PMS Olanzapine Tablet 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: It is difficult to provide a definitive answer as to how long treatment with this medicine should continue. However, 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 at doses of 10∼20 mg once 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 to treat mood symptoms (optimizing the dose as needed), according to clinical signs. 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 clinical status. 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 5 mg once daily and increase to 10 mg 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 20 mg. This medicine may be taken with or without food because food does not affect its absorption. 2. Administration in special populations 1) Older adults Starting at a dose of 5 mg or less once 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 should be increased cautiously. 3) Patients with multiple factors that delay the metabolism of this medicine (female sex, older age, and nonsmoking status) may also be started at a lower dose. 3. Precautions (for orally disintegrating tablets only) This medicine is fragile. Remove it from the outer packaging and open the blister by peeling off the metal foil on the back. Do not press the tablet through the foil when opening the blister. Immediately after opening the blister, remove the tablet with dry hands and place it directly in the mouth. The tablet disintegrates rapidly in saliva and may be swallowed with or without a drink.

This medication can cause a life-threatening condition known as neuroleptic malignant syndrome; therefore, if you experience high fever, muscle rigidity, or changes in mental status, you should stop using it immediately. This medication is not approved for patients with dementia, and particularly in elderly dementia patients, the risk of mortality and cerebrovascular events increases, so it is advisable not to use it. Long-term use may result in tardive dyskinesia, a movement disorder, and if symptoms occur, consider dose adjustment or discontinuation. Therapeutic effects may take several days to weeks to manifest, so patients should be closely monitored during this time. Patients with diabetes or at risk for hyperglycemia should regularly check blood sugar and weight changes, and consult healthcare providers immediately if any abnormal symptoms appear. Abrupt discontinuation of this medication may result in symptoms such as sweating, insomnia, anxiety, and nausea, so dosing should be gradually reduced. This medication may exacerbate symptoms in patients with Parkinson's disease; therefore, its use is not recommended. Those with heart disease or elderly patients should regularly monitor blood pressure and heart conditions and use this medication with caution. Women who are pregnant or breastfeeding should consult healthcare providers for careful use, as it may affect the fetus or newborn. This medication can cause drowsiness and dizziness; thus, caution is advised when driving or operating hazardous machinery. This medication may affect liver function, so patients with liver disease or suspected liver dysfunction require regular liver function tests. There may be interactions with other medications during use, so if taking other drugs, inform your doctor or pharmacist.

• 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 kept in a sealed container to prevent air or moisture from entering, and it is best stored in a cool place between 15 and 30 degrees Celsius. Storing it this way will help maintain its effectiveness over time.

Appearance

White, round, film-coated tablet

Package unit

30 tablets (10 tablets/Alu-Alu × 3)