Medication info
Olzapex 10 mg Tablets (Olanzapine)

Olzapex 10 mg Tablets (Olanzapine)

Prescription medicationTabletOral
Ingredient · strength
Olanzapine›10mg / 1 tablet
Manufacturer / importer
Korea Pharma Co., Ltd.
Appearance
White round film-coated tablets
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 201500444 · Approved 2015.01.28 · Insurance code 653005550

Summary

Main use
Treatment of schizophrenia and bipolar disorder (manic and depressive episodes, etc.), and 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. Increases above the usual recommended daily dose of 10 mg are recommended only after an appropriate clinical evaluation. Adults Schizophrenia: The recommended initial dose is 5∼10 mg of olanzapine once daily. Maintenance treatment of schizophrenia: Efficacy was demonstrated in a placebo-controlled study in patients with schizophrenia whose symptoms had stabilized after taking this drug for approximately 8 weeks and who 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. Treatment of manic and 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. Prevention of recurrence in bipolar disorder: The recommended initial dose is 10 mg once daily. For patients who have been receiving this drug to treat mania, continue the same dose to prevent recurrence. If a new manic, mixed, or depressive episode occurs, continue this drug, together with adjunctive treatment for mood symptoms as clinically indicated (optimizing the required dose). 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 based on the clinical condition. Increases above the recommended initial dose are recommended only after an appropriate clinical evaluation and should generally be made at intervals of at least 24 hours. If treatment with this drug is discontinued, the dose should be reduced gradually and cautiously. Acute treatment of depressive episodes associated with bipolar I disorder: Begin treatment with 5mg of olanzapine once daily, then increase to 10mg 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 20mg. Older adults: Starting at a dose of 5 mg or less daily may be considered when there is sufficient evidence based on clinical factors. Patients with renal or hepatic impairment: A low initial dose (5 mg) should be considered. In patients with moderate hepatic impairment (cirrhosis, Child-Pugh class A or B), the initial dose is 5 mg and should be increased cautiously. Patients with multiple factors that delay the metabolism of this drug (female sex, older age, and nonsmoking status) may also be started at a lower dose. Food does not affect drug absorption; therefore, this drug may be administered without regard to meals.

Ingredients

Manufacturer
Korea Pharma Co., Ltd.

Efficacy & effects

Treatment of schizophrenia and bipolar disorder (manic and depressive episodes, etc.), and prevention of recurrence

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

This medication is used for the treatment of schizophrenia and is also effective in treating manic and mixed episodes related to bipolar disorder type 1. Additionally, olanzapine administration helps in preventing relapse in patients with bipolar disorder who have responded to manic episodes. Furthermore, it is used for the acute treatment of depressive episodes associated with bipolar disorder type 1. It is effective for various mental disorders.

How to take

Adult dose

The therapeutic dose of this drug should be adjusted according to the patient's clinical condition. Increases above the usual recommended daily dose of 10 mg are recommended only after an appropriate clinical evaluation. Adults Schizophrenia: The recommended initial dose is 5∼10 mg of olanzapine once daily. Maintenance treatment of schizophrenia: Efficacy was demonstrated in a placebo-controlled study in patients with schizophrenia whose symptoms had stabilized after taking this drug for approximately 8 weeks and who 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. Treatment of manic and 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. Prevention of recurrence in bipolar disorder: The recommended initial dose is 10 mg once daily. For patients who have been receiving this drug to treat mania, continue the same dose to prevent recurrence. If a new manic, mixed, or depressive episode occurs, continue this drug, together with adjunctive treatment for mood symptoms as clinically indicated (optimizing the required dose). 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 based on the clinical condition. Increases above the recommended initial dose are recommended only after an appropriate clinical evaluation and should generally be made at intervals of at least 24 hours. If treatment with this drug is discontinued, the dose should be reduced gradually and cautiously. Acute treatment of depressive episodes associated with bipolar I disorder: Begin treatment with 5mg of olanzapine once daily, then increase to 10mg 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 20mg. Older adults: Starting at a dose of 5 mg or less daily may be considered when there is sufficient evidence based on clinical factors. Patients with renal or hepatic impairment: A low initial dose (5 mg) should be considered. In patients with moderate hepatic impairment (cirrhosis, Child-Pugh class A or B), the initial dose is 5 mg and should be increased cautiously. Patients with multiple factors that delay the metabolism of this drug (female sex, older age, and nonsmoking status) may also be started at a lower dose. Food does not affect drug absorption; therefore, this drug may be administered without regard to meals.

Precautions

This medication can cause serious side effects, such as neuroleptic malignant syndrome, which can be life-threatening. If symptoms such as high fever, muscle rigidity, or changes in mental status occur, medication use should be immediately stopped and medical consultation should be sought. This medication is not approved for the treatment of psychosis or behavioral disorders associated with dementia, and caution is needed as it may increase the risk of mortality and cerebrovascular accidents particularly in elderly patients. Long-term use can lead to tardive dyskinesia, so dosage adjustment or discontinuation should be considered if symptoms appear. New or worsening diabetes or hyperglycemia may occur, so regular monitoring of blood glucose and weight is required, and any unusual symptoms should be reported to healthcare personnel. This medication may affect liver function, so patients with liver disease or elevated liver enzymes need regular liver function tests. Drowsiness or dizziness may occur during treatment, so caution is advised when driving or operating dangerous machinery. Women who are pregnant or breastfeeding should consult a doctor before use as it may affect the fetus or newborn. Serious side effects may occur with overdose, so it is critical to adhere to the prescribed dosage, and emergency medical attention should be sought if unusual symptoms arise. This medication may interact with certain drugs, so it is essential to inform healthcare professionals of any other medications being taken. Sudden discontinuation can result in symptoms such as insomnia, anxiety, and nausea, so it should be gradually reduced according to the doctor's guidance.

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 renal failure
  • increased mortality rate
  • stroke
  • transient ischemic attack
  • delayed dyskinesia
  • drowsiness
  • weight gain
  • eosinophilia
  • elevated prolactin
  • elevated cholesterol
  • elevated blood sugar
  • elevated triglycerides
  • diabetes
  • increased appetite
  • akathisia
  • Parkinsonism
  • leukopenia
  • neutropenia
  • dyskinesia
  • orthostatic hypotension
  • anticholinergic effects
  • elevated liver transaminases
  • rash
  • weakness
  • fatigue
  • fever
  • joint pain
  • increased alkaline phosphatase
  • elevated gamma-glutamyl transferase
  • elevated uric acid
  • elevated creatine kinase
  • edema
  • blood sugar above 160-200 mg/dL
  • blood sugar above 200 mg/dL
  • elevated 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
  • ketosis
  • coma
  • gout
  • hypernatremia
  • hypoproteinemia
  • ketosis
  • water intoxication
  • hypothermia
  • dizziness
  • abnormal gait in Alzheimer's disease
  • insomnia
  • depression
  • vertigo
  • akathisia
  • all extrapyramidal symptoms
  • personality disorder
  • tremor
  • muscle hypertonicity
  • speech disorder
  • sensory disturbance
  • apathy
  • confusion
  • abnormal euphoria
  • coordination problems
  • abnormal dreams
  • delusions
  • emotional instability
  • manic response
  • schizophrenia response
  • incapacitating movements
  • alcohol abuse
  • antisocial response
  • inability to coordinate movement
  • CNS stimulation
  • cogwheel rigidity
  • gibbering
  • dementia
  • depersonalization
  • stuttering
  • facial paralysis
  • sensory loss
  • reduced motor activity
  • reduced muscle tone
  • decreased libido
  • increased libido
  • obsessive symptoms
  • phobia
  • somatization
  • stimulant abuse
  • confusion
  • delayed dyskinesia
  • lightheadedness
  • withdrawal syndrome
  • suicide attempt
  • memory loss
  • seizures
  • abnormal muscle tone
  • restless leg 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
  • fainting
  • bradycardia
  • atrial fibrillation
  • cerebrovascular accident
  • congestive heart failure
  • cardiac arrest
  • hemorrhage
  • migraine
  • pallor
  • palpitations
  • vasodilation
  • extrasystole
  • QTc prolongation
  • thromboembolism
  • arteritis
  • heart failure
  • pulmonary embolism
  • ventricular fibrillation
  • sudden death
  • diabetes
  • diabetic acidosis
  • 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
  • swollen tongue
  • dental caries
  • diarrhea
  • abdominal bloating
  • excessive salivation
  • aphthous stomatitis
  • enteritis
  • belching
  • esophageal ulcer
  • glossitis
  • intestinal obstruction
  • bowel obstruction
  • discoloration of the tongue
  • pancreatitis
  • rhinitis
  • increased cough
  • pharyngitis
  • shortness of breath
  • apnea
  • asthma
  • nosebleeds
  • hemoptysis
  • hyperventilation
  • hypoxemia
  • laryngitis
  • voice changes
  • atelectasis
  • hiccups
  • respiratory depression
  • pulmonary edema
  • stridor
  • liver 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)
  • lower back pain
  • chest pain
  • toothache
  • flu-like syndrome
  • injection site pain
  • malaise
  • candidiasis
  • neck pain
  • stiff neck
  • pelvic pain
  • hangover
  • sudden death
  • joint stiffness
  • single contraction
  • arthritis
  • arthrosis
  • leg cramps
  • myasthenia gravis
  • joint pain
  • 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
  • taste disturbances
  • tinnitus
  • corneal lesions
  • glaucoma
  • conjunctival infection
  • decreased macular pigment
  • miosis
  • mydriasis
  • lenticular pigmentation
  • urinary incontinence
  • urinary tract infection
  • dysmenorrhea
  • vaginitis
  • abnormal ejaculation
  • amenorrhea
  • breast pain
  • cystitis
  • reduced menstruation
  • urinary disorders
  • female galactorrhea
  • gynecomastia
  • hematuria
  • erectile dysfunction
  • increased menstruation
  • menorrhagia
  • uterine bleeding
  • polyuria
  • premenstrual syndrome
  • pyuria
  • frequent urination
  • urinary retention
  • hypouresis
  • uterine fibrous hypertrophy
  • vaginal bleeding
  • urine retention
  • albuminuria
  • breast hypertrophy
  • mastitis
  • reduced urination
  • male erectile dysfunction
  • benign decreased libido
  • female amenorrhea
  • hypergalactorrhea
  • breast enlargement
  • gynecomastia
  • persistent erection
  • increased plasma prolactin levels
  • elevated alkaline phosphatase
  • elevated creatine kinase
  • elevated gamma-glutamyl transferase
  • elevated uric acid
  • total bilirubin increase
  • neonatal withdrawal symptoms
  • tachycardia
  • excitement
  • aggressiveness
  • stuttering
  • various extrapyramidal symptoms
  • decreased consciousness
  • gibbering
  • convulsions
  • respiratory function suppression
  • aspiration
  • hypertension
  • hypotension
  • arrhythmia
  • cardiopulmonary arrest
  • ocular motor seizures
  • confusion
  • hypertrophic muscle cramps
  • ocular motor nerve paralysis
  • headache
  • abdominal pain
  • pain
  • weight loss
  • blood in stool
  • convulsions
  • hypomania
  • sexual discomfort
  • neurogenic reactions
  • auditory hallucinations
  • liver failure
  • decreased appetite
  • urinary retention
  • 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 sealed container to prevent air intrusion and kept in a cool place between 15 and 30 degrees Celsius. Proper storage helps maintain the effectiveness of the medicine for a longer period.

Appearance and packaging

Appearance

White round film-coated tablets

Package unit

30 tablets/bottle

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.