Medication info
Neuroperidon 2 mg (Risperidone)

Neuroperidon 2 mg (Risperidone)

Prescription medicationTabletOral
Ingredient · strength
Risperidone›2mg / 1 tablet
Manufacturer / importer
Hana Pharmaceutical Co., Ltd.
Appearance
Orange film-coated tablets shaped like a capsule
Packaging
30 tablets/bottle, 200 tablets/bottle
Approval status
Active

MFDS item code 201906427 · Approved 2019.09.11

Summary

Main use
Treatment of mental disorders (schizophrenia and mania), neurobehavioral symptoms of dementia, and behavioral disorders associated with intellectual disability
Who takes it
Adults · Children
Adult dose
The therapeutic dose of this medicine should be adjusted according to the patient's clinical condition, and the lowest effective dose should be administered whenever possible. Place this medicine on the tongue and, once it disintegrates within a few seconds, swallow it with or without water (for orally disintegrating tablets only). 1. Schizophrenia 1) Adults (1) Initial dose: Administer 1 mg of risperidone orally twice daily and increase the dose gradually. (2) Maintenance dose: Administer 1∼3 mg twice daily. Adjust the dose appropriately according to age and symptoms. (3) No additional efficacy has been observed at doses of 10 mg or more per day compared with lower doses, and such doses may increase the risk of extrapyramidal symptoms. Doses of 10 mg or more per day should be administered only when the benefits are judged to outweigh the risks for the individual patient. (4) Do not administer doses of 16 mg or more per day, as safety has not been established. (5) A benzodiazepine may be administered concomitantly if additional sedation is needed. 2) Administration in special populations ⦁ Elderly patients and patients predisposed to hypotension The initial dose is 0.5 mg twice daily. Depending on the patient's condition, increase the dose by 0.5 mg twice daily until a dose of 1–2 mg twice daily is reached. In general, increases to doses of 1.5 mg or more twice daily should be made at intervals of at least 1 week. 3) Switching from existing antipsychotic medication to this medicine When medically appropriate, begin treatment with this medicine while gradually reducing the dose of the existing medication. Also, when switching from an existing depot antipsychotic, if medically appropriate, begin treatment with this medicine in place of the next scheduled depot injection. The need to continue concomitant antiparkinsonian medication should be reassessed regularly. 2. Agitation, aggression, or psychotic symptoms in patients with dementia of the Alzheimer’s type The initial dose is 0.25 mg of this medicine twice daily. If needed, the dose may be increased by 0.25 mg twice daily at intervals of at least 2 days. The optimal dose for most patients is 0.5 mg twice daily, but the dose may be increased to 1 mg twice daily depending on the patient. Once the patient has reached the optimal dose, once-daily administration may also be considered. As with symptomatic treatment, the appropriateness of continued use of this medicine should be assessed. 3. Adjunctive treatment of mania in bipolar disorder ⦁ The recommended initial dose is 2 mg of this medicine once daily. Depending on the patient, the dose may be increased by 1 mg per day at intervals of at least 24 hours. The optimal dose for most patients is in the range of 2∼6 mg per day. As with symptomatic treatment, the appropriateness of continued use of this medicine should be assessed. Renal and hepatic impairment For patients with renal or hepatic impairment, administer half the initial and maintenance doses and adjust the dose more gradually. Use this medicine with caution in these patients (see 5. General precautions).
Child dose
⦁ Clinical experience in children and adolescents under 15 years of age is limited. ⦁ Clinical experience in children and adolescents under 15 years of age is limited. Body weight of 50 kg or more: The initial dose is 0.5 mg of this medicine once daily. If necessary, the dose may be increased by 0.5 mg per day at intervals of at least 2 days, depending on the patient. For most patients, the optimal dose is 1 mg once daily. Depending on the patient, 0.5∼1.5 mg may be administered once daily. Body weight under 50 kg: The initial dose is 0.25 mg once daily. If necessary, the dose may be increased by 0.25 mg per day at intervals of at least 2 days, depending on the patient. For most patients, the optimal dose is 0.5 mg once daily. Depending on the patient, 0.25∼0.75 mg may be administered once daily. ⦁ Clinical experience in children under 5 years of age is limited.

Ingredients

Manufacturer
Hana Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of mental disorders (schizophrenia and mania), neurobehavioral symptoms of dementia, and behavioral disorders associated with intellectual disability

  • Schizophrenia
  • agitation
  • aggression
  • psychotic symptoms
  • manic episodes
  • disruptive behavior
  • aggression
  • impulsivity
  • self-harming behavior
  • behavioral disorders
  • disruptive behavior disorders
View approved original text

This medication is used for the treatment of schizophrenia. It is also effective for the short-term treatment of agitation, aggression, and psychotic symptoms in patients with moderate to severe Alzheimer's type dementia. Additionally, it is used as an adjunctive therapy with mood stabilizers for the treatment of manic episodes associated with bipolar disorder. Furthermore, it is utilized in the treatment of behavioral disorders and other disruptive behavioral disorders in children, adolescents, and adults with intellectual disabilities or cognitive impairments, especially when characterized by aggression, impulsivity, and self-harming behaviors. In summary, this drug helps in improving the symptoms of various mental and behavioral disorders.

How to take

Adult dose

The therapeutic dose of this medicine should be adjusted according to the patient's clinical condition, and the lowest effective dose should be administered whenever possible. Place this medicine on the tongue and, once it disintegrates within a few seconds, swallow it with or without water (for orally disintegrating tablets only). 1. Schizophrenia 1) Adults (1) Initial dose: Administer 1 mg of risperidone orally twice daily and increase the dose gradually. (2) Maintenance dose: Administer 1∼3 mg twice daily. Adjust the dose appropriately according to age and symptoms. (3) No additional efficacy has been observed at doses of 10 mg or more per day compared with lower doses, and such doses may increase the risk of extrapyramidal symptoms. Doses of 10 mg or more per day should be administered only when the benefits are judged to outweigh the risks for the individual patient. (4) Do not administer doses of 16 mg or more per day, as safety has not been established. (5) A benzodiazepine may be administered concomitantly if additional sedation is needed. 2) Administration in special populations ⦁ Elderly patients and patients predisposed to hypotension The initial dose is 0.5 mg twice daily. Depending on the patient's condition, increase the dose by 0.5 mg twice daily until a dose of 1–2 mg twice daily is reached. In general, increases to doses of 1.5 mg or more twice daily should be made at intervals of at least 1 week. 3) Switching from existing antipsychotic medication to this medicine When medically appropriate, begin treatment with this medicine while gradually reducing the dose of the existing medication. Also, when switching from an existing depot antipsychotic, if medically appropriate, begin treatment with this medicine in place of the next scheduled depot injection. The need to continue concomitant antiparkinsonian medication should be reassessed regularly. 2. Agitation, aggression, or psychotic symptoms in patients with dementia of the Alzheimer’s type The initial dose is 0.25 mg of this medicine twice daily. If needed, the dose may be increased by 0.25 mg twice daily at intervals of at least 2 days. The optimal dose for most patients is 0.5 mg twice daily, but the dose may be increased to 1 mg twice daily depending on the patient. Once the patient has reached the optimal dose, once-daily administration may also be considered. As with symptomatic treatment, the appropriateness of continued use of this medicine should be assessed. 3. Adjunctive treatment of mania in bipolar disorder ⦁ The recommended initial dose is 2 mg of this medicine once daily. Depending on the patient, the dose may be increased by 1 mg per day at intervals of at least 24 hours. The optimal dose for most patients is in the range of 2∼6 mg per day. As with symptomatic treatment, the appropriateness of continued use of this medicine should be assessed. Renal and hepatic impairment For patients with renal or hepatic impairment, administer half the initial and maintenance doses and adjust the dose more gradually. Use this medicine with caution in these patients (see 5. General precautions).

Child dose

⦁ Clinical experience in children and adolescents under 15 years of age is limited. ⦁ Clinical experience in children and adolescents under 15 years of age is limited. Body weight of 50 kg or more: The initial dose is 0.5 mg of this medicine once daily. If necessary, the dose may be increased by 0.5 mg per day at intervals of at least 2 days, depending on the patient. For most patients, the optimal dose is 1 mg once daily. Depending on the patient, 0.5∼1.5 mg may be administered once daily. Body weight under 50 kg: The initial dose is 0.25 mg once daily. If necessary, the dose may be increased by 0.25 mg per day at intervals of at least 2 days, depending on the patient. For most patients, the optimal dose is 0.5 mg once daily. Depending on the patient, 0.25∼0.75 mg may be administered once daily. ⦁ Clinical experience in children under 5 years of age is limited.

Precautions

Caution is required when administering this medication to elderly dementia patients as it may increase the mortality rate. Particularly when used in conjunction with furosemide, the risk of death may be heightened; therefore, careful assessment of risks and benefits is essential before concurrent administration. This medication may increase the risk of venous thrombosis, which requires evaluation of thrombotic risk factors and preventive measures before and during treatment. This drug should not be used in patients with known allergies to the drug or its components, or who are in a state of central nervous system sedation due to alcohol or central nervous system depressants, comatose patients, patients receiving epinephrine, or those with genetic issues such as lactose intolerance. Caution should be exercised in patients with heart disease or blood pressure issues, impaired liver or kidney function, suicidal tendencies, Parkinson's disease, diabetes risk factors, elderly patients, and pregnant or breastfeeding women. This drug can cause a variety of side effects, particularly neurological symptoms, blood pressure changes, gastrointestinal issues, and skin rashes; any abnormal symptoms should prompt immediate consultation with healthcare professionals. During treatment, weight gain, changes in blood sugar, and leukopenia should be monitored, and caution is advised for activities requiring mental concentration, such as driving or operating machinery. Due to numerous drug interactions, especially with central nervous system depressants, antihypertensives, and drugs related to CYP2D6 and CYP3A4, careful monitoring is advised when co-administering this medication. During pregnancy, there may be risks to the fetus; therefore, it should only be used when absolutely necessary, and breastfeeding should be discontinued during use. In case of overdose, immediate emergency care is required. This medication is fragile, should be taken immediately after opening, and kept out of reach of children.

Side effects

Coryza, upper respiratory tract infection, sinusitis, urinary tract infection, anemia, hypersensitivity reaction, insomnia, anxiety, nervous irritability, Parkinson's disease, akathisia, drowsiness, dizziness, sedation, tremor, abnormal muscle tonicity, somnolence, orthostatic dizziness, movement disorders, syncope, blurred vision, ear pain, orthostatic hypotension, tachycardia, hypotension, nasal congestion, dyspnea, epistaxis, sinus congestion, nausea, constipation, dyspepsia, vomiting, diarrhea, hypersalivation, dry mouth, abdominal discomfort, abdominal pain, gastrointestinal discomfort, epigastric pain, rash, dry skin, dandruff, seborrheic dermatitis, back pain, arthralgia, limb pain, urinary incontinence, ejaculatory dysfunction, fatigue, asthenia, fever, chest pain, urinary tract infection, pneumonia, soft tissue infection, decreased appetite, confusion, transient ischemic attack, decreased level of consciousness, drooling, cerebrovascular accident, conjunctivitis, hypotension, cough, rhinorrhea, dysphagia, fecal impaction, erythema, abnormal posture, joint swelling, peripheral edema, gait disturbance, pitting edema, elevated body temperature, upper respiratory tract infection, rhinitis, influenza, increased appetite, middle insomnia, lethargy, drowsiness, headache, sedation, dizziness, tremor, drooling, stuttering, attention disorders, balance disorders, excessive sleep, palpitations, cough, rhinorrhea, epistaxis, pharyngolaryngeal pain, pulmonary congestion, vomiting, epigastric pain, diarrhea, hypersalivation, gastrointestinal discomfort, abdominal pain, itching, acne, myalgia, neck pain, nocturia, urinary incontinence, frequent urination, galactorrhea, fatigue, fever, mood disturbances, lethargy, chest discomfort, restlessness, insomnia, akathisia, movement disorders, dyskinesia, Parkinson's disease, hypertension, musculoskeletal pain, gait abnormalities, edema, pain, falls, ear infection, viral infection, pharyngitis, tonsillitis, bronchitis, eye infection, infection, localized infection, cystitis, otitis media, onychomycosis, dermatitis, bronchopneumonia, airway infection, bronchial tracheitis, chronic otitis media, eosinophilia, decreased hematocrit, leukopenia, neutropenia, drug hypersensitivity reaction, glucosuria, hyperprolactinemia, amenorrhea, anorexia, increased blood cholesterol, increased triglycerides in the blood, hyperglycemia, weight loss, restlessness, blunted affect, sleep disturbances, decreased libido, sexual dysfunction, depression, nightmares, unresponsive to stimuli, cooperation disorders, loss of consciousness, speech disorders, sensory loss, motor disorders, generalized dystonia, cerebral ischemia, cerebrovascular accident disorders, neuroleptic malignant syndrome, diabetic coma, head tremor, convulsions, psychomotor hyperactivity, delayed dyskinesia, cerebrovascular disorders, sensory abnormalities, eye congestion, eye discharge, eye movements, eyelid edema, photophobia, eyelid scabs, dry eyes, increased tearing, glare, glaucoma, reduced vision, tinnitus, dizziness, bradycardia, tachycardia, palpitations, I degree atrioventricular block, left bundle branch block, right bundle branch block, atrioventricular block, flushing, conduction disorders, abnormal electrocardiogram, prolonged QT interval on ECG, venous abnormalities, bradycardia, wheezing, aspiration pneumonia, voice disorders, productive cough, airway congestion, rales, respiratory disorders, nasal swelling, hyperventilation, fecal incontinence, gastritis, lip edema, cheilitis, xerostomia, abdominal distension, gastroenteritis, tongue swelling, toothache, skin discoloration, skin lesions, skin disorders, erythematous rash, papular rash, generalized rash, papulopustular rash, eczema, musculoskeletal chest pain, joint stiffness, muscle weakness, rhabdomyolysis, urination disturbances, amenorrhea, gynecomastia, vaginal discharge, erectile dysfunction, ejaculatory disorders, menstrual disorders, breast swelling, sexual dysfunction, retrograde ejaculation, breast secretion, thirst, influenza-like syndrome, edema, malaise, facial swelling, discomfort, generalized edema, chills, peripheral coldness, withdrawal syndrome, adverse drug reactions, decreased body temperature, procedure-related pain, weight gain, increased blood prolactin, agranulocytosis, thrombocytopenia, anaphylactic reaction, abnormal secretion of antidiuretic hormone, diabetic ketoacidosis, diabetes mellitus, hypoglycemia, water intoxication, increased blood cholesterol, increased blood triglycerides, mania, taste abnormalities, intraoperative iris hypotension syndrome, atrial fibrillation, deep venous thrombosis, pulmonary embolism, sleep apnea syndrome, bowel obstruction, pancreatitis, jaundice, angioedema, hair loss, neonatal drug withdrawal syndrome, urinary retention, priapism, hypothermia, chest pain, liver dysfunction, hepatitis, polydipsia, xerostomia, urinary retention, polyuria, pain, hiccups, increased sweating, urination disturbances, leukopenia, arrhythmia, epistaxis, anemia, diarrhea, hangover, ocular movement seizures, acne, dysphagia, nocturia, tic disorder, dyspnea, Rabbit syndrome, suicide attempt, accident psychosis, delusions, hallucinations, exacerbation of auditory hallucinations

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 exposure to air or moisture, ideally at room temperature between 1 degree and 30 degrees Celsius. Proper storage will help maintain the drug's effectiveness.

Appearance and packaging

Appearance

Orange film-coated tablets shaped like a capsule

Package unit

30 tablets/bottle, 200 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.