Zyprexa ODT 10mg (Olanzapine)

Adult dose

The therapeutic dose of this drug should be adjusted according to the patient's clinical condition. Increases above the generally 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 give a definitive answer as to 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 approximately 8 weeks of treatment with this drug received maintenance treatment with 10∼20 mg daily for 8 months. 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 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 drug for treatment of mania, continue the same dose to prevent recurrence. If a new manic, mixed, or depressive episode occurs, continue this drug, with adjunctive therapy to treat mood symptoms as clinically indicated (optimizing the required doses). 3) For 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 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 this drug 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 5 mg once daily and increase to 10 mg once daily. Administer this drug at bedtime. Adjust the dose as appropriate according to age and symptoms, but do not exceed 20 mg daily. Food does not affect drug absorption; therefore, this drug may be administered with or without food. 2. Dosage 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 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 may cause a serious side effect known as Neuroleptic Malignant Syndrome, which can be life-threatening. Symptoms such as high fever, muscle rigidity, and changes in mental status should prompt immediate consultation with a physician. This medication is not recommended for the treatment of psychosis or behavioral disorders related to dementia, especially in elderly patients, as it may increase the risk of mortality and cerebrovascular disorders. Long-term use may lead to Extrapyramidal Symptoms (EPS), so if unusual symptoms appear, dosage adjustment or discontinuation should be considered. While on this medication, regular monitoring of blood glucose, weight, and lipid levels is necessary to watch for the occurrence of diabetes or dyslipidemia. Sudden discontinuation may result in withdrawal symptoms such as insomnia, anxiety, and nausea, thus it is safer to gradually reduce the dosage when stopping. Patients with heart disease, elderly patients, or those with impaired liver function must consult a physician before taking this medication and should have their blood pressure and heart status regularly checked. Women who are pregnant or breastfeeding must consult a physician before taking this medication as it may affect the fetus or newborn. This medication may cause drowsiness or dizziness, so it is advisable to avoid driving or hazardous machinery operation while taking it. There may be interactions with other medications; hence, inform your doctor especially if taking drugs metabolized by the liver or those affecting the heart. Overdose may lead to serious side effects; therefore, adhere to the prescribed dosage and seek medical attention immediately if unusual symptoms occur. Keep this medication out of reach of children and store it in a place that avoids direct sunlight and moisture at a temperature between 15-30 degrees Celsius.

High fever, muscle rigidity, changes in mental state, irregular pulse, unstable blood pressure, tachycardia, sweating, cardiac arrhythmia, elevated creatine phosphokinase, myoglobinuria, acute renal failure, increased mortality rate, cerebrovascular adverse reactions, stroke, transient ischemic attack, tardive dyskinesia, drowsiness, weight gain, eosinophilia, elevated prolactin, elevated cholesterol, elevated blood sugar, elevated triglycerides, diabetes, increased appetite, inability to sit still, Parkinson's syndrome, 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 blood sugar, elevated triglycerides, elevated cholesterol levels, diabetes, acidosis, increased alkaline phosphatase, hyperbilirubinemia, dehydration, hypercholesterolemia, hyperglycemia, hyperlipidemia, hyperuricemia, hypoglycemia, hypokalemia, hyponatremia, lower limb edema, upper limb edema, hyperkalemia, ketoacidosis, coma, drowsiness, dizziness, insomnia, depression, lightheadedness, inability to sit still, all extrapyramidal symptoms, personality disorders, tremor, hypertonicity, speech disturbances, sensory disturbances, apathy, confusion, euphoria, coordination disorders, abnormal dreams, delusions, emotional instability, manic reactions, schizophrenia-like reactions, inability to move, alcohol abuse, antisocial reactions, inability to perform coordinated movements, CNS stimulation, cogwheel rigidity, nonsensical speech, dementia, depersonalization, stuttering, facial paralysis, sensory loss, reduced motor activity, decreased muscle tone, reduced libido, increased libido, obsessive symptoms, phobias, somatization, stimulant abuse, confusion, tardive dyskinesia, vertigo, withdrawal syndrome, suicide attempt, amnesia, seizures, abnormal muscle tone, restless legs syndrome, orofacial paralysis, coma, encephalopathy, neuralgia, neuropathy, nystagmus, paralysis, subarachnoid hemorrhage, tobacco abuse, neuroleptic malignant syndrome, withdrawal symptoms, orthostatic hypotension, tachycardia, hypertension, hypotension, syncope, bradycardia, atrial fibrillation, cerebrovascular accident, congestive heart failure, cardiac arrest, bleeding, migraine, pallor, palpitations, vascular dilation, premature ventricular contractions, QTc prolongation, thromboembolism, arteritis, heart failure, pulmonary embolism, ventricular fibrillation, sudden death, diabetes mellitus, 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, tongue discoloration, pancreatitis, rhinitis, increased cough, pharyngitis, shortness of breath, apnea, asthma, nosebleed, hemoptysis, hyperventilation, hypoxemia, laryngitis, voice changes, atelectasis, hiccups, respiratory depression, pulmonary edema, wheezing, hepatic steatosis, hepatitis, jaundice, sweating, photosensitivity reactions, acne, dry skin, alopecia, contact dermatitis, eczema, papular rash, itching, seborrhea, skin pigmentation, skin ulcer, urticaria, vesicular rash, hirsutism, pustular rash, drug reaction (DRESS), low back pain, chest pain, tooth pain, flu-like syndrome, injection site pain, abdominal distension, chills, facial swelling, self-harm, malaise, candidiasis, throat 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 eyes, ear pain, ocular hemorrhage, eye inflammation, eye pain, abnormal eye muscle movement, taste disturbances, tinnitus, corneal lesions, glaucoma, keratoconjunctivitis, macular pigmentary dystrophy, miosis, mydriasis, lens pigmentation, urinary incontinence, urinary tract infection, dysmenorrhea, vaginitis, abnormal ejaculation, amenorrhea, breast pain, cystitis, decreased menstruation, urinary disorder, galactorrhea, gynecomastia, hematuria, erectile dysfunction, increased menstruation, menorrhagia, uterine bleeding, polyuria, premenstrual syndrome, pyuria, frequent urination, urinary retention, oliguria, uterine fibroid hyperplasia, vaginal bleeding, urinary delay, albuminuria, breast enlargement, mastitis, reduced urine output, male erectile dysfunction, decreased libido, female amenorrhea, excessive lactation, breast enlargement, persistent erection, elevated plasma prolactin levels, increased alkaline phosphatase, elevated creatine kinase, elevated gamma-glutamyl transferase, elevated uric acid, increased total bilirubin, neonatal withdrawal syndrome, ocular motor seizures, confusion, hypertensive crisis, ocular motor nerve paralysis, headache, abdominal pain, painful sensations, weight loss, melena, convulsions, hypomania, sexual discomfort, neurogenic reactions, hallucinations, hepatic failure, decreased appetite, urinary obstruction, pyelonephritis, abnormal electrocardiogram, fixed dilated pupils, torticollis, tachycardia, agitation, aggression, stuttering, various extrapyramidal symptoms, decreased level of consciousness, nonsensical speech, convulsions, coma, respiratory depression, aspiration, hypertension, hypotension, arrhythmia, cardiopulmonary arrest

This medication should be stored in a container that prevents light and air, and it should be kept in a low humidity environment. The appropriate storage temperature is between 15 and 30 degrees Celsius.

Appearance

Pale yellow, round orally disintegrating tablet

Package unit

28 tablets (7 tablets × 4) / PTP