Medication info
Risperidone 1 Milligram Tablet (Risperidone)

Risperidone 1 Milligram Tablet (Risperidone)

Prescription medicationTabletOral
Ingredient · strength
Risperidone›1mg / 1 tablet
Manufacturer / importer
Myungin Pharmaceutical Co., Ltd.
Appearance
White oblong film-coated tablet
Packaging
30 tablets/bottle, 200 tablets/bottle
Approval status
Active

MFDS item code 200401254 · Notified 2004.07.20 · Insurance code 651900380

Summary

Main use
Treatment of psychiatric disorders (schizophrenia and mania), symptoms of Alzheimer's dementia, and behavioral disorders
Who takes it
Adults · Children
Adult dose
The therapeutic dose of this medication should be adjusted according to the patient's clinical condition, and the lowest effective dose possible should be administered. Place this medication on the tongue; 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 risperidone 1 mg 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 above 10 mg per day compared with lower doses, and such doses may increase the risk of extrapyramidal symptoms. Doses above 10 mg per day should be administered only when the benefits for the individual patient are judged to outweigh the risks. (4) Do not administer doses above 16 mg per day, as safety has not been established. (5) A benzodiazepine may be administered concomitantly if additional sedation is needed. 2) Dosing in special populations ⦁ Older adults 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 an existing antipsychotic medication to this medication When medically appropriate, start this medication while gradually reducing the dose of the existing medication. When switching from an existing depot antipsychotic medication, when medically appropriate, start this medication 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 medication 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 depending on the patient, the dose may be increased to 1 mg twice daily. 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 medication should be evaluated. 3. Adjunctive treatment of mania in bipolar disorder ⦁ The recommended initial dose is 2 mg of this medication once daily. Depending on the patient, the dose may be increased by 1 mg per day at intervals of 24 hours or more. 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 medication 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 medication with caution in these patients (see 5. General Precautions).
Child dose
There is insufficient clinical experience in children and adolescents under 15 years of age. There is insufficient clinical experience in children and adolescents under 15 years of age. Body weight 50 kg or more: The initial dose is 0.5 mg of this medication once daily. If needed, depending on the patient, the dose may be increased by 0.5 mg per day at intervals of at least 2 days. The optimal dose for most patients 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 needed, depending on the patient, the dose may be increased by 0.25 mg per day at intervals of at least 2 days. The optimal dose for most patients is 0.5 mg once daily. Depending on the patient, 0.25∼0.75 mg may be administered once daily. There is insufficient clinical experience in children under 5 years of age.

Ingredients

Manufacturer
Myungin Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of psychiatric disorders (schizophrenia and mania), symptoms of Alzheimer's dementia, and behavioral 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 patients with schizophrenia. It also helps alleviate agitation, aggression, and psychotic symptoms in patients with moderate to severe Alzheimer's disease over a short period (up to 6 weeks). It is also utilized as an adjunctive treatment with mood stabilizers for the management of manic episodes associated with bipolar disorder. Additionally, it is effective in treating disruptive behavior disorders, such as aggression, impulsivity, and self-harm behaviors in children, adolescents, and adults with intellectual disabilities or low cognitive abilities. In summary, this medication is used for the treatment of schizophrenia, psychotic symptoms related to Alzheimer's disease, mania in bipolar disorder, and disruptive behavior disorders.

How to take

Adult dose

The therapeutic dose of this medication should be adjusted according to the patient's clinical condition, and the lowest effective dose possible should be administered. Place this medication on the tongue; 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 risperidone 1 mg 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 above 10 mg per day compared with lower doses, and such doses may increase the risk of extrapyramidal symptoms. Doses above 10 mg per day should be administered only when the benefits for the individual patient are judged to outweigh the risks. (4) Do not administer doses above 16 mg per day, as safety has not been established. (5) A benzodiazepine may be administered concomitantly if additional sedation is needed. 2) Dosing in special populations ⦁ Older adults 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 an existing antipsychotic medication to this medication When medically appropriate, start this medication while gradually reducing the dose of the existing medication. When switching from an existing depot antipsychotic medication, when medically appropriate, start this medication 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 medication 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 depending on the patient, the dose may be increased to 1 mg twice daily. 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 medication should be evaluated. 3. Adjunctive treatment of mania in bipolar disorder ⦁ The recommended initial dose is 2 mg of this medication once daily. Depending on the patient, the dose may be increased by 1 mg per day at intervals of 24 hours or more. 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 medication 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 medication with caution in these patients (see 5. General Precautions).

Child dose

There is insufficient clinical experience in children and adolescents under 15 years of age. There is insufficient clinical experience in children and adolescents under 15 years of age. Body weight 50 kg or more: The initial dose is 0.5 mg of this medication once daily. If needed, depending on the patient, the dose may be increased by 0.5 mg per day at intervals of at least 2 days. The optimal dose for most patients 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 needed, depending on the patient, the dose may be increased by 0.25 mg per day at intervals of at least 2 days. The optimal dose for most patients is 0.5 mg once daily. Depending on the patient, 0.25∼0.75 mg may be administered once daily. There is insufficient clinical experience in children under 5 years of age.

Precautions

It is important to note that this medication may increase the risk of mortality when administered to elderly dementia patients, particularly when used in conjunction with certain diuretics like furosemide. Prior to administration of this medication, it is essential to assess the patient's risk factors for venous thromboembolism and take preventive measures if necessary. This medication contains the artificial sweetener aspartame, which requires caution in patients with certain genetic disorders such as phenylketonuria. Do not use this medication in patients with allergies or hypersensitivity to it or its components, patients who are in a state of central nervous system depression, those in a coma, patients receiving epinephrine, or those with lactose intolerance or genetic lactose metabolism disorders. Care should be taken in patients with cardiovascular diseases, dehydration, a history of arrhythmias or QT interval prolongation, seizure history, impaired liver or kidney function, those at risk of suicide, patients with Parkinson's disease or Lewy body dementia, individuals with risk factors for diabetes, elderly patients, and those who are pregnant or breastfeeding. This medication can cause various adverse effects, particularly affecting the psychiatric, neurological, cardiovascular, gastrointestinal, dermatological, and musculoskeletal systems; therefore, any abnormal symptoms during administration should prompt immediate consultation with a healthcare professional. Use of this medication with other central nervous system depressants or alcohol may enhance central nervous system depression, so caution is warranted, and patients should be informed about any concomitant medications. The medication should only be administered to pregnant women when the benefits outweigh the risks to the fetus, and breastfeeding should be discontinued if the medication is being taken. Dosing adjustments and monitoring are necessary for children and elderly patients, particularly considering renal function decline in the latter. In the case of overdose, immediate emergency treatment should be sought, as no specific antidote exists; appropriate treatment and monitoring based on symptoms are necessary. This medication is fragile; therefore, do not crush tablets or press the packaging open, and it should be taken immediately after opening. It should not be mixed with beverages such as tea, cola, or black tea, and it should be kept out of reach of children. Transferring it to another container is not recommended for maintaining quality.

Side effects

Increased mortality, stroke, transient ischemic attack, venous thrombosis, rhinitis, upper respiratory infection, sinusitis, urinary tract infection, anemia, hypersensitivity reactions, insomnia, anxiety, irritability, Parkinson's disease, akathisia, drowsiness, dizziness, sedation, tremor, muscle rigidity, hypersomnia, orthostatic dizziness, dyskinesia, syncope, blurred vision, ear pain, orthostatic hypotension, tachycardia, hypotension, nasal congestion, dyspnea, epistaxis, sinus congestion, nausea, constipation, dyspepsia, vomiting, diarrhea, excessive salivation, dry mouth, abdominal discomfort, abdominal pain, gastric discomfort, upper abdominal pain, rash, dry skin, dandruff, seborrheic dermatitis, back pain, arthralgia, limb pain, urinary incontinence, ejaculation dysfunction, fatigue, asthenia, fever, chest pain, elevated blood creatinine phosphokinase, increased heart rate, pneumonia, soft tissue infection, decreased appetite, confusion, transient ischemic attack, altered consciousness, salivation, cerebrovascular accident, conjunctivitis, hypotension, cough, runny nose, dysphagia, stool consistency, erythema, abnormal posture, joint swelling, peripheral edema, gait disturbance, pitting edema, elevated body temperature, upper respiratory infection, rhinitis, influenza, increased appetite, middle insomnia, lethargy, headache, stuttering, attention deficit, balance disorder, excessive sleep, palpitations, pharyngeal pain, pulmonary congestion, pruritus, acne, myalgia, neck pain, nocturnal enuresis, frequent urination, galactorrhea, emotional disturbances, apathy, chest discomfort, weight gain, elevated blood prolactin, anxiety, flat affect, sleep disorders, decreased libido, sexual dysfunction, depression, nightmares, unresponsiveness to stimuli, coordination problems, loss of consciousness, speech disorders, sensory deficits, movement disorders, generalized dyskinesia, cerebral ischemia, cerebrovascular accident disorders, neuroleptic malignant syndrome, diabetic coma, head tremors, seizures, psychomotor hyperactivity, delayed dyskinesia, cerebrovascular disorders, sensory abnormalities, eye congestion, eye discharge, eye movement, eyelid edema, photophobia, eyelid crusting, dry eyes, increased tear production, glare, glaucoma, decreased vision, tinnitus, vertigo, bradycardia, tachycardia, palpitations, I degree atrioventricular block, left bundle branch block, right bundle branch block, heart block, flushing, conduction disorders, ECG abnormalities, prolonged QT interval on ECG, right vena cava, bradycardia, wheezing, aspiration pneumonia, voice disorders, productive cough, airway congestion, crackles, respiratory disorders, nasal cavity swelling, hyperventilation, fecal incontinence, gastritis, lip swelling, cheilitis, salivary deficiency, bloating, gastroenteritis, tongue swelling, toothache, skin discoloration, skin lesions, skin disorders, erythematous rash, papular rash, generalized rash, papulopustular rash, eczema, musculoskeletal chest pain, joint rigidity, muscle weakness, rhabdomyolysis, dysuria, amenorrhea, gynecomastia, vaginal discharge, erectile dysfunction, ejaculation disorder, menstrual disorders, breast enlargement, sexual dysfunction, retrograde ejaculation, breast discharge, thirst, influenza-like illness, edema, lethargy, facial swelling, discomfort, generalized edema, chills, peripheral coldness, drug withdrawal syndrome, adverse drug reaction, decreased body temperature, procedure-related pain, increased ALT, ECG abnormalities, eosinophilia, increased AST, leukopenia, hyperglycemia, decreased hemoglobin, decreased hematocrit, hypothermia, hypotension, increased transaminases, increased gamma-glutamyl transferase, elevated liver enzymes, agranulocytosis, thrombocytopenia, antidiuretic hormone secretion abnormalities, diabetic ketoacidosis, diabetes mellitus, hypoglycemia, water intoxication, elevated blood cholesterol, increased blood triglycerides, mania, dysgeusia, intraoperative iris relaxation syndrome, atrial fibrillation, deep vein thrombosis, pulmonary embolism, sleep apnea syndrome, intestinal obstruction, pancreatitis, jaundice, vascular edema, hair loss, neonatal drug withdrawal syndrome, urinary retention, priapism, hypothermia, chest pain, abnormal liver function, hepatitis, dry mouth, xerostomia, urinary retention, polyuria, pain, hiccups, increased sweating, dysuria, leukopenia, arrhythmia, epistaxis, anemia, diarrhea, hangover, ocular movement seizure, acne, dysphagia, nocturnal enuresis, tic disorder, dyspnea, Rabbit syndrome, suicidal ideation, accident abnormalities, delusions, hallucinations, worsening of symptoms

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

Storage

This medication may be sensitive to air or moisture, so it should be stored in a tightly sealed container. The storage temperature should be maintained at room temperature between 1°C and 30°C. This will help ensure the safe preservation of the medication's efficacy.

Appearance and packaging

Appearance

White oblong film-coated tablet

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.