Olanzapine Tablets 5mg (Olanzapine)

Adult dose

The therapeutic dose of this medicine should be adjusted according to the patient's clinical condition. Dose increases exceeding 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 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 approximately 8 weeks received maintenance treatment with 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. For patients who have been receiving this medicine to treat mania, 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 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 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 5 mg once daily, and increase to 10 mg 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 20 mg. Food does not affect absorption of the medicine, so it may be taken with or without food. 2. Dosing in special populations 1) Elderly patients Starting at a dose of 5 mg or less once 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. For 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 medicine (female sex, advanced age, and nonsmoking status) may also be started at a low dose. 3. Precautions (orally disintegrating tablet only) This medicine is fragile. Remove it from the outer package and open the blister by peeling off the foil on the back. Do not push the tablet through the foil when opening. Immediately after opening the blister, remove the tablet with dry hands and place it directly in the mouth. The tablet rapidly disintegrates in saliva and may be swallowed with or without a drink.

This medication can cause a serious side effect known as Neuroleptic Malignant Syndrome, so if symptoms like high fever, muscle rigidity, or changes in mental status occur, immediate consultation with a doctor is necessary. It is generally not recommended for treating psychosis or behavioral disorders related to dementia, particularly in elderly patients, where there may be an increased risk of mortality and cerebrovascular accidents. Long-term use may cause tardive dyskinesia; thus, if symptoms of movement disorders arise, consider adjusting or discontinuing the dose in consultation with a doctor. This medication can affect blood sugar control, so diabetic patients or those with risk factors should regularly monitor blood glucose and weight. Sudden discontinuation during treatment can cause symptoms such as sweating, insomnia, and anxiety, so gradual tapering is safer. Patients with impaired liver function or signs of liver damage should use this drug with caution, and regular liver function testing is recommended. For patients with cardiovascular disease, the elderly, or those with prolonged QT interval, careful observation of cardiac status is necessary when using this drug. This medication may cause drowsiness and dizziness; caution is advised when driving or operating hazardous machinery. Pregnant or breastfeeding women should use this drug cautiously, as it may affect the fetus or newborn, and should consult a doctor before use. There may be interacting medications with this drug; therefore, inform healthcare providers of any other medications being taken. Overdose can lead to serious side effects, so follow the prescribed dosage and visit a medical institution immediately if abnormal symptoms occur.

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, stroke, transient ischemic attack, tardive dyskinesia, drowsiness, weight gain, eosinophilia, elevated prolactin, elevated 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, elevated uric acid, elevated creatine kinase, edema, increased blood glucose, elevated triglycerides, petechiae, anemia, cyanosis, leukocytosis, lymphadenopathy, neutropenia, hypersensitivity reactions, acidosis, increased alkaline phosphatase, hyperbilirubinemia, dehydration, hypercholesterolemia, hyperglycemia, hyperlipidemia, hyperuricemia, hypoglycemia, hypokalemia, hyponatremia, lower extremity edema, upper extremity edema, hyperkalemia, ketoacidosis, coma, gout, hypernatremia, hypoproteinemia, ketosis, water intoxication, hypothermia, dizziness, abnormal gait in Alzheimer's disease, insomnia, depression, dizziness, personality disorder, tremors, muscle rigidity, speech disorder, sensory disturbance, apathy, confusion, euphoric state, coordination disorders, abnormal dreams, delusions, emotional instability, manic response, schizophrenia response, akinetic mutism, alcohol abuse, antisocial responses, inability to perform coordinated movements, CNS stimulation, cogwheel rigidity, nonsensical speech, dementia, depersonalization, stuttering, facial paralysis, sensory loss, reduced movement, muscle tone reduction, decreased libido, increased libido, obsessive symptoms, phobia, somatization, stimulant abuse, confusion, tardive dyskinesia, vertigo, withdrawal syndrome, suicide attempt, amnesia, seizures, abnormal muscle tone, restless legs syndrome, maxillary paralysis, coma, encephalopathy, neuralgia, neuropathy, nystagmus, paralysis, subarachnoid hemorrhage, tobacco abuse, malignant neuroleptic syndrome, withdrawal symptoms, tachycardia, hypertension, hypotension, syncope, bradycardia, atrial fibrillation, congestive heart failure, cardiac arrest, hemorrhage, migraine, pallor, palpitations, vasodilation, premature ventricular contractions, prolonged QTc, 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, excessive salivation, rhinitis, increased cough, pharyngitis, dyspnea, apnea, asthma, nosebleed, hemoptysis, hyperventilation, hypoxemia, laryngitis, voice changes, atelectasis, hiccups, respiratory depression, pulmonary edema, wheezing, fatty liver deposition, hepatitis, jaundice, sweating, photosensitivity reaction, acne, dry skin, alopecia, contact dermatitis, eczema, papulopustular rash, itching, seborrhea, skin discoloration, skin ulcer, urticaria, vesicular rash, hirsutism, pustular rash, drug reaction (DRESS), low back pain, chest pain, toothache, flu syndrome, injection site pain, abdominal enlargement, chills, facial swelling, self-inflicted injury, lethargy, candidiasis, cervical pain, cervical 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, abnormal ocular muscles, taste disturbances, tinnitus, corneal lesions, glaucoma, keratoconjunctivitis, decreased macular pigmentation, pupil constriction, pupil dilation, lenticular pigmentation, urinary incontinence, urinary tract infection, dysmenorrhea, vaginitis, abnormal ejaculation, amenorrhea, breast pain, cystitis, reduced menstruation, urinary disorders, women's milk secretion, gynecomastia, hematuria, erectile dysfunction, increased menstruation, menorrhagia, uterine bleeding, polyuria, premenstrual syndrome, pyuria, increased frequency of urination, urine retention, oliguria, uterine fibroid hypertrophy, vaginal bleeding, urinary delay, albuminuria, breast enlargement, mastitis, decreased urination, male erectile dysfunction, benign decreased libido, female amenorrhea, galactorrhea, breast enlargement, persistent erection, elevated plasma prolactin levels, increased alkaline phosphatase, elevated creatine kinase, elevated gamma-glutamyl transferase, elevated uric acid, increased total bilirubin, neonatal withdrawal symptoms, ocular motor seizures, confusion, decerebrate rigidity, oculomotor nerve paralysis, headache, abdominal pain, pain, weight loss, hematochezia, spasms, hypomania, sexual discomfort, neuro-sensitization reactions, auditory hallucinations, liver failure, decreased appetite, urinary retention, pyelonephritis, ECG abnormalities, pupil atonia, torticollis, weight gain, drowsiness, increased appetite, sedation, hypersomnia, tachycardia, agitation, aggression, stuttering, various extrapyramidal symptoms, decreased level of consciousness, nonsensical speech, spasms, coma, respiratory function inhibition, aspiration, hypertension, hypotension, arrhythmia, cardiac arrest

Store this medication in a tightly sealed container to prevent air exposure, and it is best kept at room temperature between 15 and 30 degrees Celsius. Proper storage will help maintain the drug's efficacy and prevent degradation.

Appearance

White, round, film-coated tablet

Package unit

28 tablets (7 tablets/PTP packaging × 4), 30 tablets/bottle, 100 tablets/bottle