Risperidone ODF 1 mg (Risperidone)

Adult dose

The therapeutic dose of this drug should be adjusted according to the patient's clinical condition, and the lowest effective dose should be administered whenever possible. Place this drug on the tongue; once it disintegrates within a few seconds, swallow it with or without water. Adults with schizophrenia, initial dose: Administer risperidone orally at 1 mg twice daily and increase gradually. Adults with schizophrenia, maintenance dose: Administer 1∼3 mg twice daily. Adjust the dose as appropriate according to age and symptoms. No additional benefit was observed with doses of 10 mg or more daily compared with lower doses, and such doses may increase the risk of extrapyramidal symptoms. Doses of 10 mg or more daily should be administered only when the benefits outweigh the risks for the individual patient. Do not administer doses exceeding 16 mg daily, as safety has not been established. A benzodiazepine may be administered concomitantly if additional sedation is required. 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 reaching 1～2 mg twice daily. In general, increases to doses of 1.5 mg or more twice daily should be made at intervals of at least 1 week. Agitation, aggression, or psychotic symptoms in patients with dementia of the Alzheimer type: The initial dose is 0.25 mg twice daily. If necessary, increase 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 rationale for continued use of this drug should be evaluated. Adjunctive treatment of mania in bipolar disorder: The recommended initial dose is 2 mg once daily. Depending on the patient, the dose may be increased by 1 mg daily at intervals of 24 hours or more. The optimal dose for most patients is in the range of 2∼6 mg daily. As with symptomatic treatment, the rationale for continued use of this drug should be evaluated. When switching from an existing antipsychotic drug to this drug, initiate treatment with this drug while gradually reducing the dose of the existing drug, if medically appropriate. When switching from an existing depot antipsychotic drug, initiate treatment with this drug in place of the next scheduled depot injection, if medically appropriate. The need to continue concomitant antiparkinsonian medication should be reassessed regularly. In patients with renal or hepatic impairment, administer half the initial and maintenance doses and adjust the dose more gradually. Use this drug 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 50 kg or more: The initial dose is 0.5 mg once daily. If necessary, the dose may be increased by 0.5 mg daily 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 necessary, the dose may be increased by 0.25 mg daily 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. Clinical experience in children under 5 years of age is limited.

This medication should be administered with caution in elderly dementia patients, as it may increase mortality. Caution is also needed when taking this medication in combination with the diuretic furosemide, as the risk of death may be increased, requiring careful consideration before co-administration. There is a risk of thrombosis in venous thromboembolism; thus, thrombosis risk factors should be assessed and preventive measures taken before and during the use of this medication. Patients with hypersensitivity to this medication, those with central nervous system depression due to alcohol or central nervous system depressants, and those in a comatose state should not use this medication. Patients with cardiovascular diseases such as heart failure, myocardial infarction, conduction abnormalities, or dehydration may experience orthostatic hypotension when using this medication, thus careful dose adjustments should be made. Patients with a history of arrhythmias or those at risk for QT interval prolongation, as well as those with a history of seizures or seizure risk, should also use this medication cautiously. Patients with decreased liver or kidney function may experience slowed excretion and metabolism of this medication, and thus doses should be reduced, with gradual increases. Patients with a history of suicide attempts or suicide risk, those with Parkinson's disease or Lewy body dementia, diabetics or the elderly, and pregnant or breastfeeding females should also use this medication with care. This medication may cause various side effects such as drowsiness, dizziness, orthostatic hypotension, insomnia, anxiety, Parkinsonian symptoms, weight gain, and abnormal blood glucose, and if any abnormal symptoms arise, immediate consultation with a physician is recommended. Taking this medication with other central nervous system depressants or alcohol may enhance central nervous system depressant effects, and caution is warranted when combined with some antihypertensive medicines or medications that prolong the QT interval. Using this medication during pregnancy may lead to extrapyramidal symptoms or withdrawal symptoms in newborns, hence it should not be used during pregnancy except in special cases. In breastfeeding, this medication may be transmitted through breast milk, so discontinuation of breastfeeding is recommended. When administering to children or the elderly, dose adjustments and monitoring for side effects are essential, and in cases of overdose, immediate hospital consultation for appropriate treatment is required. This medication should not be opened by squeezing the packaging or have its tablets cut, and must be kept out of reach of children. Additionally, transferring to another container is inadvisable for preserving quality.

Increased mortality, cerebrovascular adverse reactions, venous thromboembolism, pharyngitis, upper respiratory infection, sinusitis, urinary tract infection, anemia, hypersensitivity reactions, insomnia, anxiety, nervousness, Parkinsonism, akathisia, drowsiness, dizziness, sedation, tremors, muscle rigidity, somnolence, 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, gastrointestinal discomfort, epigastric pain, rash, dry skin, dandruff, seborrheic dermatitis, hyperkeratosis, back pain, arthralgia, limb pain, urinary incontinence, ejaculatory dysfunction, fatigue, asthenia, fever, chest pain, elevated serum creatinine phosphokinase, increased heart rate, urinary tract infection, pneumonia, soft tissue infection, decreased appetite, confusion, transient ischemic attack, altered consciousness, drooling, cerebrovascular accident, conjunctivitis, hypotension, cough, runny nose, dysphagia, fecal impaction, erythema, abnormal posture, joint swelling, peripheral edema, gait disturbance, pit edema, elevated body temperature, upper respiratory infection, rhinitis, influenza, increased appetite, moderate insomnia, lethargy, headache, stuttering, attention deficit, balance disorder, hypersomnia, palpitations, pharyngeal-laryngeal pain, pulmonary congestion, itching, acne, myalgia, neck pain, nocturia, frequent urination, galactorrhea, mood disturbance, lethargy, discomfort in the chest, weight gain, elevated serum prolactin, anxiety, flattened affect, sleep disturbance, decreased libido, sexual dysfunction, depression, nightmares, unresponsiveness to stimuli, coordination disturbance, loss of consciousness, speech disorder, sensory impairment, movement disorder, generalized dyskinesia, cerebral ischemia, cerebrovascular accident disorders, neuroleptic malignant syndrome, diabetic coma, head tremor, convulsions, psychomotor agitation, delayed dyskinesia, cerebrovascular disorders, sensory disturbances, conjunctival injection, ocular discharge, eye movement, eyelid edema, photophobia, crusting of the eyelid margin, dry eyes, increased tearing, glare, glaucoma, reduced vision, tinnitus, vertigo, bradycardia, sinus bradycardia, palpitations, flushing, wheezing, aspiration pneumonia, voice disorders, productive cough, airway congestion, crackles, respiratory distress, nasal cavity edema, 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 stiffness, muscle weakness, rhabdomyolysis, voiding disorders, amenorrhea, gynecomastia, vaginal discharge, erectile dysfunction, ejaculatory disorders, menstrual disorders, breast engorgement, sexual dysfunction, retrograde ejaculation, nipple discharge, thirst, influenza-like syndrome, edema, malaise, facial swelling, discomfort, generalized edema, chills, peripheral coldness, drug withdrawal syndrome, adverse drug reactions, decreased body temperature, procedure-related pain, increased ALT, ECG abnormalities, eosinophilia, increased AST, leukopenia, elevated blood sugar, 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, elevated blood cholesterol, increased blood triglycerides, mania, dysgeusia, intraoperative intraocular pressure reduction syndrome, atrial fibrillation, deep vein thrombosis, pulmonary embolism, sleep apnea syndrome, bowel obstruction, pancreatitis, jaundice, vascular edema, hair loss, neonatal drug withdrawal syndrome, urinary retention, priapism, hypothermia, chest pain, liver dysfunction, hepatitis, xerostomia, dry mouth, urinary retention, polyuria, hiccups, leukopenia, arrhythmia, hangover, ocular motor seizures, acne, dysphagia, enuresis, tic disorder, respiratory distress, Rabbit syndrome, suicidal ideation, thought disorder, delusions, hallucinations, exacerbation of symptoms

This medication should be stored in a tightly sealed container to protect it from air and moisture and should be kept at room temperature between 1 to 30 degrees Celsius. Storing it this way will help maintain its efficacy and prevent degradation.

Appearance

White square tablet

Package unit

28 tablets/box (7 tablets/PTP x 4)