Rispeldon 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 should be administered whenever possible. Place this medicine 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 1 mg of risperidone orally twice daily and gradually increase the dose. (2) Maintenance dose: Administer 1∼3 mg twice daily. Adjust the dose appropriately according to age and symptoms. (3) 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 to the individual patient are judged to outweigh the risks. (4) Do not administer doses of 16 mg or more per day, as their safety has not been established. (5) A benzodiazepine may be administered concomitantly 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 an existing antipsychotic to this medicine When medically appropriate, start treatment with this medicine while gradually reducing the dose of the existing medicine. Also, when switching from an existing depot antipsychotic, when medically appropriate, start treatment with this medicine 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 medicine twice daily. If necessary 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 rationale for continued use of this medicine should be evaluated. 3. Adjunctive treatment of 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 in the range of 2∼6 mg per day. As with symptomatic treatment, the rationale for continued use of this medicine should be evaluated. Renal and hepatic impairment For 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

⦁ 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 of this medicine 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. ⦁ Clinical experience in children under 5 years of age is limited.

This medication may increase mortality in elderly dementia patients, thus caution is particularly advised. If elderly dementia patients are taking this medication along with certain diuretics, such as Furosemide, the risk of mortality may further increase, requiring careful consideration of risks and benefits before concomitant use. This medication may raise the risk of venous thromboembolism, and thrombotic risk factors should be assessed and preventive measures taken before and during administration. This medication contains the artificial sweetener aspartame, which should be assessed by patients with specific genetic disorders such as phenylketonuria before taking. Caution is necessary as the combined use of this medication with alcohol or central nervous system depressants may potentiate CNS depressant effects. Patients with cardiovascular disease or those at risk for arrhythmias or QT interval prolongation, as well as those with impaired liver or kidney function, require dosage adjustment and careful monitoring. Pregnant or nursing women should consult a physician regarding potential risks to the fetus or newborn when using this medication. This medication may cause drowsiness, dizziness, or orthostatic hypotension, so caution is necessary when driving or operating machinery. Weight gain, increased blood glucose levels, and worsening of diabetes have been reported during treatment, hence dietary management and blood glucose monitoring are recommended. In case of abnormal involuntary movements or serious adverse effects such as Neuroleptic Malignant Syndrome occur, immediate medical attention should be sought. In the event of overdose, immediate emergency treatment is required, as no specific antidote exists and supportive treatment according to symptoms should be received. This medication should be kept out of reach of children, and it is safer not to transfer it to another container.

Increased mortality, cerebrovascular adverse reactions, venous thromboembolism, rhinitis, upper respiratory infection, sinusitis, urinary tract infection, anemia, hypersensitivity reactions, insomnia, anxiety, neuroirritability, Parkinson's disease, akathisia, drowsiness, dizziness, sedation, tremors, muscle rigidity, hypersomnolence, orthostatic dizziness, movement disorders, syncope, blurred vision, otalgia, 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, pneumonia, soft tissue infection, decreased appetite, confusion, transient ischemic attack, decreased consciousness, sialorrhea, cerebrovascular accident, conjunctivitis, cough, rhinorrhea, dysphagia, fecal impaction, erythema, abnormal posture, joint swelling, peripheral edema, gait disturbances, pitting edema, elevated temperature, rhinitis, influenza, increased appetite, mid insomnia, lethargy, headache, stuttering, attention deficit, balance disorders, hypersomnia, palpitations, pharyngolaryngeal pain, pulmonary congestion, pruritus, acne, myalgia, neck pain, nocturia, frequency of urination, hyperprolactinemia, emotional disturbances, apathy, chest discomfort, weight gain, elevated serum prolactin, restlessness, dulled affect, sleep disturbances, decreased libido, sexual dysfunction, depression, nightmares, unresponsiveness to stimuli, cooperative disorders, loss of consciousness, speech disorders, sensory deficits, movement disorders, tardive dyskinesia, cerebral ischemia, cerebrovascular accident disorders, neuroleptic malignant syndrome, diabetic coma, tremors, seizures, psychomotor hyperactivity, akinesia, cerebrovascular disorders, sensory disturbances, conjunctival hyperemia, eye discharge, eye movements, eyelid edema, photophobia, crusted eyelids, dry eyes, increased tear production, glare, glaucoma, visual impairment, tinnitus, vertigo, bradycardia, tachycardia, palpitations, I-degree atrioventricular block, left bundle branch block, right bundle branch block, heart block, flushing, conduction disturbances, ECG abnormalities, prolonged QT interval on ECG, deep vein thrombosis, bradycardia, wheezing, aspiration pneumonia, voice disorders, productive cough, airway congestion, crackles, respiratory distress, nasal edema, hyperventilation, fecal incontinence, gastritis, lip swelling, cheilitis, hyposalivation, abdominal distension, gastroenteritis, tongue swelling, dental pain, skin discoloration, skin lesions, skin disorders, erythematous rash, papular rash, generalized rash, papulovesicular rash, eczema, musculoskeletal chest pain, joint stiffness, muscle weakness, rhabdomyolysis, voiding disorders, amenorrhea, gynecomastia, vaginal discharge, erectile dysfunction, ejaculation disorders, menstrual disorders, breast engorgement, sexual dysfunction, retrograde ejaculation, breast discharge, thirst, influenza-like syndrome, edema, lethargy, facial swelling, discomfort, generalized edema, chills, peripheral coldness, drug withdrawal syndrome, adverse drug reactions, decreased body temperature, procedure-related pain, elevated ALT, ECG abnormalities, eosinophilia, elevated AST, decreased white blood cell count, elevated blood glucose, decreased hemoglobin, decreased hematocrit, hypothermia, hypotension, elevated transaminases, increased γ-glutamyl transferase, increased liver enzymes, agranulocytosis, thrombocytopenia, anaphylactic reaction, abnormal secretion of antidiuretic hormone, diabetic ketoacidosis, diabetes mellitus, hypoglycemia, water intoxication, mania, dysgeusia, intraoperative intraocular pressure decrease syndrome, atrial fibrillation, deep vein thrombosis, pulmonary embolism, sleep apnea syndrome, intestinal 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, voiding disorders, leukopenia, arrhythmia, epistaxis, anemia, diarrhea, hangover, ocular myoclonus, acne, dysphagia, enuresis, tic disorders, dyspnea, suicidal ideation, cognitive disturbances, delusions, hallucinations, exacerbation of auditory symptoms, falls, persistent erection, orthostatic hypotension, syncope, extrapyramidal symptoms, hyperthermia, muscle rigidity, autonomic nervous system anxiety disorder, consciousness disturbances, elevated serum creatine phosphokinase, myoglobinuria, acute kidney injury, delirium, insensitivity, postural instability, frequent falls, hyperglycemia, diabetes mellitus, weight gain

This medication must be kept in a tightly sealed container to prevent air or moisture exposure and stored at a temperature between 1°C and 30°C. Storing it this way helps maintain the medication's efficacy.

Appearance

Oblong light orange film-coated tablet

Package unit

30 tablets/bottle, 200 tablets/bottle