Medication info
Zyprexa 10 mg (Olanzapine)

Zyprexa 10 mg (Olanzapine)

Prescription medicationTabletOral
Ingredient · strength
Olanzapine›10mg / 1 tablet
Manufacturer / importer
Hanin Pharmaceutical Co., Ltd.
Appearance
White or pale gray round film-coated tablet
Packaging
Domestic use: 28 tablets (7 tablets/PTP × 4), 100 tablets/bottle; Export: 28 tablets (7 tablets/PTP × 4), 56 tablets (7 tablets/PTP × 8)
Approval status
Active

MFDS item code 200810513 · Approved 2008.10.20 · Insurance code 657202160

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 medicine should be adjusted according to the patient's clinical condition. Dose increases beyond the general 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: There is no definitive answer as to how long treatment with this medicine should continue. Its efficacy was demonstrated in a placebo-controlled study in patients with schizophrenia whose symptoms had stabilized after approximately 8 weeks of treatment with this medicine and who received maintenance treatment with doses of 10∼20 mg daily for 8 months. The need for maintenance treatment at an appropriate dose should be evaluated periodically. 2) Bipolar disorder (1) Treatment of manic or 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 received this medicine for treatment of mania should continue taking 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 necessary dose optimized). 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 based on clinical status. Dose 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 tapered gradually and cautiously. 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 medicine at bedtime and adjust the dose as appropriate according to age and symptoms, but do not exceed 20mg daily. Food does not affect drug absorption; therefore, this medicine may be taken with or without food. 2. Administration in specific populations 1) Older adults Starting at a dose of 5 mg or less daily may be considered when there is sufficient clinical justification. 2) Patients with renal or hepatic impairment Consider a low initial dose (5 mg). 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 be started at a low dose.

Ingredients

Manufacturer
Hanin Pharmaceutical Co., Ltd.

Efficacy & effects

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

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

This medication is primarily used to alleviate symptoms in patients with schizophrenia. It also helps in the treatment of mania and mixed episodes associated with bipolar disorder type 1. For patients who show improvement in manic episodes, it is utilized to prevent recurrence of bipolar disorder. Additionally, it is used for the acute treatment of depressive episodes in bipolar disorder type 1. Overall, it is a useful medication for improving various symptoms of mental disorders.

How to take

Adult dose

The therapeutic dose of this medicine should be adjusted according to the patient's clinical condition. Dose increases beyond the general 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: There is no definitive answer as to how long treatment with this medicine should continue. Its efficacy was demonstrated in a placebo-controlled study in patients with schizophrenia whose symptoms had stabilized after approximately 8 weeks of treatment with this medicine and who received maintenance treatment with doses of 10∼20 mg daily for 8 months. The need for maintenance treatment at an appropriate dose should be evaluated periodically. 2) Bipolar disorder (1) Treatment of manic or 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 received this medicine for treatment of mania should continue taking 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 necessary dose optimized). 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 based on clinical status. Dose 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 tapered gradually and cautiously. 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 medicine at bedtime and adjust the dose as appropriate according to age and symptoms, but do not exceed 20mg daily. Food does not affect drug absorption; therefore, this medicine may be taken with or without food. 2. Administration in specific populations 1) Older adults Starting at a dose of 5 mg or less daily may be considered when there is sufficient clinical justification. 2) Patients with renal or hepatic impairment Consider a low initial dose (5 mg). 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 be started at a low dose.

Precautions

This medication can lead to serious side effects such as neuroleptic malignant syndrome, so if symptoms such as high fever, muscle rigidity, or changes in mental state occur, discontinue use immediately and consult a healthcare professional. It is not recommended for the treatment of psychosis or behavioral disorders related to dementia, as there may be an increased risk of mortality and cerebrovascular disease in dementia patients taking this medication. Prolonged use may lead to tardive dyskinesia, so if abnormal symptoms occur, dosage adjustment or cessation should be considered. It may take several days to weeks for the effects of this medication to be noticed, hence it is important to monitor the patient's condition closely during the early stages of treatment. It can affect blood sugar control, so diabetic patients or those at risk should regularly monitor blood glucose and weight, and report any symptoms of hyperglycemia to a healthcare professional. It may cause changes in lipid levels, requiring regular testing for patients with dyslipidemia. Sudden discontinuation of this medication can lead to withdrawal symptoms such as sweating, insomnia, and anxiety, so it is advisable to taper off gradually. It is not recommended for patients with Parkinson's disease due to the risk of symptom exacerbation. Patients with heart diseases may have an increased risk of acute cardiac events and should be monitored regularly for cardiovascular status. Patients with hypersensitivity to this medication, angle-closure glaucoma, those receiving epinephrine, or lactose intolerant individuals should not be administered this drug. Close monitoring and management are necessary for patients with liver dysfunction, history of seizures, cardiovascular diseases, elderly patients, diabetic patients, pregnant and breastfeeding women. This medication may cause drowsiness and dizziness, so caution is necessary when driving or operating machinery. Regular check-ups such as blood tests and liver function tests are recommended during treatment, and any abnormal symptoms should be reported to a healthcare professional immediately. In case of overdose, since there is no specific antidote, seek immediate medical attention.

Side effects

  • High fever
  • muscle rigidity
  • changes in mental state
  • irregular heartbeat
  • changes in blood pressure
  • tachycardia
  • sweating
  • cardiac arrhythmia
  • elevated creatine phosphokinase
  • myoglobinuria
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  • acute kidney failure
  • increased mortality rate
  • cerebrovascular adverse reactions
  • stroke
  • transient ischemic attack
  • tardive dyskinesia
  • drowsiness
  • weight gain
  • eosinophilia
  • increased 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 kinase
  • edema
  • increased blood sugar levels
  • elevated triglycerides
  • petechiae
  • anemia
  • cyanosis
  • leukocytosis
  • lymphadenopathy
  • neutropenia
  • normocytic anemia
  • thrombocytosis
  • thrombocytopenia
  • hypersensitivity reactions
  • acidosis
  • 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
  • insomnia
  • depression
  • lightheadedness
  • Parkinsonism
  • movement disorders
  • tremors
  • hypertonia
  • speech disorders
  • sensory disturbances
  • apathy
  • confusion
  • euphoric feelings
  • coordinated movement disorders
  • abnormal dreams
  • delusions
  • emotional instability
  • manic responses
  • schizophrenic responses
  • akinesia
  • alcohol abuse
  • antisocial responses
  • inability for coordinated movement
  • CNS stimulation
  • cogwheel rigidity
  • incoherence
  • dementia
  • depersonalization
  • stuttering
  • facial paralysis
  • sensory loss
  • decreased mobility
  • decreased muscle tone
  • decreased libido
  • increased libido
  • obsessive symptoms
  • phobias
  • somatization
  • stimulant abuse
  • confusion
  • tardive dyskinesia
  • vertigo
  • withdrawal syndrome
  • suicide attempts
  • amnesia
  • seizures
  • muscle tension abnormalities
  • restless legs syndrome
  • facial paralysis around the mouth
  • coma
  • encephalopathy
  • neuralgia
  • neuropathy
  • nystagmus
  • paralysis
  • subarachnoid hemorrhage
  • tobacco abuse
  • malignant neuroleptic syndrome
  • withdrawal symptoms
  • orthostatic hypotension
  • tachycardia
  • hypertension
  • hypotension
  • fainting
  • 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 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 edema
  • dental caries
  • diarrhea
  • abdominal bloating
  • excessive salivation
  • aphthous stomatitis
  • enteritis
  • belching
  • esophageal ulcer
  • glossitis
  • intestinal obstruction
  • bowel obstruction
  • discoloration of the tongue
  • pancreatitis
  • rhinitis
  • increased cough
  • pharyngitis
  • dyspnea
  • apnea
  • asthma
  • nosebleeds
  • hemoptysis
  • hyperventilation
  • hypoxemia
  • laryngitis
  • changes in voice
  • atelectasis
  • hiccups
  • reduced 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 reaction (DRESS)
  • back pain
  • chest pain
  • toothache
  • flu syndrome
  • injection site pain
  • edema
  • abdominal enlargement
  • chills
  • facial edema
  • intentional injury
  • lethargy
  • candidiasis
  • throat pain
  • neck rigidity
  • 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 reflex
  • blepharitis
  • cataract
  • deafness
  • diplopia
  • dry eyes
  • ear pain
  • ocular hemorrhage
  • ocular inflammation
  • eye pain
  • ocular muscle abnormalities
  • taste disturbances
  • tinnitus
  • corneal lesions
  • glaucoma
  • keratoconjunctivitis
  • decreased macular pigmentation
  • pupillary constriction
  • pupillary dilation
  • lenticular pigmentation
  • urinary incontinence
  • urinary tract infection
  • dysmenorrhea
  • vaginitis
  • abnormal ejaculation
  • amenorrhea
  • mastalgia
  • cystitis
  • decreased menstruation
  • urination disorders
  • galactorrhea
  • gynecomastia
  • hematuria
  • erectile dysfunction
  • increased menstruation
  • menorrhagia
  • uterine bleeding
  • polyuria
  • premenstrual syndrome
  • pyuria
  • frequency of urination
  • urinary retention
  • oliguria
  • myometrial hyperplasia
  • vaginal bleeding
  • urinary hesitance
  • albuminuria
  • breast hypertrophy
  • mastitis
  • decreased urine output
  • male erectile dysfunction
  • benign decrease in 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
  • total bilirubin increase
  • neonatal withdrawal symptoms
  • ocular motor seizures
  • confusion
  • tonic-clonic muscle spasms
  • ocular motor nerve paralysis
  • headache
  • abdominal pain
  • pain
  • weight loss
  • bloody stools
  • convulsions
  • hypomania
  • sexual discomfort
  • neurogenic response
  • hallucinations
  • hepatic failure
  • appetite loss
  • urinary retention
  • pyelonephritis
  • ECG abnormalities
  • pupillary areflexia
  • torticollis
  • tachycardia
  • agitation
  • aggression
  • stuttering
  • various extrapyramidal symptoms
  • decreased level of consciousness
  • incoherence
  • convulsions
  • respiratory depression
  • 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 kept at room temperature between 15 and 30 degrees Celsius. This will help maintain the effectiveness of the medication and prevent deterioration.

Appearance and packaging

Appearance

White or pale gray round film-coated tablet

Package unit

Domestic use: 28 tablets (7 tablets/PTP × 4), 100 tablets/bottle; Export: 28 tablets (7 tablets/PTP × 4), 56 tablets (7 tablets/PTP × 8)

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

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

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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.