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Acute and maintenance treatment of manic or mixed episodes in bipolar disorder as monotherapy; or as an
adjunct to lithium or valproate. Adjunct to antidepressants for major depressive disorder. Irritability associated
with autistic disorder.
Warnings/Precautions:
Cardio- or cerebrovascular disease. Risk of hypotension, aspiration pneumonia, seizures, or diabetes (do baseline
fasting blood sugar). Pre-existing low WBCs or history of leukopenia/neutropenia; monitor CBCs during 1st few
months of treatment; discontinue if WBCs decline. Exposure to extreme heat. Dehydration. Reevaluate
periodically. Monitor for hyperglycemia. Exclude neuroleptic malignant syndrome if fever occurs. Suicidal
tendencies. Write for smallest practical amount. Elderly (not for dementia-related psychosis). Labor & delivery.
Neonates: risk of extrapyramidal and/or withdrawal symptoms post delivery (due to exposure during 3rd-trimester
pregnancy). Pregnancy (Cat.C). Nursing mothers: not recommended.
Interactions:
Avoid alcohol. Caution with other centrally-acting drugs. Potentiates antihypertensives. Levels may be reduced
by CYP3A4 inducers (eg, carbamazepine). Levels may be increased by CYP3A4 inhibitors (eg, ketoconazole) or
CYP2D6 inhibitors (eg, quinidine, fluoxetine, paroxetine). Caution with drugs that interfere with temperature
regulation (eg, anticholinergics).
Adverse Reactions:
Headache, anxiety, insomnia, GI upset, somnolence, fatigue, akathisia, orthostatic hypotension, asthenia, blurred
vision, tremor, pyrexia, salivary hypersecretion, neuroleptic malignant syndrome, tardive dyskinesia, weight gain,
dyslipidemia, others. Inj: local reactions.
How Supplied:
Tabs 2mg30; 5mg, 10mg, 15mg, 20mg, 30mg30, 100; Oral soln (w. dosing cup)150mL; Discmelt30;
Single use vials1