Zyprexa Tablets 10mg (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. 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 give a definitive answer regarding how long treatment with this medicine should continue, 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 for 8 months at doses of 10∼20 mg daily. 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, with adjunctive therapy to treat mood symptoms as clinically indicated (optimizing the dose as needed). 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 once daily based on clinical status. Increases above the recommended initial dose are advised only after appropriate clinical evaluation, and the dose should generally be increased 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, then increase to 10mg once daily. Administer this medicine at bedtime and adjust the dose as appropriate according to age and symptoms; the daily dose should not exceed 20mg. Since food does not affect drug absorption, 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 supported by sufficient 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 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 may cause a serious side effect known as Neuroleptic Malignant Syndrome, which can be life-threatening; therefore, if symptoms such as high fever, muscle rigidity, or changes in mental state occur, usage should be discontinued immediately and consultation with healthcare professionals should occur. It is advised against using this medication for treating dementia-related psychosis or behavioral disorders, particularly as it may increase mortality and the risk of cerebrovascular disease in elderly patients, necessitating caution. Tardive dyskinesia, a movement disorder, may appear with prolonged use; thus, if abnormal symptoms arise, dosages should be reduced or discontinuation should be considered. This medication can affect blood sugar control, so diabetes patients or those with risk factors should regularly monitor their blood sugar and weight. Drowsiness or dizziness may occur at the beginning of treatment, necessitating caution while driving or operating hazardous machinery. Liver function may be affected, so patients with liver disease require regular liver function tests. This medication may induce withdrawal symptoms such as insomnia, anxiety, and nausea if suddenly discontinued, so dosage should be gradually reduced. Patients with specific cardiovascular conditions or those at risk of hypotension should carefully monitor blood pressure and heart condition during administration. Women who are pregnant or breastfeeding should consult a physician due to potential effects on the fetus or newborn. There may be interactions with other medications, so it is important to inform medical staff of any current medications, especially that epinephrine should not be co-administered. The safety and efficacy of this medication in children and adolescents have not been sufficiently confirmed, hence should be used cautiously. Serious side effects may occur with overdose, so adhering strictly to the prescribed dosage is crucial, and if abnormal symptoms manifest, immediate medical attention is necessary. This medication should be protected from light and moisture and stored at 15 to 30 degrees Celsius, out of reach of children.

• 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 exposure to air or moisture, and it is important to maintain the storage temperature between 15 and 30 degrees Celsius to preserve its efficacy and safety.

Appearance

Film-coated white round tablets

Package unit

56 tablets (7 tablets/PTPX8)/carton