Sandoz Olanzapine Tablet 10 mg

Adult dose

The therapeutic dose of this medicine should be adjusted according to the patient's clinical condition. Any increase above the usual recommended daily dose of 10 mg is 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 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 approximately 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. 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 to lithium or valproate. (2) Prevention of recurrence in bipolar disorder The recommended initial dose is 10 mg once daily. In 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, continue this medicine with adjunctive therapy to treat mood symptoms, as clinically indicated, optimizing the required dose as necessary. 3) For the treatment of schizophrenia and manic and mixed episodes associated with bipolar I disorder, and for prevention of recurrence in bipolar disorder, the daily dose may be adjusted within the range of 5 mg to 20 mg daily according to the clinical condition. Increases above the recommended initial dose are advised 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 gradually reduced with care. 4) Acute treatment of depressive episodes associated with bipolar I disorder Start treatment with 5mg of olanzapine once daily, then increase to 10mg once daily. Administer this medicine at bedtime and adjust the dose as appropriate according to age and symptoms, but do not exceed a daily dose of 20mg. This medicine may be taken with or without food, as food does not affect drug absorption. 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 with caution. 3) A low starting dose may also be used in patients with a combination of factors that delay the metabolism of this medicine (female sex, advanced age, and nonsmoking status).

This drug can cause a serious side effect known as Neuroleptic Malignant Syndrome, which includes symptoms such as high fever, muscle rigidity, changes in mental state, irregular pulse and blood pressure, and cardiac rhythm abnormalities. If these symptoms appear or if there is an unexplained high fever, discontinue this medication immediately and consult a doctor. This drug is not approved for the treatment of psychosis or behavioral disorders related to dementia, and its use is not recommended in this patient group due to an increased risk of mortality and cerebrovascular disorders. Long-term use may lead to tardive dyskinesia, which is a movement disorder, so dosage adjustments or discontinuation should be considered if symptoms appear. The effect of this drug may take days to weeks to manifest, so patients should be closely monitored. It may affect blood sugar control, so diabetic patients or those with risk factors should regularly monitor their blood sugar and weight, and should consult healthcare professionals immediately if hyperglycemia symptoms occur. Sudden discontinuation of medication can lead to symptoms such as sweating, insomnia, anxiety, and nausea, so it is safe to taper off gradually. Those with cardiovascular disease or the elderly may experience side effects such as hypotension, bradycardia, and fainting, requiring periodic blood pressure monitoring and caution. Women who are pregnant or breastfeeding should consult a doctor regarding the potential effects on the fetus or newborn when taking this medication. There may be interactions with other drugs, especially those that affect liver metabolism or when used with epinephrine or dopamine agonists, so caution is needed. This medication may cause drowsiness and dizziness, so care should be taken when driving or operating dangerous machinery. Overdose can result in serious side effects, so the prescribed dosage and administration must be strictly followed, and any abnormal symptoms should be reported to healthcare professionals immediately. When storing this medication, keep it out of the reach of children, avoid direct sunlight and moisture, and store it at a temperature between 15-30 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 closed container to prevent air or moisture from entering. It is advisable to maintain a storage temperature between 15 and 30 degrees Celsius.

Appearance

White round film-coated tablet

Package unit

30 tablets/bottle