Aprexa Tablet 10 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 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 medicine should continue. However, efficacy was demonstrated in a placebo-controlled study in which patients with schizophrenia whose symptoms had stabilized after taking this medicine 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 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 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 receiving 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 continue, together with adjunctive treatment for mood symptoms as clinically indicated (optimizing the required dose). 3) For schizophrenia and for the 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 based on clinical status. 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 treatment with this medicine is discontinued, the dose should be reduced gradually and cautiously. 4) Acute treatment of depressive episodes associated with bipolar I disorder Start treatment with 5mg of olanzapine 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, so this medicine may be taken 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 sufficiently supported by 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 medicine (female sex, older age, and nonsmoking status) may also be started at a low dose.

This medication can cause a life-threatening symptom called neuroleptic malignant syndrome, so if symptoms such as unusual high fever, muscle rigidity, or changes in mental state occur, use should be stopped immediately and medical attention sought. It is advisable not to use in treating dementia-related psychosis or behavioral disorders, particularly in elderly patients where the risk of death and cerebrovascular disorders may increase. Long-term use may lead to a movement disorder called tardive dyskinesia, thus adjustments in dosage or discontinuation should be considered if symptoms occur. During initial treatment, it may take several days to weeks for effects to manifest, requiring careful observation of the patient. Symptoms of diabetes or hyperglycemia may occur or worsen, so blood sugar and weight should be regularly checked, and any unusual signs reported immediately. There may be changes in lipid levels, thus patients with dyslipidemia or risk factors should undergo regular blood tests. Sudden discontinuation of this drug may lead to symptoms such as sweating, insomnia, tremors, anxiety, and nausea, so it is advisable to taper off gradually. Caution is advised as this drug may exacerbate symptoms in patients with Parkinson's disease, and co-administration with dopamine agonists is not recommended. Acute cardiac deaths have been reported as heart-related side effects, so patients with cardiovascular diseases should be particularly careful. This medication should not be administered to patients with hypersensitivity to it, those with angle-closure glaucoma, those currently receiving epinephrine, or those with lactose intolerance. Caution is necessary for patients with poor liver function, liver disease, a history of seizures, or elderly patients with cardiovascular disease. This drug may cause drowsiness and dizziness, requiring care when driving or operating dangerous machinery. While taking this medication, white blood cell counts should be regularly checked through blood tests to reduce infection risk, and any unusual symptoms should be discussed with a doctor immediately. Women who are pregnant or breastfeeding should consult their doctor when using this drug as it may affect the fetus or newborn. In case of overdose, symptoms such as impaired consciousness, seizures, or heart issues may occur, necessitating immediate hospital treatment. This drug should be stored away from light and moisture at 15-30 degrees Celsius, and kept out of reach of children.

High fever, muscle rigidity, changes in mental state, irregular pulse, blood pressure changes, 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, increased prolactin, elevated cholesterol, elevated blood sugar, increased triglycerides, diabetes, increased appetite, inability to sit still, 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, increased uric acid, elevated creatine phosphokinase, edema, elevated triglycerides, petechiae, anemia, cyanosis, leukocytosis, lymphadenopathy, neutropenia, normocytic anemia, thrombocytosis, 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, insomnia, depression, vertigo, personality disorder, tremor, hypertonia, speech disorder, sensory abnormalities, apathy, confusion, abnormal euphoric state, coordination movement disorder, abnormal dreams, delusions, emotional instability, manic reactions, schizophrenic reactions, akinesia, alcohol abuse, antisocial reactions, inability to perform coordinated movements, CNS stimulation, cogwheel rigidity, incoherent speech, dementia, depersonalization, stuttering, facial paralysis, sensory loss, decreased motor activity, reduced muscle tone, decreased libido, increased libido, obsessive symptoms, phobias, somatization, stimulant abuse, confusion, tardive dyskinesia, dizziness, withdrawal syndrome, suicide attempts, amnesia, seizures, abnormal muscle tonicity, restless legs 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, palpitations, vasodilation, ventricular ectopia, 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, discoloration of the tongue, pancreatitis, 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 reaction, acne, skin dryness, alopecia, contact dermatitis, eczema, papular rash, pruritus, seborrhea, skin discoloration, skin ulcer, urticaria, vesicular rash, hypertrichosis, pustular rash, drug reaction (DRESS), low back pain, chest pain, toothache, flu-like syndrome, pain at the injection site, malaise, candidiasis, neck pain, neck rigidity, 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, cataracts, hearing loss, diplopia, dry eyes, ear pain, ocular hemorrhage, eye inflammation, pain in the eyes, abnormal ocular muscle, taste disturbances, tinnitus, corneal lesions, glaucoma, keratoconjunctivitis, macular pigmentation degeneration, miosis, mydriasis, lenticular pigmentation, urinary incontinence, urinary tract infection, dysmenorrhea, vaginitis, abnormal ejaculation, amenorrhea, breast pain, cystitis, reduced menstruation, urination disorders, galactorrhea in females, gynecomastia, hematuria, erectile dysfunction, increased menstruation, menorrhagia, uterine bleeding, polyuria, premenstrual syndrome, pyuria, frequent urination, urinary retention, oliguria, uterine fibroid hypertrophy, vaginal bleeding, urine retention, albuminuria, breast hypertrophy, mastitis, decreased urination, male erectile dysfunction, benign decreased libido, female amenorrhea, hypergalactorrhea, breast enlargement, gynecomastia, persistent erection, elevated plasma prolactin levels, increased alkaline phosphatase, elevated creatine phosphokinase, increased gamma-glutamyl transferase, uric acid elevation, total bilirubin increase, neonatal withdrawal symptoms, tachycardia, agitation, aggression, stuttering, various extrapyramidal symptoms, decreased level of consciousness, incoherent speech, convulsions, respiratory function suppression, aspiration, hypertension, hypotension, arrhythmia, cardiac arrest, ocular motor seizures, delirium, muscular cramps, ocular motor nerve paralysis, headaches, abdominal pain, pain, weight loss, bloody stools, convulsions, hypomania, sexual discomfort, neurogenic sensitivity response, hallucinations, liver failure, decreased appetite, urinary obstruction, pyelonephritis, electrocardiogram abnormalities, pupil immobility, torticollis, weight gain, drowsiness, increased appetite, sedation, hypersomnia

This medication may be sensitive to air and humidity, so it must be stored in a tightly sealed container. It is recommended to maintain storage temperature between 15 to 30 degrees Celsius. This way, the effectiveness of the medication can be preserved.

Appearance

White round film-coated tablets

Package unit

28 tablets (7 tablets/PTPX4)