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Pharmacologic class: Tricyclic dibenzoxazepine derivative
Therapeutic class: Antipsychotic
Pregnancy risk category C
Unknown. Thought to block neurotransmission of postsynaptic dopamine receptors in brain, alleviating psychotic symptoms.
Capsules: 5 mg, 10 mg, 25 mg, 50 mg
Indications and dosages
Adults: 10 mg P.O. b.i.d. Dosage may be increased over first 7 to 10 days, up to 100 mg/day P.O. in two to four divided doses. Maximum dosage is 250 mg/day.
• Elderly patients
• Hypersensitivity to drug or other dibenzoxazepines
• Coma or severe drug-induced CNS depression
Use cautiously in:
• seizures, cerebral arteriosclerosis, severe hypotension, hypertension, glaucoma, breast cancer, hepatic disease, bone marrow depression, Parkinson's disease, blood dyscrasias, urinary retention, concurrent use of other CNS active drugs or anticholinergics
• pregnant or breastfeeding patients
• children younger than age 16.
• Give with or without food.
CNS: drowsiness, insomnia, vertigo, headache, dizziness, weakness, akinesia, staggering or shuffling gait, slurred speech, agitation, extrapyramidal reactions, sedation, syncope, tardive dyskinesia, numbness, confusion, pseudoparkinsonism, EEG changes, seizures, neuroleptic malignant syndrome
CV: orthostatic hypotension, hypertension, ECG changes
EENT: blurred vision, ptosis, nasal congestion
GI: nausea, vomiting, constipation, dry mouth, paralytic ileus
GU: urinary retention
Hematologic: leukopenia, agranulocytosis, thrombocytopenia
Hepatic: hepatocellular injury with hepatic enzyme elevations
Musculoskeletal: muscle twitching
Skin: rash, pruritus, seborrhea, photosensitivity, alopecia
Other: weight gain or loss, hyperpyrexia, facial edema, hypersensitivity reactions
Drug-drug. Anticholinergics, CNS depressants: additive effects
Epinephrine: severe hypotension, tachycardia, decreased epinephrine effects
Drug-diagnostic tests. Granulocytes, platelets, white blood cells: decreased counts
Liver function tests: increased values
Drug-behaviors. Alcohol use: increased CNS depression
• Measure blood pressure before and periodically during therapy.
• Monitor hematologic studies and liver function tests.
☞ Stay alert for evidence of neuroleptic malignant syndrome (extrapyramidal symptoms, hyperpyrexia, muscle rigidity, altered mental status, irregular pulse or blood pressure, tachycardia, arrhythmias, diaphoresis).
• Assess for tardive dyskinesia (involuntary jerky movements of face, tongue, jaws, trunk, arms, and legs), especially in elderly women.
• Tell patient to take with or without food.
• Inform patient that drug may cause tardive dyskinesia. Describe symptoms.
• Caution patient to avoid activities requiring mental concentration until drug's effects are known.
☞ Teach patient to immediately report sore throat, fever, rash, impaired vision, tremors, involuntary muscle twitching, muscle stiffness, or yellowing of eyes or skin.
• Instruct patient to move slowly when sitting up or standing, to avoid dizziness from sudden blood pressure decrease.
• Caution patient to avoid alcohol use.
• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs, tests, and behaviors mentioned above.