Medication info
Olzapin Tablet 2.5 mg (Olanzapine)

Olzapin Tablet 2.5 mg (Olanzapine)

Prescription medicationTabletOral
Ingredient · strength
Olanzapine›2.5mg / 1 tablet
Manufacturer / importer
Dongwha Pharmaceutical Co., Ltd.
Appearance
White round film-coated tablet
Packaging
30 tablets (10 tablets/Alu-Alu×3)
Approval status
Active

MFDS item code 201102619 · Notified 2011.04.26 · Insurance code 642705710

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. 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 5 mg once daily and increase to 10 mg 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 20 mg. 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
Dongwha 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
  • manic episodes
  • depressive episodes
View approved original text

This medication is used for the treatment of schizophrenia and is effective for the treatment of manic and mixed episodes associated with bipolar disorder type 1. Additionally, it helps prevent relapse in patients with bipolar disorder who have responded to olanzapine during manic episodes. Furthermore, it is used for the acute treatment of depressive episodes related to bipolar disorder type 1.

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 5 mg once daily and increase to 10 mg 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 20 mg. 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 rarely cause life-threatening neuroleptic malignant syndrome, so if symptoms such as high fever, muscle rigidity, or changes in mental status occur, immediate medical attention should be sought. This medication is not approved for use in dementia patients, and especially in elderly dementia patients, there may be an increased risk of mortality and cerebrovascular disorders, so use should be avoided. Prolonged use may result in movement disorders, such as tardive dyskinesia; if unusual movements occur, dosage adjustment or discontinuation should be considered. This medication can affect blood glucose control and worsen diabetes, so diabetic patients or those at risk should regularly monitor their blood glucose and weight. Sudden discontinuation may cause withdrawal symptoms such as insomnia, anxiety, and nausea, so it is safer to taper down gradually when discontinuing. In patients with heart disease or the elderly, hypotension, cardiac arrhythmia, and orthostatic hypotension may occur, so caution is necessary, and regular monitoring of blood pressure and cardiac status is recommended. Pregnant or breastfeeding women should consult a doctor before using this medication as it may affect the fetus or newborn. There may be interactions with other medications, especially those metabolized in the liver; patients should inform healthcare providers of all medications they are taking. Caution should be exercised when driving or operating dangerous machinery, as drowsiness or dizziness may occur. This medication easily disintegrates in the mouth, so it should be taken immediately with water or juice. Blood tests may show decreased white blood cell counts, so if symptoms of infection arise, immediate consultation with a healthcare provider is necessary. During the use of this medication, regular liver function tests and blood tests are important to check for any abnormalities.

Side effects

  • High fever
  • muscle rigidity
  • altered mental status
  • irregular pulse
  • changes in blood pressure
  • tachycardia
  • sweating
  • cardiac arrhythmia
  • elevated creatine phosphokinase
  • myoglobinuria
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  • acute renal failure
  • increased mortality rate
  • cerebrovascular adverse reactions
  • stroke
  • transient ischemic attacks
  • tardive dyskinesia
  • drowsiness
  • weight gain
  • eosinophilia
  • increased prolactin
  • elevated cholesterol
  • elevated blood glucose
  • increased triglycerides
  • diabetes
  • increased appetite
  • inability to sit still
  • Parkinson's disease
  • 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
  • blood glucose rising 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
  • lower limb edema
  • upper limb edema
  • hyperkalemia
  • ketoacidosis
  • coma
  • gout
  • hypernatremia
  • hypoalbuminemia
  • ketosis
  • water intoxication
  • hypothermia
  • dizziness
  • insomnia
  • depression
  • vertigo
  • personality disorders
  • tremors
  • muscle rigidity
  • speech disturbances
  • sensory abnormalities
  • apathy
  • confusion
  • feelings of euphoria
  • coordination disorders
  • abnormal dreams
  • delusions
  • emotional instability
  • manic reactions
  • schizophrenia reactions
  • akinesia
  • alcohol abuse
  • antisocial reactions
  • inability for coordinated movement
  • CNS stimulation
  • cogwheel rigidity
  • nonsensical speech
  • dementia
  • depersonalization
  • stuttering
  • facial paralysis
  • sensory loss
  • reduced motor activity
  • decreased muscle tone
  • decreased libido
  • increased libido
  • obsessive symptoms
  • phobias
  • somatization
  • stimulant abuse
  • delirium
  • tardive dyskinesia
  • dizziness
  • withdrawal syndrome
  • suicide attempts
  • amnesia
  • seizures
  • muscular dystonia
  • restless legs syndrome
  • perioral paralysis
  • coma
  • encephalopathy
  • neuralgia
  • neuropathy
  • nystagmus
  • paralysis
  • subarachnoid hemorrhage
  • tobacco abuse
  • neuroleptic malignant syndrome
  • withdrawal symptoms
  • orthostatic hypotension
  • tachycardia
  • hypertension
  • hypotension
  • syncope
  • bradycardia
  • atrial fibrillation
  • cerebrovascular accidents
  • congestive heart failure
  • cardiac arrest
  • bleeding
  • migraine
  • pallor
  • palpitations
  • vasodilation
  • ventricular ectopic contractions
  • QTc prolongation
  • thromboembolism
  • arteritis
  • heart failure
  • pulmonary embolism
  • ventricular fibrillation
  • sudden death
  • diabetes
  • diabetic acidosis
  • goiter
  • constipation
  • thirst
  • dyspepsia
  • vomiting
  • increased salivation
  • difficulty swallowing
  • esophagitis
  • fecal incontinence
  • gastritis
  • gastroenteritis
  • gingivitis
  • black stools
  • oral ulcers
  • nausea
  • oral candidiasis
  • periodontal abscess
  • rectal bleeding
  • stomatitis
  • tongue swelling
  • dental caries
  • diarrhea
  • abdominal distension
  • 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
  • dry skin
  • alopecia
  • contact dermatitis
  • eczema
  • papular rash
  • itching
  • seborrhea
  • skin discoloration
  • skin ulcers
  • hives
  • vesicular rash
  • hypertrichosis
  • pustular rash
  • drug reactions
  • low back pain
  • chest pain
  • toothache
  • flu-like syndrome
  • injection site pain
  • abdominal enlargement
  • chills
  • facial edema
  • intentional self-harm
  • lethargy
  • candidiasis
  • pain in the neck
  • neck stiffness
  • pelvic pain
  • hangover
  • sudden death
  • joint stiffness
  • single contraction
  • arthritis
  • arthrosis
  • leg cramps
  • myasthenia gravis
  • joint pain
  • bone pain
  • bursitis
  • myopathy
  • osteoporosis
  • rheumatoid arthritis
  • rhabdomyolysis
  • amblyopia
  • visual disturbances
  • conjunctivitis
  • abnormal accommodation
  • blepharitis
  • cataract
  • hearing loss
  • diplopia
  • dry eyes
  • ear pain
  • conjunctival hemorrhage
  • ocular inflammation
  • eye pain
  • abnormal ocular muscles
  • taste disturbances
  • tinnitus
  • corneal lesions
  • glaucoma
  • keratoconjunctivitis
  • macular pigmentation decrease
  • miosis
  • mydriasis
  • lenticular pigmentation
  • urinary incontinence
  • urinary tract infection
  • dysmenorrhea
  • vaginitis
  • abnormal ejaculation
  • amenorrhea
  • breast pain
  • cystitis
  • reduced menstruation
  • urination disorders
  • female galactorrhea
  • gynecomastia
  • hematuria
  • erectile dysfunction
  • increased menstruation
  • menorrhagia
  • uterine bleeding
  • polyuria
  • premenstrual syndrome
  • pyuria
  • frequent urination
  • urinary retention
  • oliguria
  • uterine fibroid hypertrophy
  • vaginal bleeding
  • urinary delay
  • albuminuria
  • breast hypertrophy
  • mastitis
  • reduced urine output
  • male erectile dysfunction
  • benign decreased libido
  • 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
  • elevated total bilirubin
  • neonatal withdrawal symptoms
  • ocular movement seizures
  • disorientation
  • muscular cramps
  • ocular motor nerve paralysis
  • headache
  • abdominal pain
  • pain
  • weight loss
  • bloody stools
  • convulsions
  • euphoria
  • increased nerve sensitivity
  • auditory hallucinations
  • liver failure
  • decreased appetite
  • urinary obstruction
  • pyelonephritis
  • electrocardiogram abnormalities
  • pupillary atony
  • torticollis
  • weight gain
  • drowsiness
  • increased appetite
  • sedation
  • hypersomnia
  • agitation
  • anxiety
  • nausea
  • vomiting
  • withdrawal symptoms
  • suicide attempts
  • amnesia
  • seizures
  • coma
  • neuroleptic malignant syndrome
  • respiratory function depression
  • aspiration
  • hypertension
  • hypotension
  • arrhythmia
  • cardiopulmonary arrest
  • tachycardia
  • agitation
  • aggression
  • stuttering
  • various extrapyramidal symptoms
  • decreased level of consciousness

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 exposure to air, and it is best to keep it at room temperature between 15°C and 30°C. Proper storage will help maintain the efficacy of the medication and prevent degradation.

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.

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.