PMS Olanzapine Tablet 2.5 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 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 provide a definite answer as to 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 at a dose 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 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 continue, with adjunctive therapy to treat mood symptoms as clinically indicated (optimizing the required dose). 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 based on the clinical condition. 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 at 5mg once daily and increase to 10mg 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 20mg. Food does not affect drug absorption; therefore, this medicine may be taken with or without food. 2. Dosage in special populations 1) Older adults Initiation at a dose of 5 mg or less once daily may be considered when sufficiently supported by clinical factors. 2) Patients with renal or hepatic impairment A low initial dose (5 mg) should be considered. In cases of 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 may delay the metabolism of this medicine (female sex, older age, and nonsmoking status) may also be started at a low dose. 3. Precautions (for orally disintegrating tablets only) This medicine is brittle. Remove it from the outer package and open the blister by peeling off the foil on the back. Do not push 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 may cause serious side effects, including neuroleptic malignant syndrome, which can be life-threatening; therefore, if symptoms such as fever or muscle rigidity occur, discontinue use immediately and seek medical attention. It is not used for the treatment of psychosis or behavioral disorders associated with dementia, and caution is necessary as mortality and risk of cerebrovascular events may increase in elderly patients. Long-term use may result in movement disorders such as tardive dyskinesia, so if symptoms arise, dosage adjustment or discontinuation should be considered. Blood sugar and weight should be regularly monitored, as diabetes or hyperglycemia may worsen; if symptoms arise, consult with healthcare professionals immediately. Sudden discontinuation may lead to withdrawal symptoms such as sweating, insomnia, or nausea, so it is safest to taper off gradually. This medication may affect liver function, so regular testing is necessary if there is a history of liver disease or elevated liver enzymes, and if hepatitis is suspected, usage should be discontinued. Drowsiness or dizziness may occur while taking this medication, so care should be taken when driving or operating hazardous machinery. Women who are pregnant or breastfeeding should consult their physician before taking this medication, as it can affect the fetus or newborn. This medication may interact with certain drugs; therefore, inform your doctor or pharmacist if you are taking other medications, particularly avoid co-administration with epinephrine. Overdose may cause serious cardiovascular issues or decreased consciousness, so dosage must be adhered to and visit a medical institution immediately if any abnormal symptoms occur.

• Hyperthermia
• muscle rigidity
• changes in mental status
• irregular pulse
• unstable blood pressure
• tachycardia
• sweating
• cardiac arrhythmia
• increased creatine phosphokinase
• myoglobinuria

This medication should be stored in a sealed container to prevent air entry and kept at room temperature between 15 and 30 degrees Celsius. Proper storage will help maintain the medication's efficacy and prevent degradation.

Appearance

White round film-coated tablet

Package unit

30 tablets (10 tablets/Alu-Alu × 3)