| Schizophrenia and other psychotic disorders; acute mania; nausea/vomiting; intractable hiccups (label-dependent). View labelExact | Dosing is individualized by indication and setting. The label emphasizes gradual titration until symptoms are controlled, then step-down to the lowest effective maintenance dose (label).
Psychotic disorders: label examples include outpatient starts such as 10 mg three or four times daily or 25 mg two or three times daily; more severe cases may be titrated upward in semi-weekly intervals (label). | Low-potency phenothiazine first-generation antipsychotic (D2 antagonism) with prominent antihistamine (H1) and anticholinergic effects; often associated with sedation and orthostatic hypotension. | Hepatic metabolism | No | - Weight
- Sedation
- EPS
- Prolactin
- QTc
| - Sedation and functional impairment (falls risk, driving safety).
- Orthostatic symptoms and blood pressure (especially early titration).
- Anticholinergic effects (bowel/urinary symptoms, delirium risk).
- Movement symptoms (akathisia, rigidity, tremor; tardive dyskinesia screening).
- Weight and cardiometabolic risk factors over time.
| No | 2026-02-22 |
|---|
| Schizophrenia; severe behavior disorders; Tourette's syndrome (tics/vocal utterances); adjunct in acute agitation. View labelExact | Schizophrenia (oral): initiate 1–5 mg two or three times daily; maintenance 5–20 mg/day divided; doses >30 mg/day increase EPS risk. | Potent dopamine D2 receptor antagonist; minimal anticholinergic. | CYP3A4, CYP2D6 | Steady-state mean 21 h | No | | - Extrapyramidal symptoms are monitored periodically; prophylaxis is generally reserved for clear need.
- QTc: ECG monitoring is often considered when risk factors or higher doses are present.
- LAI: Haloperidol decanoate every 4 weeks—product-specific conversion guidance is typically used.
- Regular AIMS screening for tardive dyskinesia (typically every 3–6 months; every 3 months in higher-risk groups or with dose increases).
- Prolactin-related symptoms (sexual dysfunction, amenorrhea, galactorrhea) and overall quality-of-life impact—consider switching if persistent.
- Orthostatic vitals and falls risk, especially in older adults and when combined with other CNS depressants or antihypertensives.
- Metabolic monitoring (weight/BMI, glucose, lipids) periodically as part of comprehensive schizophrenia care, even though metabolic risk is lower than many SGAs.
| q4wk | 2026-03-31 |
|---|
| Schizophrenia (adults) View labelExact | Initiate 4–8 mg BID/TID; titrate to 12–24 mg/day in divided doses (max 64 mg/day). | Mid-potency phenothiazine antipsychotic antagonizing dopamine D2 and serotonin 5-HT2A receptors with moderate anticholinergic activity. | CYP2D6, CYP1A2, CYP3A4 | Single-dose mean 10 h; Steady-state mean 12 h | No | - Weight
- Sedation
- EPS
- Prolactin
| - Baseline and ongoing EPS monitoring (Simpson–Angus/Barnes scales as available) and AIMS screening every 3–6 months for tardive dyskinesia.
- Weight/BMI and metabolic labs periodically even with lower metabolic risk, because sedation and appetite changes can still affect weight.
- Orthostatic vitals during titration and after medication changes, especially in older adults and with antihypertensive co-therapy.
- ECG monitoring when cardiac disease, electrolyte abnormalities, higher doses, or QT-active co-medications are present.
- Prolactin-related symptoms (sexual dysfunction, galactorrhea, amenorrhea) and overall quality-of-life impact—consider switching if persistent.
- Sedation, cognition, and falls risk; adjust dose timing and reassess driving/occupational safety after dose changes.
| No | 2025-09-26 |
|---|
| Schizophrenia; acute treatment of manic or mixed episodes (bipolar I) and maintenance; in combination with fluoxetine for bipolar depression. View labelExact | Schizophrenia (adults): initiate 5–10 mg once daily; titrate by 5 mg increments at ≥24-hour intervals to 10–20 mg/day (max 20 mg). | Antagonist at serotonin 5‑HT2A and dopamine D2 receptors; strong H1 and muscarinic activity. | CYP1A2, CYP2D6 (minor) | Steady-state mean 30 h | No | | - Metabolic monitoring (weight/BMI, waist circumference, blood pressure, fasting glucose/A1c, lipids) at baseline and periodically (early and then ongoing) because weight and glycemic changes can occur quickly.
- Appetite changes, sedation, and falls risk—reassess driving and occupational safety after dose changes and when other CNS depressants are added.
- Smoking status and CYP1A2 modulators; reduce dose when smoking stops and reassess if smoking restarts or if CYP1A2 inhibitors are introduced.
- AIMS/EPS monitoring at routine intervals, especially in older adults and at higher doses (EPS risk is lower than FGAs but not zero).
- For depot olanzapine pamoate, adhere to REMS observation and PDSS counseling requirements, including post-injection monitoring and “no driving” instructions on injection day.
| q2–4wk | 2025-12-28 |
|---|