Medication info
Myungin Haloperidol Tablets 5 mg

Myungin Haloperidol Tablets 5 mg

Prescription medicationTabletOral
Ingredient · strength
Haloperidol›5mg / 1 tablet
Manufacturer / importer
Myungin Pharmaceutical Co., Ltd.
Appearance
Light green round tablet.
Packaging
500 tablets/bottle
Approval status
Active

MFDS item code 198500632 · Notified 1985.04.17 · Insurance code 651901010

Summary

Main use
Treatment of psychotic disorders (schizophrenia), bipolar mania, and Tourette syndrome
Who takes it
Adults · Children
Adult dose
○ Adults and children (14 years and older) Schizophrenia, manic episodes associated with bipolar I disorder, symptoms of psychotic disorders, Tourette syndrome (Gilles de la Tourette's syndrome): The initial dose of haloperidol is 1-15㎎ daily, administered orally in 2-3 divided doses (up to 100㎎ may be administered in severe cases). Once a therapeutic response is achieved, gradually reduce the dose to the lowest effective maintenance dose. Adjust the dose as appropriate according to age and symptoms. Elderly and debilitated patients should receive an initial dose of haloperidol of 1-6mg daily, administered orally in 2-3 divided doses.
Child dose
Children over the age of 14 should be administered the same initial dose as adults, 1-15 mg daily divided into 2-3 doses.

Ingredients

Manufacturer
Myungin Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of psychotic disorders (schizophrenia), bipolar mania, and Tourette syndrome

  • Symptoms of schizophrenia
  • manic episodes
  • psychotic disorders
  • Tourette syndrome
View approved original text

This medication is used for the treatment of symptoms associated with schizophrenia, manic episodes related to type 1 bipolar disorder, psychotic disorders, and Tourette syndrome.

How to take

Adult dose

○ Adults and children (14 years and older) Schizophrenia, manic episodes associated with bipolar I disorder, symptoms of psychotic disorders, Tourette syndrome (Gilles de la Tourette's syndrome): The initial dose of haloperidol is 1-15㎎ daily, administered orally in 2-3 divided doses (up to 100㎎ may be administered in severe cases). Once a therapeutic response is achieved, gradually reduce the dose to the lowest effective maintenance dose. Adjust the dose as appropriate according to age and symptoms. Elderly and debilitated patients should receive an initial dose of haloperidol of 1-6mg daily, administered orally in 2-3 divided doses.

Child dose

Children over the age of 14 should be administered the same initial dose as adults, 1-15 mg daily divided into 2-3 doses.

Precautions

This medication is used to treat psychotic symptoms related to cognitive impairment in elderly patients with dementia, and caution is required as mortality may increase in these cases. Particular care is needed when administering this medication to patients at risk of stroke. There is also a risk of thrombosis; therefore, risk factors for venous thrombosis must be confirmed in advance and preventive measures should be taken. This medication should not be used in patients with hypersensitivity to it, coma, alcohol dependence, severe heart failure, Parkinson's disease, Lewy body dementia, progressive supranuclear palsy, or bronchopneumonia. Pregnant or breastfeeding women should not use this medication, and patients taking medications that prolong the QTc interval should avoid it. Patients with impaired liver or kidney function, cardiovascular disease or hypotension, a history of convulsions, and thyroid function abnormalities should use it cautiously. This medication can cause cardiovascular adverse reactions such as abnormal heartbeat, blood pressure changes, and arrhythmias, so continuous monitoring is necessary. Severe symptoms such as neuroleptic malignant syndrome may also occur, and if symptoms such as fever or muscle rigidity appear, immediate notification to medical personnel is essential. Extrapyramidal symptoms or akathisia may occur at the beginning of treatment or with long-term use, so appropriate treatment is required if symptoms arise. A variety of adverse effects including hepatic dysfunction, visual disturbances, hypersensitivity, blood disorders, digestive problems, endocrine disorders, respiratory symptoms, and neurological issues have been reported, so careful monitoring for symptom occurrence is necessary. This medication may cause drowsiness or decreased concentration, so driving or operating hazardous machinery should be avoided. Abrupt discontinuation of the medication may result in withdrawal symptoms, thus a gradual tapering is important. When used in conjunction with other central nervous system depressants, antihypertensives, or antihistamines, attention is required as interactions may exacerbate side effects. Particularly, it should not be used with epinephrine, and the effectiveness may decrease when combined with levodopa. As this medication is metabolized in the liver, when used with drugs that inhibit or induce CYP3A4 or CYP2D6 enzymes, blood levels may change requiring dosage adjustment. Use during pregnancy may harm the fetus, and abnormal symptoms may appear in the newborn during delivery, hence pregnant or nursing mothers should not use it. In children and the elderly, side effects may be more pronounced, necessitating dosage adjustment and cautious administration. In cases of overdose, severe side effects can occur requiring emergency treatment, and there is no specific antidote, so treatment will be symptomatic. This medication has been reported to carry a risk of serious sudden death, thus the patient's condition must be closely monitored during administration.

Side effects

Increased mortality rate, increased risk of cerebrovascular disease, venous thrombosis, arrhythmia, hypotension, hypertension, tachycardia, ventricular tachycardia, thromboembolism, motor paralysis, severe muscle rigidity, dysphagia, dehydration, fever, leukocytosis, elevated serum CPK, myoglobinuria, impaired kidney function, high fever, altered consciousness, dyspnea, circulatory collapse, dehydration symptoms, acute kidney failure, acute muscle rigidity, ocular motility seizure, torticollis, inability to open mouth, parkinsonian rigidity, tremors, immobility, inability to sit still, irreversible involuntary hypertonic movement disorder syndrome, hepatitis, jaundice, liver impairment, retinitis, cataracts, accommodation disorder of the eye, blurred vision, corneal opacity, lens opacity, corneal pigment deposition, edema, erythema, urticaria, exfoliative dermatitis, photosensitivity, anaphylaxis, anemia, leukocytosis, leukopenia, erythrocytopenia, agranulocytosis, loss of appetite, nausea, vomiting, constipation, diarrhea, intestinal paralysis, paralytic ileus, hyperprolactinemia, breast development in females, milk secretion, menstrual irregularities, changes in libido, hyperglycemia, hypoglycemia, weight gain, weight loss, hyponatremia, hypoo smolarity, syndrome of inappropriate antidiuretic hormone secretion, bronchospasm, laryngeal spasm, dyspnea, insomnia, anxiety, drowsiness, dizziness, headache, migraines, anxiety, depression, hallucinations, agitation, thirst, nasal congestion, lethargy, urinary retention, fever, sweating, flushing, hypothermia

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

Storage

This medication may be sensitive to light, so it should be stored in an opaque container that does not allow light in. Additionally, it should be kept in a sealed container to prevent air exposure to maintain its efficacy and prevent degradation.

Appearance and packaging

Appearance

Light green round tablet.

Package unit

500 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.

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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.