Dosing and uses of Stelazine (trifluoperazine)
Adult dosage forms and strengths
tablet
- 1mg
- 2mg
- 5mg
- 10mg
Schizophrenia
Outpatient
- 1-2 mg PO q12hr
Inpatient
- Initial: 2-5 mg PO q12hr
- Maintenance Dose: 15-20 mg/day
- Not to exceed 40mg/day
Non Psychotic Anxiety
1-2 mg PO q12hr
Maximum Dose: 6 mg/day; not to exceed 12 weeks
Renal Impairment
Dose adjustment not necessary following dialysis
Pediatric dosage forms and strengths
tablet
- 2mg
- 5mg
- 10mg
Schizophrenia/Psychosis
Inpatient
- <6 years: Safety and efficacy not established
- 6-12 years old: 1 mg PO qDay or q12hr; not to exceed 15 mg/day
- 12 years old: 2-5 mg PO q12hr
Geriatric dosage forms and strengths
Initiate dosing at the low end of the range; titrate gradually
Schizophrenia
Outpatient
- 1-2 mg PO q12hr
Inpatient
- Initial: 2-5 mg PO q12hr
- Maintenance Dose: 15-20 mg/day
- Not to exceed 40mg/day
Non Psychotic Anxiety
1-2 mg PO q12hr
Maximum Dose: 6 mg/day; not to exceed 12 weeks
Stelazine (trifluoperazine) adverse (side) effects
Frequency not defined
EPS (60%; muscle stiffness, dystonia, parkinsonism, tardive dyskinesia, akathisia)
NMS (infrequent but serious)
Sedation
Anticholinergic effects
Weight gain
Oligomenorrhea/amenorrhea
Erectile dysfunction
Insomnia
Restlessness
Anxiety
Euphoria
Agitation
Depression
Weakness
Headache
Cerebral edema
Poikilothermia
Orthostatic hypotension
Tachycardia
Dizziness
Lens opacities (prolonged use)Anorexia
Dyspepsia
Constipation
Ileus
Blood dyscrasia
ECG changes
Photosensitivity
Pruritis
Diarrhea
Galactorrhea
Ejaculatory d/o
Seizure (rare)
Priapism (rare)
Cholestatic jaundice (rare)
Warnings
Black box warnings
Patients with dementia-related psychosis who are treated with antipsychotic drugs are at an increased risk of death as shown in short-term controlled trials. The deaths appeared to be either cardiovascular (eg, heart failure, sudden death) or infectious (eg, pneumonia) in nature.
This drug is not approved for the treatment of patients with dementia-related psychosis.
Contraindications
Documented hypersensitivity to phenothiazines
Coma, severe hypotension, severe CNS depression, concurrency with large amounts of CNS depressants, poorly controlled seizure disorder, subcortical brain damage, severe cardiovascular disease, blood dyscrasias
Lactation
Cautions
Avoid using in children with suspected Reye's syndrome
Glaucoma, prostatic hypertrophy, stenosing PUD, history of NMS, Parkinson's disease, hypocalcemia, renal/hepatic impairment, patients who have exhibited a severe reaction to insulin or ECT, history of seizures, asthma, respiratory tract infections, cardiovascular disease
Risk of EPS, NMS, hypotension
Hypotension may be particularly severe in patients with pheochromocytoma or mitral insufficiency
Depresses hypothalamic thermoregulatory mechanism; exposure to extreme temperatures may cause hypo- or hyperthermia
In case of severe hypotension, use norepinephrine or phenylepinephrine, do NOT use epinephrine or dopamine
May need anticholinergic antiparkinsonian agent to counter EPs
FDA Warning regarding off-label use for dementia in elderly
Pregnancy and lactation
Pregnancy category: C
Neonates exposed to antipsychotic drugs during the 3rd trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery
These complications vary in severity; in some cases, symptoms have been self-limited, while in other cases neonates have required intensive care unit support and prolonged hospitalization
Lactation: unknown
Pregnancy categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA: Information not available.
Pharmacology of Stelazine (trifluoperazine)
Mechanism of action
Piperazine phenothiazine agent; antagonist for the postsynaptic mesolimbic dopaminergic D2 receptors in the brain; decreases the release of hypothalamic and hypophyseal hormones
Pharmacokinetics
Half-Life elimination: 24 hr
Metabolism: Liver
