Zyprexa Tablet 10 mg (Olanzapine)
Olanzapine 10mg
Tablet · Prescription medication
Boryung Co., Ltd.
MFDS item code 199704231 · Approved 1997.07.31
This product's status changed to Approval withdrawn on 2024.03.27. It may no longer be sold, so consult a doctor or pharmacist before taking it.
Treatment of schizophrenia and bipolar disorder (such as manic and depressive episodes); prevention of recurrence
This medication is used for the treatment of schizophrenia. It is also used to treat manic and mixed episodes occurring in bipolar disorder type I, and helps prevent recurrence in patients who have responded to treatment for manic episodes. It is utilized for acute treatment of depressive episodes in bipolar disorder. Thus, this drug is used to improve various symptoms of schizophrenia and bipolar disorder.
The therapeutic dose of this drug should be adjusted according to the patient's clinical condition. Dose increases beyond 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 give a definitive answer as to how long treatment with this drug should continue, its 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 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 or 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 been receiving this drug to treat mania should continue the same dose to prevent recurrence. If a new manic, mixed, or depressive episode occurs, treatment with this drug should continue along with adjunctive therapy to treat mood symptoms, according to clinical indications (optimizing the required doses). 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. Doses above the recommended initial dose are recommended only after an appropriate clinical evaluation and should generally be increased at intervals of at least 24 hours. If treatment with 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 5 mg of olanzapine once daily, and increase to 10 mg once daily. Administer this drug at bedtime and adjust the dose as appropriate according to age and symptoms; do not exceed a daily dose of 20 mg. This drug may be administered without regard to meals because food does not affect its 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 of clinical factors supporting this approach. 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 serious and potentially life-threatening side effects known as neuroleptic malignant syndrome, so if high fever, muscle rigidity, or changes in mental status occur, use should be discontinued immediately and medical attention should be sought. This medication is not approved for the treatment of psychosis or behavioral disorders associated with dementia, and caution is advised as there may be an increased risk of mortality and cerebrovascular events, especially in elderly patients. Prolonged use may lead to tardive dyskinesia, so dosage adjustment or cessation should be considered if abnormal symptoms arise. At the beginning of treatment, effect may take time to manifest, thus careful observation of the patient's condition is necessary. Patients with diabetes or risk factors for diabetes should check blood glucose and weight regularly and consult healthcare professionals immediately if symptoms such as thirst, polyuria, or fatigue occur. Abrupt withdrawal of this medication may cause symptoms like insomnia, anxiety, and nausea, so it is advisable to taper off gradually. Patients with heart disease or elderly individuals need to regularly monitor blood pressure and heart condition, and must consult with specialists if taking other medications that interact with this drug. Pregnant or breastfeeding women should consult a doctor before use, as it may affect the fetus or newborn. Safety in children and adolescents has not been established, so caution is advised when prescribing to this age group. In case of overdose, symptoms like decreased consciousness, heart problems, or seizures may occur, necessitating immediate emergency care and a visit to a medical facility. This medication may cause drowsiness and dizziness; caution is needed when driving or operating hazardous machinery. Regular blood tests, liver function tests, and monitoring of lipid and blood glucose levels are recommended during treatment. This medication is metabolized by specific enzymes, so potential interactions with smoking or other drugs should be discussed with a healthcare professional before use.
High fever, muscle stiffness, changes in mental state, irregular heartbeat, changes in blood pressure, tachycardia, sweating, cardiac arrhythmias, 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, akathisia, 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 phosphoribosyl transferase, edema, blood sugar increase over 160-200 mg/dL, blood sugar increase over 200 mg/dL, elevated triglycerides, anemia, cyanosis, leukocytosis, lymphadenopathy, neutropenia, hypersensitivity reactions, acidosis, elevated alkaline phosphatase, hyperbilirubinemia, dehydration, hypercholesterolemia, hyperglycemia, hyperlipidemia, hyperuricemia, hypoglycemia, hypokalemia, hyponatremia, peripheral edema, upper limb edema, hyperkalemia, ketoacidosis, coma, gout, hypernatremia, hypoproteinemia, ketosis, water intoxication, hypothermia, dizziness, abnormal gait in Alzheimer's disease, insomnia, depression, vertigo, personality disorders, tremors, hypermuscle tone, speech disorders, sensory disturbances, apathy, confusion, abnormal euphoria, coordination dysfunction, abnormal dreams, delusions, emotional instability, manic reactions, schizophrenia reactions, motor incapacitation, alcohol abuse, antisocial reactions, coordination exercise incapacity, CNS stimulation, cogwheel rigidity, nonsense, dementia, depersonalization, stuttering, facial paralysis, sensory loss, reduced mobility, muscle tone reduction, decreased libido, increased libido, obsessive-compulsive symptoms, phobias, somatization, stimulant abuse, stupor, tardive dyskinesia, vertigo, withdrawal syndrome, suicide attempts, amnesia, seizures, abnormal muscle tone, restless legs syndrome, paralysis of the area around the mouth, 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, vasodilation, ventricular extrasystole, QT prolongation, thromboembolism, arteritis, heart failure, pulmonary embolism, ventricular fibrillation, sudden death, diabetes, diabetic acidosis, 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, tooth decay, diarrhea, abdominal bloating, excessive salivation, rhinitis, increased cough, pharyngitis, dyspnea, apnea, asthma, nosebleeds, hemoptysis, hyperventilation, hypoxia, 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 rash, itching, seborrhea, skin pigmentation, skin ulcer, urticaria, vesicular rash, hypertrichosis, pustular rash, drug reaction (DRESS), low back pain, chest pain, toothache, influenza syndrome, injection site pain, abdominal enlargement, chills, facial edema, intentional injury, lethargy, candidiasis, neck pain, neck stiffness, pelvic pain, hangover, sudden death, joint stiffness, single contraction, arthritis, arthrosis, leg cramps, myasthenia gravis, arthralgia, bone pain, bursitis, myopathy, osteoporosis, rheumatoid arthritis, rhabdomyolysis, amblyopia, visual disturbances, conjunctivitis, abnormal accommodation, blepharitis, cataracts, hearing loss, diplopia, dry eyes, ear pain, ocular hemorrhage, eye inflammation, eye pain, ocular muscle abnormality, taste disturbances, tinnitus, corneal lesions, glaucoma, keratoconjunctivitis, decreased macular pigmentation, miosis, mydriasis, lenticular pigmentation, urinary incontinence, urinary tract infection, dysmenorrhea, vaginitis, abnormal ejaculation, amenorrhea, breast pain, cystitis, decreased menstruation, urination disorders, female lactation, gynecomastia, hematuria, erectile dysfunction, increased menstruation, heavy menstrual bleeding, uterine bleeding, polyuria, premenstrual syndrome, pyuria, frequent urination, urinary retention, oliguria, uterine fibroid hypertrophy, vaginal bleeding, urinary delay, albuminuria, breast hypertrophy, mastitis, decreased urination, male erectile dysfunction, benign overall decreased libido, female amenorrhea, hyperlactation, breast enlargement, gynecomastia, persistent erection, elevated plasma prolactin levels, increased alkaline phosphatase, elevated creatine phosphoribosyl transferase, elevated gamma-glutamyl transferase, elevated uric acid, increased total bilirubin, neonatal withdrawal symptoms, tachycardia, agitation, aggressiveness, stuttering, various extrapyramidal symptoms, decreased level of consciousness, nonsense, convulsions, respiratory function suppression, aspiration, hypertension, hypotension, arrhythmia, cardiopulmonary arrest, oculomotor seizures, confusion, myotonic cramps, oculomotor nerve paralysis, headache, abdominal pain, somatic pain, weight loss, bloody stools, convulsions, hypomania, sexual discomfort, neuroexcitability reactions, hallucinations, liver failure, decreased appetite, urinary obstruction, pyelonephritis, ECG abnormalities, pupil rigidity, torticollis, weight gain, drowsiness, increased appetite, sedation, hypersomnia
Not everyone experiences these, and they can vary from person to person.
This medication should be stored in a tightly sealed container to protect it from air and moisture. Additionally, it should be kept at room temperature between 15°C and 30°C, avoiding extreme temperatures.
Film-coated white round tablets
56 tablets (7 tablets/PTPX8) / carton
Even with the same ingredient, strength, dosage form and how it is taken can differ.
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Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.
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For anything that needs medical judgment, consult a doctor or pharmacist.
This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.