Risperdal Tablets 2 mg (Risperidone)

Adult dose

The therapeutic dose of this medication 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 increase the dose gradually. (2) Maintenance dose: Administer 1∼3 mg twice daily. Adjust the dose as appropriate according to age and symptoms. (3) No additional benefit 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 considered 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 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 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 per administration, twice daily, should be made at intervals of at least 1 week. 3) Switching from an existing antipsychotic medication to this medication When medically appropriate, initiate this medication while gradually reducing the dose of the existing medication. Also, when switching from an existing depot antipsychotic medication, if medically appropriate, initiate this medication in place of the next scheduled depot injection. Regularly reassess whether concomitant antiparkinsonian medication needs to be continued. 2. Agitation, aggression, or psychotic symptoms in patients with dementia of the Alzheimer type The initial dose is 0.25 mg of this medication twice daily. If needed, depending on the patient, the dose may be increased by 0.25 mg per administration 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 medication should be evaluated. 3. Adjunctive treatment of mania in bipolar disorder • The recommended initial dose is 2 mg of this medication once daily. Depending on the patient, the dose may be increased by 1 mg per day at intervals of at least 24 hours. 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 medication 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. Exercise caution when administering this medication to these patients (see 5. General Precautions).

Child dose

Schizophrenia: Clinical experience in children and adolescents under 15 years of age is limited. Adjunctive treatment of mania in bipolar disorder: 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 medication once daily. If needed, depending on the patient, the dose may be increased by 0.5 mg per day 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 needed, depending on the patient, the dose may be increased by 0.25 mg per day 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. Clinical experience in children under 5 years of age is limited.

Caution is needed when administering this medication to elderly dementia patients as it may increase mortality rates. In particular, when this medication is used in conjunction with furosemide, there may be a heightened risk of mortality, so the risks and benefits should be carefully considered prior to combined administration. Furthermore, this medication poses a risk of venous thromboembolism, so thrombotic risk factors should be assessed and preventive measures taken before and during administration. This medication should not be used in patients with hypersensitivity to it, severe central nervous system depression, comatose states, patients receiving epinephrine, and patients with genetic issues such as lactose intolerance. It should be used with caution in patients with cardiovascular disease, impaired liver or kidney function, a history of seizures, or those taking medications that prolong the QT interval, as well as in elderly patients, diabetic patients, and pregnant or breastfeeding women. This medication can cause a range of side effects, with common side effects including drowsiness, dizziness, insomnia, weight gain, indigestion, and orthostatic hypotension. Serious adverse reactions, such as neuroleptic malignant syndrome, tardive dyskinesia, and leukopenia, have been reported; if symptoms manifest, immediate consultation with medical personnel is required. Caution should be taken when this medication is taken with other central nervous system depressants or alcohol, as central nervous system depression can be exacerbated, and there may be drug interactions that require dosage adjustments. Use during pregnancy may affect the fetus, thus pregnant women should consult their physician, and breastfeeding should be discontinued if nursing. In case of overdose, immediate medical attention should be sought, as orthostatic hypotension or fainting may occur, especially when beginning treatment or changing doses. It is advisable to avoid activities requiring mental concentration, such as driving or operating machinery, during treatment. Keep this medication out of reach of children and avoid transferring it to other containers.

Increased mortality, cerebrovascular adverse reactions, venous thrombosis, rhinitis, upper respiratory infection, sinusitis, urinary tract infection, anemia, hypersensitivity, insomnia, anxiety, nervous excitability, Parkinsonism, akathisia, drowsiness, dizziness, sedation, tremor, muscle rigidity, somnolence, orthostatic dizziness, movement disorders, syncope, blurriness, ear pain, orthostatic hypotension, tachycardia, hypotension, nasal congestion, dyspnea, nosebleed, 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, arthralgia, limb pain, urinary incontinence, ejaculatory dysfunction, fatigue, weakness, fever, chest pain, elevated blood creatinine phosphokinase, increased heart rate, pneumonia, soft tissue infection, decreased appetite, confusional state, transient ischemic attack, decreased level of consciousness, drooling, cerebrovascular accident, conjunctivitis, hypotension, cough, runny nose, difficulty swallowing, fecal mass, erythema, abnormal posture, joint swelling, peripheral edema, gait disturbance, pitting edema, elevated temperature, upper respiratory infection, rhinitis, influenza, increased appetite, moderate insomnia, lethargy, headache, stuttering, attention deficit, balance disorder, excessive sleep, palpitations, pharyngeal and laryngeal pain, pulmonary congestion, itching, acne, myalgia, neck pain, nocturia, polyuria, galactorrhea, emotional disturbance, lethargy, chest discomfort, weight gain, elevated blood prolactin, agitation, flattened affect, sleep disorder, decreased libido, sexual dysfunction, depression, nightmares, unresponsiveness to stimuli, difficulty in collaboration, loss of consciousness, speech disorder, sensory loss, movement disorder, generalized movement disorders, cerebral ischemia, cerebrovascular accident disorder, neuroleptic malignant syndrome, diabetic coma, head tremors, seizures, psychomotor hyperactivity, delayed movement disorders, cerebrovascular disorders, sensory disturbances, conjunctival injection, eye discharge, eye movement, eyelid edema, photophobia, crusting of 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 disturbance, abnormal electrocardiogram, prolonged QT interval on electrocardiogram, venous obstruction, bradycardia, wheezing, aspiration pneumonia, voice disorder, moist cough, airway congestion, rales, respiratory distress, nasal cavity edema, hyperventilation, fecal incontinence, gastritis, lip swelling, cheilitis, salivary deficiency, bloating, enteritis, tongue swelling, toothache, skin discoloration, skin lesions, skin problems, erythematous rash, papular rash, generalized rash, papulopustular rash, eczema, musculoskeletal chest pain, joint rigidity, muscle weakness, rhabdomyolysis, urinary disturbance, amenorrhea, gynecomastia, vaginal discharge, erectile dysfunction, ejaculatory disorder, menstrual disorder, breast engorgement, sexual dysfunction, retrograde ejaculation, nipple discharge, thirst, influenza-like syndrome, edema, malaise, facial edema, discomfort, generalized edema, chills, peripheral coldness, drug withdrawal syndrome, adverse drug reactions, decreased body temperature, procedural pain, weight loss, increased γ-GT, elevated liver enzymes, glucosuria, falls, agranulocytosis, thrombocytopenia, abnormal secretion of antidiuretic hormone, diabetic ketoacidosis, diabetes mellitus, hypoglycemia, water intoxication, increased serum cholesterol, increased serum triglycerides, mania, altered taste, intraoperative iris hypotonia syndrome, atrial fibrillation, deep vein thrombosis, pulmonary embolism, sleep apnea syndrome, intestinal obstruction, pancreatitis, jaundice, vascular edema, alopecia, neonatal drug withdrawal syndrome, urinary retention, priapism, hypothermia, chest pain, liver dysfunction, hepatitis, dry mouth, oral dryness, urinary retention, polyuria, pain, hiccups, increased sweating, urinary disturbance, leukopenia, arrhythmia, nosebleed, anemia, diarrhea, hangover, ocular motor seizures, acne, swallowing difficulties, enuresis, tic disorder, respiratory distress, Rabbit syndrome, suicide attempt, accident-related anomalies, delusions, hallucinations, exacerbation of symptoms

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

Appearance

Elongated light orange film-coated tablet

Package unit

30 tablets/bottle, 200 tablets/bottle