Teva Olanzapine Tablets 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 assessment. 1. Adults 1) Schizophrenia (1) The initial recommended 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 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 with lithium or valproate. (2) Prevention of recurrence in bipolar disorder The initial recommended 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, along with adjunctive therapy to treat mood symptoms according to clinical indications (optimizing the required doses as needed). 3) For the treatment of schizophrenia and 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 daily based on clinical condition. Increases above the initial recommended dose are recommended only after an appropriate clinical assessment, and the dose should generally be increased at intervals of 24 hours or more. 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 5mg of olanzapine once daily and 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. 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, older age, nonsmoking status) may also be started at a lower dose.

This medication can cause a serious and life-threatening side effect known as Neuroleptic Malignant Syndrome, so if you experience high fever, muscle rigidity, or changes in mental state, you should immediately stop taking it and consult a physician. This medication is not approved for the treatment of psychosis or behavioral disturbances associated with dementia, and caution is needed particularly in elderly patients as there may be an increased risk of mortality and cerebrovascular accidents. Long-term use may lead to tardive dyskinesia, a movement disorder, so if abnormal symptoms occur, dose adjustment or discontinuation should be considered. In the early phases of treatment, it may take several days to weeks for the effects to appear, thus careful monitoring of the patient's condition is necessary. This medication may affect blood sugar control, so diabetic patients or those at risk should regularly check their blood sugar and weight. Abrupt discontinuation of the medication may lead to symptoms such as sweating, insomnia, and anxiety, so it is recommended to taper off gradually. This medication may affect liver function; therefore, regular testing is needed if there is a history of liver disease or elevated liver enzymes. Patients with heart conditions, elderly individuals, or those with electrolyte imbalances should be cautious of the risk of arrhythmias or blood pressure fluctuations. Drowsiness or dizziness may occur while driving or operating hazardous machinery, so caution is advised. Consuming alcohol while taking this medicine may enhance sedative effects, so it is best to avoid alcohol. Pregnant or breastfeeding women should consult their physician before using it as it may affect the fetus or newborn. This drug is metabolized by specific enzymes, so there may be interactions with other medications; therefore, it is advisable to consult with a physician or pharmacist. Overdose may lead to severe side effects, so adherence to prescribed dosage and administration is crucial. Keep out of reach of children and store in a dry place, avoiding light and moisture, and at an appropriate temperature.

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

Store this medication in a sealed container to protect it from air and moisture. It is advisable to maintain a storage temperature between 15 to 30 degrees Celsius to preserve the effectiveness of the drug.

Appearance

White, circular, biconvex, film-coated tablets

Package unit

30 tablets (10 tablets/PTP x 3)