentrate contains benzyl alcohol as a preservative and must not be given to premature babies or neonates. The administration of medicines containing benzyl alcohol as a preservative may cause toxic reactions and anaphylactoid reactions in children up to 3 years old.

The administration of medications containing benzyl alcohol to newborns or premature neonates has been associated with fatal ‘Gasping Syndrome’ (symptoms include a striking onset of gasping syndrome, hypotension, bradycardia, and cardio-vascular collapse). As benzyl alcohol may cross the placenta, solution for injection should be used with caution in pregnancy.

4.5 Interaction with other medicinal products and other forms of interaction

The possibility should be borne in mind that phenothiazines may:

  1. Increase the central nervous system depression produced by drugs such as alcohol, general anaesthetics, hypnotics, sedatives or strong analgesics.
  2. Antagonise the action of adrenaline and other sympathomimetic agents and reverse the blood-pressure lowering effects of adrenergic-blocking agents such as guanethidine and clonidine.
  3. Impair: the anti-parkinsonian effect of L-dopa; the effect of anti-convulsants; metabolism of tricyclic antidepressants; the control of diabetes.
  4. Increase the effect of anticoagulants and antidepressants.
  5. Interact with lithium.

Anticholinergic effects may be enhanced by anti-parkinsonian or other anticholinergic drugs.

Phenothiazines may enhance: the absorption of corticosteroids, digoxin, and neuromuscular blocking agents.

Fluphenazine is metabolised by P450 2D6 and is itself an inhibitor of this drug metabolising enzyme. The plasma concentrations and the effects of fluphenazine may therefore be increased and prolonged by drugs that are either the substrates or inhibitors of this P450 isoform, possibly resulting in severe hypotension, cardiac arrhythmias or CNS side effects. Examples of drugs which are substrates or inhibitors of cytochrome P450 2D6 include anti-arrhythmics, certain antidepressants including SSRIs and tricyclics, certain antipsychotics, β-blockers, protease inhibitors, opiates, cimetidine and ecstasy (MDMA). This list is not exhaustive.

Concomitant use of barbiturates with phenothiazines may result in reduced serum levels of both drugs, and an increased response if one of the drugs is withdrawn.

The effect of fluphenazine on the QT interval is likely to be potentiated by concurrent use of other drugs that also prolong the QT interval. Therefore, concurrent use of these drugs and fluphenazine is contraindicated. Examples include certain anti-arrhythmics, such as those of Class 1A (such as quinidine, disopyramide and procainamide) and Class III (such as amiodarone and sotalol), tricyclic antidepressants (such as amitriptyline); certain tetracyclic antidepressants (such as maprotiline); certain antipsychotic medications (such as phenothiazines and pimozide); certain antihistamines (such as terfenadine); lithium, quinine, pentamidine and sparfloxacin. This list is not exhaustive.

Electrolyte imbalance, particularly hypokalaemia, greatly increases the risk of QT interval prolongation. Therefore, concurrent use of drugs that cause electrolyte imbalance should be avoided.

Concurrent use of MAO inhibitors may increase sedation, constipation, dry mouth and hypotension.

Owing to their adrenolytic action, phenothiazines may reduce the pressor effect of adrenergic vasoconstrictors (i.e. ephedrine, phenylephrine).

Phenylpropanolamine has been reported to interact with phenothiazines and cause ventricular arrhythmias.

Concurrent use of phenothiazines and ACE inhibitors or angiotensin II antagonists may result in severe postural hypotension.

Concurrent use of thiazide diuretics may cause hypotension. Diuretic-induced hypokalaemia may potentiate phenothiazine-induced cardiotoxicity.

Clonidine may decrease the antipsychotic activity of phenothiazines.

Methyldopa increases the risk of extrapyramidal side effects with phenothiazines.

The hypotensive effect of calcium channel blockers is enhanced by concurrent use of antipsychotic drugs.

Phenothiazines may predispose to metrizamide-induced seizures.

Concurrent use of phenothiazines and amfetamine/anorectic agents may produce antagonistic pharmacological effects.

Concurrent use of phenothiazines and cocaine may increase the risk of acute dystonia.

There have been rare reports of acute Parkinsonism when an SSRI has been used in combination with a phenothiazine.

Phenothiazines may impair the action of anti-convulsants. Serum levels of phenytoin may be increased or decreased.

Phenothiazines inhibit glucose uptake into cells, and hence may affect the interpretation of PET studies using labelled glucose.

4.6 Fertility, pregnancy and lactation

Use in pregnancy: The safety for the use of this drug during pregnancy has not been established; therefore, the possible hazards should be weighed against the potential benefits when administering this drug to pregnant patients.

Neonates exposed to antipsychotics (including Fluphenazine Decanoate Injection USP 125mg/5ml Taj Pharma) 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.

Nursing mothers: Breast feeding is not recommended during treatment with depot fluphenazines, owing to the possibility that fluphenazine is excreted in the breast milk.

4.7 Effects on ability to drive and use machines

The use of this drug may impair the mental and physical abilities required for driving a car or operating heavy machinery.

4.8 Undesirable effects

Side effects: Acute dystonic reactions occur infrequently, as a rule within the first 24-48 hours, although delayed reactions may occur. In susceptible individuals they may occur after only small doses. These may include such dramatic manifestations as oculogyric crises and opisthotonos. They are rapidly relieved by intravenous administration of an anti-parkinsonian agent such as procyclidine.

Parkinsonian-like states may occur particularly between the second and fifth days after each injection, but often decrease with subsequent injection. These reactions may be reduced by using smaller doses more frequently, or by the concomitant use of anti-parkinsonian drugs such as trihexyphenidyl, benzatropine or procyclidine. Anti-parkinsonian drugs should not be prescribed routinely, because of the possible risks of aggravating anti-cholinergic side effects or precipitating toxic confusional states, or of impairing therapeutic efficacy.

With careful monitoring of the dose the number of patients requiring anti-parkinsonian drugs can be minimised.

Tardive Dyskinesia: As with all antipsychotic agents, tardive dyskinesia may appear in some patients on long term therapy or may occur after drug therapy has been discontinued. The risk seems to be greater in elderly patients on high dose therapy, especially females. The symptoms are persistent and in some patients appear to be irreversible.

The syndrome is characterised by rhythmical involuntary movements of the tongue, face, mouth or jaw (eg. protrusion of tongue, puffing of cheeks, puckering of mouth, chewing movements). Sometimes these may be accompanied by involuntary movements of the extremities. There is no known effective treatment for tardive dyskinesia: anti-parkinsonian agents usually do not alleviate the symptoms of this syndrome. It is suggested that all antipsychotic agents be discontinued if these symptoms appear. Should it be necessary to reinstitute treatment, or increase the dosage of the agent, or switch to a different antipsychotic agent, the syndrome may be masked. It has been reported that fine vermicular movements of the tongue may be an early sign of the syndrome and if the medication is stopped at that time, the syndrome may not develop.

Other Undesirable Effects: As with other phenothiazines, drowsiness, lethargy, blurred vision, dryness of the mouth, constipation, urinary hesitancy or incontinence, mild hypotension, impairment of judgement and mental skills, and epileptiform attacks are occasionally seen.

Headache, nasal congestion, vomiting, agitation, excitement and insomnia, and hyponatraemia have also been observed during phenothiazine therapy.

Blood dyscrasias have rarely been reported with phenothiazine derivatives. Blood counts should be performed if the patient develops signs of persistent infection. Transient leucopenia and thrombocytopenia have been reported. Antinuclear antibodies and SLE have been reported very rarely.

Jaundice has rarely been reported. Transient abnormalities of liver function tests may occur in the absence of jaundice.

A transient rise in serum cholesterol has been reported rarely in patients on oral fluphenazine.

Abnormal skin pigmentation and lens opacities have sometimes been seen following long-term administration of high doses of phenothiazines.

Phenothiazines are known to cause photosensitivity reactions but this has not been reported for fluphenazine. Skin rashes, hypersensitivity and anaphylactic reactions have occasionally been reported.

Elderly patients may be more susceptible to the sedative and hypotensive effects.

The effects of phenothiazines on the heart are dose-related. ECG changes with prolongation of the QT interval and T-Wave changes have been reported commonly in patients treated with moderate to high dosage; they have been reported to precede serious arrhythmias, including ventricular tachycardia and fibrillation, which have also occurred after overdosage. Sudden, unexpected and unexplained deaths have been reported in hospitalised psychotic patients receiving phenothiazines.

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

Phenothiazines may impair body temperature regulation. Elderly or hypothyroid patients may be particularly susceptible to hypothermia. The hazard of hyperpyrexia may be increased by especially hot or humid weather, or by drugs such as anti-parkinsonian agents, which impair sweating.

Rare occurrences of neuroleptic malignant syndrome (NMS) have been reported in patients on neuroleptic therapy. The syndrome is characterised by hyperthermia, together with some or all of the following: muscular rigidity, autonomic instability (labile blood pressure, tachycardia, diaphoresis), akinesia, and altered consciousness, sometimes progressing to stupor or coma. Leucocytosis, elevated CPK, liver function abnormalities, and acute renal failure may also occur. Neuroleptic therapy should be discontinued immediately and vigorous symptomatic treatment implemented since the syndrome is potentially fatal.

Hormonal effects of phenothiazines include hyperprolactinaemia, which may cause galactorrhoea, gynaecomastia and oligomenorrhoea or amenorrhoea. Sexual function may be impaired, and false results may be observed with pregnancy tests. Syndrome of inappropriate anti-diuretic hormone secretion has also been observed.

Oedema has been reported with phenothiazine medication.

Pregnancy, puerperium and perinatal conditions; drug withdrawal syndrome neonatal (see section 4.6) – Frequency not known.

Reporting of suspected adverse reactions

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

4.9 Overdose

Overdosage should be treated symptomatically and supportively, extrapyramidal reactions will respond to oral or parenteral anti-parkinsonian drugs such as procyclidine or benzatropine. In cases of severe hypotension, all procedures for the management of circulatory shock should be instituted, eg. vasoconstrictors and/or intravenous fluids. However, only the vasoconstrictors metaraminol or noradrenaline should be used, as adrenaline may further lower the blood pressure through interaction with the phenothiazine.

  1. PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Psycholeptics; Phenothiazines with piperazine structure

Fluphenazine decanoate is an ester of the potent neuroleptic fluphenazine, a phenothiazine derivative of the piperazine type. The ester is slowly absorbed from the intramuscular site of injection and is then hydrolysed in the plasma to the active therapeutic agent, fluphenazine.

Extrapyramidal reactions are not uncommon, but fluphenazine does not have marked sedative or hypotensive properties.

5.2 Pharmacokinetic properties

Plasma level profiles of fluphenazine following intramuscular injection have shown half-lives of plasma clearance ranging from 2.5 – 16 weeks, emphasising the importance of adjusting dose and interval to the individual requirements of each patient. The slow decline of plasma levels in most patients means that a reasonably stable plasma level can usually be achieved with injections spaced at 2 – 4 week intervals.

5.3 Preclinical safety data

Not applicable.

  1. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Benzyl alcohol

Sesame oil

6.2 Incompatibilities

None.

6.3 Shelf life

2 years.

6.4 Special precautions for storage

Store below 25°C. Keep the ampoules in the outer carton in order to protect from light.

6.5 Nature and contents of container

Colourless type I glass ampoules with an OPC (one point cut) breaking system containing 0.5ml (packs of 10) and 1ml (packs of 5).

Prefilled syringe with neoprene or pharma-gummi rubber plunger and stopper containing 0.5ml (packs of 10).

Not all pack sizes may be marketed.

6.6 Special precautions for disposal and other handling

No special requirements.

  1. 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

PACKAGE LEAFLET: INFORMATION FOR THE USER

FLUPHENAZINE DECANOATE INJECTION USP
125MG/5ML
TAJ PHARMA

Fluphenazine decanoate

Read all of this leaflet carefully before you start using this medicine

  • Keep this leaflet. You may need to read it again
  • If you have any further questions, ask your doctor, nurse or pharmacist
  • If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, nurse or pharmacist

IN THIS LEAFLET:

  1. What Fluphenazine Decanoate Injection USP 125mg/5ml Taj Pharma Injection is and what it is used for
  2. Before you are given Fluphenazine Decanoate Injection USP 125mg/5ml Taj Pharma Injection
  3. How Fluphenazine Decanoate Injection USP 125mg/5ml Taj Pharma Injection is given
  4. Possible side effects
  5. How to store Fluphenazine Decanoate Injection USP 125mg/5ml Taj Pharma Injection
  6. Further information

    1. WHAT FLUPHENAZINE DECANOATE INJECTION USP 125MG/5ML TAJ PHARMA INJECTION IS AND WHAT IT IS USED FOR

The name of your medicine is Fluphenazine Decanoate Injection USP 125mg/5ml Taj Pharma Injection 100ml/ml Injection (called Fluphenazine Decanoate Injection USP 125mg/5ml Taj Pharma Injection throughout this leaflet). Fluphenazine Decanoate Injection USP 125mg/5ml Taj Pharma Injection contains a medicine called fluphenazine decanoate. This belongs to a group of medicines called ‘phenothiazines’. It works by blocking the effect of a chemical in the brain.

Fluphenazine Decanoate Injection USP 125mg/5ml Taj Pharma Injection can be used for:

  • Schizophrenia – this illness can make you feel, see or hear things which do not exist, have strange and frightening thoughts, change how you act and make you feel alone. Sometimes people with these symptoms may also feel tense, anxious or depressed
  • Paranoid psychoses – this illness may make you feel very anxious or afraid for your own well-being.
  1. BEFORE YOU ARE GIVEN FLUPHENAZINE DECANOATE INJECTION USP 125MG/5ML TAJ PHARMA INJECTION

Do not have this medicine and tell your doctor if:

  • You are allergic (hypersensitive) to:
    • fluphenazine decanoate
    • other phenothiazine medicines
    • the other ingredients of Fluphenazine Decanoate Injection USP 125mg/5ml Taj Pharma (listed in Section 6 below)
      Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue
  • You have a tumour on the adrenal gland called a ‘phaeochromocytoma’
  • You have ever had a stroke or mini stroke (otherwise known as a transient ischaemic attack or TIA)
  • You have severe heart problems
  • You have severe liver or kidney problems
  • You have severe depression
  • You have a blood disorder
  • You have been recently exposed to organophosphates

Do not have this medicine if any of the above apply to you. If you are not sure, talk to your doctor or nurse before being given Fluphenazine Decanoate Injection USP 125mg/5ml Taj Pharma Injection.

You should not be given Fluphenazine Decanoate Injection USP 125mg/5ml Taj Pharma Injection if you are in a coma.

Take special care with Fluphenazine Decanoate Injection USP 125mg/5ml Taj Pharma Injection

Check with your doctor or nurse before you have this medicine if:

  • You have liver or kidney problems
  • You have an uneven heartbeat or heart disease. If you or a member of your family has ever had heart disease, your doctor may carry out tests on your heart and blood before giving you this medicine
  • You or someone else in your family has a history of blood clots, as medicines like these have been associated with formation of blood clots
  • You have problems with your thyroid gland
  • You have severe breathing problems
  • You have brain damage
  • You have Parkinson’s disease
  • You have epilepsy
  • You have had problems with other medicines for psychotic diseases
  • You or members of your family have ever had glaucoma (painful eyes with blurred vision)
  • You have suddenly stopped drinking alcohol and are having signs of withdrawal. This may happen if you suddenly stop after drinking large amounts for a long time, or stop after a period of very heavy drinking
  • You have a form of muscle weakness called ‘myasthenia gravis’
  • You have an enlarged prostate gland. This means you may have problems when passing water (urine)
  • You are going to be exposed to very hot weather
  • You are elderly (65 years of age or older) particularly if you are in poor health or during very cold weather
  • You are going to have an operation soon

If you are not sure if any of the above apply to you, talk to your doctor or nurse before having Fluphenazine Decanoate Injection USP 125mg/5ml Taj Pharma Injection.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines you buy without a prescription, including herbal medicines. This is because Fluphenazine Decanoate Injection USP 125mg/5ml Taj Pharma Injection can affect the way some other medicines work. Also some medicines can affect the way Fluphenazine Decanoate Injection USP 125mg/5ml Taj Pharma Injection works.

In particular, do not have this medicine and tell your doctor if you are taking:

  • Medicines to control your heartbeat (such as amiodarone, sotalol, procainamide, disopyramide or quinidine)
  • Medicines used for depression
  • Other medicines used to calm emotional and mental health problems such as chlorpromazine, lithium and pimozide
  • Some medicines used for infections such as sparfloxacin and pentamidine
  • Some medicines used for hay fever, rashes or other allergies called antihistamines (such as terfenadine)
  • Water tablets (diuretics)
  • Quinine – used for malaria

The following medicines can increase the chance of you getting side effects, when taken with Fluphenazine Decanoate Injection USP 125mg/5ml Taj Pharma Injection:

  • General anaesthetics – used during surgery
  • Medicines to help you sleep (sedatives, barbiturates)
  • Medicines for severe pain
  • Medicines used to prevent blood clotting (anticoagulants), such as warfarin. Your doctor may change your dose and may monitor your treatment closely
  • Digoxin — used for heart problems. Your doctor may change your dose and may monitor your treatment clos
  • Anticholinergic medicines — includes some medicines used for irritable bowel syndrome, asthma or incontinence
  • Corticosteroids used for inflammation such as hydrocortisone, betamethasone or prednisolone
  • Medicines used for muscle spasms such as suxamethonium, pancuronium and dantrolene
  • Medicines for high blood pressure
  • Some medicine used for HIV infection (protease inhibitors) such as amprenavir and indinavir
  • Cimetidine – for stomach ulcers or excess acid
  • Cocaine or Ecstasy (MDMA)
  • Phenylpropanolamine – used in colds and flu medicines

The following medicines can affect the way Fluphenazine Decanoate Injection USP 125mg/5ml Taj Pharma Injection works or Fluphenazine Decanoate Injection USP 125mg/5ml Taj Pharma can affect the way some of these medicines work:

  • Some medicines used for life threatening allergic reactions or conditions such as adrenaline, dobutamine and dopamine
  • Medicines for Parkinson’s disease (such as l-dopa, apomorphine, pergolide, lisuride, bromocriptine or cabergoline)
  • Medicines used for fits (epilepsy) such as phenytoin and carbamazepine
  • Medicines for diabetes
  • Medicines used to raise blood pressure (adrenergic vasoconstrictors) such as ephedrine and phenylephrine
  • Metrizamide – used to help with tests such as X-ray examinations
  • Amfetamines – used for Attention Deficit Hyperactive Disorder (ADHD)

Positron Emission Tomography (PET) Studies

Having Fluphenazine Decanoate Injection USP 125mg/5ml Taj Pharma Injection may affect the results PET studies carried out using labelled glucose. If you are going to have a PET study, it is important to tell your doctor you are having Fluphenazine Decanoate Injection USP 125mg/5ml Taj Pharma Injection.

Having Fluphenazine Decanoate Injection USP 125mg/5ml Taj Pharma Injection with food and drink

Do not drink alcohol while you are having Fluphenazine Decanoate Injection USP 125mg/5ml Taj Pharma Injection. This is because alcohol can increase the effects of Fluphenazine Decanoate Injection USP 125mg/5ml Taj Pharma Injection and cause serious breathing problems.

Pregnancy and breast-feeding

Talk to your doctor before taking this medicine if you are pregnant, might become pregnant, or think you may be pregnant. Fluphenazine Decanoate Injection USP 125mg/5ml Taj Pharma may cause an incorrect false negative result on a pregnancy test.

The following symptoms may occur in newborn babies, of mothers that have used Fluphenazine Decanoate Injection USP 125mg/5ml Taj Pharma 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.

You should not breast-feed if you are taking Fluphenazine Decanoate Injection USP 125mg/5ml Taj Pharma Injection. This is because small amounts may pass into mothers’ milk. If you are breast-feeding or planning to breast-feed, talk to your doctor or pharmacist before taking any medicine.

Ask your doctor or nurse for advice before taking any medicine if you are pregnant or breast-feeding.

Driving and using machines

You may feel sleepy, tired, have blurred eyesight or your ability to think or respond may be lowered after having this medicine. If this happens, do not drive or use any tools or machines.

Important information about some of the ingredients of Fluphenazine Decanoate Injection USP 125mg/5ml Taj Pharma Injection

Fluphenazine Decanoate Injection USP 125mg/5ml Taj Pharma Injection contains:

  • Sesame oil.This may cause severe allergic (hypersensitivity) reactions. The chances of this happening are rare. Tell a doctor or nurse straight away if you get a rash, swallowing or breathing problems and swelling of your lips, face, throat or tongue
  • Benzyl alcohol.Fluphenazine Decanoate Injection USP 125mg/5ml Taj Pharma Injection contains 15 mg/ml of benzyl alcohol. It must not be given to premature or newborn babies. Benzyl alcohol may cause toxic reactions and allergic reactions in infants and children up to 3 years old.
  1. HOW FLUPHENAZINE DECANOATE INJECTION USP 125MG/5ML TAJ PHARMA INJECTION IS GIVEN

Fluphenazine Decanoate Injection USP 125mg/5ml Taj Pharma Injection is normally given by a doctor or nurse. This is because it needs to be given as a deep injection into a muscle.

How much Fluphenazine Decanoate Injection USP 125mg/5ml Taj Pharma Injection is given

If you are not sure why you are being given Fluphenazine Decanoate Injection USP 125mg/5ml Taj Pharma Injection or have any questions about how much Fluphenazine Decanoate Injection USP 125mg/5ml Taj Pharma Injection is being given to you, speak to your doctor or nurse.

The usual dose is:

Adults Fluphenazine Decanoate Injection USP 125mg/5ml Taj Pharma Injection is usually given every 2 to 5 weeks.

  • Your first dose will be 12.5mg
  • This may be increased up to 100mg depending on your illness
  • The usual dose is 12.5 to 100mg

Elderly Your doctor will start you on a lower dose of 6.25mg

Children

Fluphenazine Decanoate Injection USP 125mg/5ml Taj Pharma Injection should not be given to children.

Tests

Before and during treatment your doctor may want to carry out some tests. These might include blood tests and an ECG to check your heart is working properly.

If you have more Fluphenazine Decanoate Injection USP 125mg/5ml Taj Pharma Injection than you should

It is unlikely that your doctor or nurse will give you too much medicine. Your doctor and nurse will monitor your progress, and check the medicine you are given. Ask them if you are not sure why you are getting a dose of medicine.

Having too much Fluphenazine Decanoate Injection USP 125mg/5ml Taj Pharma Injection may make you feel drowsy and you may become unconscious. You may also feel very cold, have a fast or irregular heartbeat or severe muscle spasms. If you start getting any of these symptoms tell your doctor or nurse straight away. If you are away from the hospital, return straight away and speak to your doctor or nurse or go to the casualty department.

If you miss a dose of Fluphenazine Decanoate Injection USP 125mg/5ml Taj Pharma Injection

Your doctor or nurse will have instructions on when to give you this medicine. It is unlikely that you will not be given the medicine as it has been prescribed.

However, if you do think you have missed a dose, tell your doctor or nurse.

If you stop being given Fluphenazine Decanoate Injection USP 125mg/5ml Taj Pharma Injection

Keep having Fluphenazine Decanoate Injection USP 125mg/5ml Taj Pharma Injection until your doctor tells you to stop. If you stop having Fluphenazine Decanoate Injection USP 125mg/5ml Taj Pharma Injection, your illness may come back and you may have other effects after stopping such as feeling or being sick, sweating and difficulty sleeping. You may also get tics (such as muscle spasms in your face, rolling eyes, jerking muscles) or feel restless.

  1. POSSIBLE SIDE EFFECTS

Like all medicines, Fluphenazine Decanoate Injection USP 125mg/5ml Taj Pharma Injection can cause side effects, although not everybody gets them.

Tell a nurse or doctor straight away if you have;

  • An allergic reaction. The signs may include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue
  • Yellowing of the skin or eyes (jaundice)
  • A sudden high temperature or an infection due to low numbers of white blood cells. These could be signs of a problem called ‘leucopenia’
  • High temperature, sweating, stiff muscles, fast heartbeat, fast breathing and feel confused, drowsy or agitated. These could be signs of a serious side effect called ‘neuroleptic malignant syndrome’
  • Low temperature, unusually pale skin complexion, cold skin, uncontrollable shivering, slow breathing and slow heart beat. You may have low body temperature (hypothermia)
  • Bruise more easily than usual. This could be because of a blood disorder (thrombocytopenia)
  • Movements that you cannot control of the tongue, mouth, eyes, jaw, arms and legs
  • Feel tired, weak, confused and have muscles that ache, are stiff or do not work well. This may be due to low sodium levels in your blood or a condition called Syndrome of Inappropriate Anti-diuretic Hormone Secretion (SIADH)
  • Joint aches and pains, swollen joints, increased sensitivity to sunlight, mouth ulcers, hair loss, anxiety, fevers, night sweats, stomach pain, chest pain and shortness of breath. This could also be due to changes to your immune system or an immune condition called Systemic Lupus Erythematosus (SLE)
  • Fits
  • An uneven or fast heartbeat
  • 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.

Tell a nurse or doctor as soon as possible if you have any of the following side effects:

  • Rigid or stiff muscles, trembling or shaking, difficulty moving
  • Feeling dizzy, light-headed or faint (due to low blood pressure)
  • Changes in skin or eye colour after having Fluphenazine Decanoate Injection USP 125mg/5ml Taj Pharma for a long time
  • Swelling of the feet and legs (oedema)

Talk to your doctor or nurse if any of the following side effects gets serious or lasts longer than a few days:

  • Feeling drowsy or tired
  • Abnormal production of breast milk in men and women
  • Breast enlargement in men
  • Infrequent, light or loss of menstrual periods
  • Sexual problems
  • Difficulty sleeping (insomnia)
  • Feeling excited, agitated
  • Headache, stuffy nose, being sick (vomiting)
  • Difficulty passing water (urine) or lack of control over passing water
  • Blurred eyesight, dry mouth
  • Less ability to perform mental tasks or having poor judgement
  • Skin rashes
  • Constipation

Tests

  • Fluphenazine Decanoate Injection USP 125mg/5ml Taj Pharma can change the levels of liver enzymes or body fats such as cholesterol shown up on blood test
  • Blood tests may show changes to your immune system

As with other phenothiazine medicines, there have been very rare reports of sudden death with Fluphenazine Decanoate Injection USP 125mg/5ml Taj Pharma Injection. These are possibly caused by heart problems.

In elderly 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. This includes any possible side effects not listed in this leaflet.

  1. HOW TO STORE FLUPHENAZINE DECANOATE INJECTION USP 125MG/5ML TAJ PHARMA INJECTION

This medicine will be kept by your doctor or pharmacist in a safe place where children cannot see or reach it. Store below 25°C, protected from light.

Do not use Fluphenazine Decanoate Injection USP 125mg/5ml Taj Pharma Injection after the expiry date, which is stated on the ampoule and the carton. The expiry date refers to the last day of the month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

  1. FURTHER INFORMATION

What Fluphenazine Decanoate Injection USP 125mg/5ml Taj Pharma Injection contains

Each ml of ampoule contains:
Fluphenazine Decanoate……………25mg

The other ingredients are sesame oil and benzyl alcohol

What Fluphenazine Decanoate Injection USP 125mg/5ml Taj Pharma Injection looks like and contents of the pack

Fluphenazine Decanoate Injection USP 125mg/5ml Taj Pharma Injection 100 mg/ml Injection is a pale yellow clear liquid supplied in 0.5ml and 1ml colourless glass ampoules with an OPC (one point cut) breaking system.

Not all pack sizes may be marketed.

  1. 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.