Aprexa 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 appropriate clinical evaluation. 1. Adults 1) Schizophrenia (1) The recommended initial dose is olanzapine 5∼10 mg once daily. (2) Maintenance treatment: Although it is difficult to give a definitive answer as to how long treatment with this medicine should continue, its efficacy was demonstrated in a placebo-controlled study in which patients with schizophrenia whose symptoms had stabilized after taking this medicine for about 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 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 be continued, together with adjunctive therapy to treat mood symptoms according to clinical signs (optimizing the required dose). 3) Treatment of schizophrenia and manic or 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 advised only after appropriate clinical evaluation and should generally be made at intervals of at least 24 hours. When discontinuing this medicine, the dose should be reduced gradually and cautiously. 4) Acute treatment of depressive episodes associated with bipolar I disorder Start treatment with olanzapine 5mg once daily, then increase to 10mg once daily. Administer this medicine at bedtime and adjust the dose appropriately according to age and symptoms; do not exceed a daily dose of 20mg. Food does not affect drug absorption; therefore, this medicine may be administered with or without food. 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 Consider a low initial dose (5 mg). In 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 a combination of factors that delay the metabolism of this medicine (female sex, older age, and nonsmoking status) may also be started at a low dose.

This medication may cause serious side effects known as neuroleptic malignant syndrome, with symptoms including high fever, muscle rigidity, and changes in mental state. If these occur, discontinue use immediately. It is advisable not to use this medication for the treatment of psychosis associated with dementia, especially in elderly patients, as it may increase mortality. Prolonged use may lead to a movement disorder called tardive dyskinesia; if symptoms develop, dose adjustment or discontinuation should be considered. Clinical improvement may take time, so regular monitoring and management is required. Blood sugar and weight should be regularly checked as diabetes or hyperglycemia may occur or worsen; consult a physician immediately if related symptoms appear. Patients who are at risk for hyperlipidemia should undergo regular blood tests as lipid levels may change. Abrupt discontinuation can lead to symptoms such as insomnia, anxiety, and nausea, so it is best to taper the dose gradually. This medication is not recommended for patients with Parkinson's disease, as symptoms may worsen or hallucinations may occur. Regular cardiac assessments are necessary for patients with cardiovascular disease due to the risk of cardiac-related side effects. Patients with hypersensitivity, closed-angle glaucoma, those receiving epinephrine, or certain genetically linked lactose intolerant patients should not take this medication. Patients with poor liver function or a history of seizures should be monitored closely while taking this medication, including liver function tests and observation for seizures. Co-administration with alcohol or central nervous system depressants may exacerbate side effects; caution is advised. Pregnant or breastfeeding women should consult with a physician before use, as it may affect the fetus and newborn. Safety for children and adolescents has not been well established; caution is required. In case of overdose, symptoms may include altered consciousness, seizures, and cardiac abnormalities, necessitating immediate emergency treatment. This medication may cause drowsiness and dizziness, so driving or operating hazardous machinery should be avoided. Regular monitoring of blood tests, weight, blood sugar, liver function, and cardiac status during treatment is important.

High fever, muscle rigidity, changes in mental state, irregular pulse, blood pressure instability, tachycardia, sweating, cardiac arrhythmia, elevated creatine phosphokinase, myoglobinuria, acute renal failure, increased mortality rate, cerebrovascular adverse reactions, stroke, transient ischemic attacks, tardive dyskinesia, drowsiness, weight gain, eosinophilia, increased prolactin, elevated cholesterol, elevated blood glucose, increased triglycerides, diabetes, increased appetite, akathisia, Parkinsonism, 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, increased creatine kinase, edema, increased blood glucose levels, elevated triglycerides, eosinophilia, petechial hemorrhage, anemia, cyanosis, leukocytosis, lymphadenopathy, neutropenia, hypersensitivity reactions, acidosis, increased 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, generalized muscle rigidity, speech disturbances, sensory abnormalities, apathy, confusion, euphoric state, coordination impairments, abnormal dreams, delusions, emotional instability, manic responses, schizophrenia reactions, akinesia, alcohol abuse, antisocial responses, inability to perform coordinated movements, CNS stimulation, cogwheel rigidity, incoherence, dementia, depersonalization, stuttering, facial paralysis, sensory loss, decreased motor activity, decreased muscle tone, decreased libido, increased libido, obsessive symptoms, phobias, somatization, stimulant abuse, confusion, tardive dyskinesia, vertigo, withdrawal syndrome, suicide attempts, amnesia, seizures, muscle tone abnormalities, restless leg syndrome, perioral 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, hemorrhage, migraine, pallor, heart palpitations, vasodilation, premature ventricular contractions, QTc prolongation, thrombosis, 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 ulcers, nausea, oral candidiasis, periodontal abscess, rectal bleeding, stomatitis, tongue edema, 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 coughing, pharyngitis, dyspnea, apnea, asthma, epistaxis, hemoptysis, hyperventilation, hypoxia, laryngitis, changes in voice, atelectasis, hiccups, respiratory depression, pulmonary edema, stridor, hepatic steatosis, hepatitis, jaundice, sweating, photosensitivity, acne, skin dryness, alopecia, contact dermatitis, eczema, papular rash, itching, seborrhea, skin discoloration, skin ulcers, urticaria, vesicular rash, hirsutism, pustular rash, drug reaction (DRESS), lumbago, chest pain, toothache, influenza syndrome, injection site pain, malaise, 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, uveitis, eye pain, abnormal eye muscle movement, taste disorder, tinnitus, corneal lesions, glaucoma, keratoconjunctivitis, decreased macular pigmentation, miosis, mydriasis, lenticular pigmentation, urinary incontinence, urinary tract infection, dysmenorrhea, vaginitis, abnormal ejaculation, amenorrhea, mastalgia, cystitis, decreased menstruation, urination disorders, 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 hesitation, albuminuria, breast enlargement, mastitis, decreased urine output, male erectile dysfunction, benign reduced libido, female amenorrhea, galactorrhea, breast enlargement, persistent erection, elevated plasma prolactin levels, increased alkaline phosphatase, elevated creatine kinase, increased gamma-glutamyl transferase, elevated uric acid, increased total bilirubin, neonatal withdrawal symptoms, ocular convulsions, confusion, muscular cramps, oculomotor nerve paralysis, headache, abdominal pain, pain, weight loss, bloody stools, convulsions, hypomania, sexual discomfort, nervous hyperreactivity, auditory hallucinations, hepatic failure, decreased appetite, urinary retention, pyelonephritis, ECG abnormalities, pupillary atony, torticollis, weight gain, drowsiness, increased appetite, sedation, hypersomnia

Store this medication in a tightly sealed container to protect it from air and moisture, preferably at room temperature between 15 and 30 degrees Celsius. Proper storage will help maintain the medication's effectiveness and safety.

Appearance

White, round, film-coated tablet

Package unit

28 tablets (7 tablets/PTPX4)