Brand and Other Names:Navane
- Classes: Antipsychotics, 1st Generation
Dosing & Uses
Dosage Forms & Strengths
Mild-Moderate: initial: 2 mg PO q8hr; may increase to 15 mg/day
Severe: initial 5 mg PO q12hr
Maintenance: 20-30 mg/day; no more than 60 mg/day PO divided q8-12hr
Dosage Forms & Strengths
- Not recommended
- Mild-Moderate: initial: 2 mg PO q8hr; may increase to 15 mg/day
- Severe: initial 5 mg PO q12hr
- Maintenance: 20-30 mg/day; no more than 60 mg/day PO divided q8-12hr
Serious - Use Alternative
Significant - Monitor Closely
Frequency Not Defined
EPS ( muscle stiffness, dystonia, Parkinsonism, tardive dyskinesia, akathisia) (60%)
Lens opacities (prolonged use)
Agranulocytosis, blood dyscrasias (rare)
Heat stroke (rare)
NMS (infrequent but serious)
Obstructive hyperbilirubinemia (rare)
Decr gag reflex
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.
CNS depression (including coma)
Neuroleptic malignant syndrome (NMS)
Poorly controlled seizure disorder
Alcohol withdrawal, cardiovascular disease, glaucoma, BPH, history of seizure disorder, Parkinsonism, urinary retention, liver disease
Potential cross sensitivity between thioxanthenes & phenothiazine derivatives
FDA Warning regarding off-label use for dementia in elderly
Leukopenia/neutropenia and agranulocytosis reported; possible risk factors for leukopenia/neutropenia include pre-existing low white blood cell count (WBC) and history of drug-induced leukopenia/neutropenia
If history of clinically significant low WBC or drug-induced leukopenia/neutropenia, monitor complete blood count (CBC) frequently during first few months of therapy; discontinue drug at first sign of a clinically significant decline <1000/mm³ in WBC in absence of other causative factors and continue monitoring WBC until recovery
Pregnancy & 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: may be excreted in breast milk; not advised
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.
Mechanism of Action
Thioxanthene; dopamine D2 receptor antagonist; may also have anticholinergic and alpha-blocking effects
Half-life elimination: 24 hr
Metabolism: Liver (CYP1A2)
Protein bound: 90%
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