Risperidone Tablet 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 and, 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 per dose, twice daily orally, and increase the dose gradually. (2) Maintenance dose: Administer 1∼3 mg per dose, twice daily. Adjust the dose as appropriate 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 judged 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 an additional sedative effect is needed. 2) Administration in special populations • Elderly patients and patients predisposed to hypotension The initial dose is 0.5 mg per dose, twice daily. Depending on the patient's condition, increase the dose by 0.5 mg twice daily until the dose reaches 1～2 mg per dose, twice daily. 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 to this medicine from an existing antipsychotic When medically appropriate, start this medicine while gradually reducing the dose of the existing medicine. Also, when medically appropriate, when switching from an existing depot antipsychotic, start 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 per dose, twice daily, of this medicine. If necessary for 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, but the dose may be increased to 1 mg per dose, 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 appropriateness of continued use of this medicine should be evaluated. 3. Adjunctive therapy for manic episodes in bipolar disorder • The recommended initial dose is 2 mg once daily of this medicine. 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 within 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

There is insufficient clinical experience in children and adolescents under 15 years of age. There is insufficient clinical experience in children and adolescents under 15 years of age. Body weight 50 kg or more: The initial dose is 0.5 mg of this medicine once daily. If necessary for 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 necessary for 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. There is insufficient clinical experience in children under 5 years of age.

Caution is needed when using this medication in elderly dementia patients, as it may increase mortality. In particular, when used in conjunction with furosemide, the risk of death may be further elevated, so the risks and benefits should be carefully considered before concurrent administration. Furthermore, this medication may increase the risk of venous thrombosis; therefore, risk factors for thrombosis should be confirmed and preventive measures taken in at-risk patients. This medication contains the artificial sweetener aspartame, so patients with phenylketonuria must consult with a physician before taking this medication and should limit aspartame intake. It should not be administered to patients with hypersensitivity, those who have CNS depression due to alcohol or central nervous system depressants, patients in a comatose state, those receiving epinephrine, and patients with genetic issues such as lactose intolerance. Caution should be exercised when administering to patients with cardiovascular disease or a history of arrhythmias, patients with a history of seizures, patients with impaired liver or kidney function, patients at risk of suicide, patients with Parkinson's disease or Lewy body dementia, patients with risk factors for diabetes, the elderly, and pregnant or breastfeeding women. This medication has been reported to cause various side effects, so if any abnormal symptoms occur during administration, immediate consultation with medical personnel is necessary. In particular, serious neurological side effects such as tardive dyskinesia or neuroleptic malignant syndrome may occur, so careful observation is required. Since this medication has central nervous system depressant effects, symptoms may worsen when combined with alcohol or other CNS depressants. Women who are pregnant or may become pregnant, and breastfeeding women should only use this medication after consulting a physician, as it may affect the fetus or newborn. When administered to children or the elderly, special care should be taken with dosage adjustments and monitoring. In case of overdose, immediate medical attention should be sought, and as there is no antidote for this medication, supportive treatment is important. This medication is fragile, so do not open the packaging randomly or cut the tablets, and take it immediately after opening. Moreover, mixing this medication with tea or cola may reduce its efficacy, so it is advisable not to mix. Store this medication in a safe place out of reach of children and do not transfer it to other containers.

Increased mortality, stroke, transient ischemic attack, venous thrombosis, rhinitis, upper respiratory infection, sinusitis, urinary tract infection, anemia, hypersensitivity reaction, insomnia, anxiety, neural excitability, Parkinsonism, akathisia, drowsiness, dizziness, sedation, tremor, muscle rigidity, somnolence, orthostatic dizziness, movement disorders, syncope, blurred vision, ear pain, orthostatic hypotension, tachycardia, hypotension, nasal congestion, dyspnea, nosebleed, 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, weakness, fever, chest pain, increased serum creatinine phosphokinase, increased heart rate, pneumonia, soft tissue infection, decreased appetite, confusion, transient ischemic attack, decreased consciousness state, drooling, cerebrovascular accident, conjunctivitis, hypotension, cough, runny nose, dysphagia, fecal impaction, erythema, abnormal postures, joint swelling, peripheral edema, gait disturbance, pitting edema, increased body temperature, upper respiratory infection, rhinitis, influenza, increased appetite, moderate insomnia, lethargy, headache, stuttering, attention deficit, balance disorder, excessive sleep, palpitations, oropharyngeal pain, pulmonary congestion, itching, acne, myalgia, neck pain, nocturia, frequent urination, galactorrhea, mood disturbances, lethargy, chest discomfort, anxiety, blunted affect, sleep disorders, decreased libido, sexual dysfunction, depression, nightmares, hypo-reactivity to stimuli, coordination abnormalities, loss of consciousness, speech disorders, sensory deficits, movement disorders, tardive dyskinesia, cerebral ischemia, cerebrovascular accident disorders, neuroleptic malignant syndrome, diabetic coma, head tremors, seizures, psychomotor agitation, delayed movement disorders, cerebrovascular disorders, sensory disturbances, conjunctival injection, eye discharge, eye movement, eyelid swelling, photophobia, eyelid crusting, dry eyes, increased tearing, glare, glaucoma, decreased vision, tinnitus, vertigo, bradycardia, tachycardia, palpitations, I-degree atrioventricular block, left bundle branch block, right bundle branch block, atrioventricular block, flushing, conduction disorders, electrocardiogram abnormalities, QT interval prolongation, vena cava obstruction, bradycardia, wheezing, aspiration pneumonia, voice disorders, wet cough, airway congestion, rales, respiratory distress, nasal cavity swelling, hyperventilation, fecal incontinence, gastritis, lip swelling, cheilitis, sialorrhea, bloating, gastroenteritis, tongue swelling, toothache, skin discoloration, skin lesions, skin disorders, erythematous rash, papular rash, generalized rash, papulopustular rash, eczema, musculoskeletal chest pain, joint rigidity, muscle weakness, rhabdomyolysis, urination disorders, amenorrhea, gynecomastia, vaginal discharge, erectile dysfunction, ejaculation disorders, menstrual disorders, breast distention, sexual dysfunction, retrograde ejaculation, breast discharge, thirst, influenza-like syndrome, edema, malaise, facial edema, discomfort, generalized edema, chills, peripheral coldness, drug withdrawal syndrome, adverse drug reactions, decreased body temperature, procedure-related pain, increased ALT, electrocardiogram abnormalities, increased eosinophil count, increased AST, decreased leukocyte count, increased blood glucose, decreased hemoglobin, decreased hematocrit, decreased body temperature, decreased blood pressure, increased transaminases, increased gamma-glutamyl transferase, increased liver enzymes, agranulocytosis, thrombocytopenia, dysregulation of antidiuretic hormone secretion, diabetic ketoacidosis, diabetes mellitus, hypoglycemia, water intoxication, increased cholesterol levels in the blood, increased triglycerides in the blood, mania, altered taste sensation, intraoperative iris tension decrease 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, oral dryness, urinary retention, polyuria, pain, hiccups, increased sweating, urination disorders, leukopenia, arrhythmia, nosebleed, anemia, diarrhea, hangover, ocular movement seizures, acne, dysphagia, enuresis, tic disorder, dyspnea, suicidal ideation, accident anomalies, delusions, hallucinations, exacerbation of auditory hallucinations, falls, extrapyramidal symptoms, hyperthermia, muscle rigidity, autonomic nervous system anxiety, consciousness disturbances, elevated serum creatine phosphokinase, myoglobinuria, acute renal failure, confusion, insensitivity, postural instability, frequent falls, weight gain, priapism, orthostatic hypotension, syncope, hypotension, QT interval prolongation, seizures, Torsades de Pointes

This medication may be sensitive to air or moisture, so it should be stored in a sealed container. It is advisable to maintain a storage temperature between 1 to 30 degrees Celsius. This way, the effectiveness of the medication can be preserved for a longer period.

Appearance

White rectangular film-coated tablet

Package unit

30 tablets/bottle, 300 tablets/bottle