Risperidone Orally Disintegrating Tablet 2 mg (Risperidone)

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. Place this medicine on the tongue and, once it has disintegrated 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 effects were 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 to the individual patient are judged 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 another antipsychotic to this medicine When medically appropriate, start this medicine while gradually reducing the dose of the existing medicine. Also, when medically appropriate, when switching from an existing depot antipsychotic, start this medicine in place of the next scheduled depot injection. Regularly reassess whether continued use of any concomitant antiparkinsonian medicine is necessary. 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 for 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 assessed. 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 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 medicine should be assessed. 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. 4. Conduct disorder and other disruptive behavior disorders Body weight 50 kg or more: The initial dose is 0.5 mg of this drug 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. As with symptomatic treatment, the appropriateness of continued use of this drug should be evaluated. ⦁ There is limited clinical experience in children under 5 years of age.

This medication should be used with caution in elderly patients with dementia, as it may increase mortality. In particular, if this medication is taken in conjunction with certain diuretics, such as furosemide, the risk of death may be increased, so the risks and benefits should be carefully considered before co-administration. Furthermore, this medication may increase the risk of thrombosis, particularly venous thrombosis, so risk factors for thrombosis should be assessed and preventive measures taken prior to and during treatment. This medication contains the artificial sweetener aspartame, which should not be administered to patients with phenylketonuria. This medication should not be administered to individuals with hypersensitivity to it, or to patients who have suppressed central nervous systems due to the use of alcohol or central nervous system depressants, patients in comatose states, or patients receiving epinephrine. Patients with cardiovascular diseases or impaired liver or kidney function may require dose adjustments and monitoring when using this medication, and patients with a history of seizures should also be cautious. This medication can cause various neurological, gastrointestinal, and psychiatric adverse reactions; therefore, if any abnormal symptoms arise, immediate consultation with healthcare professionals is needed. During treatment, metabolic abnormalities, such as hyperglycemia, worsening of diabetes, and weight gain, should also be monitored, and caution is needed when combining with other medications requiring sedative effects. This medication affects the central nervous system, so caution is necessary when driving or operating machinery, and regular testing for blood abnormalities, such as leukopenia, is recommended. It is advisable for pregnant or breastfeeding women not to use this medication, especially in late pregnancy, as there may be abnormal symptoms in newborns. In case of an overdose, immediate visit to a medical institution for appropriate emergency treatment is necessary. Store this medication out of reach of children, and it should be taken immediately after opening the package. Additionally, since this medication may interact with other drugs, it is essential to inform healthcare professionals about any medications being taken.

Increased mortality, cerebrovascular adverse reactions, venous thrombosis, hypersensitivity reactions, insomnia, anxiety, neuroexcitation, Parkinson's syndrome, inability to sit still, 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, indigestion, vomiting, diarrhea, excessive salivation, dry mouth, abdominal discomfort, abdominal pain, gastrointestinal discomfort, upper abdominal pain, rash, dry skin, dandruff, seborrheic dermatitis, back pain, arthralgia, limb pain, urinary incontinence, erectile dysfunction, fatigue, weakness, fever, chest pain, 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, pitting edema, elevated body temperature, upper respiratory tract infection, rhinitis, influenza, increased appetite, mid-sleep insomnia, lethargy, headache, stuttering, attention deficit, balance disorders, hypersomnia, palpitations, pharyngolaryngeal pain, pulmonary congestion, itching, acne, myalgia, neck pain, nocturia, urinary frequency, galactorrhea, emotional disturbances, lethargy, discomfort in the chest, anxiety, blunted affect, sleep disorders, decreased libido, anhedonia, depression, nightmares, unresponsiveness to stimuli, coordination disturbances, loss of consciousness, language disorders, sensory deficits, movement disorders, hyperkinetic movement disorder, cerebral ischemia, cerebrovascular accident complications, neuroleptic malignant syndrome, diabetic coma, head tremors, seizures, psychomotor hyperactivity, delayed dyskinesia, cerebrovascular disorders, sensory disturbances, conjunctival injection, eye discharge, ocular movement, eyelid swelling, photophobia, crusting of the eyelid margins, dry eyes, increased tearing, glare, glaucoma, decreased vision, tinnitus, vertigo, bradycardia, tachycardia, palpitations, I degree AV block, left bundle branch block, right bundle branch block, AV block, flushing, conduction disturbances, abnormal ECG, QT interval prolongation on ECG, pulmonary embolism, bradycardia, wheezing, aspiration pneumonia, voice disorders, wet cough, airway edema, rales, respiratory distress, nasal turbinate swelling, hyperventilation, fecal incontinence, gastritis, lip swelling, cheilitis, salivary gland deficiency, flatulence, gastroenteritis, tongue swelling, dental pain, skin discoloration, skin lesions, skin disorders, erythematous rash, papular rash, generalized rash, semi-papular rash, eczema, musculoskeletal chest pain, joint stiffness, muscle weakness, rhabdomyolysis, urinary disorders, amenorrhea, gynecomastia, vaginal discharge, erectile dysfunction, ejaculation disorders, menstrual disorders, breast engorgement, sexual dysfunction, retrograde ejaculation, breast discharge, thirst, influenza-like syndrome, edema, malaise, facial swelling, discomfort, generalized edema, chills, peripheral coldness, drug withdrawal syndrome, drug adverse reactions, decreased body temperature, procedure-related pain, elevated serum creatinine phosphokinase, increased heart rate, agranulocytosis, thrombocytopenia, abnormal secretion of antidiuretic hormone, diabetic ketoacidosis, diabetes mellitus, hypoglycemia, water intoxication, increased serum cholesterol, increased serum triglycerides, mania, dysgeusia, intraoperative iris hypotonic 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, QT prolongation on ECG, chest pain, liver dysfunction, hepatitis, dry mouth, xerostomia, urinary retention, polyuria, pain, hiccups, increased sweating, voiding dysfunction, leukopenia, arrhythmia, epistaxis, anemia, diarrhea, hangover, oculomotor seizures, acne, dysphagia, enuresis, tic disorder, dyspnea, Rabbit syndrome, suicidal ideation, abnormal accidents, delusions, hallucinations, exacerbation of auditory hallucinations, delayed movement disorders, neuroleptic malignant syndrome, confusion, desensitization, postural instability, falls, weight gain, persistent erection, hypothermia

This medication should be stored in a tightly sealed container that can protect it from air and moisture, and it is important to keep it in a cool place below 30 degrees Celsius. Storing it this way will help maintain the efficacy of the medication for a longer duration.

Appearance

Blue round orally disintegrating tablet

Package unit

100 tablets (10 tablets/PTP x 10)