Risoperidone 1 mg Tablet (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 Initial dose for adults: Administer 1 mg of risperidone orally twice daily, and gradually increase the dose. Maintenance dose for adults: Administer 1∼3 mg twice daily. Adjust the dose appropriately according to age and symptoms. When doses of 10 mg or more per day are administered, no additional efficacy has been observed compared with lower doses, and the risk of extrapyramidal symptoms may increase. 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. Do not administer doses of 16 mg or more per day, as safety has not been established. A benzodiazepine may be administered concomitantly if additional sedation is required. 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. Switching from an existing antipsychotic to this medicine: 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 type The initial dose is 0.25 mg of this medicine twice daily. If necessary, 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 has reached the optimal dose, once-daily dosing may also be considered. As with symptomatic treatment, the appropriateness of continued use of this medicine should be evaluated. 3. Adjunctive treatment for 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 up to 1 mg per day at intervals of at least 24 hours. 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 For patients with renal or hepatic impairment, administer half the initial and maintenance doses and adjust the dose more gradually. Exercise caution when administering this medicine to these patients (see 5. General Precautions)

Child dose

Children and adolescents under 15 years of age: There is limited clinical experience with schizophrenia. Children and adolescents under 15 years of age: There is limited clinical experience with adjunctive therapy for manic episodes of bipolar disorder. 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. Body weight less than 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. Children under 5 years of age: There is limited clinical experience.

This drug may increase mortality when administered to elderly dementia patients, so special caution is necessary. The risk of death may be higher in elderly dementia patients taking this drug in combination with certain diuretics; thus, the risks and benefits should be carefully considered before concurrent administration. Ensure proper hydration and monitoring to prevent dehydration during the use of this drug. Due to the risk of venous thrombosis, patient thrombotic risk factors should be assessed and preventive measures taken before using this drug. This drug contains the artificial sweetener aspartame; patients with phenylketonuria should consult a physician before use. This drug should not be administered to patients with hypersensitivity to this drug or its components, patients whose central nervous system is depressed due to alcohol or central nervous system depressants, comatose patients, patients receiving epinephrine, or lactose intolerant patients. Caution is required when administering this drug to patients with cardiovascular diseases, history of arrhythmias, liver or kidney dysfunction, patients at risk of suicide, those with Parkinson's disease or Lewy body dementia, diabetic patients, elderly patients, and pregnant or nursing women. This drug may cause side effects such as drowsiness, dizziness, orthostatic hypotension, insomnia, anxiety, and parkinsonism; any abnormal symptoms occurring during use should be reported to a physician immediately. Caution is required as concurrent use with other central nervous system depressants or alcohol may enhance central nervous system depressant effects. Interactions with specific medications may alter blood concentration levels, so disclose all medications being taken. Women who are pregnant or may become pregnant and nursing mothers should consult a physician as this drug may affect the fetus or newborn. It is advisable to avoid activities requiring mental concentration, such as driving or operating machinery while taking this medication. In case of overdose, seek medical attention immediately, and handle the packaging with care as this drug is fragile. Store out of reach of children and do not transfer to other containers for safety.

Increased mortality, cerebrovascular adverse reactions, venous thrombosis, nasopharyngitis, upper respiratory infection, sinusitis, urinary tract infection, anemia, hypersensitivity reactions, insomnia, anxiety, nervousness, Parkinsonism, akathisia, drowsiness, dizziness, sedation, tremors, muscle hypertonia, somnolence, postural dizziness, movement disorders, syncope, blurred 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, gastrointestinal discomfort, upper abdominal pain, rash, dry skin, dandruff, seborrheic dermatitis, hyperkeratosis, back pain, arthralgia, limb pain, urinary incontinence, ejaculation failure, fatigue, asthenia, fever, chest pain, elevated serum 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 lump, erythema, abnormal postures, joint swelling, peripheral edema, gait disturbances, pitting edema, increased body temperature, upper respiratory infection, rhinitis, influenza, increased appetite, middle insomnia, fatigue, headache, stuttering, attention disorder, balance disorder, hypersomnia, palpitations, pharyngolaryngeal pain, pulmonary congestion, itching, acne, myalgia, neck pain, nocturia, frequency of urination, galactorrhea, emotional disturbances, laziness, chest discomfort, anxiety, blunted affect, sleep disturbances, decreased libido, sexual dysfunction, depression, nightmares, unresponsiveness to stimuli, abnormal cooperation, loss of consciousness, speech disorders, sensory loss, movement disorders, generalized dyskinesia, cerebral ischemia, cerebrovascular accident disturbances, neuroleptic malignant syndrome, diabetic coma, head tremors, seizures, psychomotor hyperactivity, delayed dyskinesia, cerebrovascular disorders, sensory disturbances, conjunctival injection, ocular discharge, eye movements, eyelid edema, photophobia, crusting of eyelid margins, dry eyes, increased tear flow, glare, glaucoma, decreased vision, tinnitus, dizziness, bradycardia, tachycardia, palpitation, I degree atrioventricular block, left bundle branch block, right bundle branch block, heart block, flushing, conduction abnormalities, ECG abnormalities, prolonged QT interval on ECG, pulmonary veins, bradycardia, wheezing, aspiration pneumonia, voice disorders, wet cough, airway congestion, rales, respiratory disorders, nasal mucosa swelling, hyperventilation, fecal incontinence, gastritis, lip swelling, cheilitis, salivary deficiency syndrome, distension, gastroenteritis, tongue swelling, dental pain, skin discoloration, skin lesions, skin disorders, erythematous rash, papular rash, generalized rash, papulopustular rash, eczema, musculoskeletal thoracic pain, joint stiffness, muscle weakness, rhabdomyolysis, urinary disorders, amenorrhea, gynecomastia, vaginal discharge, erectile dysfunction, ejaculation disorders, menstrual irregularities, breast engorgement, 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, weight gain, elevated serum prolactin, agranulocytosis, thrombocytopenia, abnormal secretion of antidiuretic hormone, diabetic ketoacidosis, diabetes, hypoglycemia, water intoxication, increased serum cholesterol, increased serum triglycerides, mania, paresthesia, intraoperative iris hypotonia syndrome, atrial fibrillation, deep vein thrombosis, pulmonary embolism, sleep apnea syndrome, bowel obstruction, pancreatitis, jaundice, vascular edema, hair loss, drug withdrawal syndrome in neonates, urinary retention, persistent erection, hypothermia, prolonged QT on ECG, chest pain, liver dysfunction, hepatitis, thirst, dry mouth, urinary retention, polyuria, pain, hiccups, increased sweating, urinary disorders, leukopenia, arrhythmia, epistaxis, anemia, diarrhea, hangover, oculomotor seizures, acne, difficulty swallowing, enuresis, tic disorder, respiratory distress, suicidal ideation, accident anomalies, delusions, hallucinations, exacerbation of auditory hallucinations, falls, extrapyramidal symptoms, hyperthermia, muscle rigidity, autonomic nervous anxiety, consciousness disturbance, elevated serum creatine phosphokinase, myoglobinuria, acute renal failure, confusion, desensitization, postural instability, frequent falls, hyperglycemia, diabetes, increased body weight, sedative effect, leukopenia, neutropenia, agranulocytosis, intraoperative iris hypotonia syndrome, persistent erection, orthostatic hypotension, syncope, decreased deep body temperature, antiemetic effect

This drug should be stored in a tightly closed container to avoid exposure to air or moisture, and it is best stored at room temperature between 1 to 30 degrees Celsius. Storing in this manner will help maintain the drug's efficacy and safety.

Appearance

Oblong white film-coated tablet

Package unit

30 tablets/bottle, 200 tablets/bottle