Medication info
Zyprexa Tablet 2.5 mg (Olanzapine)

Zyprexa Tablet 2.5 mg (Olanzapine)

Prescription medicationTabletOral
Ingredient · strength
Olanzapine›2.5mg / 1 tablet
Manufacturer / importer
Boryung Pharmaceutical Co., Ltd.
Appearance
Film-coated white round tablet
Packaging
28 tablets (7 tablets/PTPX4)/carton
Approval status
Active

MFDS item code 202400667 · Approved 2024.03.27 · Insurance code 641908400

Summary

Main use
Treatment of schizophrenia and bipolar disorder (including manic and depressive episodes); prevention of recurrence
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 appropriate clinical evaluation. Adults Schizophrenia: The recommended initial dose is 5∼10 mg of olanzapine once daily. Maintenance treatment of schizophrenia: Although it is difficult to give a definitive answer regarding how long treatment with this medicine should continue, efficacy was demonstrated in a placebo-controlled study in which patients with schizophrenia whose symptoms had stabilized after taking this medicine for approximately 8 weeks 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 of this medicine 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 receiving 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, with adjunctive therapy to treat mood symptoms as clinically indicated (optimizing the dose 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 once daily based on clinical status. Increases above the recommended initial dose are advised only after appropriate clinical evaluation, and the dose should generally be increased at intervals of at least 24 hours. 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, then increase to 10mg once daily. Administer this medicine at bedtime and adjust the dose as appropriate according to age and symptoms; the daily dose should not exceed 20mg. Since food does not affect drug absorption, this medicine may be taken with or without food. Elderly patients: Starting at a dose of 5 mg or less daily may be considered when supported by sufficient 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 a combination of 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
Boryung Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of schizophrenia and bipolar disorder (including manic and depressive episodes); prevention of recurrence

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

This medication is used for the treatment of schizophrenia and is effective in treating mania and mixed episodes associated with bipolar disorder type I. Additionally, it helps prevent recurrence in patients with bipolar disorder who have shown a response to olanzapine in manic episodes. It is also used for the acute treatment of depressive episodes associated with bipolar disorder type I. In summary, it is widely used for the treatment and prevention of recurrence of various symptoms related to schizophrenia and bipolar disorder.

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 appropriate clinical evaluation. Adults Schizophrenia: The recommended initial dose is 5∼10 mg of olanzapine once daily. Maintenance treatment of schizophrenia: Although it is difficult to give a definitive answer regarding how long treatment with this medicine should continue, efficacy was demonstrated in a placebo-controlled study in which patients with schizophrenia whose symptoms had stabilized after taking this medicine for approximately 8 weeks 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 of this medicine 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 receiving 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, with adjunctive therapy to treat mood symptoms as clinically indicated (optimizing the dose 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 once daily based on clinical status. Increases above the recommended initial dose are advised only after appropriate clinical evaluation, and the dose should generally be increased at intervals of at least 24 hours. 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, then increase to 10mg once daily. Administer this medicine at bedtime and adjust the dose as appropriate according to age and symptoms; the daily dose should not exceed 20mg. Since food does not affect drug absorption, this medicine may be taken with or without food. Elderly patients: Starting at a dose of 5 mg or less daily may be considered when supported by sufficient 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 a combination of 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 is an antipsychotic and can cause serious side effects such as neuroleptic malignant syndrome, which can be life-threatening. It is not approved for the treatment of psychosis or behavioral disorders associated with dementia, and the mortality rate and the risk of cerebrovascular events may increase in elderly patients receiving this medication. Long-term use may result in movement disorders such as tardive dyskinesia, and if symptoms appear, consideration should be given to dose adjustment or discontinuation. Monitoring of patients is essential as it may take time for clinical conditions to improve. Patients with diabetes or risk factors should regularly monitor their blood sugar and weight, as this medication can affect blood sugar control. Sudden discontinuation may cause symptoms such as insomnia, anxiety, and nausea, so gradual tapering is important. Caution is necessary for patients with certain heart conditions, elderly patients, and patients with liver dysfunction, and attention must be paid to drug interactions. Pregnant or breastfeeding women should consult a physician before use, as it may affect the fetus or newborn. This medication can cause drowsiness and dizziness, so caution is required when driving or operating hazardous machinery. Serious side effects may occur with overdose, and the prescribed dosage must be strictly adhered to, keeping the medication out of reach of children.

Side effects

  • High fever
  • muscle rigidity
  • changes in mental status
  • irregular pulse
  • blood pressure changes
  • 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
  • elevated prolactin
  • elevated cholesterol
  • elevated blood sugar
  • elevated 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 kinase
  • edema
  • blood sugar increase 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
  • ketosis
  • coma
  • gout
  • hypernatremia
  • hypoalbuminemia
  • ketosis
  • water intoxication
  • hypothermia
  • dizziness
  • abnormal gait in Alzheimer's disease
  • insomnia
  • depression
  • vertigo
  • inability to sit still
  • movement abnormalities
  • extrapyramidal symptoms
  • personality disorders
  • tremor
  • hypertonia
  • speech disorders
  • sensory disturbances
  • apathy
  • confusion
  • unusual euphoria
  • coordination disorders
  • abnormal dreams
  • delusions
  • emotional instability
  • manic responses
  • schizophrenia reactions
  • akinesia
  • alcohol abuse
  • antisocial reactions
  • coordination impairment
  • CNS stimulation
  • cog-wheel rigidity
  • incoherence
  • dementia
  • depersonalization
  • stuttering
  • facial paralysis
  • sensory loss
  • reduced motor activity
  • decreased muscle tone
  • decreased libido
  • increased libido
  • compulsive symptoms
  • phobias
  • somatization
  • stimulant abuse
  • confusion
  • tardive dyskinesia
  • dizziness
  • withdrawal syndrome
  • suicide attempts
  • amnesia
  • seizures
  • muscle tone abnormalities
  • 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
  • congestive heart failure
  • cardiac arrest
  • hemorrhage
  • migraine
  • pallor
  • palpitations
  • vasodilation
  • premature ventricular contractions
  • QTc prolongation
  • thromboembolism
  • arteritis
  • heart failure
  • pulmonary embolism
  • ventricular fibrillation
  • sudden death
  • diabetes mellitus
  • diabetic acidosis
  • goiter
  • constipation
  • thirst
  • dyspepsia
  • vomiting
  • increased salivation
  • difficulty swallowing
  • esophagitis
  • fecal incontinence
  • gastritis
  • gastroenteritis
  • gingivitis
  • melena
  • oral ulcers
  • 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
  • tongue discoloration
  • pancreatitis
  • rhinitis
  • increased cough
  • pharyngitis
  • dyspnea
  • apnea
  • asthma
  • nosebleeds
  • hemoptysis
  • hyperventilation
  • hypoxemia
  • 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
  • hirsutism
  • pustular rash
  • drug reaction (DRESS)
  • low back pain
  • chest pain
  • toothache
  • influenza-like syndrome
  • injection site pain
  • abdominal enlargement
  • chills
  • facial swelling
  • self-injury
  • lethargy
  • candidiasis
  • throat pain
  • neck stiffness
  • 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 accommodation
  • blepharitis
  • cataracts
  • hearing loss
  • diplopia
  • dry eyes
  • ear pain
  • ocular hemorrhage
  • eye inflammation
  • eye pain
  • ocular muscle abnormalities
  • taste disturbances
  • tinnitus
  • corneal lesions
  • glaucoma
  • keratoconjunctivitis
  • macular pigment deposition syndrome
  • miosis
  • mydriasis
  • lenticular pigment deposition
  • urinary incontinence
  • urinary tract infection
  • dysmenorrhea
  • vaginitis
  • abnormal ejaculation
  • amenorrhea
  • mastalgia
  • 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 enlargement
  • mastitis
  • decreased urination
  • male erectile dysfunction
  • benign sexual desire decrease
  • female amenorrhea
  • excessive galactorrhea
  • breast enlargement
  • persistent erection
  • elevated plasma prolactin levels
  • increased alkaline phosphatase
  • elevated creatine phosphokinase
  • elevated gamma-glutamyl transferase
  • elevated uric acid
  • increased total bilirubin
  • neonatal withdrawal symptoms
  • ocular movement seizures
  • confusion
  • acanthocytosis
  • ocular motoneuron paralysis
  • headache
  • abdominal pain
  • pain
  • weight loss
  • bloody stools
  • spasms
  • hypomania
  • sexual displeasure
  • neuroexcitability reactions
  • hallucinations
  • liver failure
  • decreased appetite
  • urinary obstruction
  • pyelonephritis
  • abnormal electrocardiogram
  • pupillary atony
  • torticollis
  • tachycardia
  • excitement
  • aggression
  • stuttering
  • various extrapyramidal symptoms
  • decreased consciousness level
  • incoherence
  • spasms
  • respiratory function inhibition
  • aspiration
  • hypertension
  • hypotension
  • arrhythmia
  • cardiac arrest

Not everyone experiences these, and they can vary from person to person.

Storage

This medication should be stored in a tightly closed container to prevent air or moisture from entering, preferably at room temperature between 15 and 30 degrees Celsius. This storage method helps maintain the efficacy of the medication for a long time.

Appearance and packaging

Appearance

Film-coated white round tablet

Package unit

28 tablets (7 tablets/PTPX4)/carton

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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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.