Medication info
Zyprexa Tablet 5 mg (Olanzapine)

Zyprexa Tablet 5 mg (Olanzapine)

Prescription medicationTabletOral
Ingredient · strength
Olanzapine›5mg / 1 tablet
Manufacturer / importer
Hallym Pharmaceutical Co., Ltd.
Appearance
White round film-coated tablet
Packaging
30 tablets (10 tablets/Alu-Alu X3)
Approval status
Active

MFDS item code 201007770 · Notified 2010.12.30 · Insurance code 645304960

Summary

Main use
Treatment and prevention of recurrence of bipolar disorder (manic and depressive episodes, etc.); treatment of schizophrenia
Who takes it
Adults
Adult dose
The therapeutic dose of this medication should be adjusted according to the patient's clinical condition. Increasing the dose above the general recommended daily dose of 10 mg is recommended only after an appropriate clinical evaluation. 1. Adults 1) Schizophrenia (1) The initial recommended 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 medication should continue, its efficacy was demonstrated in a placebo-controlled study in which patients with schizophrenia whose symptoms had stabilized after taking this medication for about 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 medication once daily when used as monotherapy, or 10 mg once daily when used as adjunctive therapy with lithium or valproate. (2) Prevention of recurrence in bipolar disorder The initial recommended dose is 10 mg once daily. In patients who have been taking this medication to treat mania, continue the same dose to prevent recurrence. If a new manic, mixed, or depressive episode occurs, treatment with this medication should be continued, together with adjunctive therapy to treat mood symptoms as clinically indicated (optimizing the required doses). 3) For schizophrenia; 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 daily based on clinical status. Increases above the initial recommended dose are recommended only after an appropriate clinical evaluation and should generally be made at intervals of 24 hours or more. If this medication is discontinued, the dose should be gradually reduced with care. 4) Acute treatment of depressive episodes associated with bipolar I disorder Initiate treatment with 5mg of olanzapine once daily, then increase to 10mg once daily. Administer this medication 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, so this medication 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 there is sufficient evidence based on 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 with caution. 3) Patients with a combination of factors that delay the metabolism of this medication (female sex, older age, nonsmoking status) may also be started at a lower dose.

Ingredients

Manufacturer
Hallym Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment and prevention of recurrence of bipolar disorder (manic and depressive episodes, etc.); treatment of schizophrenia

  • Schizophrenia
  • mania
  • mixed episodes
  • recurrence of bipolar disorder
  • depressive episodes
View approved original text

This medication is used for the treatment of schizophrenia and bipolar disorder. In the case of bipolar disorder, it is effective in treating mania and mixed episodes, as well as helping to prevent relapse in patients who have responded to acute mania episodes. It is also utilized for the acute treatment of depressive episodes related to bipolar disorder type I. This contributes to mental stability and symptom improvement.

How to take

Adult dose

The therapeutic dose of this medication should be adjusted according to the patient's clinical condition. Increasing the dose above the general recommended daily dose of 10 mg is recommended only after an appropriate clinical evaluation. 1. Adults 1) Schizophrenia (1) The initial recommended 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 medication should continue, its efficacy was demonstrated in a placebo-controlled study in which patients with schizophrenia whose symptoms had stabilized after taking this medication for about 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 medication once daily when used as monotherapy, or 10 mg once daily when used as adjunctive therapy with lithium or valproate. (2) Prevention of recurrence in bipolar disorder The initial recommended dose is 10 mg once daily. In patients who have been taking this medication to treat mania, continue the same dose to prevent recurrence. If a new manic, mixed, or depressive episode occurs, treatment with this medication should be continued, together with adjunctive therapy to treat mood symptoms as clinically indicated (optimizing the required doses). 3) For schizophrenia; 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 daily based on clinical status. Increases above the initial recommended dose are recommended only after an appropriate clinical evaluation and should generally be made at intervals of 24 hours or more. If this medication is discontinued, the dose should be gradually reduced with care. 4) Acute treatment of depressive episodes associated with bipolar I disorder Initiate treatment with 5mg of olanzapine once daily, then increase to 10mg once daily. Administer this medication 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, so this medication 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 there is sufficient evidence based on 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 with caution. 3) Patients with a combination of factors that delay the metabolism of this medication (female sex, older age, nonsmoking status) may also be started at a lower dose.

Precautions

This medication can cause serious side effects known as neuroleptic malignant syndrome, so if high fever, muscle rigidity, or changes in mental state occur, discontinue use immediately and consult a doctor. It is not recommended for the treatment of psychosis or behavior disorders related to dementia, especially since the mortality rate and risk of cerebrovascular disease may increase in elderly patients. Long-term use may lead to a movement disorder known as tardive dyskinesia, so if abnormal symptoms appear, consider dose adjustment or discontinuation. During treatment with this medication, blood sugar and weight may increase, so diabetic patients or those with risk factors should regularly monitor their blood sugar and weight. Sudden discontinuation can cause symptoms such as insomnia, anxiety, and nausea, so dosage should be reduced gradually according to the doctor's instructions. Patients with cardiovascular disease or the elderly may be at risk for hypotension, bradycardia, and fainting, so caution is needed, and regular blood pressure monitoring is recommended. This medication can cause drowsiness and dizziness, so care should be taken when driving or operating hazardous machinery. Patients with liver function abnormalities should undergo regular liver function tests and consult a doctor if abnormalities are found. This medication is metabolized by certain enzymes, so there may be interactions with other drugs; inform the doctor of any other medications being taken. Pregnant or breastfeeding women should consult a doctor before use, as it may affect the fetus or newborn. Safety in children and adolescents has not been established, so it should be used with caution in this age group. Serious side effects can occur in the case of overdose, so it's important to adhere to the prescribed dosage and seek medical attention immediately if abnormal symptoms arise. When storing, keep out of reach of children, avoid direct sunlight and moisture, and store at a temperature between 15°C and 30°C.

Side effects

High fever, muscle rigidity, changes in mental status, irregular pulse, blood pressure changes, tachycardia, sweating, cardiac arrhythmia, elevated creatine phosphokinase, myoglobinuria, acute kidney failure, increased mortality rate, cerebrovascular adverse reactions, stroke, transient ischemic attack, tardive dyskinesia, drowsiness, weight gain, eosinophilia, elevated prolactin, elevated cholesterol, elevated blood sugar, elevated 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, elevated creatine phosphokinase, edema, elevated 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 limb edema, upper limb edema, hyperkalemia, ketoacidosis, coma, gout, hypernatremia, hypoproteinemia, ketosis, water intoxication, hypothermia, dizziness, abnormal gait in Alzheimer's disease patients, insomnia, depression, lightheadedness, Parkinsonism, all extrapyramidal symptoms, personality disorders, tremors, hypertonia, dysarthria, sensory disturbances, apathy, confusion, abnormal euphoria, coordination disorders, abnormal dreams, delusions, emotional instability, manic reactions, schizophrenia responses, akinesia, alcohol abuse, antisocial reactions, coordination impairment, CNS stimulation, cogwheel rigidity, nonsensical speech, dementia, depersonalization, stuttering, facial paralysis, sensory loss, decreased mobility, muscle hypotonia, decreased libido, increased libido, obsessive symptoms, phobias, somatization, stimulant abuse, confusion, tardive dyskinesia, vertigo, withdrawal syndrome, suicide attempts, amnesia, seizures, muscle tone abnormalities, restless legs syndrome, perioral paralysis, coma, encephalopathy, neuralgia, neuropathy, nystagmus, paralysis, subarachnoid hemorrhage, tobacco abuse, neuroleptic malignant syndrome, withdrawal symptoms, orthostatic hypotension, tachycardia, hypotension, syncope, bradycardia, atrial fibrillation, cerebrovascular accident, congestive heart failure, cardiac arrest, hemorrhage, migraine, pallor, palpitations, vasodilation, ventricular ectopic beats, QTc prolongation, thromboembolism, arteritis, heart failure, pulmonary embolism, ventricular fibrillation, sudden death, diabetes mellitus, diabetic acidosis, 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, 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 reactions, low back pain, chest pain, dental pain, flu-like syndrome, injection site pain, abdominal distension, chills, facial edema, self-harm, fatigue, candidiasis, throat pain, neck stiffness, pelvic pain, hangover, sudden death, joint rigidity, single contraction, arthritis, arthrosis, leg cramps, myasthenia gravis, arthralgia, bone pain, bursitis, myopathy, osteoporosis, rheumatoid arthritis, rhabdomyolysis, amblyopia, visual disturbances, conjunctivitis, abnormal accommodation, blepharitis, cataracts, hearing loss, diplopia, dry eyes, ear pain, hemorrhage in the eye, uveitis, eye pain, ocular muscle abnormalities, taste disturbances, tinnitus, corneal lesions, glaucoma, keratoconjunctivitis, macular pigmentary degeneration, miosis, mydriasis, lenticular pigmentation, urinary incontinence, urinary tract infection, dysmenorrhea, vaginitis, abnormal ejaculation, amenorrhea, mastalgia, cystitis, reduced menstruation, urination disorders, female galactorrhea, gynecomastia, hematuria, erectile dysfunction, increased menstruation, menorrhagia, uterine bleeding, polyuria, premenstrual syndrome, pyuria, frequency of urination, urinary retention, oliguria, uterine fibrotic hypertrophy, vaginal bleeding, urinary hesitation, albuminuria, breast hypertrophy, mastitis, reduced urination, male erectile dysfunction, benign sexual desire decrease, female amenorrhea, galactorrhea, breast enlargement, gynecomastia, persistent erection, elevated plasma prolactin levels, increased alkaline phosphatase, elevated creatine phosphokinase, elevated gamma-glutamyl transferase, increased uric acid, increased total bilirubin, neonatal withdrawal symptoms, ocular motor seizures, disorientation, myotonic contractions, oculomotor nerve paralysis, headache, abdominal pain, pain, weight loss, hematochezia, convulsions, hypomania, sexual discomfort, neuroexcitability reactions, auditory hallucinations, hepatic failure, decreased appetite, urinary retention, pyelonephritis, abnormal ECG, pupil unresponsiveness, torticollis, weight gain, drowsiness, increased appetite, sedation, hypersomnia, tachycardia, agitation, aggression, stuttering, various extrapyramidal symptoms, decreased level of consciousness, nonsensical speech, convulsions, neuroleptic malignant syndrome, respiratory function inhibition, aspiration, hypertension, hypotension, arrhythmia, cardiopulmonary arrest

Not everyone experiences these, and they can vary from person to person.

Storage

This medication should be stored in a tightly sealed container to prevent air from entering and is best kept at room temperature between 15°C and 30°C. Proper storage helps maintain the medication's effectiveness and prevents deterioration.

Appearance and packaging

Appearance

White round film-coated tablet

Package unit

30 tablets (10 tablets/Alu-Alu X3)

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

Questions about this medicine

No questions yet.

For anything that needs medical judgment, consult a doctor or pharmacist.

Related searches

Search tags

Suggested searches

This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.