Risperdal Tablets 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. 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 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 considered to outweigh the risks. (4) Doses of 16 mg or more per day should not be administered because their safety has not been established. (5) A benzodiazepine may be administered concomitantly if additional sedation is needed. 2) Dosage 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 existing antipsychotic medication to this medicine When medically appropriate, initiate treatment with this medicine while gradually reducing the dose of the existing medication. Also, when switching from an existing depot antipsychotic medication, when medically appropriate, initiate 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 type The initial dose is 0.25 mg of this medicine twice daily. If needed, the dose may be increased by 0.25 mg twice daily at intervals of at least 2 days, depending on the patient. 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 dosing may also be considered. As with all symptomatic treatments, continued use of this medicine should be continuously evaluated and justified. 3. Adjunctive treatment of manic episodes in bipolar disorder • An initial dose of 2 mg of this medicine once daily is recommended. 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 all symptomatic treatments, continued use of this medicine should be continuously evaluated and justified. 4. Conduct disorder and other disruptive behavior disorders As with all symptomatic treatments, continued use of this medicine should be continuously evaluated and justified. 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. Behavioral 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, 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. 4. Behavioral disorders and other disruptive behavior disorders — 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. There is limited clinical experience in children under 5 years of age.

This medication can increase mortality when administered to elderly dementia patients, hence special precautions are necessary. In particular, when used together with certain diuretics such as furosemide, the risk of mortality may increase, so the risks and benefits should be carefully evaluated before concomitant use. Additionally, this medication has the potential to cause vascular issues such as thrombosis; therefore, it is necessary to confirm and take preventive measures for patients with risk factors for venous thromboembolism. Patients with hypersensitivity to this medication, those in states of central nervous system depression, those who are comatose, patients receiving epinephrine, and those with specific genetic lactose intolerance should not use this medication. Patients with heart disease or those with renal and liver dysfunction, those with a history of seizures, those at risk of suicide, and those with Parkinson's disease or Lewy body dementia should exercise extra caution when using this medication. Women who are pregnant or breastfeeding should strictly consider the risks and benefits of using this medication due to potential effects on the fetus or newborn. This medication can cause various side effects such as drowsiness, dizziness, hypotension, and movement disorders; if any of these symptoms occur during treatment, immediate consultation with a healthcare provider is necessary. Additionally, caution is required if this medication is used with other central nervous system medications or alcohol, as the central nervous system depressant effects may be intensified. Since this medication is metabolized in the liver, patients with reduced liver or renal function should adjust the dose and increase it slowly. It is important to periodically check blood glucose and weight changes during treatment to manage the risks of diabetes or obesity. Special care should be taken when engaging in activities that require concentration, such as driving or operating machinery while taking this medication. In case of overdose, immediate emergency treatment is required, and there is no antidote for this medication; supportive treatment according to symptoms is necessary. Finally, store this medication in a safe place out of reach of children and avoid transferring it into other containers.

Increased mortality, stroke, transient ischemic attack, venous thrombosis, rhinitis, upper respiratory infection, sinusitis, urinary tract infection, anemia, hypersensitivity reactions, insomnia, anxiety, irritability, Parkinsonism, akathisia, drowsiness, dizziness, sedation, tremor, muscle rigidity, hypersomnia, orthostatic dizziness, dyskinesia, syncope, blurred vision, ear pain, orthostatic hypotension, tachycardia, hypotension, nasal congestion, breathing difficulties, nosebleeds, sinus congestion, nausea, constipation, dyspepsia, vomiting, diarrhea, hypersalivation, dry mouth, abdominal discomfort, abdominal pain, gastrointestinal discomfort, epigastric pain, rash, dry skin, dandruff, seborrheic dermatitis, hyperkeratosis, back pain, joint pain, limb pain, urinary incontinence, ejaculation failure, fatigue, weakness, fever, chest pain, elevated blood creatinine phosphokinase, increased heart rate, urinary tract infection, pneumonia, soft tissue infection, decreased appetite, confused state, transient ischemic attack, altered consciousness, drooling, cerebrovascular accident, conjunctivitis, hypotension, cough, runny nose, difficulty swallowing, fecal impaction, erythema, abnormal posture, joint swelling, peripheral edema, gait disturbance, pitting edema, elevated body temperature, upper respiratory infection, rhinitis, influenza, increased appetite, moderate insomnia, lethargy, headache, stuttering, attention deficit, balance disorders, excessive sleep, palpitations, oropharyngeal pain, pulmonary congestion, itching, acne, myalgia, neck pain, nocturnal enuresis, frequency of urination, hyperprolactinemia, emotional disturbances, lethargy, chest discomfort, weight gain, increased blood prolactin, anxiety, blunted affect, sleep disorders, decreased libido, sexual dysfunction, depression, nightmares, non-responsiveness to stimuli, coordination disorders, loss of consciousness, speech disorders, sensory loss, movement disorders, generalized dyskinesia, cerebral ischemia, cerebrovascular accident disorders, neuroleptic malignant syndrome, diabetic coma, head tremors, convulsions, psychomotor hyperactivity, delayed dyskinesia, cerebrovascular disorders, sensory disturbances, eye congestion, ocular discharge, eye movement, eyelid edema, photophobia, eyelid crusting, dry eyes, increased lacrimation, glare, glaucoma, decreased vision, tinnitus, vertigo, tachycardia, bradycardia, palpitations, I degree AV block, left bundle branch block, right bundle branch block, AV block, flushing, conduction disorders, abnormal electrocardiogram, prolonged QT interval on electrocardiogram, deep vein thrombosis, bradycardia, wheezing, aspiration pneumonia, voice disorders, wet cough, airway congestion, rales, respiratory distress, nasal congestion, hyperventilation, fecal incontinence, gastritis, lip swelling, cheilitis, salivary deficiency, abdominal distension, enteritis, tongue swelling, dental pain, skin discoloration, skin lesions, skin disorders, erythematous rash, papular rash, generalized rash, annular papular rash, eczema, musculoskeletal chest pain, joint stiffness, muscle weakness, rhabdomyolysis, dysuria, amenorrhea, gynecomastia, vaginal discharge, erectile dysfunction, ejaculation disorders, menstrual disorders, breast swelling, sexual dysfunction, retrograde ejaculation, breast 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, elevated ALT, abnormal electrocardiogram, increased eosinophils, elevated AST, leukopenia, elevated blood glucose, decreased hemoglobin, decreased hematocrit, hypothermia, hypotension, increased transaminases, increased gamma-glutamyl transferase, elevated liver enzymes, agranulocytosis, thrombocytopenia, anaphylactic reaction, abnormal secretion of antidiuretic hormone, diabetic ketoacidosis, diabetes, hypoglycemia, water intoxication, elevated blood cholesterol, elevated blood triglycerides, tension syndrome, mania, somnambulism, sleep-related eating disorder, altered taste, surgical intraoperative iris tension reduction syndrome, atrial fibrillation, deep vein thrombosis, pulmonary embolism, sleep apnea syndrome, intestinal obstruction, pancreatitis, jaundice, vascular edema, hair loss, drug reactions accompanied by eosinophilia and systemic symptoms, Stevens-Johnson syndrome, toxic epidermal necrolysis, neonatal drug withdrawal syndrome, urinary retention, priapism, hypothermia, prolonged QT interval on electrocardiogram, chest pain, liver function abnormalities, hepatitis, thirst, dry mouth, urinary retention, polyuria, pain, hiccups, increased sweating, dysuria, leukopenia, arrhythmia, nosebleeds, anemia, diarrhea, hangover, ocular motility seizures, acne, difficulty swallowing, enuresis, tic disorders, respiratory distress, Rabbit syndrome, suicidal ideation, behavioral abnormalities, delusions, hallucinations, exacerbation of hallucinations

This medication may be sensitive to air or moisture; therefore, it should be stored in a tightly closed container. Additionally, avoid direct sunlight and store at room temperature between 1°C and 30°C.

Appearance

White oblong film-coated tablets

Package unit

30 tablets/bottle, 200 tablets/bottle