Medication info

Zyprexa Tablets 5 mg (Olanzapine)

Prescription medicationTabletOralApproval withdrawn
Ingredient · strength
Olanzapine›5mg / 1 tablet
Manufacturer / importer
Boryung Co., Ltd.
Appearance
Film-coated white round tablets
Packaging
28 tablets (7 tablets/PTPX4) / carton
Approval status
Approval withdrawn

MFDS item code 199704229 · Approved 1997.07.31

This product's status changed to Approval withdrawn on 2024.03.27. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment of schizophrenia and bipolar disorder (such as manic and depressive episodes); prevention of recurrence
Who takes it
Adults
Adult dose
The therapeutic dose of this drug should be adjusted according to the patient's clinical condition. Dose increases beyond 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 as to how long treatment with this drug should continue, its efficacy was demonstrated in a placebo-controlled study in which patients with schizophrenia whose symptoms had stabilized after taking this drug for approximately 8 weeks received maintenance treatment 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 or mixed episodes associated with bipolar I disorder The initial dose is 15 mg of this drug 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 drug to treat mania should continue the same dose to prevent recurrence. If a new manic, mixed, or depressive episode occurs, treatment with this drug should continue along with adjunctive therapy to treat mood symptoms, according to clinical indications (optimizing the required doses). 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 daily 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 drug 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 drug at bedtime and adjust the dose as appropriate according to age and symptoms; do not exceed a daily dose of 20 mg. This drug may be administered without regard to meals because food does not affect its absorption. 2. Administration in special populations 1) Elderly patients Starting at a dose of 5 mg or less daily may be considered when there is sufficient evidence of clinical factors supporting this approach. 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 drug (female sex, advanced age, and nonsmoking status) may also be started at a low dose.

Ingredients

Importer
Boryung Co., Ltd.

Efficacy & effects

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

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

This medication is used for the treatment of schizophrenia and bipolar disorder. In the case of bipolar disorder, it is effective for the treatment of manic episodes and mixed episodes, and helps to prevent recurrences in patients who have experienced manic episodes. It is also used for the acute treatment of depressive episodes. This drug improves the quality of life of patients by alleviating symptoms of psychiatric disorders and preventing relapses.

How to take

Adult dose

The therapeutic dose of this drug should be adjusted according to the patient's clinical condition. Dose increases beyond 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 as to how long treatment with this drug should continue, its efficacy was demonstrated in a placebo-controlled study in which patients with schizophrenia whose symptoms had stabilized after taking this drug for approximately 8 weeks received maintenance treatment 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 or mixed episodes associated with bipolar I disorder The initial dose is 15 mg of this drug 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 drug to treat mania should continue the same dose to prevent recurrence. If a new manic, mixed, or depressive episode occurs, treatment with this drug should continue along with adjunctive therapy to treat mood symptoms, according to clinical indications (optimizing the required doses). 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 daily 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 drug 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 drug at bedtime and adjust the dose as appropriate according to age and symptoms; do not exceed a daily dose of 20 mg. This drug may be administered without regard to meals because food does not affect its absorption. 2. Administration in special populations 1) Elderly patients Starting at a dose of 5 mg or less daily may be considered when there is sufficient evidence of clinical factors supporting this approach. 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 drug (female sex, advanced age, and nonsmoking status) may also be started at a low dose.

Precautions

This medication can cause a very serious and potentially life-threatening side effect known as neuroleptic malignant syndrome, so if symptoms such as high fever or muscle rigidity occur, usage should be discontinued immediately and consultation with a doctor should be sought. It is advisable not to use this drug for the treatment of dementia-related psychosis or behavioral disturbances, especially in elderly patients as there is an increased risk of mortality and cerebrovascular disorders. Long-term use may result in tardive dyskinesia, which is an involuntary movement disorder, so if abnormal symptoms appear, dose adjustments or discontinuation should be considered. During the use of this medication, regular monitoring of blood glucose, weight, and lipid levels is necessary to manage the risk of diabetes or cardiovascular diseases. Drowsiness or dizziness may occur at the beginning of treatment, so it is safer to avoid driving or operating hazardous machinery. Patients with poor liver function or liver disease should regularly undergo liver function tests and discontinue if symptoms of hepatitis occur. This drug should be administered cautiously to pregnant or breastfeeding women, especially in the third trimester of pregnancy, as newborns may exhibit withdrawal symptoms or movement disorders. In case of overdose, symptoms such as decreased consciousness, cardiac issues, seizures, etc., may occur, requiring immediate emergency treatment, and since there is no specific antidote, treatment according to symptoms is necessary. When co-administered with other medications, possible interactions may occur, hence appropriate dose adjustments and monitoring should be discussed with a doctor or pharmacist. The safety and efficacy of this drug have not been sufficiently confirmed in children and adolescents, so it should be used with caution.

Side effects

  • High fever
  • muscle rigidity
  • changes in mental state
  • irregular pulse
  • changes in blood pressure
  • tachycardia
  • sweating
  • cardiac 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
  • increased prolactin
  • elevated cholesterol
  • elevated blood sugar
  • increased triglycerides
  • diabetes
  • increased appetite
  • akathisia
  • Parkinson's disease
  • leukopenia
  • neutropenia
  • movement disorders
  • orthostatic hypotension
  • anticholinergic effects
  • increased liver transaminases
  • rash
  • asthenia
  • fatigue
  • fever
  • arthralgia
  • increased alkaline phosphatase
  • elevated gamma-glutamyl transferase
  • increased uric acid
  • elevated creatine kinase
  • edema
  • acidosis
  • hyperbilirubinemia
  • dehydration
  • hypercholesterolemia
  • hyperglycemia
  • hyperlipidemia
  • hyperuricemia
  • hypoglycemia
  • hypokalemia
  • hyponatremia
  • lower extremity edema
  • upper extremity edema
  • hyperkalemia
  • ketosis
  • 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
  • generalized muscle hypertonia
  • speech disorder
  • sensory abnormalities
  • apathy
  • confusion
  • euphoric state
  • coordination difficulties
  • abnormal dreams
  • delusions
  • emotional instability
  • manic reactions
  • schizophrenia reactions
  • motor incapacity
  • alcohol abuse
  • antisocial reactions
  • coordination failure
  • CNS stimulation
  • cogwheel rigidity
  • delirium
  • dementia
  • depersonalization
  • stuttering
  • facial paralysis
  • sensory reduction
  • reduced motor activity
  • decreased muscle tone
  • decreased libido
  • increased libido
  • obsessive symptoms
  • phobia
  • somatization
  • stimulant abuse
  • stupor
  • tardive dyskinesia
  • dizziness
  • withdrawal syndrome
  • suicidal attempts
  • amnesia
  • seizures
  • muscle tone abnormalities
  • restless legs syndrome
  • peri-oral 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 accident
  • congestive heart failure
  • cardiac arrest
  • bleeding
  • migraine
  • pallor
  • palpitations
  • vasodilation
  • premature ventricular contractions
  • QTc prolongation
  • thromboembolism
  • arteritis
  • heart failure
  • pulmonary embolism
  • ventricular fibrillation
  • sudden death
  • diabetes
  • diabetic ketoacidosis
  • 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 distension
  • hypersalivation
  • aphtous stomatitis
  • enteritis
  • belching
  • esophageal ulcer
  • glossitis
  • intestinal obstruction
  • bowel obstruction
  • discoloration of the tongue
  • pancreatitis
  • rhinitis
  • increased cough
  • pharyngitis
  • dyspnea
  • apnea
  • asthma
  • epistaxis
  • hemoptysis
  • hyperventilation
  • hypoxia
  • laryngitis
  • voice changes
  • atelectasis
  • hiccups
  • respiratory depression
  • pulmonary edema
  • stridor
  • fatty liver
  • hepatitis
  • jaundice
  • sweating
  • photosensitivity reaction
  • acne
  • dry skin
  • alopecia
  • contact dermatitis
  • eczema
  • papular rash
  • itching
  • seborrhea
  • skin discoloration
  • skin ulcer
  • urticaria
  • vesicular rash
  • hirsutism
  • pustular rash
  • drug reaction (DRESS)
  • low back pain
  • chest pain
  • tooth pain
  • influenza-like syndrome
  • injection site pain
  • abdominal enlargement
  • chills
  • facial edema
  • intentional injury
  • malaise
  • candidiasis
  • neck pain
  • neck stiffness
  • pelvic pain
  • hangover
  • sudden death
  • joint stiffness
  • single contraction
  • arthritis
  • arthrosis
  • leg cramping
  • myasthenia
  • arthralgia
  • bone pain
  • bursitis
  • myopathy
  • osteoporosis
  • rheumatoid arthritis
  • rhabdomyolysis
  • amblyopia
  • visual disturbances
  • conjunctivitis
  • abnormal accommodation
  • blepharitis
  • cataract
  • hearing loss
  • diplopia
  • dry eyes
  • ear pain
  • retinal bleeding
  • eye inflammation
  • eye pain
  • ocular muscle abnormalities
  • taste disturbances
  • tinnitus
  • corneal lesions
  • glaucoma
  • keratoconjunctivitis
  • macular pigmented degeneration
  • miosis
  • mydriasis
  • pigmented lens
  • urinary incontinence
  • urinary tract infection
  • dysmenorrhea
  • vaginitis
  • abnormal ejaculation
  • amenorrhea
  • breast pain
  • cystitis
  • decreased menstruation
  • urination disorders
  • female lactation
  • 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
  • decreased urine output
  • male erectile dysfunction
  • benign decreased libido
  • female amenorrhea
  • galactorrhea
  • breast enlargement
  • persistent erection
  • elevated plasma prolactin levels
  • increased alkaline phosphatase
  • elevated creatine kinase
  • increased gamma-glutamyl transferase
  • elevated uric acid
  • increased total bilirubin
  • neonatal withdrawal symptoms
  • oculomotor seizures
  • confusion
  • muscular cramps
  • ocular motor nerve paralysis
  • headache
  • abdominal pain
  • pain
  • weight loss
  • bloody stools
  • convulsions
  • euphoria
  • sexual discomfort
  • neural hyperreactivity
  • auditory hallucinations
  • liver failure
  • decreased appetite
  • urinary retention
  • pyelonephritis
  • electrocardiogram abnormalities
  • pupillary atony
  • torticollis
  • weight gain
  • drowsiness
  • increased appetite
  • sedation
  • hypersomnia
  • tachycardia
  • excitation
  • aggression
  • stuttering
  • various extrapyramidal symptoms
  • decreased level of consciousness
  • delirium
  • convulsions
  • coma
  • respiratory function suppression
  • aspiration
  • hypertension
  • hypotension
  • arrhythmia
  • cardiopulmonary arrest

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

Storage

Store this medication in a tightly closed container to prevent air and moisture from entering, and it is advisable to keep it at room temperature, between 15 and 30 degrees Celsius. Proper storage will help maintain the drug's effectiveness for a long time.

Appearance and packaging

Appearance

Film-coated white round tablets

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.

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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.