Uses
Psychotic Disorders
Pending revision, the material in this section should be considered in light of more recently available information in the MEDWATCH notification at the beginning of this monograph.
Symptomatic management of psychotic disorders (i.e., schizophrenia).
Nonpsychotic Anxiety
Short-term management of nonpsychotic anxiety in patients with generalized anxiety disorder.
Not established whether trifluoperazine is useful for the management of other nonpsychotic conditions in which anxiety or manifestations that mimic anxiety are evident (e.g., physical illness, organic mental conditions, agitated depression, character pathologies).
Because of the risks of toxicity, use only as an alternative to other less toxic anxiolytic agents (e.g., benzodiazepines) in most patients.
Mental Retardation
Efficacy not established for the management of behavioral complications in patients with mental retardation.
Dosage and Administration
General
- Adjust dosage carefully according to individual requirements and response; use the lowest possible effective dosage.
- For symptomatic relief of psychotic disorders, optimum therapeutic response usually occurs within 2–3 weeks.
- Periodically evaluate patients receiving long-term therapy to determine whether maintenance dosage can be decreased or drug therapy discontinued.
Administration
Oral Administration
Administered orally. Has been given parenterally† as trifluoperazine hydrochloride, but a parenteral dosage form of the drug is no longer commercially available in the US.
Because of the long duration of action, may be administered once or twice daily.
Dosage
Pending revision, the material in this section should be considered in light of more recently available information in the MEDWATCH notification at the beginning of this monograph.
Available as trifluoperazine hydrochloride; dosage expressed in terms of trifluoperazine.
Pediatric Patients
Psychotic Disorders
Oral
Adjust dosage based on weight and severity of symptoms.
Children 6–12 years of age: Initially, 1 mg once or twice daily for hospitalized or well-supervised children. Gradually increase dosage until symptoms are controlled or adverse effects become troublesome. Most children respond to a dosage of ≤15 mg daily.
Dosage for children <6 years of age not established.
Adults
Psychotic Disorders
Pending revision, the material in this section should be considered in light of more recently available information in the MEDWATCH notification at the beginning of this monograph.
Oral
Initially, 2–5 mg given twice daily. Gradually increase dosage until symptoms are controlled or adverse effects become troublesome. Although most patients exhibit optimum response with 15–20 mg daily, dosages up to 40 mg or more daily may be required in some patients.
Nonpsychotic Anxiety
Oral
Usually, 1 or 2 mg twice daily for ≤12 weeks.
Prescribing Limits
Pediatric Patients
Psychotic Disorders
Oral
Maximum 15 mg daily for children 6–12 years of age. Dosages >15 mg daily should be used only in older children with severe symptoms .
Adults
Nonpsychotic Anxiety
Oral
Maximum 6 mg daily; do not administer for >12 weeks.
Special Populations
Geriatric Patients
Generally, select dose at the lower end of recommended range; increase dosage more gradually and monitor closely. (See Geriatric Use under Cautions.)
Debilitated or Emaciated Patients
Increase dosage more gradually.
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