Olzapex Tablet 2.5 mg (Olanzapine)

Adult dose

The therapeutic dose of this medicine should be adjusted according to the patient's clinical condition. Dose increases above the generally recommended daily dose of 10 mg are recommended only after an appropriate clinical evaluation. The recommended initial dose for schizophrenia is 5∼10 mg of olanzapine once daily. Maintenance treatment of schizophrenia: It is difficult to give a definitive answer as to how long treatment with this medicine should continue. However, its efficacy was demonstrated in a placebo-controlled study in patients with schizophrenia whose symptoms had stabilized after taking this medicine for approximately 8 weeks and who received maintenance treatment at a dose of 10∼20 mg daily for 8 months. The need for maintenance treatment at an appropriate dose should be evaluated periodically. 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. Prevention of recurrence in bipolar disorder: The recommended initial dose is 10 mg once daily. For patients who have received 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, with adjunctive therapy to treat mood symptoms as clinically indicated (optimizing the required dose). 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. Acute treatment of depressive episodes associated with bipolar I disorder: Start treatment with 5 mg of olanzapine once daily, then increase to 10 mg once daily. Administer this medicine at bedtime and adjust the dose appropriately according to age and symptoms; do not exceed a daily dose of 20mg. This medicine may be taken with or without food, as food does not affect drug absorption. Elderly patients: Starting at a dose of 5 mg or less daily may be considered when there is sufficient evidence of clinical factors. Patients with renal or hepatic impairment: A low initial dose (5 mg) should be considered. In moderate hepatic impairment (cirrhosis, Child-Pugh class A or B), the initial dose is 5 mg and the dose should be increased cautiously. Patients with multiple factors that delay the metabolism of this medicine (female sex, advanced age, and nonsmoking status) may also be started at a low dose.

This drug may cause a life-threatening serious side effect known as neuroleptic malignant syndrome, so if high fever, muscle rigidity, or changes in mental status occur, use should be immediately discontinued and a doctor's evaluation sought. It is not approved for the treatment of psychosis or behavioral disturbances related to dementia, and its use is not recommended, especially for elderly patients, due to increased mortality and risk of cerebrovascular disorders. Long-term use may lead to tardive dyskinesia, a movement disorder, so if any abnormal symptoms occur, dosage adjustments or discontinuation should be considered. It may take several days to weeks for effects to manifest at the beginning of treatment, requiring careful monitoring of patients. Diabetes or hyperglycemia may worsen, so blood sugar levels and weight should be regularly monitored, and immediate consultation with a physician is advised if there are any abnormal symptoms. Sudden discontinuation may cause symptoms such as sweating, insomnia, and nausea, so gradual tapering is recommended. Patients with cardiovascular diseases, elderly individuals, and those at risk of QT interval prolongation should use this medication cautiously and have their blood pressure and heart condition regularly monitored. Pregnant or breastfeeding women should consult with a physician before taking this medication, as it may affect the fetus or newborn. This medication can cause drowsiness and dizziness, so caution should be exercised when driving or operating hazardous machinery. Patients with certain liver diseases, a history of seizures, cardiovascular diseases, and low white blood cell counts require extra caution when using this medication. There may be interactions when this drug is taken with other medications, so it is essential to inform doctors or pharmacists of any other medications being taken. In case of overdose, there is no specific antidote, so prompt medical treatment is required, and symptoms such as hypotension or respiratory depression should be anticipated. This medication must be kept out of reach of children and stored away from light and moisture at 15-30 degrees Celsius.

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

This medication can be sensitive to air or moisture, so it should be stored in a tightly sealed container. It is recommended to maintain the storage temperature between 15 and 30 degrees Celsius to preserve the drug's effectiveness for an extended period.

Appearance

White round film-coated tablet

Package unit

Bottle - 100 tablets/bottle, PTP - 30 tablets/PTP [10 tablets/PTP x 3]