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Concomitant Illness: Olan has showed a low incidence of anticholinergic in clinical trials. Caution is advised when prescribing for patients with prostatic hypertrophy, or paralytic ileus and related conditions since clinical experience with Olan in patients with concomitant illness is limited.
Transient, asymptomatic elevations of hepatic transaminases, ALT, AST have been seen occasionally especially in early treatment. Caution should be exercised in patients with elevated ALT and/or AST, in patients with signs and symptoms of hepatic impairment, in patients with preexisting conditions associated with limited hepatic functional reserve and in patients who are being treated with potentially hepatotoxic drugs. In the event of elevated ALT and/or AST during treatment, follow up should be organized and dose reduction should be considered.
As with other neuroleptic drugs, caution should be exercised in patients with low leucocyte and/or neutrophil counts for any reason, in patients with a history of drug-induced bone marrow depression caused by concomitant illness, radiation therapy or chemotherapy and in patients with hypereosinophilic conditions or with myeloproliferative disease. Thirty-two patients with clozapine-related neutropenia or agranulocytosis histories received Olan without decreases in baseline neutrophil counts.
Neuroleptic Malignant Syndrome (NMS): NMS, a potentially fatal symptom complex, has been reported in association with other antipsychotic drugs. In clinical trials, there were no reported cases of NMS in patients receiving Olan.
NMS is associated with hyperpyrexia, muscle rigidity, altered mental status and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis and cardiac dysrhythmia). Additional signs may include elevated creatinine phosphokinase, myoglobinuria (rhabdomyolysis) and acute renal failure. In such an event or with unexplained high fever without additional clinical manifestations of NMS, all antipsychotic drugs, including Olan, must be discontinued.
Olan should be cautiously used in patients who have a history of seizures or have conditions associated with seizures.
Tardive Dyskinesia: Olan was associated with a statistically significant lower incidence of treatment-emergent dyskinesia in comparative studies of ≤1 year. However, the risk of tardive dyskinesia increases with long-term exposure, and therefore, if signs or symptoms of tardive dyskinesia appear in a patient on Olan, a dose reduction or drug discontinuation should be considered. These symptoms can temporarily deteriorate or even arise after discontinuation of treatment.
Caution should be used when Olan is taken in combination with other centrally acting drugs and alcohol (given the primary CNS effect of Olan).
As it exhibits in vitro dopamine antagonism, Olan may antagonize the effects of direct and indirect dopamine agonists.
Postural hypotension was infrequently observed in the elderly in the Olan clinical trials. As with other antipsychotics, it is recommended that blood pressure is measured periodically in patients >65 years.
In clinical trials, Olan was not associated with a persistent increase in absolute QT intervals. However, as with other antipsychotics, caution should be exercised when Olan is prescribed with drugs known to increase QTc interval, especially in the elderly.
Effects on the Ability to Drive or Operate Machinery: There are chances that Olan may cause somnolence, patients should be cautioned about operating hazardous machinery, including motor vehicles.
Use in pregnancy & lactation: There are no adequate and well-controlled studies in pregnant women. Patients should be advised to notify their physician if they become pregnant or intend to become pregnant during treatment with Olan. Nevertheless, because human experience is limited, this drug should be used in pregnancy only if the potential benefit justifies the potential risk to the fetus.
Olan was excreted in milk of treated rats during lactation. It is not known if Olan is excreted in human milk. Patients should be advised not to breastfeed an infant if they are taking Olan.
Use in children: Olan has not been studied in subjects <18 years.
