PMS Olanzapine Tablet 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 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 provide a definite answer as to how long treatment with this medicine should continue, 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 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 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 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 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 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 olanzapine at 5mg once daily and increase to 10mg once daily. Administer this medicine at bedtime and adjust the dose as appropriate according to age and symptoms; do not exceed a daily dose of 20mg. Food does not affect drug absorption; therefore, this medicine may be taken with or without food. 2. Dosage in special populations 1) Older adults Initiation at a dose of 5 mg or less once 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 cases of 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 multiple factors that may 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 severe side effects known as neuroleptic malignant syndrome; immediate cessation of use is required if high fever, muscle rigidity, or changes in mental state occur. It is not recommended for use in dementia patients, as there may be an increased risk of mortality and cerebrovascular disorders with this medication. Prolonged use may result in a movement disorder known as tardive dyskinesia, so dosage adjustment or cessation should be considered if symptoms appear. Diabetic patients or those at risk of diabetes should regularly monitor blood sugar and weight, and consult a physician immediately if any abnormalities arise. This medication can cause drowsiness and dizziness; therefore, it is advisable to avoid driving or operating machinery while taking it. Patients with impaired liver function or liver disease should undergo regular liver function tests and may need to cease use if abnormalities are found. Those with cardiovascular diseases or the elderly should regularly check blood pressure and heart condition, particularly as orthostatic hypotension can occur. Pregnant or breastfeeding women should consult a physician before taking this medication, and it is safest to avoid use while breastfeeding. This medication may interact with other drugs; therefore, it is essential to inform healthcare professionals of any current medications being taken. Abrupt cessation of use may lead to withdrawal symptoms such as insomnia, anxiety, or nausea; therefore, gradual reduction as per the physician's instructions is necessary. In case of overdose, one should seek immediate medical treatment, as there is no specific antidote and symptomatic treatment is required.

High fever, muscle rigidity, changes in mental state, irregular pulse, changes in blood pressure, tachycardia, sweating, cardiac arrhythmia, elevated creatine phosphokinase, myoglobinuria, acute kidney failure, increased mortality rate, stroke, transient ischemic attack, tardive dyskinesia, drowsiness, weight gain, eosinophilia, elevated prolactin, increased cholesterol, elevated blood sugar, elevated 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 blood glucose, increased triglycerides, petechiae, anemia, cyanosis, leukocytosis, lymphadenopathy, neutropenia, hypersensitivity, 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, decreased body temperature, dizziness, abnormal gait in Alzheimer’s disease, insomnia, depression, vertigo, inability to sit still, all extrapyramidal symptoms, personality disorders, tremors, muscle hypertonicity, speech disorders, sensory disturbances, apathy, confusion, abnormal euphoria, coordination disorders, abnormal dreams, delusions, emotional instability, manic reactions, schizophrenic reactions, movement disability, alcohol abuse, antisocial reactions, inability to perform coordinated movements, CNS stimulation, cogwheel rigidity, delirium, dementia, depersonalization, stuttering, facial paralysis, sensory loss, reduced motor function, decreased muscle tone, decreased libido, increased libido, obsessive symptoms, phobias, somatization, stimulant abuse, confusion, tardive dyskinesia, dizziness, withdrawal syndrome, suicide attempts, memory loss, seizures, abnormal muscle tone, restless legs syndrome, peripheral facial paralysis, coma, encephalopathy, neuralgia, neuropathy, nystagmus, paralysis, subarachnoid hemorrhage, tobacco abuse, neuroleptic malignant syndrome, withdrawal symptoms, orthostatic hypotension, tachycardia, hypertension, hypotension, fainting, bradycardia, atrial fibrillation, cerebrovascular accident, congestive heart failure, cardiac arrest, hemorrhage, migraine, pallor, palpitations, vasodilation, ventricular ectopic contraction, QTc prolongation, thromboembolism, arteritis, heart failure, pulmonary embolism, ventricular fibrillation, sudden death, diabetes mellitus, diabetic ketoacidosis, goiter, constipation, polydipsia, 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, rhinitis, increased cough, pharyngitis, dyspnea, apnea, asthma, epistaxis, hemoptysis, hyperventilation, hypoxia, laryngitis, voice changes, atelectasis, hiccups, respiratory depression, pulmonary edema, stridor, hepatic steatosis, hepatitis, jaundice, sweating, photosensitivity reactions, acne, skin dryness, alopecia, contact dermatitis, eczema, papular rash, itching, seborrhea, skin discoloration, skin ulcers, urticaria, vesicular rash, hirsutism, pustular rash, drug reaction (DRESS), low back pain, chest pain, toothache, influenza-like syndrome, injection site pain, abdominal enlargement, chills, facial edema, self-harm, 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, cataract, hearing loss, diplopia, dry eyes, ear pain, ocular hemorrhage, ocular inflammation, eye pain, ocular muscle abnormalities, taste disturbances, tinnitus, corneal lesions, glaucoma, conjunctival keratitis, decreased macular pigmentation, miosis, mydriasis, lens pigmentation, urinary incontinence, urinary tract infection, dysmenorrhea, vaginitis, abnormal ejaculation, amenorrhea, breast pain, cystitis, reduced menstruation, urination disorders, female galactorrhea, gynecomastia, hematuria, erectile dysfunction, increased menstruation, menorrhagia, uterine bleeding, polyuria, premenstrual syndrome, pyuria, frequent urination, urinary retention, anuria, uterine fibroid hypertrophy, vaginal bleeding, urinary delay, albuminuria, breast enlargement, mastitis, oliguria, male erectile dysfunction, benign hypersexuality, female amenorrhea, galactorrhea, breast enlargement, persistent erection, elevated plasma prolactin levels, increased total bilirubin, neonatal withdrawal syndrome, tachycardia, excitement, aggression, stuttering, various extrapyramidal symptoms, decreased level of consciousness, delirium, seizures, neuroleptic malignant syndrome, respiratory function inhibition, aspiration, hypertension, hypotension, arrhythmia, cardiac arrest, ocular movement seizures, confusion, tonic-clonic seizures, ocular movement nerve paralysis, headache, abdominal pain, pain, weight loss, bloody stool, spasms, hypomania, sexual discomfort, neurosthenic reactions, auditory hallucinations, liver failure, decreased appetite, urinary retention, pyelonephritis, ECG abnormalities, pupillary atonia, torticollis, weight gain, drowsiness, sedation, hypersomnolence

This medication should be stored in a tightly sealed container to prevent exposure to air or moisture. It is advisable to keep it at room temperature between 15 to 30 degrees Celsius.

Appearance

White round film-coated tablet

Package unit

30 tablets (10 tablets/Alu-Alu × 3)