Trifluoperazine 10mg

First Generation (Typical) Antipsychotic; Phenothiazine Derivative

“ALERT: US Boxed Warning

Increased mortality in elderly patients with dementia-related psychosis:

Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analyses of 17 placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in drug-treated patients between 1.6 and 1.7 times the risk of death in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was approximately 4.5%, compared to a rate of approximately 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (eg, heart failure, sudden death) or infectious (eg, pneumonia) in nature. Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patients is not clear. Trifluoperazine is not approved for the treatment of patients with dementia-related psychosis.”

CSA NA – FDA Approved – REMS (N) – Can Ship

Trifluoperazine is a piperazine phenothiazine antipsychotic which blocks dopamine, subtype 2 (D2), receptors in mesolimbocortical and nigrostriatal areas of the brain 

Schizophrenia

Before starting Trifluoperazine make sure your physician is aware of any allergies or medications you currently take, if you have liver disease, blood dyscrasias, bone marrow suppression, cardiovascular disease, dementia, a seizure disorder, are pregnant, or breastfeeding.  Trifluoperazine use has been associated with rare but serious adverse events such as changes in cardiac conduction resulting in life-threatening arrhythmias, anticholinergic effects (i.e. constipation, dry mouth and eyes, urinary retention, blurred vision), blood dyscrasias (i.e. leukopenia, neutropenia and agranulocytosis), central nervous system depression, esophageal dysmotility, extrapyramidal symptoms (i.e acute dystonic reactions, akathisia, tardive dyskinesia), hyperprolactinemia, hepatic effects, hypotension, neuroleptic malignant syndrome, ocular effects, orthostatic hypotension, and issues with temperature regulation. 

Oral: Initial: 2 to 5 mg twice daily titrate dose gradually based on response and tolerability; some patients require up to 50mg/day for adequate response

How to Take: Follow instructions provided by physician/pharmacy label, take consistently at same times each day unless otherwise directed, store at room temperature.  May be taken with food to decrease GI upset and do not take within 2 hours of any antacids.

You Need to Avoid:  Gradual dose reduction is advised to avoid withdrawal symptoms (ie, insomnia, headache, GI symptoms) unless discontinuation is due to significant adverse effects.         

 ECG abnormality (non-specific QT changes), hypotension, orthostatic hypotension, decreased seizure threshold, dizziness, disruption of body temperature regulation, extrapyramidal reaction (akathisia, dystonia, Parkinsonian-like syndrome, tardive dyskinesia), headache, neuroleptic malignant syndrome (NMS), skin discoloration (blue-gray), skin photosensitivity (includes increased sensitivity to sun), skin rash, change in libido, change in menstrual flow, galactorrhea, gynecomastia, hyperglycemia, hypoglycemia, weight gain, constipation, nausea, stomach pain, vomiting, xerostomia, difficulty in micturition, ejaculatory disorder, lactation, mastalgia, priapism, urinary retention, agranulocytosis, aplastic anemia, eosinophilia, hemolytic anemia, immune thrombocytopenia, leukopenia, pancytopenia, cholestatic jaundice, hepatotoxicity, tremor, nasal congestion, corneal changes, lens disease, retinitis pigmentosa

The frequency of side effects has not been defined

1. What can I do if this medication sedates me too much?
   It is a common side effect but in most cases the tablet can be split for smaller dosages to alleviate fatigue.  Discuss with your pharmacist or physician a plan to manage this or potential alternative medications.
2. This medication has a lot of scary side effects, is it safe?
   All medications have side effects however this medication works on a lot of different neurotransmitter receptors in the brain which can lead to a variety of intentional and unintentional effects.  These are mostly dosage dependant and in lower doses the risk is minimal.  In all cases regular lab work will allow your physician to see if your blood sugar, cholesterol etc. start to move in the wrong direction so action can be taken before they become a problem.
3. What are extra-pyramidal reactions?
   Blocking dopamine in the extra-pyramidal system in the central nervous system that regulates posture and skeletal muscle tone may cause a variety of movement disorders.  This can include dystonic reactions (muscular spasms, usually repetitive), akathisia (motor restlessness/uneasiness), pseudoparkinsonism (drug induced Parkinsonism – tremor, rigidity, bradykinesia, etc.), tardive dyskinesia (involuntary complex muscle movements in lower face and extremities).  These side effects are generally dose dependant and generally occur with long term use of medications that block dopamine.  If any of these effects may be occurring, speak to your physician as soon as possible to discuss your options.
4. What is Neuroleptic Malignant Syndrome?
   NMS is a rare but serious reaction from significant blockade of dopamine which can occur from antipsychotic medications or from being on high dosages of levodopa (dopamine analogue) and stopping suddenly.  Presents initially as muscle cramps, tremors, fever, unstable blood pressure, and sudden changes in mental status.  As it progresses over 8-40 hours it can lead to complications of rhabdomyolysis, hyperkalemia, kidney failure, or seizures.  Seek medical attention immediately if this reaction is suspected.