Olza-5 Special Precautions

Anticholinergic properties of olanzapine: Use with caution in patients with clinically significant prostatic hypertrophy, narrow angle glaucoma or history of paralytic ileus.
Body temperature elevation (eg, strenuous exercise, extreme heat exposure, dehydration, concomitant anticholinergic use): Increased risk of hyperthermia.
Cardiovascular or cerebrovascular disease or conditions that predispose patients to hypotension (eg, dehydration, hypovolemia, antihypertensive medications): increased risk of orthostatic hypotension associated with bradycardia, syncope and sinus pause.
Cognitive and motor impairment (sedation-related events) has been reported. Concomitant use of parenteral benzodiazepine and intramuscular olanzapine is not recommended. If considered, monitor for excessive sedation and cardiorespiratory depression is recommended.
Diabetes mellitus, preexisting or borderline increased blood glucose level (fasting 100-126 mg/dL, nonfasting 140-200 mg/dL): increased risk of hyperglycemia that may not resolve upon discontinuation. Monitoring is recommended.
Hyperglycemia, in some extreme cases associated with ketoacidosis or hyperosmolar coma or death, has been reported. Baseline and periodic monitoring is recommended.
Preexisting diseases or conditions affecting hemodynamic response among elderly patients especially in women: Increased risk of tardive dyskinesia. Treatment discontinuation should be considered.
Hepatic impairment, significant, preexisting conditions associated with limited hepatic functional reserve, or due to concomitant use of hepatotoxic drugs: may increase risk of hepatic impairment.
Hyperlipidemia, hypercholesterolemia and significant hypertriglyceridemia have been reported. Baseline and periodic monitoring is recommended.
Hyperprolactinemia may induce cascade of suppressed hypothalamic gonadotropin releasing hormone (GnRH), reduced pituitary gonadotropin, impaired gonadal steroidogenesis (male/female), and potentially decreased bone density (male/female, when longstanding and associated with hypogonadism).
Increased duration of therapy and/or higher cumulative doses: Increased risk of tardive dyskinesia that is potentially irreversible.
Leukopenia, neutropenia, agranulocytosis temporal relationship has been reported. Monitoring is recommended. Discontinue with significant declines.
Neuroleptic malignant syndrome, potentially fatal, has been reported in association with olanzapine therapy. Immediate discontinuation and supportive treatment are recommended.
Orthostatic hypotension, in some severe cases, has been reported.
Seizure disorder, history, or conditions that may lower seizure threshold (eg, Alzheimer's disease), may increase seizure risk.
Weight gain, some cases clinically significant, has been reported. Monitoring is recommended.
Use in Children: Adolescents 13-17 years: Higher tendency to gain more weight and experience worse hyperlipidemia compared with adults. Assess long-term risk and comprehensive treatment program prior to initiating olanzapine.
Use in the Elderly: Elderly patients with dementia-related psychosis (unapproved use) have increased risk of death. Most deaths were attributed to cardiovascular events (eg, heart failure or sudden death) or infections (eg, pneumonia).
Elderly patients, especially women have increased risk of tardive dyskinesia. Consider treatment discontinuation.