Medication info
Olzapin Tablet 5 mg (Olanzapine)

Olzapin Tablet 5 mg (Olanzapine)

Prescription medicationTabletOral
Ingredient · strength
Olanzapine›5mg / 1 tablet
Manufacturer / importer
Donghwa Pharmaceutical Co., Ltd.
Appearance
White round film-coated tablet
Packaging
30 tablets (10 tablets/Alu-Alu×3)
Approval status
Active

MFDS item code 201102755 · Notified 2011.04.29 · Insurance code 642705720

Summary

Main use
Treatment of schizophrenia; treatment and prevention of recurrence of bipolar disorder (manic and depressive episodes, etc.)
Who takes it
Adults
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. Schizophrenia: The recommended initial dose is 5∼10 mg of olanzapine once daily. Maintenance treatment of schizophrenia: Efficacy was demonstrated in a placebo-controlled study in patients with schizophrenia whose symptoms had stabilized after taking this medicine for approximately 8 weeks and who received maintenance treatment for 8 months at doses of 10∼20 mg daily. The need for maintenance treatment at an appropriate dose should be assessed periodically. Treatment of manic and mixed episodes associated with bipolar I disorder: The initial dose is 15 mg once daily as monotherapy, or 10 mg once daily as adjunctive therapy with lithium or valproate. 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, together with adjunctive therapy to treat mood symptoms as clinically indicated (with the dose optimized as needed). Treatment of schizophrenia and 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 the clinical condition. Increases above the recommended initial dose are recommended only after an appropriate clinical evaluation, and the dose should generally be increased at intervals of 24 hours or longer. If treatment with this medicine is discontinued, the dose should be reduced gradually and cautiously. Acute treatment of depressive episodes associated with bipolar I disorder: Start treatment with olanzapine 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, but do not exceed a daily dose of 20mg. This medicine may be taken with or without food because food does not affect its absorption. Older adults: Starting at a dose of 5 mg or less daily may be considered when there is sufficient evidence based on clinical factors. 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. 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.

Ingredients

Manufacturer
Donghwa Pharmaceutical Co., Ltd.

Efficacy & effects

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

  • Schizophrenia
  • mania
  • mixed episodes
  • manic episodes
  • depressive episodes
View approved original text

This medication is used for the treatment of schizophrenia and bipolar disorder. Specifically, it is effective in treating manic and mixed episodes associated with bipolar disorder type I and helps prevent recurrence in patients who respond to manic episodes. It is also used for the acute treatment of depressive episodes associated with bipolar disorder type I, contributing to symptom relief. These properties help improve the mental health of patients.

How to take

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. Schizophrenia: The recommended initial dose is 5∼10 mg of olanzapine once daily. Maintenance treatment of schizophrenia: Efficacy was demonstrated in a placebo-controlled study in patients with schizophrenia whose symptoms had stabilized after taking this medicine for approximately 8 weeks and who received maintenance treatment for 8 months at doses of 10∼20 mg daily. The need for maintenance treatment at an appropriate dose should be assessed periodically. Treatment of manic and mixed episodes associated with bipolar I disorder: The initial dose is 15 mg once daily as monotherapy, or 10 mg once daily as adjunctive therapy with lithium or valproate. 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, together with adjunctive therapy to treat mood symptoms as clinically indicated (with the dose optimized as needed). Treatment of schizophrenia and 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 the clinical condition. Increases above the recommended initial dose are recommended only after an appropriate clinical evaluation, and the dose should generally be increased at intervals of 24 hours or longer. If treatment with this medicine is discontinued, the dose should be reduced gradually and cautiously. Acute treatment of depressive episodes associated with bipolar I disorder: Start treatment with olanzapine 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, but do not exceed a daily dose of 20mg. This medicine may be taken with or without food because food does not affect its absorption. Older adults: Starting at a dose of 5 mg or less daily may be considered when there is sufficient evidence based on clinical factors. 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. 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.

Precautions

This medication can cause serious side effects such as neuroleptic malignant syndrome, which may be life-threatening. If symptoms such as high fever, muscle rigidity, or altered mental status occur, do not use the medication and seek medical attention immediately. It is advisable not to use this drug for the treatment of psychosis or behavioral disorders associated with dementia, especially in older patients, as it may increase the risk of mortality and cerebrovascular events. Long-term use of this drug may lead to tardive dyskinesia, a movement disorder, so if any abnormal symptoms appear, consider adjusting the dosage or discontinuing use. During the initial treatment, effects may take time to manifest, so patients should be closely monitored. Diabetes symptoms may worsen or newly develop, so blood sugar and weight should be checked regularly, and if symptoms such as thirst, frequent urination, or fatigue occur, report them immediately. Lipid levels may change, necessitating regular blood lipid tests, and sudden discontinuation of the medication may result in insomnia, anxiety, nausea, etc., so it is safer to taper the dose gradually. It is not recommended for patients with Parkinson's disease, and special caution is needed for patients with heart disease, elderly individuals, or those with impaired liver function. Women who are pregnant or breastfeeding should consult a doctor, as this medication may affect the fetus or newborn. This drug can cause drowsiness and dizziness, so care should be taken when driving or operating dangerous machinery. In cases of overdose, symptoms such as decreased consciousness, seizures, and cardiac abnormalities may occur, requiring immediate emergency treatment; there is no specific antidote. Store this medication out of the reach of children, in an airtight container, avoiding direct sunlight and moisture, at a temperature between 15 to 30 degrees Celsius.

Side effects

High fever, muscle rigidity, changes in mental state, irregular pulse, unstable blood pressure, tachycardia, sweating, cardiac arrhythmia, elevated creatine phosphokinase, myoglobinuria, acute renal failure, increased mortality rate, 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 syndrome, 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, elevated blood glucose, elevated triglycerides, petechiae, anemia, cyanosis, leukocytosis, lymphadenopathy, neutropenia, hypersensitivity reactions, acidosis, increased alkaline phosphatase, hyperbilirubinemia, dehydration, hypercholesterolemia, hyperglycemia, dyslipidemia, 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, insomnia, depression, lightheadedness, inability to sit still, all extrapyramidal symptoms, personality disorder, tremor, muscle rigidity, speech disorder, sensory disturbance, apathy, confusion, euphoric state, coordination movement disorder, abnormal dreams, delusions, emotional instability, manic episodes, schizophrenia response, akinesia, alcohol abuse, antisocial reactions, inability to perform coordinated movements, CNS stimulation, cogwheel rigidity, nonsense speech, dementia, depersonalization, stuttering, facial paralysis, sensory loss, reduced motor activity, decreased muscle tone, decreased libido, increased libido, obsessive symptoms, phobia, somatization, stimulant abuse, confusion, tardive dyskinesia, vertigo, withdrawal syndrome, suicide attempt, amnesia, seizures, muscle tone disorders, restless legs syndrome, paralysis around the mouth, coma, encephalopathy, neuralgia, neuropathy, nystagmus, paralysis, subarachnoid hemorrhage, tobacco abuse, malignant neuroleptic 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 ectopic contractions, QTc prolongation, 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, swelling of the tongue, dental caries, diarrhea, abdominal bloating, excessive salivation, rhinitis, increased cough, pharyngitis, shortness of breath, apnea, asthma, nosebleeds, hemoptysis, hyperventilation, hypoxia, laryngitis, voice changes, atelectasis, hiccups, respiratory depression, pulmonary edema, stridor, fatty liver, hepatitis, jaundice, sweating, photosensitivity reactions, acne, skin dryness, alopecia, contact dermatitis, eczema, papular rash, itching, seborrhea, skin discoloration, skin ulcers, hives, vesicular rash, hirsutism, pustular rash, drug reaction (DRESS), low back pain, chest pain, toothache, influenza syndrome, injection site pain, edema, abdominal enlargement, chills, facial edema, intentional self-harm, lethargy, candidiasis, neck pain, neck stiffness, pelvic pain, hangover, sudden death, joint stiffness, single contraction, arthritis, arthropathy, 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, retinal hemorrhage, ocular inflammation, eye pain, ocular muscle abnormalities, taste disturbances, tinnitus, corneal lesions, glaucoma, keratoconjunctivitis, decreased macular pigmentation, miosis, mydriasis, lens pigmentation, urinary incontinence, urinary tract infection, dysmenorrhea, vaginitis, abnormal ejaculation, amenorrhea, mastalgia, cystitis, decreased menstruation, urinary disorders, female galactorrhea, gynecomastia, hematuria, erectile dysfunction, increased menstruation, menorrhagia, uterine bleeding, polyuria, premenstrual syndrome, pyuria, urinary frequency, oliguria, anuria, uterine fibroid hypertrophy, vaginal bleeding, urinary retention, albuminuria, breast enlargement, mastitis, reduced urine output, male erectile dysfunction, decreased libido in benign conditions, 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 movement seizures, confusion, metabolic muscle spasm, oculomotor nerve paralysis, headache, abdominal pain, painful sensations, weight loss, bloody stools, spasms, hypomania, sexual discomfort, neurogenic hypersensitivity reactions, hallucinations, liver failure, decreased appetite, urinary retention, pyelonephritis, abnormal ECG, pupillary atony, torticollis, tachycardia, excitement, aggression, stuttering, various extrapyramidal symptoms, decreased level of consciousness, nonsense speech, spasms, respiratory function suppression, 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 an airtight container to prevent air exposure, preferably at room temperature between 15 to 30 degrees Celsius. Proper storage will help maintain the drug's effectiveness for a longer time.

Appearance and packaging

Appearance

White round film-coated tablet

Package unit

30 tablets (10 tablets/Alu-Alu×3)

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.

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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.