Olanzapine Tablets 10 mg (Olanzapine)

Adult dose

The therapeutic dose of this medicine should be adjusted according to the patient's clinical condition. Dose increases exceeding the usual recommended daily dose of 10 mg are recommended only after an appropriate clinical evaluation. 1. Adults 1) Schizophrenia (1) The recommended initial dose is 5∼10 mg of olanzapine once daily. (2) Maintenance treatment: Although it is difficult to provide a definitive answer as to how long treatment with this medicine should continue, its efficacy was demonstrated in a placebo-controlled study in which patients with schizophrenia whose symptoms had stabilized after taking this medicine for approximately 8 weeks received maintenance treatment with 10∼20 mg daily for 8 months. The need for maintenance treatment at an appropriate dose should be assessed periodically. 2) Bipolar disorder (1) Treatment of manic and mixed episodes associated with bipolar I disorder The initial dose is 15 mg of this medicine once daily as monotherapy, or 10 mg once daily as adjunctive therapy with lithium or valproate. (2) Prevention of recurrence in bipolar disorder The recommended initial dose is 10 mg once daily. For patients who have been receiving this medicine to treat mania, continue the same dose to prevent recurrence. If a new manic, mixed, or depressive episode occurs, treatment with this medicine should continue, together with adjunctive therapy to treat mood symptoms as clinically indicated (optimizing the required dose). 3) For the treatment of schizophrenia and manic and mixed episodes associated with bipolar I disorder, and for the prevention of recurrence in bipolar disorder, the daily dose may be adjusted within the range of 5 mg to 20 mg based on the clinical condition. Increases above the recommended initial dose are recommended only after an appropriate clinical evaluation and should generally be made at intervals of at least 24 hours. If treatment with this medicine is discontinued, the dose should be reduced gradually and cautiously. 4) Acute treatment of depressive episodes associated with bipolar I disorder Start treatment with olanzapine 5mg once daily, and increase to 10mg once daily. Administer this medicine at bedtime and adjust the dose as appropriate according to age and symptoms; do not exceed a daily dose of 20mg. Food does not affect absorption of the medicine, so it may be taken with or without food. 2. Dosing in special populations 1) Elderly patients Starting at a dose of 5 mg or less once daily may be considered when there is sufficient clinical justification. 2) Patients with renal or hepatic impairment A low initial dose (5 mg) should be considered. For moderate hepatic impairment (cirrhosis, Child-Pugh class A or B), the initial dose is 5 mg and should be increased cautiously. 3) Patients with multiple factors that may slow the metabolism of this medicine (female sex, advanced age, and nonsmoking status) may also be started at a low dose.

This medication can cause a serious side effect known as Neuroleptic Malignant Syndrome (NMS). NMS includes symptoms such as high fever, muscle rigidity, changes in mental status, and autonomic instability, such as irregular pulse or blood pressure; if any of these symptoms occur, medication should be stopped immediately. It is advisable not to use this medication in patients with dementia. It has not been approved for the treatment of psychosis or behavioral disorders associated with dementia, and its use may increase the risk of mortality and cerebrovascular events. Long-term use can lead to a movement disorder known as tardive dyskinesia; if symptoms arise, consideration should be given to reducing or stopping the dosage. It may take several days to weeks for the patient's condition to improve while taking this medication, so careful monitoring is necessary during the initial treatment period. Patients with diabetes or at risk of hyperglycemia should regularly monitor blood sugar levels and weight changes, and should consult a doctor if any abnormal symptoms occur. Abrupt discontinuation of the medication can lead to withdrawal symptoms such as sweating, insomnia, anxiety, and nausea; therefore, it is safer to gradually reduce the dosage when stopping. Patients with cardiovascular disease, the elderly, or those at risk of QT interval prolongation should have their heart condition monitored regularly while taking this medication. Women who are pregnant or breastfeeding should consult their doctor as this medication may have side effects on the fetus or neonate. This medication can cause drowsiness and dizziness, so caution is needed when driving or operating hazardous machinery. Patients with impaired liver function should have their liver enzyme levels monitored regularly and should consult with a doctor if abnormalities occur. This medication is metabolized by certain enzymes, so caution is needed with smoking or combination with other medications as this can alter drug concentrations. In case of overdose, consciousness decline, seizures, and heart abnormalities may occur, and appropriate treatment should be sought immediately.

• Hyperthermia
• muscle rigidity
• changes in mental state
• irregular pulse
• changes in blood pressure
• tachycardia
• sweating
• cardiac arrhythmia
• elevated creatine phosphokinase
• myoglobinuria

Store this medication in a tightly sealed container to prevent air ingress, and keep it at a temperature between 15 and 30 degrees Celsius. This will help maintain the drug's effectiveness over time.

Appearance

White round film-coated tablets

Package unit

28 tablets (7 tablets/PTP packaging × 4), 30 tablets/bottle, 100 tablets/bottle