Medication info
Zyprexa OD Tablets 5 mg (Olanzapine)

Zyprexa OD Tablets 5 mg (Olanzapine)

Prescription medicationOrally disintegrating TabletOral
Ingredient · strength
Olanzapine›5mg / 1 tablet
Manufacturer / importer
Korea Pharamaceutical Co., Ltd.
Appearance
Light yellow oval oral disintegrating tablet
Packaging
28 tablets (7 tablets × 4)/PTP
Approval status
Active

MFDS item code 201109301 · Approved 2011.10.31 · Insurance code 642802420

Summary

Main use
Treatment of schizophrenia, treatment of 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. Dose increases above 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 regarding 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 taking this medicine for approximately 8 weeks received maintenance treatment at a dose 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 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. In 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, treatment with this medicine should be continued, together with adjunctive therapy to treat mood symptoms as clinically indicated (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 based on 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 carefully. 4) Acute treatment of depressive episodes associated with bipolar I disorder Start treatment with olanzapine 5 mg once daily, then increase to 10 mg once daily. Administer this medicine at bedtime and adjust the dose as appropriate according to age and symptoms; the daily dose should not exceed 20 mg. Food does not affect drug absorption, so 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 once daily may be considered when there is sufficient evidence based on 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 by peeling back the metal foil on the back of the blister to open it. Do not push the tablet through the metal 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 rapidly disintegrates in saliva and may be swallowed with or without a drink.

Ingredients

Manufacturer
Korea Pharamaceutical Co., Ltd.

Efficacy & effects

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

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

This medication is used for the treatment of schizophrenia and is also effective in treating mania and mixed episodes associated with bipolar disorder type 1. It helps prevent the recurrence of bipolar disorder in patients who have responded to manic episodes. Additionally, it is used for the acute treatment of depressive episodes related to bipolar disorder type 1. It is used to improve various symptoms of 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. Dose increases above 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 regarding 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 taking this medicine for approximately 8 weeks received maintenance treatment at a dose 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 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. In 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, treatment with this medicine should be continued, together with adjunctive therapy to treat mood symptoms as clinically indicated (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 based on 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 carefully. 4) Acute treatment of depressive episodes associated with bipolar I disorder Start treatment with olanzapine 5 mg once daily, then increase to 10 mg once daily. Administer this medicine at bedtime and adjust the dose as appropriate according to age and symptoms; the daily dose should not exceed 20 mg. Food does not affect drug absorption, so 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 once daily may be considered when there is sufficient evidence based on 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 by peeling back the metal foil on the back of the blister to open it. Do not push the tablet through the metal 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 rapidly disintegrates in saliva and may be swallowed with or without a drink.

Precautions

This medication affects the nervous system and can rarely cause serious side effects such as neuroleptic malignant syndrome, which can be life-threatening. If symptoms occur, discontinue use immediately and consult a doctor. It is not recommended for the treatment of psychosis or behavioral disorders related to dementia, as this patient group may have increased mortality and risk of cerebrovascular disorders. Prolonged use may lead to the emergence of tardive dyskinesia; if symptoms occur, dosage adjustment or cessation should be considered. Initial treatment may take time for symptom improvement, so close observation of the patient's condition is necessary. In patients with diabetes or high-risk groups, there may be a worsening in blood sugar control, necessitating regular monitoring of blood sugar and weight. Abruptly discontinuing this medication may result in withdrawal symptoms such as insomnia, anxiety, and tremors; therefore, it is safer to taper the dosage gradually. Caution should be exercised when prescribing to patients with specific liver diseases, seizure history, cardiovascular diseases, elderly patients, pregnant women, and nursing mothers, and consultation with a physician is advised. This medication may cause drowsiness and dizziness, so caution is needed while driving or operating hazardous machinery. There may be drug interactions; inform your doctor of any medications you are taking, especially since co-administration with epinephrine is prohibited. Overdose may result in serious heart problems or loss of consciousness, necessitating immediate medical intervention. Keep out of reach of children and store in a cool place away from direct sunlight and moisture.

Side effects

  • High fever
  • muscle rigidity
  • changes in mental state
  • irregular pulse
  • fluctuations in blood pressure
  • tachycardia
  • sweating
  • arrhythmia
  • elevated creatine phosphokinase
  • myoglobinuria
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  • acute renal failure
  • increased mortality rate
  • stroke
  • transient ischemic attack
  • delayed dyskinesia
  • drowsiness
  • weight gain
  • eosinophilia
  • elevated prolactin
  • increased cholesterol
  • elevated blood glucose
  • increased triglycerides
  • diabetes
  • increased appetite
  • akathisia
  • Parkinson's disease
  • leukopenia
  • neutropenia
  • dyskinesia
  • orthostatic hypotension
  • anticholinergic effects
  • elevated liver transaminases
  • rash
  • weakness
  • fatigue
  • fever
  • arthralgia
  • increased alkaline phosphatase
  • elevated gamma-glutamyl transferase
  • increased uric acid
  • elevated creatine kinase
  • edema
  • elevated blood glucose levels
  • increased triglycerides
  • petechiae
  • 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
  • decreased body temperature
  • dizziness
  • abnormal gait in Alzheimer's disease
  • insomnia
  • depression
  • vertigo
  • personality disorder
  • tremors
  • muscle rigidity disorders
  • speech disorders
  • sensory disturbances
  • apathy
  • confusion
  • euphoria
  • coordination motor impairment
  • abnormal dreams
  • delusions
  • emotional instability
  • manic reactions
  • schizophrenia reactions
  • akinesia
  • alcohol abuse
  • antisocial reactions
  • impaired coordination
  • CNS stimulation
  • cogwheel rigidity
  • nonsense
  • 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
  • abnormal muscle tone
  • restless legs syndrome
  • facial paralysis around the mouth
  • 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
  • hemorrhage
  • migraine
  • pallor
  • palpitations
  • vasodilation
  • premature ventricular contractions
  • QTc prolongation
  • thromboembolism
  • arteritis
  • heart failure
  • pulmonary embolism
  • ventricular fibrillation
  • sudden death
  • diabetes mellitus
  • diabetic ketoacidosis
  • goiter
  • constipation
  • thirst
  • dyspepsia
  • vomiting
  • increased salivation
  • dysphagia
  • esophagitis
  • fecal incontinence
  • gastritis
  • gastroenteritis
  • gingivitis
  • black stools
  • oral ulcers
  • nausea
  • oral candidiasis
  • periodontal abscess
  • rectal bleeding
  • stomatitis
  • tongue swelling
  • tooth decay
  • diarrhea
  • abdominal distension
  • excessive salivation
  • 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
  • skin dryness
  • alopecia
  • contact dermatitis
  • eczema
  • papular rash
  • itching
  • seborrhea
  • skin discoloration
  • skin ulcers
  • hives
  • vesicular rash
  • hypertrichosis
  • pustular rash
  • drug reaction (DRESS)
  • low back pain
  • chest pain
  • toothache
  • flu-like syndrome
  • injection site pain
  • abdominal enlargement
  • chills
  • facial swelling
  • intentional 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
  • ocular inflammation
  • eye pain
  • abnormal ocular muscle function
  • taste disturbances
  • tinnitus
  • corneal lesions
  • glaucoma
  • keratoconjunctivitis
  • decreased macular pigmentation
  • miosis
  • mydriasis
  • lenticular pigmentation
  • incontinence
  • urinary tract infection
  • dysmenorrhea
  • vaginitis
  • abnormal ejaculation
  • amenorrhea
  • mastalgia
  • cystitis
  • decreased menstruation
  • urinary dysfunction
  • 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
  • oliguria
  • male erectile dysfunction
  • decreased libido
  • female amenorrhea
  • hypergalactorrhea
  • breast enlargement
  • persistent erection
  • elevated plasma prolactin levels
  • increased alkaline phosphatase
  • elevated creatine kinase
  • increased gamma-glutamyl transferase
  • increased uric acid
  • total bilirubin elevation
  • neonatal withdrawal symptoms
  • ocular motor seizures
  • delirium
  • myotonic contractions
  • ocular motor nerve palsy
  • headache
  • abdominal pain
  • pain
  • weight loss
  • bloody stools
  • convulsions
  • hypomania
  • sexual discomfort
  • neurogenic response
  • hallucinations
  • liver failure
  • decreased appetite
  • urinary obstruction
  • pyelonephritis
  • electrocardiogram abnormalities
  • pupil non-reactiveness
  • torticollis
  • tachycardia
  • agitation
  • aggression
  • stuttering
  • various extrapyramidal symptoms
  • decreased level of consciousness
  • nonsense
  • convulsions
  • coma
  • respiratory function suppression
  • 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 special container to protect it from light and air, avoiding humid areas and keeping it in a cool temperature between 15 and 30 degrees Celsius. Proper storage will help maintain the medication's effectiveness for an extended period.

Appearance and packaging

Appearance

Light yellow oval oral disintegrating tablet

Package unit

28 tablets (7 tablets × 4)/PTP

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.