Trifluoperazine Tablets USP 2mg Taj Pharma

  1. Name of the medicinal product

Trifluoperazine Tablets USP 1mg Taj Pharma
Trifluoperazine Tablets USP 2mg Taj Pharma
Trifluoperazine Tablets USP 5mg Taj Pharma

  1. Qualitative and quantitative composition

Each tablet contains
Trifluoperazine hydrochloride
equivalent to trifluoperazine               1mg
Excipients                                             q.s

Each tablet contains
Trifluoperazine hydrochloride
equivalent to trifluoperazine               2mg
Excipients                                             q.s

Each tablet contains
Trifluoperazine hydrochloride
equivalent to trifluoperazine               5mg
Excipients                                             q.s

  1. Pharmaceutical form

Tablet

  1. Clinical particulars

4.1 Therapeutic indications

Low dosage: ‘Trifluoperazine’ is indicated as an adjunct in the short-term management of anxiety states, depressive symptoms secondary to anxiety, and agitation. It is also indicated in the symptomatic treatment of nausea and vomiting.

High dosage: Treatment of symptoms and prevention of relapse in schizophrenia and in other psychoses, especially of the paranoid type, but not in depressive psychoses. It may also be used as an adjunct in the short-term management of severe psychomotor agitation and of dangerously impulsive behaviour in, for example, mental subnormality.

4.2 Posology and method of administration

Dosage:

AdultsLow dosage: 2-4 mg a day, given in divided doses, according to the severity of the patient’s condition. If necessary, dosage may be increased to 6 mg a day, but above this level extrapyramidal symptoms are more likely to occur in some patients.

High dosage: The recommended starting dose for physically fit adults is 5 mg twice a day; after a week this may be increased to 15 mg a day. If necessary, further increases of 5 mg may be made at three-day intervals, but not more often. When satisfactory control has been achieved, dosage should be reduced gradually until an effective maintenance level has been established.

As with all major tranquillisers clinical improvement may not be evident for several weeks after starting treatment, and there may also be delay before recurrence of symptoms after stopping treatment. Gradual withdrawal from high-dosage treatment is advisable.

Children: Low dosage: For children aged 6-12 years, up to a maximum of 4 mg a day given in divided doses.

High dosage: For children aged under 12 years, the initial oral dosage should not exceed 5mg a day, given in divided doses. Any subsequent increase should be made with caution, at intervals of not less than three days, and taking into account age, body weight and severity of symptoms.

Elderly: The starting dose for elderly or frail patients should be reduced by at least half.

Administration:

Oral

4.3 Contraindications

Do not use ‘Trifluoperazine’ in comatose patients, particularly is associated with other central nervous system depressants. Do not use ‘Trifluoperazine’ in those patients with existing blood dyscrasias or known liver damage, or in those hypersensitive to trifluoperazine, related compounds, or any of the excipients. Patients with uncontrolled cardiac decompensation should not be given ‘Trifluoperazine’.

4.4 Special warnings and precautions for use

‘Trifluoperazine’ should be discontinued at the first sign of clinical symptoms of tardive dyskinesia and Neuroleptic Malignant Syndrome.

Patients on long-term phenothiazine therapy require regular and careful surveillance with particular attention to tardive dyskinesia and possible eye changes, blood dyscrasias, liver dysfunction and myocardial conduction defects, particularly if other concurrently administered drugs have potential effects in these systems.

Care should be taken when treating elderly patients, and the initial dosage should be reduced. Such patients can be especially sensitive, particularly to extrapyramidal and hypotensive effects. Patients with cardiovascular disease including arrhythmias should also be treated with caution. Because ‘Trifluoperazine’ may increase activity, care should be taken in patients with angina pectoris. If an increase in pain is noted, the drug should be discontinued. Patients who have demonstrated bone marrow suppression or jaundice with a phenothiazine should not be re-exposed to ‘Trifluoperazine (or any trifluoperazine) unless in the judgement of the physician the potential benefits of treatment outweigh the possible hazard.

In patients with Parkinson’s disease, symptoms may be worsened, and the effects of levodopa reversed. Since phenothiazines may lower the convulsive threshold, patients with epilepsy should be treated with caution, and metrizamide avoided. Although ‘Trifluoperazine’ has minimal anticholinergic activity, this should be borne in mind when treating patients with narrow angle glaucoma, myasthenia gravis or prostatic hypertrophy.

Nausea and vomiting as a sign of organic disease may be masked by the antiemetic action of ‘Trifluoperazine’.

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

Caution should be used in patients with cardiovascular disease or family history of QT prolongation. Concomitant use of neuroleptics should be avoided.

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 Trifluoperazine and preventive measures undertaken

Acute withdrawal symptoms including nausea, vomiting and insomnia have been described after abrupt cessation of high doses 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, a gradual withdrawal is advisable.

Phenothiazines should be used with care in extremes of temperature since they may affect body temperature control.

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.

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

4.5 Interaction with other medicinal products and other forms of interaction

Potentiation may occur if antipsychotic drugs are combined with CNS depressants such as alcohol, hypnotics, anaesthetics and strong analgesics, or with antihypertensives or other drugs with hypotensive activity, anticholinergics or antidepressants. Phenothiazines may antagonise the action of levodopa. Avoid drugs that depress leucopoiesis.

Serum levels of phenothiazine can be reduced to non-therapeutic concentrations by concurrent administration of lithium.

Desferrioxamine should not be used in combination with ‘Trifluoperazine’, since prolonged unconsciousness has occurred after combination with the related prochlorperazine.

Trifluoperazine may diminish the effect of oral anticoagulants.

Severe extrapyramidal side-effects or neurotoxicity have been observed in patients concurrently treated with lithium and trifluoperazine. Sleep walking has been described in some patients taking phenothiazines and lithium.

Antacids can reduce the absorption of phenothiazines.

Phenothiazines increase the risk of ventricular arrhythmias when given with drugs which prolong the Q-T interval, drugs causing electrolyte imbalances.

4.6 Pregnancy and lactation

‘Trifluoperazine’ has been available since 1958. There are some animal studies that indicate a teratogenic effect, but results are conflicting. There is no clinical evidence (including follow-up surveys in over 800 women who had taken low-dosage ‘Trifluoperazine’ during pregnancy) to indicate that trifluoperazine has a teratogenic effect in man. Nevertheless, drug treatment should be avoided in pregnancy unless essential, especially during the first trimester.

Neonates exposed to antipsychotics (including Trifluoperazine) 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.

Trifluoperazine crosses the placenta and passes into the milk of lactating dogs; breast feeding should only be allowed at the discretion of the physician.

4.7 Effects on ability to drive and use machines

Trifluoperazine may cause side effects including drowsiness, dizziness and visual disturbances which interfere with the ability to drive and operate machinery. Do not drive or use machines when you first start to take this medicine until you are certain that you are not getting these side effects

4.8 Undesirable effects

Lassitude, drowsiness, dizziness, transient restlessness, insomnia, dry mouth, blurred vision, muscular weakness, anorexia, mild postural hypotension, skin reactions including photosensitivity reactions, weight gain, oedema and confusion may occasionally occur. Tachycardia, constipation, urinary hesitancy and retention, and hyperpyrexia have been reported very rarely. Adverse reactions tend to be dose-related and to disappear.

Hyperprolactinaemia may occur at higher dosages with associated effects such as galactorrhoea, amenorrhoea or gynaecomastia; certain hormone-dependent breast neoplasms may be affected. Phenothiazines can produce ECG changes with prolongation of the QT interval and T-wave changes; ventricular arrhythmias( VF,VT(rare)), sudden unexplained deaths; cardiac arrest and Torsades de pointes have been reported. Such effects are rare with ‘Trifluoperazine’.

In some patients, especially non-psychotic patients, ‘Trifluoperazine’ even at low dosage may cause unpleasant symptoms of being dulled or, paradoxically, of being agitated.

Extrapyramidal symptoms are rare at oral daily dosages of 6 mg or less; they are considerably more common at higher dosage levels. These symptoms include parkinsonism; akathisia, with motor restlessness and difficulty in sitting still; and acute dystonia or dyskinesia, which may occur early in treatment and may present with torticollis, facial grimacing, trismus, tongue protrusion and abnormal eye movements including oculogyric crises. These effects are likely to be particularly severe in children. Such reactions may often be controlled by reducing the dosage or by stopping medication. In more severe dystonic reactions, an anticholinergic antiparkinsonism drug should be given.

Tardive dyskinesia of the facial muscles, sometimes with involuntary movements of the extremities, has occurred in some patients on long-term, high-dosage and, more rarely, low-dosage phenothiazine therapy, including ‘Trifluoperazine’. Symptoms may appear for the first time either during or after a course of treatment; they may become worse when treatment is stopped. The symptoms may persist for many months or even years, and while they gradually disappear in some patients, they appear to be permanent in others.

Patients have most commonly been elderly, female or with organic brain damage. Particular caution should be observed in treating such patients.

Periodic gradual reduction of dosage to reveal persisting dyskinesia has been suggested, so that treatment may be stopped if necessary.

Anticholinergic antiparkinsonism agents may aggravate the condition. Since the occurrence of tardive dyskinesia may be related to length of treatment and dosage, Trifluoperazine should be given for as short a time and at as low a dosage as possible

The neuroleptic malignant syndrome is a rare but occasionally fatal complication of treatment with neuroleptic drugs, and is characterised by hyperpyrexia, muscle rigidity, altered consciousness and autonomic instability. Intensive symptomatic treatment, following discontinuation of ‘Trifluoperazine’, should include cooling. Intravenous dantrolene has been suggested for muscle rigidity.

Mild cholestatic jaundice and blood dyscrasias such as agranulocytosis, pancytopenia, leucopenia and thrombocytopenia have been reported very rarely.

Signs of persistent infection should be investigated.

Very rare cases of skin pigmentation and lenticular opacities have been reported with Trifluoperazine’. Withdrawal reactions have been reported in association with antipyschotic drugs(see 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.

Pregnancy, puerperium and perinatal conditions-Drug withdrawal syndrome neonatal (see 4.6) –Frequency not known.

4.9 Overdose

Signs and symptoms will be predominantly extrapyramidal; hypotension may occur. Absorption of trifluoperazine from the ‘Spansule’ capsule is likely to be prolonged and this should be borne in mind. Treatment consists of gastric lavage together with supportive and symptomatic measures. Do not induce vomiting. Extrapyramidal symptoms may be treated with an anticholinergic antiparkinsonism drug. Treat hypotension with fluid replacement; if severe or persistent, noradrenaline may be considered. Adrenaline is contra-indicated.

  1. Pharmacological properties

5.1 Pharmacodynamic properties

‘Trifluoperazine’ is a Piperazine Phenothiazine tranquiliser with potent anti-psychotic, anxiolytic and antiemetic activity, and a pharmacological profile of moderate sedative and hypotensive properties, and fairly pronounced tendency to cause extrapyramidal reactions.

5.2 Pharmacokinetic properties

Trifluoperazine is well absorbed but undergoes extensive first pass metabolism. Distribution is wide and elimination occurs in the bile and urine. Inactive ingredients in the tablets include sucrose.

5.3 Preclinical safety data

Not applicable.

  1. Pharmaceutical particulars

6.1 List of excipients

Calcium Sulphate, Icing sugar(Sucrose), Maize Starch, Gelatin

Talc, Stearic acid

Coating

Opadry Blue, Carnauba wax, Purified water

6.2 Incompatibilities

None known.

6.3 Shelf life

3 years.

6.4 Special precautions for storage

Do not store above 25°C. Protect from light and moisture.

6.5 Nature and contents of container

Opaque PVC/aluminium foil blisters in packs containing 28, 56, 100 and 112 tablets.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal and other handling

Not applicable

  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.comTrifluoperazine Tablets USP 1mg, 2mg, 5mg Taj Pharma

PATIENT INFORMATION LEAFLET

Trifluoperazine hydrochloride Tablets

(trifluoperazine hydrochloride)

This product is available using the above name but will be referred to as Trifluoperazine hydrochloride Tablets throughout the rest of this leaflet. Please note that this leaflet also contains information about other strength (Trifluoperazine hydrochloride 1mg Tablets).

Read all of this leaflet carefully before you start taking this medicine.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:
  1. What Trifluoperazine hydrochloride Tablets are and what they are used for
  2. Before you take Trifluoperazine hydrochloride Tablets
  3. How to take Trifluoperazine hydrochloride Tablets
  4. Possible side effects
  5. How to store Trifluoperazine hydrochloride Tablets
  6. Further information
1. What Trifluoperazine hydrochloride Tablets are and what they are used for

Trifluoperazine hydrochloride Tablets contain the active ingredient trifluoperazine hydrochloride, which belongs to a class of drugs called phenothiazine tranquilisers. It influences the activity of certain brain cells by decreasing the effect of dopamine, a natural chemical in the brain.

  • At a low dose, Trifluoperazine hydrochloride Tablets are used to manage anxiety and depression. It is used in this way for short periods of time
  • Trifluoperazine hydrochloride Tablets may also be used to treat nausea (feeling sick) and vomiting (being sick)
  • At high doses, Trifluoperazine hydrochloride Tablets are used to treat and prevent relapses of schizophrenia (a serious mental illness) and related
2. Before you take Trifluoperazine hydrochloride Tablets
DO NOT take Trifluoperazine hydrochloride Tablets if:
  • You know that you are allergic to trifluoperazine hydrochloride or any of the other ingredients of Trifluoperazine hydrochloride Tablets (see section 6 of this leaflet)
  • You are suffering from liver problems, blood disorders, inability of the heart to maintain adequate circulation causing breathlessness and swelling of the ankles
  • You have previously had to stop taking other medicines for psychiatric problems like Trifluoperazine hydrochloride (known as phenothiazines) because they have affected your blood cells or caused jaundice (yellowing of the skin and eyes). Ask your doctor about this
  • You are having a special X-ray examination of the brain or spinal cord involving a chemical called metrizamide (your doctor will be able to help you).

Take special care with Trifluoperazine hydrochloride Tablets and tell your doctor if you are:
  • if you or any member of your family is suffering from any disease involving the heart and blood vessels (cardiovascular disease) including chest pain (angina) and irregular heart beats
  • suffering from a brain disorder causing tremors, rigidity and slowing of movement (Parkinson’s disease).
  • suffering from fits (epilepsy)
  • suffering from an eye disease called narrow angle glaucoma which causes increased pressure inside the eye, abnormal muscle weakness (Myasthenia gravis) or enlargement of prostate gland
  • exposed to extremes in temperature as this medicine can affect body temperature control
  • an elderly person
  • if you suffer from loss of cognitive (memory, language, intelligence) ability – dementia
  • If 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 had a stroke or you have any of the following that can increase your risk of having a stroke – a heart attack
    • a TIA (transient ischaemic attack). This is a type of stroke where symptoms last less than 24 hours
    • an artificial heart valve
    • uncontrolled high blood pressure
    • diabetes
    • high cholesterol
    • a family history of strokes
    • you smoke
    • you drink excess alcohol (this tends to weaken blood vessels and can raise blood pressure).

Even though some of the above may appear obvious, it is important that your doctor is aware if any of them apply to you.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. The effects of these medicines may change, especially if you are taking:

  • sleeping tablets
  • anaesthetics used prior to surgery
  • strong pain killers (e.g. codeine)
  • medicines which result in lowering of blood pressure (e.g. guanethidine)
  • anticholinergic medicines used to reduce saliva and lung secretions (e.g. atropine, procyclidine)
  • antidepressants (e.g. other phenothiazines, lithium)
  • medicines for fits (anticonvulsants)
  • medicines for Parkinson’s disease (e.g. levodopa)
  • blood thinning medicines (anticoagulants such as warfarin)
  • medicines used to treat iron poisoning (desferrioxamine)
  • antacids used to treat indigestion
  • medicines for psychiatric conditions (neuroleptics)
  • heart medicines which prolong the QT interval (e.g. quinidine, disopyramide, procainamide, amiodarone, sotalol)
  • drugs causing electrolyte imbalances (e.g. diuretics).

Taking Trifluoperazine hydrochloride Tablets with food and drink

You should not drink alcohol whilst you are taking this medicine.

Pregnancy and breast feeding

Do not take Trifluoperazine hydrochloride Tablets if you are pregnant, think you may be pregnant or are planning to become pregnant or while breast feeding, unless your doctor decides that treatment is essential. It is particularly important not to take Trifluoperazine hydrochloride Tablets during the first three months of pregnancy.

Ask your doctor or pharmacist for advice before taking any medicine.

The following symptoms may occur in newborn babies, of mothers that have used trifluoperazine 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.

Driving and using machines

Trifluoperazine hydrochloride Tablets may make you feel drowsy or dizzy or give you blurred vision. You should not drive or use machines when you first start to take this medicine until you are certain that you are not getting these side effects. If in any doubt, speak to your doctor before you drive or use machines.

Important information about some of the ingredients of Trifluoperazine hydrochloride Tablets

This medicine also contains sucrose. If you have been told by your doctor that you are intolerant to some sugars, contact your doctor before taking this medicine.

3. How to take Trifluoperazine hydrochloride Tablets

Always take Trifluoperazine hydrochloride Tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. Swallow the tablets with a glass of water. The tablets can be taken with or without food.

Your doctor will decide on a suitable dose depending on your condition.

Adults:
  • The normal adult dose for anxiety or vomiting is 2-6mg daily, and for schizophrenia is 10-15mg The dose may be split over two or three times a day.

Children:
  • For children aged 6-12 years the dose for anxiety or nausea and vomiting is no more than 4mg a day, and for children aged under 12 years the starting dose for schizophrenia is no more than 5mg a

The pharmacist’s label on your pack will tell you how much and how often you should take your tablets. Please read the label carefully. Do not take more than your doctor has recommended.

During treatment your doctor should regularly check you for physical side effects, changes in your blood counts or liver function, and any heart problem, especially if you are also taking other medicines.

If you stop taking Trifluoperazine hydrochloride Tablets:
  • Continue to take Trifluoperazine hydrochloride Tablets even if you no longer feel ill. Do not stop taking this medicine without talking with your doctor first, especially if you have taken large doses for a long time. When the time comes to stop, your doctor will probably decrease your dose gradually as stopping the tablets suddenly may cause ill-effects such as nausea (feeling sick), vomiting (being sick), sweating and difficulty in
  • For mood disorders and schizophrenia, it may take several weeks for you to feel the full benefit of this medicine. If you stop taking this medicine suddenly, your symptoms may come

If you take more Trifluoperazine hydrochloride Tablets than you should:

If you think that you, or any other person, have taken too many tablets, contact your doctor or hospital casualty department immediately. Take this leaflet and any remaining tablets with you so that the medical staff know exactly what you have taken.

If you forget to take your Trifluoperazine hydrochloride Tablets:

If you miss a dose, wait until your next dose. Do not take the dose you have missed. You can then carry on as before. Do not take more than one dose at a time.

  1. Possible side effects
    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.

Like all medicines, Trifluoperazine hydrochloride Tablets can sometimes cause side effects, although not everybody gets them.

Stop taking Trifluoperazine hydrochloride Tablets immediately and call your doctor if you experience signs of allergic reaction.

Signs of an allergic reaction include a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue. Tell your doctor straight away if you notice any of the following serious side effects:

  • Rarely patients may develop Neuroleptic Malignant Syndrome. This causes a high temperature, rigid muscles, drowsiness, occasional loss of consciousness, and requires emergency admission to hospital for treatment
  • If you have chest pain (angina) and your pain is getting worse
  • Rarely, Trifluoperazine hydrochloride Tablets can affect certain types of breast cancers or lead to breast enlargement in men or to inappropriate milk production or altered menstrual cycle (e.g. periods stop)
  • If you suffer from a sore throat, high fever, feel very tired, become pale, develop bruises and nose bleeds. These may indicate blood problems developing as a result of using this medicine
  • Very occasionally, medicines such as Trifluoperazine hydrochloride Tablets can have effects on muscle control. If this happens, symptoms can include slurred speech, odd movements of the face, particularly of the tongue, eyes, head or neck (such as twisting of the neck which causes an unnatural positioning of the head, rigid muscles, tremors or restlessness and difficulty in sitting still). Some patients (especially on high doses of this medicine) experience problems with muscle control which may continue for years. Such patients may experience constant chewing or tongue movements or other gentle movements of the neck, head or trunk. Uncontrollable movements of the arms and legs have also been reported in these patients
  • Very rarely, patients may also experience a fast or irregular heartbeat, constipation, difficulty or inability to pass urine or a high temperature
  • Occasionally, some patients have complained of feeling slowed down, whilst others of being
  • If you have angina and your pain is getting worse
  • There have been very rare reports of jaundice (yellowing of skin and whites of eyes), eye problems, skin colouring (pigmentation) and blood 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

Some patients may also experience weakness, drowsiness, dizziness, restlessness, difficulty in sleeping, dry mouth, blurred vision or eye problems, muscle weakness, loss of appetite, faintness on standing up, weight gain, water retention causing swelling or confusion.

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. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Trifluoperazine hydrochloride Tablets

Keep out of the sight and reach of children.

Do not use after the expiry date which is stated on the box. The expiry date refers to the last day of that month. If your tablets are out of date, take them to your pharmacist who will get rid of them safely.

Do not store above 25°C. Protect from light and moisture.

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.

If your medicine become discoloured or show signs of any deterioration, consult your doctor or pharmacist who will tell you what to do.

6. Further information

The active substance in Trifluoperazine hydrochloride Tablets is trifluoperazine hydrochloride. Each film-coated tablet contains 5mg trifluoperazine as hydrochloride.

Trifluoperazine hydrochloride Tablets also contains calcium sulfate dihydrate, sucrose, stearic acid, gelatin, maize starch, talc, opadry blue (hypromellose, titanium dioxide, macrogol, indigo carmine aluminium lake and carnauba wax.

What Trifluoperazine hydrochloride Tablets look like and contents of the pack

Trifluoperazine hydrochloride 5mg Tablets are round, blue, convex, film-coated tablets with no markings. They are available in blister packs of 20, 100 or 120 tablets.

 

  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