Medication info
Zyprexa Tablet 5 mg (Olanzapine)

Zyprexa Tablet 5 mg (Olanzapine)

Prescription medicationTabletOral
Ingredient · strength
Olanzapine›5mg / 1 tablet
Manufacturer / importer
Boryung Pharmaceutical Co., Ltd.
Appearance
White film-coated round tablet
Packaging
28 tablets (7 tablets/PTPX4)/carton
Approval status
Active

MFDS item code 202400668 · Approved 2024.03.27 · Insurance code 641908390

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. 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, 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. 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. 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). 3) For the treatment of schizophrenia and manic and mixed episodes associated with bipolar I disorder, and for the 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. 4) 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. 2. Administration in special populations 1) Elderly patients 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 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. 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 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 a drink.

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 various symptoms of schizophrenia and bipolar disorder. It helps alleviate symptoms in patients with schizophrenia and treats episodes of mania and mixed episodes in bipolar disorder type I. It also assists in preventing relapses in patients who have shown effectiveness during manic episodes. Additionally, it is used for the acute treatment of depressive episodes associated with bipolar disorder type I. Overall, it contributes to the improvement of these mental health issues.

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. 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, 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. 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. 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). 3) For the treatment of schizophrenia and manic and mixed episodes associated with bipolar I disorder, and for the 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. 4) 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. 2. Administration in special populations 1) Elderly patients 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 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. 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 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 a drink.

Precautions

This medication can cause a severe side effect known as Neuroleptic Malignant Syndrome, which can be life-threatening; therefore, if symptoms such as high fever, muscle rigidity, or changes in mental state occur, usage should be immediately discontinued and medical attention sought. This medication is not approved for the treatment of psychosis or behavioral disorders related to dementia and should be used cautiously in elderly patients, as it may increase mortality and the risk of cerebrovascular events. Long-term use may lead to a movement disorder called tardive dyskinesia, necessitating dosage adjustment or discontinuation if symptoms occur. Blood sugar levels may rise or diabetes may worsen during treatment; thus, regular blood glucose checks and weight management are necessary for diabetic patients or those at risk. Drowsiness and dizziness may occur in the early stages of treatment, so caution is advised when driving or operating dangerous machinery. Patients with impaired liver function or liver disease should undergo regular liver function tests and consult a doctor if abnormalities are detected. This medication may lower blood pressure, leading to orthostatic hypotension or fainting risks; hence, care should be taken, particularly when first taking the medication, to rise slowly. Pregnant or breastfeeding women should consult a doctor before taking, as it may affect the fetus or newborn. It may interact with other medications; therefore, it is essential to inform your doctor of any medications currently being taken, especially avoiding co-administration with epinephrine or dopamine agonists. Abrupt discontinuation can lead to withdrawal symptoms such as insomnia, anxiety, and nausea; hence, it should be tapered off gradually under medical direction. Overdosing may cause severe cardiac issues or central nervous system depression, so adherence to the prescribed dosage is crucial, and medical assistance should be sought immediately if side effects are suspected.

Side effects

  • Hyperpyrexia
  • muscle rigidity
  • changes in mental state
  • irregular pulse
  • blood pressure changes
  • tachycardia
  • sweating
  • cardiac arrhythmia
  • elevated creatine phosphokinase
  • myoglobinemia
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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
  • elevated cholesterol
  • increased 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
  • increased creatine phosphokinase
  • edema
  • elevated blood sugar levels
  • increased triglycerides
  • 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
  • dizziness
  • personality disorders
  • tremors
  • muscle stiffness
  • speech disorders
  • sensory abnormalities
  • apathy
  • confusion
  • abnormal euphoria
  • coordination disorders
  • abnormal dreams
  • delusions
  • emotional instability
  • manic reactions
  • schizophrenia reactions
  • akinesia
  • alcohol abuse
  • antisocial reactions
  • impaired coordination
  • CNS stimulation
  • cogwheel rigidity
  • nonsense speech
  • dementia
  • depersonalization
  • stuttering
  • facial paralysis
  • sensory loss
  • hypokinesia
  • muscle tone decrease
  • decreased libido
  • increased libido
  • obsessive symptoms
  • phobias
  • somatization
  • stimulant abuse
  • confusion
  • tardive dyskinesia
  • vertigo
  • withdrawal syndrome
  • suicide attempts
  • amnesia
  • seizures
  • muscular hypertonia
  • 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
  • congestive heart failure
  • cardiac arrest
  • hemorrhage
  • migraine
  • pallor
  • palpitations
  • vasodilation
  • premature ventricular contractions
  • QTc prolongation
  • thromboembolic events
  • arteritis
  • heart failure
  • pulmonary embolism
  • ventricular fibrillation
  • sudden death
  • constipation
  • thirst
  • dyspepsia
  • vomiting
  • increased salivation
  • dysphagia
  • esophagitis
  • fecal incontinence
  • gastritis
  • gastroenteritis
  • gingivitis
  • melena
  • oral ulcers
  • nausea
  • oral candidiasis
  • periodontal abscess
  • rectal bleeding
  • stomatitis
  • tongue swelling
  • dental caries
  • diarrhea
  • abdominal bloating
  • hypersalivation
  • rhinitis
  • increased cough
  • pharyngitis
  • dyspnea
  • apnea
  • asthma
  • epistaxis
  • hemoptysis
  • hyperventilation
  • hypoxemia
  • laryngitis
  • voice changes
  • atelectasis
  • hiccups
  • respiratory depression
  • pulmonary edema
  • wheezing
  • 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
  • malaise
  • candidiasis
  • neck pain
  • neck rigidity
  • 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
  • eye inflammation
  • eye pain
  • abnormal eye muscle function
  • taste disturbances
  • tinnitus
  • corneal lesions
  • glaucoma
  • keratoconjunctivitis
  • reduced macular pigmentation
  • miosis
  • mydriasis
  • lens 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
  • uterine fibroid hypertrophy
  • vaginal bleeding
  • urinary delay
  • albuminuria
  • breast enlargement
  • mastitis
  • decrease in urine output
  • male erectile dysfunction
  • benign loss of libido
  • female amenorrhea
  • hypersecretion of breast milk
  • breast enlargement
  • persistent erection
  • increased plasma prolactin levels
  • increased alkaline phosphatase
  • elevated creatine phosphokinase
  • elevated gamma-glutamyl transferase
  • increased uric acid
  • total bilirubin increase
  • neonatal withdrawal symptoms
  • tachycardia
  • agitation
  • aggression
  • stuttering
  • various extrapyramidal symptoms
  • sedation
  • decreased level of consciousness
  • nonsense speech
  • convulsions
  • neuroleptic malignant syndrome
  • respiratory function inhibition
  • aspiration
  • hypertension
  • hypotension
  • arrhythmias
  • cardiac arrest
  • oculomotor seizures
  • disturbance
  • hypertrophic muscle cramping
  • oculomotor nerve paralysis
  • headache
  • abdominal pain
  • pain
  • weight loss
  • bloody stools
  • convulsions
  • hypomania
  • sexual discomfort
  • neurogenic reaction
  • auditory hallucinations
  • liver failure
  • decreased appetite
  • urinary obstruction
  • pyelonephritis
  • ECG abnormalities
  • pupillary atony
  • torticollis
  • weight gain
  • drowsiness
  • increased appetite
  • 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 prevent exposure to air and moisture. It is best kept at room temperature between 15 to 30 degrees Celsius.

Appearance and packaging

Appearance

White film-coated 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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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.