Medication info
Zyprexa Tablets 10 mg (Olanzapine)

Zyprexa Tablets 10 mg (Olanzapine)

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

MFDS item code 201002996 · Notified 2010.04.21 · Insurance code 645304970

Summary

Main use
Treatment and prevention of recurrence of bipolar disorder (such as manic and depressive episodes); 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. 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: Although it is difficult to give a definitive answer regarding 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 approximately 8 weeks of treatment received maintenance therapy 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 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. For patients who have been receiving this medicine to treat mania, continue the same dose to prevent recurrence. If a new manic, mixed, or depressive episode occurs, continue treatment with this medicine, together with adjunctive therapy to treat mood symptoms as clinically indicated (optimizing the required dose). 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. 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 reduced gradually and cautiously. 4) Acute treatment of depressive episodes associated with bipolar I disorder Start treatment with 5 mg of olanzapine once daily and increase to 10 mg once daily. Administer this medicine at bedtime and adjust the dose appropriately according to age and symptoms; do not exceed a daily dose of 20 mg. Food does not affect drug absorption, so 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 sufficiently supported by clinical factors. 2) Patients with renal or hepatic impairment A low initial dose (5 mg) should be considered. In cases of 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 on a lower dose. 3. Precautions (for orally disintegrating tablets only) This medicine is fragile. Remove it from the outer package and open the blister by peeling off the metal foil on the back. Do not press the tablet through the metal foil when opening the blister. Immediately after opening the blister, remove the tablet with dry hands and place it directly in the mouth. The tablet disintegrates rapidly in saliva and may be swallowed with or without liquid.

Ingredients

Manufacturer
Hanlim Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment and prevention of recurrence of bipolar disorder (such as manic and depressive episodes); treatment of schizophrenia

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

This medication is primarily used for the treatment of schizophrenia. It is also effective in treating manic and mixed episodes associated with bipolar disorder type 1. In patients who respond to manic episodes, this drug can help prevent the recurrence of bipolar disorder. Additionally, it is used for the acute treatment of depressive episodes related to bipolar disorder type 1. This is a medication that aids in symptom improvement and prevention of recurrence for various mental illnesses.

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. 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 regarding 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 approximately 8 weeks of treatment received maintenance therapy 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 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. For patients who have been receiving this medicine to treat mania, continue the same dose to prevent recurrence. If a new manic, mixed, or depressive episode occurs, continue treatment with this medicine, together with adjunctive therapy to treat mood symptoms as clinically indicated (optimizing the required dose). 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. 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 reduced gradually and cautiously. 4) Acute treatment of depressive episodes associated with bipolar I disorder Start treatment with 5 mg of olanzapine once daily and increase to 10 mg once daily. Administer this medicine at bedtime and adjust the dose appropriately according to age and symptoms; do not exceed a daily dose of 20 mg. Food does not affect drug absorption, so 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 sufficiently supported by clinical factors. 2) Patients with renal or hepatic impairment A low initial dose (5 mg) should be considered. In cases of 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 on a lower dose. 3. Precautions (for orally disintegrating tablets only) This medicine is fragile. Remove it from the outer package and open the blister by peeling off the metal foil on the back. Do not press the tablet through the metal foil when opening the blister. Immediately after opening the blister, remove the tablet with dry hands and place it directly in the mouth. The tablet disintegrates rapidly in saliva and may be swallowed with or without liquid.

Precautions

This medication can cause a very serious side effect called Neuroleptic Malignant Syndrome, so if symptoms such as high fever, muscle stiffness, or changes in mental status appear, use should be stopped immediately and a healthcare professional should be consulted. This drug is not used for treating psychosis or behavioral disorders in patients with dementia, and caution should be exercised as there may be an increased risk of death and cerebrovascular problems in elderly dementia patients. Long-term use may lead to tardive dyskinesia, an involuntary movement disorder, and if symptoms occur, consideration should be given to reducing or discontinuing the dose. During the initial treatment period, it may take several weeks for effects to appear, so patient conditions should be closely monitored. Patients with diabetes or risk factors should regularly check blood sugar levels and pay attention to weight gain. Abruptly stopping the medication may result in symptoms such as sweating, insomnia, anxiety, and nausea, so it is recommended to taper off gradually. This drug may affect liver function, so patients with liver disease or elevated liver enzymes require regular liver function tests. Patients with cardiovascular diseases, elderly patients, or those at risk for hypotension should regularly check blood pressure and heart condition. Women who are pregnant or may become pregnant should consult a healthcare professional before administration as it may affect the fetus, and breastfeeding should be discontinued while taking this medication. This medication can cause drowsiness and dizziness, so caution is advised when driving or operating dangerous machinery. Additionally, this medication may interact with other drugs, so it is important to inform a healthcare professional or pharmacist of any other medications being taken. In case of overdose, there is no specific antidote, so immediate medical attention is required.

Side effects

  • High fever
  • muscle rigidity
  • changes in mental state
  • irregular pulse
  • changes in blood pressure
  • tachycardia
  • sweating
  • cardiac arrhythmia
  • increased creatine phosphokinase
  • myoglobinuria
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  • acute renal failure
  • increased mortality rate
  • cerebrovascular adverse reactions
  • stroke
  • transient ischemic attack
  • tardive dyskinesia
  • drowsiness
  • weight gain
  • eosinophilia
  • increased prolactin
  • increased cholesterol
  • increased blood sugar
  • elevated triglycerides
  • diabetes
  • increased appetite
  • akathisia
  • Parkinsonism
  • leukopenia
  • neutropenia
  • abnormal movement disorder
  • orthostatic hypotension
  • anticholinergic effects
  • elevated liver transaminases
  • rash
  • asthenia
  • fatigue
  • fever
  • arthralgia
  • increased alkaline phosphatase
  • elevated gamma-glutamyl transferase
  • elevated uric acid
  • increased creatine phosphokinase
  • edema
  • blood sugar above 160-200 mg/dL
  • 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
  • ketoacidosis
  • coma
  • gout
  • hypernatremia
  • hypoalbuminemia
  • ketosis
  • water intoxication
  • decreased body temperature
  • dizziness
  • abnormal gait in Alzheimer's disease
  • insomnia
  • depression
  • lightheadedness
  • akathisia
  • all extrapyramidal symptoms
  • personality disorder
  • tremor
  • hypertonia
  • speech disturbance
  • sensory disturbances
  • apathy
  • confusion
  • euphoric state
  • coordination disorder
  • abnormal dreams
  • delusions
  • emotional instability
  • manic reactions
  • schizophrenia reactions
  • motor incapacitation
  • alcohol abuse
  • antisocial reactions
  • coordination dysfunction
  • CNS stimulation
  • cogwheel rigidity
  • delirium
  • dementia
  • depersonalization
  • stuttering
  • facial paralysis
  • sensory loss
  • decremented movement
  • hypotonia
  • reduced libido
  • increased libido
  • obsessive symptoms
  • phobias
  • somatization
  • stimulant abuse
  • confusion
  • tardive dyskinesia
  • vertigo
  • withdrawal syndrome
  • suicide attempt
  • amnesia
  • seizure
  • abnormal muscle tone
  • restless legs syndrome
  • paralysis around the mouth
  • coma
  • brain disease
  • 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
  • premature ventricular contractions
  • QTc prolongation
  • thrombosis
  • arteritis
  • heart failure
  • pulmonary embolism
  • ventricular fibrillation
  • sudden death
  • diabetes
  • 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
  • aphthous stomatitis
  • enteritis
  • belching
  • esophageal ulcer
  • glossitis
  • intestinal obstruction
  • bowel obstruction
  • discoloration of the tongue
  • pancreatitis
  • rhinitis
  • increased cough
  • pharyngitis
  • shortness of breath
  • apnea
  • asthma
  • nosebleed
  • hemoptysis
  • hyperventilation
  • hypoxemia
  • laryngitis
  • voice change
  • atelectasis
  • hiccups
  • respiratory depression
  • pulmonary edema
  • wheezing
  • 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
  • hypertrichosis
  • 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
  • isolated contraction
  • arthritis
  • arthropathy
  • leg cramps
  • myasthenia gravis
  • 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 activity
  • taste disturbance
  • tinnitus
  • corneal lesions
  • glaucoma
  • keratoconjunctivitis
  • decreased macular pigment
  • miosis
  • mydriasis
  • lens pigmentation
  • urinary incontinence
  • urinary tract infection
  • dysmenorrhea
  • vulvovaginitis
  • abnormal ejaculation
  • amenorrhea
  • mastalgia
  • cystitis
  • reduced menstruation
  • voiding dysfunction
  • galactorrhea
  • gynecomastia
  • hematuria
  • erectile dysfunction
  • increased menstruation
  • menorrhagia
  • uterine bleeding
  • polyuria
  • premenstrual syndrome
  • pyuria
  • frequency of urination
  • urinary retention
  • oliguria
  • uterine fibroid hypertrophy
  • vaginal bleeding
  • urinary delay
  • albuminuria
  • breast enlargement
  • mastitis
  • reduced urine output
  • male erectile dysfunction
  • benign decrease in libido
  • female amenorrhea
  • galactorrhea
  • breast enlargement
  • persistent erection
  • elevated plasma prolactin levels
  • increased total bilirubin
  • neonatal withdrawal symptoms
  • tachycardia
  • agitation
  • aggression
  • stuttering
  • various extrapyramidal symptoms
  • sedation
  • decreased consciousness level
  • delirium
  • convulsions
  • respiratory function inhibition
  • aspiration
  • hypertension
  • hypotension
  • arrhythmia
  • cardiac arrest
  • ocular motor seizures
  • confusion
  • hypertrophic muscle spasms
  • ocular motor nerve paralysis
  • headache
  • abdominal pain
  • algia
  • weight loss
  • hematochezia
  • convulsions
  • hypomania
  • sexual discomfort
  • hyperreactivity
  • hallucinations
  • liver failure
  • decreased appetite
  • urinary retention
  • pyelonephritis
  • abnormal ECG
  • pupillary disorders
  • torticollis
  • weight gain
  • sedation
  • hypersomnia
  • somnolence
  • decreased total bilirubin
  • increased GGT

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 and moisture from entering, ideally at room temperature between 15 to 30 degrees Celsius. Proper storage will help maintain the medication's effectiveness and prevent degradation.

Appearance and packaging

Appearance

White round film-coated tablets

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

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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.