Olanzapine 10 mg Tablet (Olanzapine)

Adult dose

The therapeutic dose of this drug should be adjusted according to the patient's clinical condition. Dose increases exceeding the general 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: It is difficult to provide a definitive answer regarding how long treatment with this drug should continue. However, efficacy was demonstrated in a placebo-controlled study in which patients with schizophrenia whose symptoms had stabilized after taking this drug for approximately 8 weeks received maintenance treatment for 8 months at a dose of 10∼20 mg daily. The need for maintenance treatment at an appropriate dose should be evaluated periodically. 2) Bipolar disorder (1) Treatment of manic and mixed episodes associated with bipolar I disorder The initial dose is 15 mg of this drug 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 received this drug to treat mania should continue to receive the same dose to prevent recurrence. If a new manic, mixed, or depressive episode occurs, treatment with this drug should be continued, with adjunctive therapy to treat mood symptoms as clinically indicated (optimizing the required dose). 3) For schizophrenia, treatment of 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 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. When discontinuing this drug, the dose should be reduced gradually and carefully. 4) Acute treatment of depressive episodes associated with bipolar I disorder Start treatment with 5 mg of olanzapine once daily, and increase to 10 mg once daily. Administer this drug at bedtime and adjust the dose appropriately according to age and symptoms; do not exceed a daily dose of 20 mg. This drug may be administered 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 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 patients with moderate hepatic impairment (cirrhosis, Child-Pugh class A or B), the initial dose is 5 mg and should be increased cautiously. 3) Patients with multiple factors that delay the metabolism of this drug (female sex, advanced age, and nonsmoking status) may also be started at a low dose.

This medication can cause a serious and potentially life-threatening side effect known as Neuroleptic Malignant Syndrome; therefore, if symptoms such as unusual high fever, muscle rigidity, or changes in mental state occur, treatment should be discontinued immediately. It is advisable not to use it to treat psychosis or behavioral disturbances associated with dementia, especially in elderly patients, as this may increase the risk of mortality and cerebrovascular disorders. Long-term use may result in tardive dyskinesia, which is a movement disorder, so if symptoms occur, dosage adjustment or discontinuation should be considered. Initially, the medication may take time to show effects, so the patient's condition should be carefully monitored. Patients with diabetes or at risk should regularly check blood glucose and weight, and consult a healthcare professional if any abnormal symptoms arise. Sudden discontinuation may cause symptoms such as sweating, insomnia, and anxiety, so it is safe to taper off gradually. Patients with cardiovascular disease or elderly patients should regularly monitor blood pressure and heart condition, and those at risk of QT interval prolongation should be cautious. Pregnant or breastfeeding women should consult a doctor before use, as it may affect the fetus or newborn. This medication may cause drowsiness or dizziness, so caution is needed when driving or operating hazardous machinery. Additionally, care should be taken when administering to patients with impaired liver function or a history of seizures, as hematological abnormalities such as reduced white blood cell count may occur; therefore, regular monitoring is recommended. This medication can interact with other drugs, so patients must inform healthcare professionals of any medications they are taking, especially not to combine with epinephrine. In cases of overdose, serious symptoms such as decreased consciousness and heart problems may occur, necessitating immediate medical attention. When storing this medication, keep it out of the reach of children, avoiding light and moisture, and store it at an appropriate temperature.

High fever, muscle rigidity, changes in mental state, irregular pulse, changes in blood pressure, tachycardia, sweating, cardiac arrhythmia, elevated creatine phosphokinase, myoglobinuria, acute kidney failure, increased mortality rate, stroke, transient ischemic attack, tardive dyskinesia, drowsiness, weight gain, eosinophilia, elevated prolactin, elevated cholesterol, elevated blood sugar, elevated triglycerides, diabetes, increased appetite, akathisia, Parkinson's disease, leukopenia, neutropenia, movement disorders, orthostatic hypotension, anticholinergic effects, elevated liver transaminases, rash, weakness, fatigue, fever, arthralgia, increased alkaline phosphatase, elevated gamma-glutamyl transferase, elevated uric acid, elevated creatine kinase, edema, elevated triglycerides, anemia, cyanosis, leukocytosis, lymphadenopathy, thrombocytopenia, hypersensitivity reactions, acidosis, increased alkaline phosphatase, hyperbilirubinemia, dehydration, hypercholesterolemia, hyperglycemia, hyperlipidemia, hyperuricemia, hypoglycemia, hypokalemia, hyponatremia, lower limb edema, upper limb edema, hyperkalemia, ketoacidosis, coma, gout, hypernatremia, hypoalbuminemia, ketosis, water intoxication, hypothermia, dizziness, abnormal gait in Alzheimer's disease patients, insomnia, depression, vertigo, personality disorders, tremors, dyskinesia, speech disturbances, sensory abnormalities, apathy, confusion, derealization, coordination disorder, abnormal dreams, delusions, emotional instability, manic reactions, schizophrenia reactions, akinesia, alcohol abuse, antisocial reactions, impaired coordination, CNS stimulation, cogwheel rigidity, delirium, dementia, depersonalization, stuttering, facial paralysis, sensory loss, movement reduction, decreased muscle tone, decreased libido, increased libido, obsessive symptoms, phobias, somatization, stimulant abuse, confusion, tardive dyskinesia, vertigo, withdrawal syndrome, suicide attempt, amnesia, seizures, muscular hypertonia, restless leg syndrome, perioral paralysis, coma, encephalopathy, neuralgia, neuropathy, nystagmus, paralysis, subarachnoid hemorrhage, tobacco abuse, malignant neuroleptic syndrome, withdrawal symptoms, orthostatic hypotension, tachycardia, hypertension, hypotension, syncope, bradycardia, atrial fibrillation, cerebrovascular accident, congestive heart failure, cardiac arrest, bleeding, migraine, pallor, palpitations, vasodilation, ventricular ectopic beats, QTc prolongation, thromboembolism, arteritis, heart failure, pulmonary embolism, ventricular fibrillation, sudden death, diabetes, diabetic ketoacidosis, goiter, constipation, thirst, dyspepsia, vomiting, increased salivation, dysphagia, esophagitis, fecal incontinence, gastritis, gastroenteritis, gingivitis, melena, oral ulcer, nausea, oral candidiasis, periodontal abscess, rectal bleeding, stomatitis, tongue swelling, dental caries, diarrhea, abdominal bloating, excessive salivation, aphthous stomatitis, enteritis, belching, esophageal ulcer, glossitis, intestinal obstruction, bowel obstruction, discoloration of the tongue, pancreatitis, rhinitis, increased cough, pharyngitis, shortness of breath, apnea, asthma, epistaxis, hemoptysis, hyperventilation, hypoxemia, laryngitis, voice changes, atelectasis, hiccups, respiratory depression, pulmonary edema, stridor, hepatic steatosis, hepatitis, jaundice, sweating, photosensitivity reactions, acne, dry skin, alopecia, contact dermatitis, eczema, papular eruption, pruritus, seborrhea, skin discoloration, skin ulcers, urticaria, vesicular rash, hirsutism, pustular rash, drug reactions, low back pain, chest pain, toothache, flu-like syndrome, injection site pain, abdominal distension, chills, facial edema, intentional self-harm, lethargy, candidiasis, neck pain, neck stiffness, pelvic pain, hangover, sudden death, joint stiffness, single contraction, arthritis, arthrosis, leg cramps, myasthenia, arthralgia, bone pain, bursitis, myopathy, osteoporosis, rheumatoid arthritis, rhabdomyolysis, amblyopia, visual disturbances, conjunctivitis, abnormal accommodation, blepharitis, cataract, hearing loss, diplopia, dry eye, ear pain, ocular hemorrhage, ocular inflammation, eye pain, ocular muscle abnormalities, taste disturbances, tinnitus, corneal lesions, glaucoma, keratoconjunctivitis, decreased macular pigmentation, pupil constriction, pupil dilation, lenticular pigmentation, incontinence, urinary tract infection, dysmenorrhea, vaginitis, abnormal ejaculation, amenorrhea, breast pain, cystitis, decreased menstruation, urination disorders, female galactorrhea, gynecomastia, hematuria, erectile dysfunction, increased menstruation, menorrhagia, uterine bleeding, polyuria, premenstrual syndrome, pyuria, frequency of urination, urinary retention, oliguria, uterine fibromatosis, vaginal bleeding, urinary delay, albuminuria, breast enlargement, mastitis, decreased urine output, male erectile dysfunction, benign decreased libido, female amenorrhea, excessive lactation, breast enlargement, priapism, elevated plasma prolactin levels, increased total bilirubin, neonatal withdrawal syndrome, ocular motor seizures, confusion, myotonic contractions, oculomotor nerve paralysis, headache, abdominal pain, pain, weight loss, blood in stool, convulsions, hypomania, sexual discomfort, neuro-excitability, hallucinations, liver failure, decreased appetite, urinary obstruction, nephritis, ECG abnormalities, pupil abnormalities, torticollis, tachycardia, agitation, aggression, stuttering, various extrapyramidal symptoms, decreased level of consciousness, delirium, convulsions, respiratory function inhibition, aspiration, hypertension, hypotension, arrhythmia, cardiac arrest

This medication should be stored in a tightly sealed container to prevent air and moisture ingress, and it is best kept at room temperature between 15 degrees and 30 degrees Celsius. This will help maintain the efficacy of the medication and prevent degradation.

Appearance

White round film-coated tablet

Package unit

30 tablets (10 tablets/Alu-Alu packaging × 3)