Medication info
Zyprexa 2.5 mg (Olanzapine)

Zyprexa 2.5 mg (Olanzapine)

Prescription medicationTabletOral
Ingredient · strength
Olanzapine›2.5mg / 1 tablet
Manufacturer / importer
Hanlim Pharmaceutical Co., Ltd.
Appearance
White round film-coated tablet
Packaging
Bottle - 100 tablets/bottle, PTP - 30 tablets/PTP [10 tablets/PTP x 3]
Approval status
Active

MFDS item code 202402585 · Approved 2024.11.04 · Insurance code 645307110

Summary

Main use
Treatment and prevention of recurrence of bipolar disorder (e.g., 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. Doses exceeding 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: It is difficult to provide a definitive answer as to 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 with this medicine received maintenance treatment for 8 months at doses of 10∼20 mg daily. The need for maintenance treatment at an appropriate dose should be evaluated periodically. 2) Bipolar disorder (1) 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. (2) Prevention of recurrence in bipolar disorder The recommended initial dose is 10 mg once daily. For patients who have received this medicine to treat mania, continue the same dose to prevent recurrence. If a new manic, mixed, or depressive episode occurs, continue this medicine, together with adjunctive treatment for 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 the clinical condition. Doses above the recommended initial dose are recommended only after an appropriate clinical evaluation and 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. 4) Acute treatment of depressive episodes associated with bipolar I disorder Start treatment with 5 mg of olanzapine once daily, then 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. Since food does not affect drug absorption, this medicine may be taken with or without food. 2. Dosing in special populations 1) Older adults Starting at a dose of 5 mg or less daily may be considered when supported by sufficient clinical factors. 2) 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. 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 lower dose. 3. Precautions (for orally disintegrating tablets only) This medicine is fragile. Remove it from the outer package by peeling off the foil backing of the blister to open it. Do not push the tablet through the 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 (e.g., manic and depressive episodes); 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 bipolar disorder. It is particularly effective in treating manic and mixed episodes associated with bipolar disorder type I, and it helps prevent relapse of bipolar disorder in patients who responded to olanzapine treatment for manic episodes. It is also used for the acute treatment of depressive episodes in bipolar disorder type I. This medication helps improve the symptoms of these mental illnesses and prevents relapse.

How to take

Adult dose

The therapeutic dose of this medicine should be adjusted according to the patient's clinical condition. Doses exceeding 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: It is difficult to provide a definitive answer as to 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 with this medicine received maintenance treatment for 8 months at doses of 10∼20 mg daily. The need for maintenance treatment at an appropriate dose should be evaluated periodically. 2) Bipolar disorder (1) 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. (2) Prevention of recurrence in bipolar disorder The recommended initial dose is 10 mg once daily. For patients who have received this medicine to treat mania, continue the same dose to prevent recurrence. If a new manic, mixed, or depressive episode occurs, continue this medicine, together with adjunctive treatment for 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 the clinical condition. Doses above the recommended initial dose are recommended only after an appropriate clinical evaluation and 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. 4) Acute treatment of depressive episodes associated with bipolar I disorder Start treatment with 5 mg of olanzapine once daily, then 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. Since food does not affect drug absorption, this medicine may be taken with or without food. 2. Dosing in special populations 1) Older adults Starting at a dose of 5 mg or less daily may be considered when supported by sufficient clinical factors. 2) 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. 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 lower dose. 3. Precautions (for orally disintegrating tablets only) This medicine is fragile. Remove it from the outer package by peeling off the foil backing of the blister to open it. Do not push the tablet through the 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 serious side effects such as neuroleptic malignant syndrome. If symptoms such as high fever, muscle rigidity, or changes in mental state occur, use should be discontinued immediately. It is not recommended for the treatment of psychosis or behavioral disorders associated with dementia, especially in elderly patients, as it may increase mortality and the risk of cerebrovascular disease. Long-term use may result in movement disorders known as tardive dyskinesia, so dosage adjustment or discontinuation should be considered if symptoms emerge. This medication may cause metabolic side effects such as weight gain, elevated blood sugar, and dyslipidemia, thus regular health check-ups and monitoring are necessary. Sudden discontinuation can lead to withdrawal symptoms such as sweating, insomnia, and anxiety, so it is safer to taper off gradually. Caution is required for patients with impaired liver function, a history of seizures, or cardiovascular diseases when using this medication. Women who are pregnant or breastfeeding should consult a doctor before using it, as it may affect the fetus or newborn. This medication may cause drowsiness and dizziness, thus caution is necessary when driving or operating dangerous machinery. There may be interactions with other medications, so it is important to inform healthcare providers of any other medications being taken, especially not to use concurrently with epinephrine. Overdose may lead to serious side effects, so prescribed dosages must be adhered to and healthcare professionals should be informed immediately if any unusual symptoms arise. This medication should be kept out of reach of children and stored in a cool and dry place away from direct sunlight.

Side effects

  • High fever
  • muscle rigidity
  • changes in mental state
  • irregular pulse
  • changes in blood pressure
  • tachycardia
  • sweating
  • 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
  • elevated prolactin
  • increased cholesterol
  • elevated blood sugar
  • increased triglycerides
  • diabetes
  • increased appetite
  • inability to sit still
  • Parkinson's syndrome
  • leukopenia
  • neutropenia
  • dyskinesia
  • 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 sugar above 160
  • blood sugar above 200
  • elevated triglycerides
  • petechial hemorrhage
  • anemia
  • cyanosis
  • leukocytosis
  • lymphadenopathy
  • neutropenia
  • hypersensitivity reactions
  • acidosis
  • hyperbilirubinemia
  • dehydration
  • hypercholesterolemia
  • hyperglycemia
  • hyperlipidemia
  • hyperuricemia
  • hypoglycemia
  • hypokalemia
  • hyponatremia
  • lower limb edema
  • upper limb edema
  • hyperkalemia
  • ketonemia
  • coma
  • gout
  • hypernatremia
  • hypoproteinemia
  • ketosis
  • water intoxication
  • hypothermia
  • dizziness
  • abnormal gait in Alzheimer's disease
  • insomnia
  • depression
  • dizziness
  • personality disorders
  • tremors
  • hypertonia
  • dysarthria
  • sensory disturbances
  • apathy
  • confusion
  • euphoric mood changes
  • coordination difficulties
  • abnormal dreams
  • delusions
  • emotional instability
  • manic reactions
  • schizophrenia reactions
  • akinesia
  • alcohol abuse
  • antisocial reactions
  • incoordinated motor activity
  • CNS stimulation
  • cogwheel rigidity
  • delirium
  • dementia
  • derealization
  • stuttering
  • facial paralysis
  • sensory loss
  • decreased exercise
  • decreased muscle tone
  • decreased libido
  • increased libido
  • obsessive symptoms
  • phobias
  • somatization
  • stimulant abuse
  • delirium
  • tardive dyskinesia
  • vertigo
  • withdrawal syndrome
  • suicide attempts
  • amnesia
  • seizures
  • muscle hypertonicity
  • restless leg 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
  • diabetic ketoacidosis
  • goiter
  • constipation
  • polydipsia
  • dyspepsia
  • vomiting
  • increased salivation
  • dysphagia
  • esophagitis
  • fecal incontinence
  • gastritis
  • gastroenteritis
  • gingivitis
  • black stools
  • oral ulceration
  • nausea
  • oral candidiasis
  • periodontal abscess
  • rectal bleeding
  • stomatitis
  • tongue swelling
  • dental caries
  • diarrhea
  • abdominal bloating
  • excessive salivation
  • rhinitis
  • increased coughing
  • pharyngitis
  • dyspnea
  • apnea
  • asthma
  • epistaxis
  • hemoptysis
  • hyperventilation
  • hypoxia
  • laryngitis
  • changes in voice
  • atelectasis
  • hiccups
  • respiratory depression
  • pulmonary edema
  • stridor
  • fatty liver
  • hepatitis
  • jaundice
  • sweating
  • photosensitivity
  • acne
  • dry skin
  • alopecia
  • contact dermatitis
  • eczema
  • papular rash
  • pruritus
  • seborrhea
  • skin discoloration
  • skin ulcer
  • urticaria
  • vesicular rash
  • hirsutism
  • pustular rash
  • drug reaction (DRESS)
  • low back pain
  • chest pain
  • dental pain
  • influenza-like syndrome
  • injection site pain
  • edema
  • abdominal distention
  • chills
  • facial edema
  • intentional injury
  • malaise
  • candidiasis
  • neck pain
  • neck stiffness
  • pelvic pain
  • hangover
  • sudden death
  • joint stiffness
  • single contraction
  • arthritis
  • arthrosis
  • 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
  • uveitis
  • eye pain
  • abnormal eye muscle function
  • taste disturbances
  • tinnitus
  • corneal lesions
  • glaucoma
  • keratoconjunctivitis
  • macular pigmentary degeneration
  • miosis
  • mydriasis
  • lenticular pigmentation
  • urinary incontinence
  • urinary tract infection
  • dysmenorrhea
  • vaginitis
  • abnormal ejaculation
  • amenorrhea
  • breast pain
  • cystitis
  • less menstruation
  • urinary disorder
  • galactorrhea
  • gynecomastia
  • hematuria
  • erectile dysfunction
  • increased menstruation
  • menorrhagia
  • uterine bleeding
  • polyuria
  • premenstrual syndrome
  • pyuria
  • frequent urination
  • urinary retention
  • anuria
  • uterine fibroid hypertrophy
  • vaginal bleeding
  • urine delay
  • albuminuria
  • breast enlargement
  • mastitis
  • reduced urination
  • male erectile dysfunction
  • benign generalized decreased libido
  • female amenorrhea
  • excessive lactation
  • 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
  • tachycardia
  • agitation
  • aggression
  • stuttering
  • various extrapyramidal symptoms
  • decreased level of consciousness
  • delirium
  • convulsions
  • respiratory function suppression
  • aspiration
  • hypertension
  • hypotension
  • arrhythmia
  • cardiac arrest
  • ocular movement seizures
  • confusion
  • interstitial muscle spasms
  • ocular motor nerve paralysis
  • headache
  • abdominal pain
  • pain
  • weight loss
  • bloody stools
  • convulsions
  • hypomania
  • sexual discomfort
  • hyperreactivity
  • auditory hallucinations
  • liver failure
  • loss of appetite
  • urinary retention
  • pyelonephritis
  • ECG abnormalities
  • pupillary atony
  • 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 closed container to protect it from air or moisture. It is advisable to maintain a storage temperature between 15 and 30 degrees Celsius. Storing it this way helps to preserve the medication's efficacy and safety.

Appearance and packaging

Appearance

White round film-coated tablet

Package unit

Bottle - 100 tablets/bottle, PTP - 30 tablets/PTP [10 tablets/PTP x 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.