Medication info
Myungmoon Risperidone Tablet 2 mg

Myungmoon Risperidone Tablet 2 mg

Prescription medicationTabletOral
Ingredient · strength
Risperidone›2mg / 1 tablet
Manufacturer / importer
Myungmoon Pharmaceutical Co., Ltd.
Appearance
Oblong, light orange film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 201504182 · Approved 2015.06.29

Summary

Main use
Treatment of mental disorders (schizophrenia, mania), symptoms of dementia (such as agitation), and disruptive behavior disorders
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 possible should be administered. 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 benefit was observed with 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 for an individual patient are considered to outweigh the risks. (4) Do not administer doses of 16 mg or more per day, as safety has not been established. (5) A benzodiazepine may be coadministered 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, start treatment with this medicine while gradually reducing the dose of the existing medication. Also, when medically appropriate, when switching from an existing depot antipsychotic, start treatment with this medicine in place of the next scheduled injection of the depot formulation. The need to continue any concomitant antiparkinsonian medication should be reassessed regularly. 2. Agitation, aggression, or psychotic symptoms in patients with dementia of the Alzheimer type The initial dose is 0.25 mg of this medicine twice daily. If needed, depending on the patient, 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 evaluated. 3. Adjunctive therapy for manic episodes 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 within the range of 2∼6 mg per day. As with symptomatic treatment, the appropriateness of continued use of this medicine should be evaluated. Renal and hepatic impairment In 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
⦁ There is limited clinical experience in children and adolescents under 15 years of age. ⦁ There is limited clinical experience in children and adolescents under 15 years of age. Body weight 50 kg or more: The initial dose is 0.5 mg 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 less than 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. ⦁ There is limited clinical experience in children under 5 years of age.

Ingredients

Manufacturer
Myungmoon Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of mental disorders (schizophrenia, mania), symptoms of dementia (such as agitation), and disruptive behavior disorders

  • 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 and helps manage agitation, aggression, or psychotic symptoms in patients with moderate to severe Alzheimer's-type dementia for a short duration (up to 6 weeks). Furthermore, it is used as an adjunctive treatment for mood stabilizers in the treatment of manic episodes associated with bipolar disorder. Additionally, it is effective in improving behavioral disorders, particularly disruptive behaviors such as aggression, impulsivity, and self-harm in children, adolescents, and adults with intellectual disabilities or low intelligence. Overall, it is widely used for the treatment of various psychiatric symptoms 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 possible should be administered. 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 benefit was observed with 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 for an individual patient are considered to outweigh the risks. (4) Do not administer doses of 16 mg or more per day, as safety has not been established. (5) A benzodiazepine may be coadministered 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, start treatment with this medicine while gradually reducing the dose of the existing medication. Also, when medically appropriate, when switching from an existing depot antipsychotic, start treatment with this medicine in place of the next scheduled injection of the depot formulation. The need to continue any concomitant antiparkinsonian medication should be reassessed regularly. 2. Agitation, aggression, or psychotic symptoms in patients with dementia of the Alzheimer type The initial dose is 0.25 mg of this medicine twice daily. If needed, depending on the patient, 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 evaluated. 3. Adjunctive therapy for manic episodes 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 within the range of 2∼6 mg per day. As with symptomatic treatment, the appropriateness of continued use of this medicine should be evaluated. Renal and hepatic impairment In 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

⦁ There is limited clinical experience in children and adolescents under 15 years of age. ⦁ There is limited clinical experience in children and adolescents under 15 years of age. Body weight 50 kg or more: The initial dose is 0.5 mg 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 less than 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. ⦁ There is limited clinical experience in children under 5 years of age.

Precautions

This medication may increase mortality when administered to elderly dementia patients and should be used with caution. The risk of death may be higher when used with certain diuretics in elderly dementia patients, necessitating careful consideration of concomitant use. Because this medication has central nervous system depressant effects, caution is needed when used with alcohol or other CNS depressants. There is a risk of venous thromboembolism, so risk factors for thrombosis should be assessed and preventive measures taken before and during treatment with this medication. This medication contains the artificial sweetener aspartame, so patients with certain genetic disorders such as phenylketonuria must be informed before taking it. Do not administer to patients with hypersensitivity to this drug, CNS depression, coma, those receiving epinephrine, or patients with certain hereditary lactose intolerance. Patients with cardiovascular diseases, liver or kidney dysfunction, patients at risk for suicide, elderly patients, and pregnant or breastfeeding women should use this medication carefully, and dose adjustments may be needed. This medication can cause various adverse reactions such as drowsiness, dizziness, insomnia, weight gain, increased blood glucose, and extrapyramidal symptoms, so careful monitoring of symptoms during treatment is necessary. Serious side effects such as tardive dyskinesia and neuroleptic malignant syndrome can occur, so if any abnormal symptoms appear, consult medical personnel immediately. This medication may interact with other drugs, so patients should inform their healthcare provider of any concomitant medications, especially antihypertensives, antidepressants, antifungals, anticonvulsants, and epinephrine. Pregnant or lactating women should take this medication only when absolutely necessary, considering the effects on the fetus and newborn, and it is recommended to discontinue breastfeeding while on this medication. For children or elderly patients, dosage should be adjusted according to their physical condition, and thorough consultation with healthcare providers is necessary before taking it. In case of overdose, seek medical attention immediately, as there is no specific antidote for this medication; supportive treatment according to symptoms is essential. This medication should be stored out of reach of children and should not be transferred to another container for safety.

Side effects

Increased mortality, cerebrovascular adverse reactions, venous thrombosis, rhinitis, upper respiratory infection, sinusitis, urinary tract infection, anemia, hypersensitivity, insomnia, anxiety, neuroexcitation, Parkinsonism, restlessness, drowsiness, dizziness, sedation, tremor, muscle tension disorder, hypersomnia, orthostatic dizziness, movement disorders, syncope, blurred vision, ear pain, orthostatic hypotension, tachycardia, hypotension, nasal congestion, dyspnea, nosebleed, sinus congestion, nausea, constipation, dyspepsia, vomiting, diarrhea, hypersalivation, dry mouth, abdominal discomfort, abdominal pain, gastrointestinal discomfort, upper abdominal pain, rash, dry skin, dandruff, seborrheic dermatitis, hyperkeratosis, back pain, arthralgia, limb pain, incontinence, ejaculatory dysfunction, fatigue, asthenia, fever, chest pain, blood creatinine phosphokinase increase, increased heart rate, pneumonia, soft tissue infection, decreased appetite, confusion, transient ischemic attack, decreased consciousness, drooling, cerebrovascular accident, conjunctivitis, hypotension, cough, runny nose, dysphagia, fecal impaction, erythema, abnormal posture, joint swelling, peripheral edema, gait disturbance, pitting edema, elevated body temperature, rhinitis, influenza, increased appetite, moderate insomnia, fatigue, headache, stuttering, attention disorder, balance disorder, hypersomnia, palpitations, oropharyngeal pain, pulmonary congestion, pruritus, acne, myalgia, neck pain, nocturia, frequent urination, galactorrhea, mood disorders, lethargy, chest discomfort, weight gain, blood prolactin increase, anxiety, blunted affect, sleep disorders, decreased libido, sexual dysfunction, depression, nightmares, unresponsive to stimuli, coordination abnormalities, loss of consciousness, speech disorders, sensory loss, movement disorders, paroxysmal movement disorders, cerebral ischemia, cerebrovascular accident disorders, neuroleptic malignant syndrome, diabetic coma, head tremors, convulsions, psychomotor agitation, delayed movement disorders, cerebrovascular disorders, sensory disturbances, conjunctival injection, eye discharge, eye movement, eyelid edema, photophobia, crusting of eyelid margins, dry eyes, increased tearing, glare, glaucoma, vision impairment, tinnitus, dizziness, sinus bradycardia, sinus tachycardia, palpitations, I-degree atrioventricular block, left bundle branch block, right bundle branch block, heart block, flushing, conduction disturbances, electrocardiogram abnormalities, prolonged QT interval on electrocardiogram, right venous thrombosis, bradycardia, wheezing, aspiration pneumonia, voice disorders, persistent cough, airway congestion, rales, respiratory disorders, nasal cavity swelling, hyperventilation, fecal incontinence, gastritis, lip swelling, cheilitis, salivary deficiency, abdominal distension, gastroenteritis, tongue swelling, toothache, skin discoloration, skin lesions, skin disorders, erythematous rash, papular rash, generalized rash, hemispherical papular rash, eczema, musculoskeletal chest pain, joint rigidity, muscle weakness, rhabdomyolysis, dysuria, amenorrhea, gynecomastia, vaginal discharge, erectile dysfunction, ejaculatory disorder, menstrual disorder, breast engorgement, sexual dysfunction, retrograde ejaculation, breast discharge, thirst, influenza-like symptoms, edema, malaise, facial swelling, discomfort, generalized edema, chills, peripheral coldness, drug withdrawal syndrome, drug adverse reactions, decreased body temperature, procedure-related pain, increased ALT, electrocardiogram abnormalities, eosinophilia, increased AST, leukopenia, increased blood glucose, decreased hemoglobin, decreased hematocrit, hypothermia, decreased blood pressure, increased transaminases, increased gamma-glutamyl transferase, increased liver enzymes, agranulocytosis, thrombocytopenia, abnormal secretion of antidiuretic hormone, diabetic ketoacidosis, diabetes mellitus, hypoglycemia, water intoxication, increased blood cholesterol, increased serum triglycerides, mania, dysgeusia, intraoperative iris tension reduction syndrome, atrial fibrillation, deep vein thrombosis, pulmonary embolism, sleep apnea syndrome, intestinal obstruction, pancreatitis, jaundice, vascular edema, alopecia, neonatal drug withdrawal syndrome, urinary retention, priapism, hypothermia, prolonged QT interval on electrocardiogram, chest pain, liver dysfunction, hepatitis, dry mouth, xerostomia, urinary retention, polyuria, hiccups, increased sweating, dysuria, leukopenia, arrhythmia, nosebleed, hangover, ocular movement seizure, acne, dysphagia, enuresis, tic disorder, dyspnea, Rabbit syndrome, suicide attempt, accident abnormalities, delusions, hallucinations, exacerbation of auditory hallucinations

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

Storage

Store this medication in a well-closed container to protect it from air and moisture, and keep it at a temperature between 1 and 30 degrees Celsius. Storing it this way will maintain the drug's efficacy and safety.

Appearance and packaging

Appearance

Oblong, light orange film-coated tablet

Package unit

30 tablets/bottle, 100 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.