Medication info
Olzapeck 5 mg (Olanzapine)

Olzapeck 5 mg (Olanzapine)

Prescription medicationTabletOral
Ingredient · strength
Olanzapine›5mg / 1 tablet
Manufacturer / importer
Korea Pharma Co., Ltd.
Appearance
White round film-coated tablets
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 201500445 · Approved 2015.01.28 · Insurance code 653005560

Summary

Main use
Treatment of schizophrenia and bipolar disorder (manic and depressive episodes, etc.), and prevention of recurrence
Who takes it
Adults
Adult dose
The therapeutic dose of this drug 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: It is difficult to give a definitive answer as to how long treatment with this drug should continue. However, efficacy was demonstrated in a placebo-controlled study in patients with schizophrenia whose symptoms had stabilized after taking this drug for approximately 8 weeks and who received maintenance treatment at doses 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 drug 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 drug to treat mania, continue the same dose to prevent recurrence. If a new manic, mixed, or depressive episode occurs, continue this drug, together with adjunctive treatment for mood symptoms as clinically indicated (optimizing the required dose). 3) For 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 should generally be made at intervals of at least 24 hours. If treatment with this drug is discontinued, the dose should be reduced gradually and cautiously. 4) Acute treatment of depressive episodes associated with bipolar I disorder Begin treatment with 5mg of olanzapine once daily, then increase to 10mg once daily. Administer this drug 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 drug may be administered without regard to meals. 2. Administration in special populations 1) Older adults 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 patients with 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 drug (female sex, older age, and nonsmoking status) may also be started at a lower dose.

Ingredients

Manufacturer
Korea Pharma Co., Ltd.

Efficacy & effects

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

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

This medication is used to relieve the symptoms of schizophrenia and stabilize the mental condition of the patient. It is also used in the treatment of manic and mixed episodes of bipolar disorder type I and is administered to patients who have shown effectiveness in manic episodes for the prevention of relapse. Additionally, it is utilized in the acute treatment of depressive episodes associated with bipolar disorder type I. In simple terms, this medication plays a crucial role in improving various symptoms caused by schizophrenia and bipolar disorder.

How to take

Adult dose

The therapeutic dose of this drug 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: It is difficult to give a definitive answer as to how long treatment with this drug should continue. However, efficacy was demonstrated in a placebo-controlled study in patients with schizophrenia whose symptoms had stabilized after taking this drug for approximately 8 weeks and who received maintenance treatment at doses 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 drug 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 drug to treat mania, continue the same dose to prevent recurrence. If a new manic, mixed, or depressive episode occurs, continue this drug, together with adjunctive treatment for mood symptoms as clinically indicated (optimizing the required dose). 3) For 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 should generally be made at intervals of at least 24 hours. If treatment with this drug is discontinued, the dose should be reduced gradually and cautiously. 4) Acute treatment of depressive episodes associated with bipolar I disorder Begin treatment with 5mg of olanzapine once daily, then increase to 10mg once daily. Administer this drug 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 drug may be administered without regard to meals. 2. Administration in special populations 1) Older adults 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 patients with 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 drug (female sex, older age, and nonsmoking status) may also be started at a lower dose.

Precautions

This medication can cause a serious side effect called Neuroleptic Malignant Syndrome, which can be life-threatening. If symptoms such as high fever, muscle rigidity, or changes in mental state occur, use should be immediately discontinued and consult a healthcare professional. It is not approved for the treatment of psychosis and behavioral disorders associated with dementia, and special caution is required as it may increase the risk of mortality and cerebrovascular disorders in elderly patients receiving this medication. Long-term use may lead to a movement disorder called tardive dyskinesia, so if any unusual symptoms occur, consider adjusting the dosage or discontinuing the treatment. While taking this medication, regular monitoring of blood sugar, weight, and lipid levels is needed to manage the risk of diabetes or hyperlipidemia. Abrupt discontinuation of the medication may trigger withdrawal symptoms such as sweating, insomnia, and anxiety; hence, tapering off is safer. Patients with heart disease or those with cardiovascular risk factors should carefully monitor their heart condition while taking this medication, as the risk of acute cardiac events may increase. Pregnant or breastfeeding women should consult healthcare professionals before taking this medication due to potential effects on the fetus or infant. Safety in children and adolescents has not been sufficiently established, and use may lead to increased side effects such as weight gain and sedation. This medication may cause drowsiness and dizziness, so caution is advised when driving or operating hazardous machinery. Interactions with other medications may occur, so inform healthcare professionals of any other medications being taken, especially for patients with impaired liver function who require regular liver function tests.

Side effects

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, cerebrovascular adverse reactions, stroke, transient ischemic attack, tardive dyskinesia, drowsiness, weight gain, eosinophilia, increased prolactin, elevated cholesterol, increased 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, increased uric acid, elevated creatine kinase, edema, blood sugar over 160, blood sugar over 200, increased triglycerides, 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, hypoalbuminemia, ketosis, water intoxication, hypothermia, dizziness, abnormal gait in Alzheimer's disease patients, insomnia, depression, lightheadedness, inability to sit still, movement abnormalities, personality disorders, tremors, hypertonia, dysarthria, sensory disturbances, apathy, confusion, euphoria, coordination movement disorders, abnormal dreams, delusions, emotional instability, manic reactions, schizophrenia reactions, akinesia, alcohol abuse, antisocial reactions, impaired coordination, CNS stimulation, cogwheel rigidity, nonsensical speech, dementia, derealization, stuttering, facial paralysis, sensory loss, reduced mobility, decreased muscle tone, decreased libido, increased libido, compulsive symptoms, phobias, somatization, stimulant abuse, confusion, tardive dyskinesia, vertigo, withdrawal syndrome, suicide attempts, amnesia, seizures, muscle tone disorders, restless legs syndrome, perioral paralysis, 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, bleeding, migraine, pallor, palpitations, vasodilation, ventricular ectopic beats, QTc 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 ulcer, nausea, oral candidiasis, periodontal abscess, rectal bleeding, stomatitis, tongue swelling, tooth decay, diarrhea, abdominal bloating, excessive salivation, rhinitis, increased cough, pharyngitis, dyspnea, apnea, asthma, nosebleed, hemoptysis, hyperventilation, hypoxia, laryngitis, voice changes, atelectasis, hiccups, decreased respiration, pulmonary edema, stridor, hepatic steatosis, hepatitis, jaundice, sweating, photosensitivity reactions, acne, dry skin, 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, toothache, influenza-like syndrome, injection site pain, abdominal enlargement, chills, facial swelling, intentional injury, lethargy, candidiasis, neck pain, neck rigidity, 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, cataracts, hearing loss, diplopia, dry eyes, ear pain, ocular hemorrhage, eye inflammation, eye pain, abnormal eye muscle function, taste disturbances, tinnitus, corneal lesions, glaucoma, keratoconjunctivitis, macular pigmentation reduction, miosis, mydriasis, pigmentation of the lens, urinary incontinence, urinary tract infection, dysmenorrhea, vaginitis, abnormal ejaculation, amenorrhea, breast pain, cystitis, decreased 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, reduced urine output, male erectile dysfunction, benign global sexual desire decrease, female amenorrhea, hypergalactorrhea, breast enlargement, gynecomastia, persistent erection, elevated plasma prolactin levels, increased alkaline phosphatase, elevated creatine kinase, elevated gamma-glutamyl transferase, increased uric acid, elevated total bilirubin, neonatal withdrawal syndrome, tachycardia, agitation, aggression, stuttering, various extrapyramidal symptoms, decreased level of consciousness, nonsensical speech, convulsions, respiratory function suppression, aspiration, hypertension, hypotension, arrhythmia, cardiac arrest, ocular movement seizures, confusion, myotonic contractions, ocular motor nerve paralysis, headache, abdominal pain, pain, weight loss, bloody stools, convulsions, hypomania, sexual discomfort, neurogenic hypersensitivity reactions, hallucinations, liver failure, decreased appetite, urinary retention, pyelonephritis, abnormal electrocardiogram, abnormal pupil response, torticollis, weight gain, drowsiness, hyperphagia, sedation, hypersomnia

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 exposure, preferably in a cool place between 15 and 30 degrees Celsius. Storing it this way helps maintain the medication's efficacy over time.

Appearance and packaging

Appearance

White round film-coated tablets

Package unit

30 tablets/bottle

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.