Youngjin Olanzapine Tablet 10 mg

Adult dose

The therapeutic dose of this medicine should be adjusted according to the patient's clinical condition. Increases above 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 there is no clear answer as to how long treatment with this medicine should continue, 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 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. Patients who have been receiving this medicine to treat mania should 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 for mood symptoms as clinically indicated (optimizing the required dose). 3) For schizophrenia, treatment of manic and mixed episodes associated with bipolar I disorder, and 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 carefully. 4) Acute treatment of depressive episodes associated with bipolar I disorder Start treatment with 5mg of olanzapine once daily, and increase to 10mg once daily. Administer this medicine before bedtime and adjust the dose as appropriate according to age and symptoms; do not exceed a daily dose of 20mg. Food does not affect drug absorption, so this medicine may be taken with or without food. 2. Administration in special populations 1) Elderly patients Starting at a dose of 5 mg or less daily may be considered when there is sufficient evidence based on clinical factors. 2) 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. 3) 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 medication may cause a serious side effect known as Neuroleptic Malignant Syndrome, which can be life-threatening, so if symptoms such as high fever, muscle rigidity, or changes in mental status occur, use should be stopped immediately and medical attention should be sought. It is not recommended for treating psychosis or behavioral disturbances associated with dementia, and caution is needed particularly in elderly patients as the risk of mortality and cerebrovascular disorders may increase. Long-term use may lead to tardive dyskinesia, a movement disorder, so if abnormal symptoms occur, dosage adjustments or discontinuation should be considered. Patients with diabetes or those at risk of high blood sugar should regularly monitor blood glucose and weight, and should consult a doctor immediately if symptoms such as thirst, excessive urination, or dry mouth appear. This medication may affect liver function, so patients with liver dysfunction or elevated liver enzyme levels require regular liver function tests. Drowsiness and dizziness may occur while taking this medication, so driving or operating dangerous machinery should be avoided. Women who are pregnant or breastfeeding should consult a doctor before taking this medication, as it may affect the fetus or newborn. This medication may interact with other drugs, so smoking and other medications should be disclosed to the doctor before taking it. Sudden discontinuation may trigger withdrawal symptoms such as sweating, insomnia, and anxiety, so it should be gradually reduced under the guidance of a doctor. Safety in children and adolescents has not been established, so it should be used cautiously in this age group. Severe side effects may occur in the case of overdose, so dosages must be strictly adhered to, and if suspected, immediate emergency treatment should be sought. When storing, keep out of reach of children, avoid direct sunlight and moisture, and store between 15 and 30 degrees Celsius.

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

This medication should be stored in a tightly sealed container to prevent air from entering and is best kept at room temperature, between 15 and 30 degrees Celsius. Proper storage helps maintain the effectiveness of the medication.

Appearance

White round film-coated tablet

Package unit

Bottle - 30 tablets/bottle, Box - 30 tablets/box [(10 tablets/PTP x 3)]