Risperidone Tablet 3mg (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 disintegrates within a few seconds, swallow it with or without water (for orally disintegrating tablets only). Adults with schizophrenia Initial dose: Administer 1 mg of risperidone orally twice daily, and increase the dose gradually. Maintenance dose: Administer 1∼3 mg twice daily. Adjust the dose appropriately according to age and symptoms. 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 for the individual patient are judged to outweigh the risks. Do not administer doses of 16 mg or more per day, as safety has not been established. A benzodiazepine may be coadministered if additional sedation is needed. Older patients with schizophrenia 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. Switching from existing antipsychotic medication to this medicine When medically appropriate, start treatment with this medicine while gradually reducing the dose of the existing medication. Also, when medically appropriate, when switching from an existing depot antipsychotic, start treatment with this medicine in place of the next scheduled depot injection. The need to continue concomitant antiparkinsonian medication should be reassessed regularly. Agitation, aggression, or psychotic symptoms in patients with Alzheimer's-type dementia The initial dose is 0.25 mg of this medicine twice daily. If needed, depending on 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 reaches the optimal dose, once-daily administration may also be considered. As with symptomatic treatment, the appropriateness of continued use of this medicine should be evaluated. Adjunctive treatment of mania 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 up to 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 appropriateness of 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

Clinical experience in children and adolescents under 15 years of age with schizophrenia is limited. Clinical experience with adjunctive treatment of manic episodes in children and adolescents under 15 years of age with bipolar disorder is limited. 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. Conduct disorder 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. Clinical experience in children under 5 years of age with conduct disorder and other disruptive behavior disorders is limited.

This medication should be administered with caution to elderly dementia patients as it may increase mortality risk. When used together with certain diuretics like furosemide in elderly dementia patients, the risk of death may be higher, thus careful consideration of risks versus benefits is advised before combination therapy. Since there is a risk of venous thromboembolism, thrombotic risk factors should be checked and preventive measures taken before and during use of this medication. Patients with hereditary phenylketonuria must limit their intake of the artificial sweetener aspartame contained in this medication, ensuring it does not exceed WHO recommended limits. This medication should not be administered to patients with hypersensitivity, central nervous system depression, coma, ongoing epinephrine treatment, or certain genetic lactose intolerance. Patients with cardiovascular diseases, impaired liver or renal function, history of seizures or suicide risk, and patients with Parkinson's disease should use this medication cautiously. This medication can cause various adverse reactions, including drowsiness, dizziness, orthostatic hypotension, weight gain, gastrointestinal symptoms, skin rashes, among others. In particular, elderly dementia patients may be at higher risk for pneumonia, urinary tract infections, and cerebrovascular accidents. Since this medication has central nervous system depressant effects, caution is required when used in combination with alcohol or other CNS depressants. Furthermore, there may be potential interactions with various medications, so it is important to verify compatibility with other medications being taken. Women who are pregnant or breastfeeding should carefully evaluate the necessity and risks of using this medication as it may cause adverse effects in the fetus or newborn. This medication requires dose adjustments for children and the elderly, and in the event of overdose, immediate medical attention should be sought. It is recommended to avoid activities requiring mental concentration, such as driving or operating machinery, while taking this medication. This medication should be kept out of reach of children, and should be taken immediately after opening the package, and should not be mixed with tea or cola.

Increased mortality, cerebrovascular adverse reactions, venous thrombosis, nasopharyngitis, upper respiratory tract infection, sinusitis, urinary tract infection, anemia, hypersensitivity reactions, insomnia, anxiety, irritability, Parkinsonism, akathisia, drowsiness, dizziness, sedation, tremor, muscle hypertonicity, somnolence, orthostatic dizziness, dyskinesia, syncope, blurred vision, ear pain, orthostatic hypotension, tachycardia, hypotension, nasal congestion, dyspnea, nosebleed, sinus congestion, nausea, constipation, dyspepsia, vomiting, diarrhea, hypersalivation, dry mouth, abdominal discomfort, abdominal pain, abdominal unease, epigastric pain, rash, dry skin, dandruff, seborrheic dermatitis, back pain, joint pain, limb pain, urinary incontinence, ejaculatory dysfunction, fatigue, asthenia, fever, chest pain, elevated blood creatinine phosphokinase, increased heart rate, pneumonia, soft tissue infection, decreased appetite, confusion, transient ischemic attack, decreased level of consciousness, drooling, cerebrovascular accident, conjunctivitis, cough, runny nose, difficulty swallowing, fecal impaction, erythema, abnormal posture, joint swelling, peripheral edema, gait disturbance, pitting edema, increased body temperature, rhinitis, influenza, increased appetite, middle insomnia, fatigue, headache, stuttering, attention deficit, balance disorder, hypersomnia, palpitations, pharyngolaryngeal pain, pulmonary congestion, pruritus, acne, myalgia, neck pain, nocturia, increased frequency of urination, hyperprolactinemia, emotional disturbances, lethargy, chest discomfort, weight gain, elevated blood prolactin, anxiety, blunted affect, sleep disturbances, decreased libido, anhedonia, depression, nightmares, unresponsiveness to stimulation, impaired cooperation, loss of consciousness, speech disorder, sensory loss, motor disturbance, generalized dyskinesia, cerebral ischemia, cerebrovascular accident disorder, neuroleptic malignant syndrome, diabetic coma, head tremors, convulsions, psychomotor hyperactivity, delayed dyskinesia, cerebrovascular disorder, sensory abnormalities, conjunctival injection, eye discharge, eye movement, eyelid edema, photophobia, crusting of eyelid margins, dry eyes, increased tearing, glare, glaucoma, decreased vision, tinnitus, vertigo, sinus bradycardia, sinus tachycardia, palpitations, I-degree AV block, left bundle branch block, right bundle branch block, AV block, flushing, conduction disorders, electrocardiogram abnormalities, prolonged QT interval in electrocardiogram, venous thrombosis, bradycardia, wheezing, aspiration pneumonia, dysphonia, productive cough, airway congestion, rales, respiratory distress, nasal cavity swelling, hyperventilation, fecal incontinence, gastritis, lip swelling, cheilitis, salivary deficiency, distension, 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, urination disorders, amenorrhea, gynecomastia, vaginal discharge, erectile dysfunction, ejaculatory disorder, menstrual irregularities, breast swelling, sexual dysfunction, retrograde ejaculation, breast discharge, thirst, influenza-like syndrome, edema, malaise, facial edema, discomfort, systemic edema, chills, peripheral coldness, drug withdrawal syndrome, adverse drug reactions, decreased body temperature, procedure-related pain, weight loss, increased eosinophils, decreased white blood cell count, increased blood glucose, decreased hemoglobin, decreased hematocrit, lowered blood pressure, increased transaminases, increased gamma-glutamyl transferase, elevated liver enzymes, falls, agranulocytosis, thrombocytopenia, anaphylactic reaction, abnormal secretion of antidiuretic hormone, diabetic ketoacidosis, diabetes, hypoglycemia, water intoxication, increased blood cholesterol, increased blood triglycerides, mania, taste abnormalities, intraoperative iris tension reduction syndrome, atrial fibrillation, deep vein thrombosis, pulmonary embolism, sleep apnea syndrome, intestinal obstruction, pancreatitis, jaundice, vascular edema, hair loss, neonatal drug withdrawal syndrome, urinary retention, priapism, hypothermia, chest pain, liver dysfunction, hepatitis, dry mouth, xerostomia, urinary retention, polyuria, hiccups, leukopenia, arrhythmia, hangover, oculomotor seizures, acne, swallowing difficulty, enuresis, tic disorder, respiratory distress, suicidal ideation, personality abnormalities, delusions, hallucinations, worsening auditory hallucinations, extrapyramidal symptoms, delayed movement disorders, neuroleptic malignant syndrome, confusion, insensitivity, postural instability, falls, hyperglycemia, diabetes, weight gain, priapism, orthostatic hypotension, syncope

This medication should be stored in a tightly sealed container to protect it from air and moisture. It is advisable to maintain storage temperatures between 1 and 30 degrees Celsius.

Appearance

Light yellow oblong film-coated tablets

Package unit

[Domestic use: 30 tablets/bottle, 300 tablets/bottle], [Export: Export 20 tablets (10 tablets/PTP X 2)]