Medication info
Risperidone ODT 2 mg (Risperidone)

Risperidone ODT 2 mg (Risperidone)

Prescription medicationOrally disintegrating TabletOral
Ingredient · strength
Risperidone›2mg / 1 tablet
Manufacturer / importer
Hanmi Pharmaceutical Co., Ltd.
Appearance
White round tablet
Packaging
28 tablets/box (7 tablets/PTPx4)
Approval status
Active

MFDS item code 201200211 · Approved 2012.01.06 · Insurance code 643506170

Summary

Main use
Treatment of psychiatric 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 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 without water or with water. Initial dose for adults with schizophrenia: Administer 1 mg of risperidone orally twice daily and increase the dose gradually. Maintenance dose for adults with schizophrenia: Administer 1∼3 mg twice daily. Adjust the dose appropriately according to age and symptoms. No additional effect 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 the individual patient are judged to outweigh the risks. Do not administer doses of 16 mg or more per day, as safety has not been established. A benzodiazepine may be administered concomitantly if additional sedation is needed. Elderly patients and patients predisposed to hypotension: The initial dose is 0.5 mg twice daily. Depending on the patient's condition, increase 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. When switching from an existing antipsychotic medication to this medication, if medically appropriate, initiate this medication while gradually reducing the dose of the existing medication. Also, if medically appropriate, when switching from an existing depot antipsychotic medication, initiate this medication in place of the next scheduled injection of the depot preparation. Regularly reassess whether concomitant antiparkinsonian medication needs to be continued. Agitation, aggression, or psychotic symptoms in patients with dementia of the Alzheimer type: The initial dose is 0.25 mg of this medication twice daily. If needed for the individual 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 reaches 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. 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 slowly. 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 for the individual 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 less than 50 kg: The initial dose is 0.25 mg once daily. If needed for the individual 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
Hanmi Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of psychiatric 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-harm behavior
  • behavioral disorders
  • disorganized behavior disorders
View approved original text

This medication is used to alleviate symptoms in patients with schizophrenia. It also helps in the short-term treatment (up to 6 weeks) of agitation, aggression, or psychotic symptoms in patients with moderate to severe Alzheimer's type dementia. It is effective as an adjunctive therapy to mood stabilizers in the treatment of manic episodes associated with bipolar disorder. Additionally, it is used for the treatment of disruptive behavior, aggression, impulsivity, and self-harm behavior in children, adolescents, and adults with intellectual disabilities or below-average intellectual abilities. Overall, it is used to improve symptoms of various mental and behavioral 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 without water or with water. Initial dose for adults with schizophrenia: Administer 1 mg of risperidone orally twice daily and increase the dose gradually. Maintenance dose for adults with schizophrenia: Administer 1∼3 mg twice daily. Adjust the dose appropriately according to age and symptoms. No additional effect 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 the individual patient are judged to outweigh the risks. Do not administer doses of 16 mg or more per day, as safety has not been established. A benzodiazepine may be administered concomitantly if additional sedation is needed. Elderly patients and patients predisposed to hypotension: The initial dose is 0.5 mg twice daily. Depending on the patient's condition, increase 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. When switching from an existing antipsychotic medication to this medication, if medically appropriate, initiate this medication while gradually reducing the dose of the existing medication. Also, if medically appropriate, when switching from an existing depot antipsychotic medication, initiate this medication in place of the next scheduled injection of the depot preparation. Regularly reassess whether concomitant antiparkinsonian medication needs to be continued. Agitation, aggression, or psychotic symptoms in patients with dementia of the Alzheimer type: The initial dose is 0.25 mg of this medication twice daily. If needed for the individual 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 reaches 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. 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 slowly. 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 for the individual 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 less than 50 kg: The initial dose is 0.25 mg once daily. If needed for the individual 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

This drug may increase the mortality rate when administered to elderly dementia patients, thus caution is needed. In particular, when used in conjunction with specific diuretics such as furosemide, the risk of death may increase, and co-administration should be carefully considered. There is a risk of venous thrombosis, so thrombotic risk factors should be assessed and preventive measures taken before and during the use of this drug. Patients with known allergies to this drug or its components, patients with severe central nervous system depression, patients in a comatose state, and those receiving epinephrine should not use this drug. Caution is also needed in patients with cardiovascular diseases, impaired liver or kidney function, a history of seizures, suicidal risk, Parkinson's disease, diabetes, and the elderly. This drug can cause various side effects, particularly neurological symptoms, gastrointestinal symptoms, and skin reactions; if there are abnormal symptoms, medical consultation should be sought immediately. This drug interacts with other medications, so be sure to inform healthcare providers of any concomitant medications. Pregnant or breastfeeding women should consult with a doctor as this drug may affect the fetus or newborn, and breastfeeding is recommended to be discontinued. There is limited experience using this drug in children, caution is advised when using it, and in the elderly, dosage adjustment should be considered due to diminished kidney function. In cases of overdose, one should visit a medical institution immediately for appropriate emergency treatment; this drug is fragile, so do not open the packaging carelessly or cut tablets, and take it immediately after opening. Additionally, store it out of reach of children and do not transfer it to another container for safety purposes.

Side effects

Increased mortality, cerebrovascular adverse reactions, venous thrombosis, nasopharyngitis, upper respiratory infection, sinusitis, urinary tract infection, anemia, hypersensitivity reactions, insomnia, anxiety, nervousness, Parkinson's disease, akathisia, drowsiness, dizziness, sedation, tremor, muscle rigidity, hypersomnia, orthostatic dizziness, movement disorders, syncope, blurred vision, ear pain, orthostatic hypotension, tachycardia, hypotension, nasal congestion, dyspnea, epistaxis, sinus congestion, nausea, constipation, indigestion, vomiting, diarrhea, excessive salivation, 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, increased blood creatinine phosphokinase, increased heart rate, pneumonia, soft tissue infection, decreased appetite, confusional state, transient ischemic attack, decreased level of consciousness, drooling, cerebrovascular accident, conjunctivitis, hypotension, cough, runny nose, dysphagia, fecal impaction, erythema, abnormal posture, joint swelling, peripheral edema, gait disturbance, pitting edema, increased body temperature, rhinitis, influenza, increased appetite, middle-of-the-night insomnia, lethargy, headache, stuttering, attention deficit, balance disturbance, excessive sleep, palpitations, pharyngolaryngeal pain, pulmonary congestion, itching, acne, myalgia, neck pain, nocturia, frequency of urination, galactorrhea, mood disturbances, lethargy, chest discomfort, increased blood prolactin, agitation, flattened affect, sleep disturbances, decreased libido, sexual dysfunction, depression, nightmares, unresponsiveness to stimuli, cooperative disturbances, loss of consciousness, speech disorders, sensory deficits, movement disorders, hyperkinetic movement disorders, cerebral ischemia, cerebrovascular accident disorders, neuroleptic malignant syndrome, diabetic coma, head tremor, convulsions, psychomotor hyperactivity, delayed movement disorders, cerebrovascular disorders, sensory abnormalities, conjunctival injection, ocular discharge, eye movement, eyelid swelling, photophobia, eyelid crusting, dry eyes, increased tear flow, glare, glaucoma, impaired vision, tinnitus, dizziness, bradycardia, tachycardia, palpitations, I degree atrioventricular block, left bundle branch block, right bundle branch block, heart block, flushing, conduction disorders, abnormal electrocardiogram, prolonged QT interval in electrocardiogram, deep vein thrombosis, bradycardia, wheezing, aspiration pneumonia, voice disorders, wet cough, airway congestion, rales, respiratory disorders, nasal mucosal edema, 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, papulovesicular rash, eczema, musculoskeletal chest pain, joint stiffness, muscle weakness, rhabdomyolysis, urinary disorders, amenorrhea, gynecomastia, vaginal discharge, erectile dysfunction, ejaculatory disorder, menstrual disorders, breast enlargement, sexual function disorder, retrograde ejaculation, breast secretions, thirst, influenza-like symptoms, edema, malaise, facial edema, discomfort, generalized edema, chills, peripheral coldness, drug withdrawal syndrome, drug adverse reactions, hypothermia, procedure-related pain, increased ALT, abnormal electrocardiogram, 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, anaphylactic reaction, abnormal secretion of antidiuretic hormone, diabetic ketoacidosis, diabetes, hypoglycemia, water intoxication, increased blood cholesterol, increased blood triglycerides, mania, abnormal taste, intraoperative iris tension reduction syndrome, atrial fibrillation, deep vein thrombosis, pulmonary embolism, sleep apnea syndrome, bowel obstruction, pancreatitis, jaundice, vascular edema, alopecia, neonatal drug withdrawal syndrome, urinary retention, persistent erection, hypothermia, chest pain, liver dysfunction, hepatitis, dry mouth, xerostomia, urinary retention, polyuria, pain, hiccups, increased sweating, urination disorders, leukopenia, arrhythmia, epistaxis, anemia, diarrhea, hangover, ocular movement disorders, acne, dysphagia, enuresis, tic disorders, dyspnea, Rabbit syndrome, suicidal ideation, thought disorder, delusions, hallucinations, exacerbation of auditory symptoms, delayed movement abnormalities, neuroleptic malignant syndrome, confusion, insensitivity, unstable posture, frequent falls, weight gain, persistent erection, falls

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

Storage

This drug should be stored in a tightly closed container to prevent air or moisture from entering, and it is safe to store it at room temperature between 1 to 30 degrees Celsius. Storing in this manner can help maintain the drug's effectiveness for a longer period.

Appearance and packaging

Appearance

White round tablet

Package unit

28 tablets/box (7 tablets/PTPx4)

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.