Neurozapin Tablets 2.5 mg (Olanzapine)

Adult dose

The therapeutic dose of this drug should be adjusted according to the patient's clinical condition. Doses exceeding the usual recommended daily dose of 10 mg are recommended only after an appropriate clinical assessment. 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 determine exactly how long treatment with this drug should continue, efficacy was demonstrated in a placebo-controlled study in which patients with schizophrenia whose symptoms had stabilized after taking this drug for about 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 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, 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 the 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. Dose increases above the recommended initial dose are recommended only after an appropriate clinical assessment and should generally be made at intervals of at least 24 hours. If treatment with this drug is discontinued, the dose should be tapered gradually and cautiously. 4) Acute treatment of depressive episodes associated with bipolar I disorder Start treatment with olanzapine 5mg once daily, and increase to 10mg once daily. This drug should be taken at bedtime; the dose may be adjusted as appropriate according to age and symptoms, but the daily dose should not exceed 20mg. This drug may be taken with or without food, as 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 clinical justification. 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 may slow the metabolism of this drug (female sex, advanced age, and nonsmoking status) may also be started at a lower dose.

Although this medication can rarely cause a serious side effect called Neuroleptic Malignant Syndrome, which can be life-threatening, if symptoms such as high fever, muscle rigidity, or changes in mental state occur, use should be immediately discontinued and a doctor should be consulted. This medication is not approved for the treatment of psychosis or behavioral disorders related to dementia and can especially increase mortality and risk of cerebrovascular accidents in elderly patients, so caution is necessary. Prolonged use may result in movement disorders such as tardive dyskinesia, so if abnormal symptoms appear, consideration should be given to dosage adjustment or discontinuation. Diabetes or hyperglycemia may occur or worsen, so blood glucose and weight should be checked regularly, and if symptoms such as thirst or frequent urination occur, immediate consultation with a doctor is necessary. If there are problems with liver function or elevated liver enzymes, use of this drug should be cautious, and dosage adjustments or discontinuation may be needed if necessary. This medication may cause drowsiness and dizziness, therefore caution is needed when driving or operating dangerous machinery. Women who are pregnant or nursing should consult a doctor before use as it may affect the fetus or newborn. This medication may interact with certain drugs, so it is essential to inform the doctor about any other drugs being taken, and it should particularly not be used with epinephrine. Sudden discontinuation of the drug may lead to withdrawal symptoms such as sweating, insomnia, and anxiety, thus tapering should be done gradually according to the doctor's instructions. The safety for use in children or adolescents has not been sufficiently confirmed, therefore caution should be exercised in this age group.

High fever, muscle rigidity, changes in mental state, irregular pulse, changes in blood pressure, tachycardia, sweating, arrhythmia, elevated creatine phosphokinase, myoglobinuria, acute renal failure, increased mortality rate, cerebrovascular adverse reactions, stroke, transient ischemic attack, tardive dyskinesia, drowsiness, weight gain, eosinophilia, increased prolactin, increased cholesterol, increased blood sugar, increased triglycerides, diabetes, increased appetite, akathisia, Parkinson's syndrome, leukopenia, neutropenia, movement disorders, orthostatic hypotension, anticholinergic effects, elevated liver transaminases, rash, asthenia, fatigue, fever, arthralgia, increased alkaline phosphatase, elevated gamma-glutamyl transferase, hyperuricemia, elevated creatine kinase, edema, elevated blood glucose levels, elevated triglycerides, anemia, cyanosis, leukocytosis, lymphadenopathy, neutropenia, hypersensitivity reactions, acidosis, increased alkaline phosphatase, hyperbilirubinemia, dehydration, hypercholesterolemia, hyperglycemia, hyperlipidemia, hyperuricemia, hypoglycemia, hypokalemia, hyponatremia, peripheral edema, upper body edema, hyperkalemia, ketosis, coma, gout, hypernatremia, hypoalbuminemia, ketosis, water intoxication, hypothermia, dizziness, abnormal gait in Alzheimer's disease, insomnia, depression, vertigo, akathisia, all extrapyramidal symptoms, personality disorders, tremors, hypertonia, speech disturbances, sensory disturbances, apathy, confusion, euphoria, clumsiness in movement, abnormal dreams, delusions, emotional instability, manic reactions, schizophrenia reactions, akinesia, alcohol abuse, antisocial reactions, inability to perform coordinated movements, CNS stimulation, cogwheel rigidity, nonsense speech, dementia, depersonalization, stuttering, facial paralysis, sensory loss, reduced mobility, decreased muscle tone, decreased libido, increased libido, obsessive symptoms, phobias, somatization, stimulant abuse, confusion, tardive dyskinesia, dizziness, withdrawal syndrome, suicide attempts, amnesia, seizures, muscle tension abnormalities, restless legs syndrome, paralysis 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, premature ventricular contractions, 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 ulcers, nausea, oral candidiasis, periodontal abscess, rectal bleeding, stomatitis, tongue swelling, dental caries, diarrhea, abdominal bloating, hypersecretion of saliva, rhinitis, increased cough, pharyngitis, dyspnea, apnea, asthma, epistaxis, hemoptysis, hyperventilation, hypoxemia, laryngitis, voice changes, atelectasis, hiccups, respiratory depression, pulmonary edema, wheezing, fatty liver, hepatitis, jaundice, sweating, photosensitivity reactions, acne, dry skin, alopecia, contact dermatitis, eczema, papular rash, itching, seborrhea, skin discoloration, skin ulcers, urticaria, vesicular rash, hypertrichosis, pustular rash, drug reaction (DRESS), lumbago, chest pain, toothache, flu-like syndrome, injection site pain, 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 eyes, ear pain, ocular hemorrhage, ocular inflammation, eye pain, ocular muscle abnormalities, taste disturbances, tinnitus, corneal lesions, glaucoma, keratoconjunctivitis, macular pigmentation decrease, miosis, mydriasis, lenticular pigmentation, urinary incontinence, urinary tract infection, dysmenorrhea, vaginitis, abnormal ejaculation, amenorrhea, mastalgia, 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 fibroid hypertrophy, vaginal bleeding, urinary delay, albuminuria, breast enlargement, mastitis, reduced urine output, male erectile dysfunction, benign overall decreased libido, female amenorrhea, hypergalactorrhea, breast enlargement, gynecomastia, prolonged erection, elevated plasma prolactin levels, increased alkaline phosphatase, elevated creatine kinase, increased gamma-glutamyl transferase, elevated uric acid, increased total bilirubin, neonatal withdrawal syndrome, tachycardia, excitement, aggression, stuttering, various extrapyramidal symptoms, decreased level of consciousness, nonsense speech, convulsions, respiratory function suppression, aspiration, hypertension, hypotension, arrhythmia, cardiac arrest, ocular movement seizures, confusion, hypertrophic muscle spasms, ocular movement nerve paralysis, headache, abdominal pain, pain, weight loss, bloody stools, convulsions, hypomania, sexual discomfort, neural hyperreactivity, auditory hallucinations, liver failure, decreased appetite, urinary retention, pyelonephritis, ECG abnormalities, pupillary atony, torticollis, weight gain, drowsiness, increased appetite, sedation, hypersomnia, suicidal ideation, suicide attempts, anxiety, restlessness, excitement, panic attacks, irritability, hostility, aggression, impulsivity, restless legs syndrome, psychomotor agitation

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

Appearance

white round film-coated tablet

Package unit

30 tablets/bottle, 200 tablets/bottle