Aprexa Tablet 5 mg (Olanzapine)

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 appropriate clinical evaluation. Schizophrenia: The recommended initial dose is olanzapine 5∼10 mg once daily. Maintenance treatment of schizophrenia: Although it is difficult to give 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 about 8 weeks received maintenance treatment at doses of 10∼20 mg daily for 8 months. The need for maintenance treatment at an appropriate dose should be assessed periodically. Treatment of manic or 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. Patients who have been taking 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 be continued, together with adjunctive therapy to treat mood symptoms according to clinical signs (optimizing the required dose). Treatment of schizophrenia and manic or 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 advised only after appropriate clinical evaluation and should generally be made at intervals of at least 24 hours. When discontinuing this medicine, the dose should be reduced gradually and cautiously. Acute treatment of depressive episodes associated with bipolar I disorder: Start treatment with olanzapine 5mg once daily, then increase to 10mg 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. Food does not affect drug absorption; therefore, this medicine may be administered with or without food. Elderly patients: Starting at a dose of 5 mg or less daily may be considered when there is sufficient clinical justification. Patients with renal or hepatic impairment: Consider a low initial dose (5 mg). 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 a combination of factors that delay the metabolism of this medicine (female sex, older age, and nonsmoking status) may also be started at a low dose.

This medication has the potential to cause a life-threatening serious side effect known as neuroleptic malignant syndrome. Symptoms may present as hyperthermia, muscle rigidity, altered mental status, and autonomic instability such as irregular pulse or blood pressure. If these symptoms are suspected, discontinue the medication immediately and consult a healthcare professional. It is not recommended to use this medication for the treatment of psychiatric or behavioral disorders related to dementia. Caution is necessary when administering to elderly patients due to an increased risk of mortality and stroke. Prolonged use may lead to tardive dyskinesia, which is an involuntary movement disorder, so considerations for dose adjustment or discontinuation are needed if such symptoms occur. In the early stages of treatment, it may take time to see effects, so careful observation of the patient's condition is required. There have been reports of diabetes onset or worsening and hyperglycemia symptoms, so regular monitoring of blood glucose and weight is important. Sudden discontinuation of this medication may result in symptoms such as insomnia, anxiety, nausea, and vomiting; therefore, a gradual reduction is advisable when discontinuing. Caution should be exercised in patients with specific conditions such as cardiovascular disease, liver dysfunction, seizure history, hypotension, and elderly patients. Women who are pregnant or breastfeeding should consult with a physician before taking this medication as it may affect the fetus or neonate. This medication may cause drowsiness or dizziness, so caution is advised when driving or operating machinery. There may be interactions with other medications, so inform healthcare professionals of any other medications being taken.

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

This medication may be sensitive to air or moisture, so it must be stored in a tightly sealed container. The recommended storage temperature is between 15 to 30 degrees Celsius to maintain the medication's effectiveness for a longer period.

Appearance

White round film-coated tablets

Package unit

28 tablets (7 tablets/PTPX4)