Zyprexa 5 mg Tablet (Olanzapine)

Adult dose

The therapeutic dose of this medicine should be adjusted according to the patient's clinical condition. Increases above the generally 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 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 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 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 therapy to treat mood symptoms as clinically indicated (optimizing the required doses). 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 daily based on clinical condition. Increases above the recommended initial dose are recommended only after an appropriate clinical evaluation, and dose increases should generally be made at intervals of 24 hours or longer. If treatment with this medicine is discontinued, the dose should be gradually reduced with caution. 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 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. Administration in special populations 1) Older adults Starting at a dose of 5 mg or less daily may be considered when supported by sufficient 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 start at a lower dose. 3. Precautions (for orally disintegrating tablets only) This medicine is fragile. Remove it from the outer packaging and open the blister by peeling off the metal foil on the back. Do not press the tablet through the metal foil when opening. Immediately after opening the blister, remove the tablet with dry hands and place it directly in the mouth. The tablet dissolves rapidly in saliva and may be swallowed with or without a drink.

This drug may cause a serious side effect known as neuroleptic malignant syndrome, which can be life-threatening, so if unusual symptoms or unexplained high fever occur, use should be stopped immediately and medical attention should be sought. It is recommended not to use this drug for the treatment of psychosis or behavioral disturbances associated with dementia, especially in elderly patients where there may be an increased risk of mortality and cerebrovascular disorders. Long-term use may lead to tardive dyskinesia, a movement disorder, so dosage adjustment or discontinuation should be considered if symptoms appear. The initial treatment may take time to show effects, so close observation of the patient's condition is necessary. Patients at risk for diabetes or hyperglycemia should regularly monitor blood sugar and weight, and consult medical personnel immediately if any abnormal symptoms appear. Sudden discontinuation of this medication may result in symptoms such as insomnia, anxiety, and vomiting, so gradual dosage reduction is recommended. For those with heart conditions or elderly patients, it is necessary to regularly check blood pressure and cardiac status. Pregnant or breastfeeding women should consult a doctor as this medication can affect the fetus or newborn. This drug may cause drowsiness and dizziness, so caution should be taken when driving or operating hazardous machinery. It may interact with other medications, so if you are taking other drugs, be sure to inform your healthcare provider, and dosage adjustment may be necessary, especially in cases of smoking or taking certain medications. Serious side effects may occur in the case of overdose, so prescribed usage and dosage should be strictly followed, and it should be stored out of reach of children.

Hyperthermia, muscle rigidity, change in mental status, irregular pulse, blood pressure changes, tachycardia, sweating, cardiac arrhythmia, increased creatine phosphokinase, myoglobinuria, acute kidney failure, increased mortality rate, cerebrovascular adverse reactions, stroke, transient ischemic attacks, tardive dyskinesia, drowsiness, weight gain, eosinophilia, increased prolactin, elevated cholesterol, elevated blood sugar, increased triglycerides, diabetes, increased appetite, akathisia, Parkinsonism, leukopenia, neutropenia, movement disorders, orthostatic hypotension, anticholinergic effects, increased liver transaminases, rash, weakness, fatigue, fever, arthralgia, increased alkaline phosphatase, elevated gamma-glutamyl transferase, increased uric acid, elevated creatine kinase, edema, elevated blood glucose levels, increased triglycerides, 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, ketosis, coma, gout, hypernatremia, hypoalbuminemia, ketonemia, water intoxication, hypothermia, dizziness, abnormal gait in Alzheimer's disease, insomnia, depression, vertigo, Parkinsonism, dyskinesia, extrapyramidal symptoms, personality disorders, tremors, hypertonia, verbal dyspraxia, sensory disturbances, apathy, confusion, abnormal euphoria, coordination disorders, abnormal dreams, delusions, emotional instability, manic reactions, schizophrenic reactions, motor incapacitation, alcohol abuse, antisocial reactions, coordination deficits, CNS stimulation, cogwheel rigidity, nonsense speech, dementia, depersonalization, stuttering, facial paralysis, sensory deficit, decreased motor activity, decreased muscle tone, decreased libido, increased libido, obsessive symptoms, phobias, somatisation, stimulant abuse, confusion, tardive dyskinesia, vertiginous dizziness, withdrawal syndrome, suicide attempts, amnesia, seizures, abnormal muscle tone, 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, ventricular ectopy, QT 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 ulcers, nausea, oral candidiasis, periodontitis, rectal bleeding, stomatitis, tongue edema, dental caries, diarrhea, abdominal distension, sialorrhea, aphthous stomatitis, enteritis, belching, esophageal ulcer, glossitis, intestinal obstruction, bowel obstruction, tongue discoloration, pancreatitis, rhinitis, increased cough, pharyngitis, dyspnea, apnea, asthma, epistaxis, hemoptysis, hyperventilation, hypoxia, laryngitis, voice changes, atelectasis, hiccups, decreased respiration, pulmonary edema, stridor, liver steatosis, hepatitis, jaundice, sweating, phototoxic reactions, acne, dry skin, 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, flu-like 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, eye inflammation, eye pain, abnormal eye muscle function, taste disturbances, tinnitus, corneal lesions, glaucoma, keratoconjunctivitis, decreased macular pigmentation syndrome, miosis, mydriasis, lenticular pigmentation, urinary incontinence, urinary tract infection, dysmenorrhea, vaginitis, abnormal ejaculation, amenorrhea, mastalgia, cystitis, reduced menstruation, micturition disorders, female lactation, gynecomastia, hematuria, erectile dysfunction, increased menstruation, menorrhagia, uterine bleeding, polyuria, premenstrual syndrome, pyuria, frequent urination, urinary retention, anuria, uterine fibrous hypertrophy, vaginal bleeding, delayed urination, albuminuria, breast enlargement, mastitis, decreased urine output, male erectile dysfunction, decreased libido in benign all conditions, female amenorrhea, hyperlactation, breast enlargement, persistent erection, elevated plasma prolactin levels, increased alkaline phosphatase, elevated creatine phosphokinase, increased gamma-glutamyl transferase, elevated uric acid, increased total bilirubin, neonatal withdrawal symptoms, oculomotor seizures, confusion, myotonic muscle spasms, oculomotor nerve paralysis, headache, abdominal pain, pain, weight loss, bloody stools, seizures, myoclonus, sexual discomfort, neuro-sensitivity reactions, hallucinations, liver failure, decreased appetite, urinary retention, pyelonephritis, abnormal ECG, pupillary atony, torticollis, tachycardia, excitement, aggressiveness, stuttering, various extrapyramidal symptoms, reduced level of consciousness, nonsense speech, seizures, coma, respiratory function inhibition, aspiration, hypertension, hypotension, arrhythmia, cardiopulmonary arrest

This drug should be stored in a tightly sealed container to prevent air exposure, and it is best to keep it at room temperature between 15 to 30 degrees Celsius. Proper storage will maintain the drug's efficacy and prevent degradation.

Appearance

White or light gray round film-coated tablet

Package unit

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