Ripedon 1 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; 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 per dose orally twice daily and increase the dose gradually. (2) Maintenance dose: Administer 1∼3 mg per dose twice daily. Adjust as appropriate according to age and symptoms. (3) No additional benefit was observed with doses of 10 mg or more daily compared with lower doses, and the risk of extrapyramidal symptoms may increase. Doses of 10 mg or more daily 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 daily, as safety has not been established. (5) A benzodiazepine may be administered concomitantly if additional sedation is needed. 2) Administration in special populations • Older adults and patients predisposed to hypotension The initial dose is 0.5 mg per dose twice daily. Depending on the patient's condition, increase by 0.5 mg per dose twice daily until a dose of 1～2 mg per dose twice daily is reached. In general, increases to doses of 1.5 mg or more per dose twice daily should be made at intervals of at least 1 week. 3) Switching from another 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, if medically appropriate, start this medicine in place of the next scheduled injection of the depot formulation. The need to continue concomitant antiparkinsonian medication should be reassessed regularly. 2. Agitation, aggression, or psychotic symptoms in patients with dementia of the Alzheimer type The initial dose is 0.25 mg per dose twice daily. If necessary, depending on the patient, the dose may be increased by 0.25 mg per dose twice daily at intervals of at least 2 days. The optimal dose for most patients is 0.5 mg per dose twice daily, although the dose may be increased to 1 mg per dose 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 medicine should be evaluated. 3. Adjunctive treatment of mania in bipolar disorder • An initial dose of 2 mg once daily is recommended. Depending on the patient, the dose may be increased by 1 mg daily at intervals of at least 24 hours. The optimal dose for most patients is within the range of 2∼6 mg daily. As with symptomatic treatment, the rationale for continued use of this medicine 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 medicine with caution in these patients (see 5. General precautions).

Child dose

1. Schizophrenia There is limited clinical experience in children and adolescents under 15 years of age. 3. Adjunctive treatment of mania in bipolar disorder There is limited clinical experience in children and adolescents under 15 years of age. 4. Disruptive behavior disorders and other disruptive behavior disorders Body weight 50 kg or more: The initial dose is 0.5 mg of this medicine once daily. If necessary, depending on the patient, 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 less than 50 kg: The initial dose is 0.25 mg once daily. If necessary, depending on the patient, 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. There is limited clinical experience in children under 5 years of age.

This medication may increase mortality when used in elderly dementia patients, requiring special caution. In elderly dementia patients, dehydration should be managed, and there is a higher risk of mortality when used in conjunction with certain diuretics, so careful consideration before concomitant use is necessary. This medication may increase the risk of venous thromboembolism, hence thrombotic risk factors should be checked and preventive measures taken before and during administration. Patients with phenylketonuria must inform healthcare providers due to the artificial sweetener aspartame included in this medication. It should not be administered to patients with hypersensitivity, central nervous system depression, coma, under treatment with epinephrine, or certain hereditary lactose-related disorders. Patients with cardiovascular diseases, liver and kidney dysfunction, history of seizures, suicide risk, Parkinson's disease, diabetes risk factors, the elderly, pregnant women, and breastfeeding mothers should use this medication with caution. Various adverse reactions can occur with this medication, so special attention must be given to neurological symptoms, cardiovascular abnormalities, gastrointestinal symptoms, and skin reactions. During administration, be prepared for the possibility of serious side effects such as tardive dyskinesia and neuroleptic malignant syndrome, and consult healthcare providers immediately if symptoms arise. This medication may enhance central nervous system depressant effects when used with other central nervous system depressants or alcohol, requiring caution. Additionally, there may be interactions with multiple medications, so it's essential to inform healthcare providers of any other medications being taken. Use during pregnancy may affect the fetus, therefore it should be administered cautiously, and breastfeeding is recommended to be discontinued. In case of overdose, promptly visit a medical institution for appropriate emergency treatment, as there is no antidote for this medication and supportive treatment based on symptoms is necessary. This medication should be stored out of the reach of children, kept in tightly closed containers to protect from air and moisture, and should not be opened by crushing the package or cutting the tablets, as mixing can lead to a reduction in content.

Increased mortality, stroke, transient ischemic attack, venous thrombosis, rhinopharyngitis, upper respiratory tract infection, sinusitis, urinary tract infection, anemia, hypersensitivity reaction, insomnia, anxiety, neural hyperexcitability, Parkinsonism, akathisia, drowsiness, dizziness, sedation, tremor, muscle rigidity, hypersomnia, orthostatic dizziness, dyskinesia, syncope, blurry 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, epigastric pain, rash, dry skin, dandruff, seborrheic dermatitis, hyperkeratosis, back pain, arthralgia, limb pain, urinary incontinence, ejaculatory dysfunction, fatigue, asthenia, fever, chest pain, elevated blood creatinine and phosphocreatine kinase, increased heart rate, pneumonia, soft tissue infection, decreased appetite, confusion, transient ischemic attack, decreased consciousness, drooling, cerebrovascular accident, conjunctivitis, hypotension, cough, runny nose, dysphagia, fecaloma, erythema, abnormal posture, joint swelling, peripheral edema, gait disturbance, pitting edema, elevated temperature, rhinitis, influenza, increased appetite, middle insomnia, lethargy, headache, stuttering, attention deficit, balance disorder, hypersomnia, palpitations, pharyngolaryngeal pain, pulmonary congestion, itching, acne, myalgia, neck pain, nocturia, polyuria, galactorrhea, emotional disturbances, lethargy, chest discomfort, weight gain, elevated blood prolactin, agitation, flattened affect, sleep disturbances, decreased libido, sexual dysfunction, depression, nightmares, unresponsiveness to stimuli, cooperation disturbances, loss of consciousness, speech disorders, sensory deficits, movement disorders, generalized dyskinesia, cerebral ischemia, cerebrovascular accident dysfunction, neuroleptic malignant syndrome, diabetic coma, head tremor, seizures, psychomotor hyperactivity, delayed dyskinesia, cerebrovascular disorders, sensory abnormalities, conjunctival injection, eye discharge, eye movement, eyelid edema, photophobia, eyelid crusting, dry eyes, increased tearing, glare, glaucoma, impaired vision, tinnitus, vertigo, sinus bradycardia, sinus tachycardia, palpitations, type I atrioventricular block, left bundle branch block, right bundle branch block, heart block, flushing, conduction disorders, ECG abnormalities, prolonged QT interval on ECG, venous return, bradycardia, wheezing, aspiration pneumonia, dysphonia, productive cough, airway congestion, crackles, respiratory distress, nasal cavity swelling, 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 retention, 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, withdrawal syndrome, drug side effects, decreased body temperature, procedure-related pain, increased ALT, ECG abnormalities, eosinophilia, increased AST, decreased white blood cell count, increased blood glucose, decreased hemoglobin, decreased hematocrit, hypothermia, hypotension, increased transaminases, increased gamma-glutamyl transferase, increased liver enzymes, agranulocytosis, thrombocytopenia, anaphylactic reaction, abnormal secretion of antidiuretic hormone, diabetic ketoacidosis, diabetes mellitus, hypoglycemia, water intoxication, increased serum cholesterol, increased serum triglycerides, mania, dysgeusia, intraoperative iris hypotension syndrome, atrial fibrillation, deep vein thrombosis, pulmonary embolism, obstructive sleep apnea syndrome, bowel obstruction, pancreatitis, jaundice, vascular edema, hair loss, neonatal drug withdrawal syndrome, urinary obstruction, priapism, hypothermia, QT interval prolongation on ECG, chest pain, liver function abnormalities, hepatitis, dry mouth, xerostomia, urinary retention, polyuria, pain, hiccups, increased sweating, micturition disorders, leukopenia, arrhythmia, epistaxis, anemia, diarrhea, hangover, ocular movement seizures, acne, dysphagia, enuresis, tic disorder, respiratory distress, Rabbit syndrome, suicidal ideation, thought disorder, delusions, hallucinations, worsening of auditory hallucinations

This medication should be stored in a tightly closed container to prevent exposure to air or moisture. The recommended storage temperature is between 1 to 30 degrees Celsius at room temperature.

Appearance

White oblong film-coated tablets

Package unit

30 tablets/bottle, 300 tablets/bottle