Risperidone 2 mg Tablets (Risperidone)

Adult dose

The therapeutic dose of this drug should be adjusted according to the patient's clinical condition, and the lowest effective dose possible should be administered. Place this drug on the tongue. Once it disintegrates within a few seconds, swallow it without water or with water (for orally disintegrating tablets only). 1. Schizophrenia 1) Adults (1) Initial dose: Administer risperidone orally at 1 mg per dose twice daily, and increase gradually. (2) Maintenance dose: Administer 1∼3 mg per dose twice daily. Adjust the dose appropriately according to age and symptoms. (3) No additional benefit was observed at doses of 10 mg or more per day 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 benefit to the individual patient is judged to outweigh the risk. (4) Do not administer doses of 16 mg or more per day, as safety has not been established. (5) A benzodiazepine may be coadministered if additional sedation is needed. 2) Administration in special populations • Older adults and patients predisposed to hypotension The initial dose is 0.5 mg per dose twice daily. Depending on the patient's condition, increase by 0.5 mg per dose twice daily until reaching 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 from an existing antipsychotic to this drug When medically appropriate, start treatment with this drug while gradually reducing the dose of the existing medication. When switching from an existing depot antipsychotic, if medically appropriate, start treatment with this drug 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 per dose twice daily. If needed, depending on 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 depending on the patient, it may be increased up to 1 mg per dose twice daily. Once the patient reaches the optimal dose, once-daily administration may also be considered. As with symptomatic treatment, the rationale for continued use of this drug should be evaluated. 3. Adjunctive therapy for manic episodes in bipolar disorder • The recommended initial dose is 2 mg of this drug 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 rationale for continued use of this drug 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 drug with caution in these patients (see 5. General Precautions).

Child dose

Schizophrenia: Clinical experience in children and adolescents under 15 years of age is limited. Adjunctive therapy for manic episodes in bipolar disorder: Clinical experience in children and adolescents under 15 years of age 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 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. Conduct disorder and other disruptive behavior disorders - body weight below 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. Conduct disorder and other disruptive behavior disorders: Clinical experience in children under 5 years of age is limited.

This medication may increase mortality when used in elderly dementia patients, so caution is required. Especially, the risk of death may increase when used with certain diuretics such as Furosemide; therefore, the risks and benefits should be carefully considered before concomitant administration. There is a risk of thrombosis, known as venous thromboembolism; thus, risk factors for venous thromboembolism should be identified and precautions taken before and during use of this medication. Since this medication contains aspartame, patients with certain genetic disorders such as phenylketonuria should be cautious when taking it. It should not be given to patients with known allergies to this medication or its ingredients, to patients whose consciousness is depressed due to alcohol or central nervous system depressants, patients in a coma, patients using epinephrine, or lactose intolerant patients. Caution should be exercised when administering this medication to patients with cardiovascular issues like heart disease, dehydration, reduced blood volume, or cerebrovascular disease, as they may experience side effects such as orthostatic hypotension; dosage should be slowly adjusted and administered cautiously. Caution is also required for patients with a history of arrhythmia or risk of QT prolongation, those with a history of seizures or prone to seizures, patients with impaired liver or kidney function, those at risk of suicide, patients with Parkinson's disease or Lewy body dementia, diabetic patients, elderly patients, and pregnant or nursing women. This medication can cause various side effects, commonly including drowsiness, dizziness, insomnia, anxiety, weight gain, gastrointestinal discomfort, and orthostatic hypotension. Rarely, severe side effects such as neuroleptic malignant syndrome, tardive dyskinesia, and leukopenia may occur, and symptoms require immediate consultation with medical personnel. Caution is necessary when taking this medication with other central nervous system depressants or alcohol, as it may enhance central nervous system depressant effects. Additionally, it may interact with dopamine-acting medications, reducing their effectiveness, and dosage adjustment may be necessary when used with antihypertensive agents, QT prolonging drugs, or certain metabolic enzyme inhibitors or inducers. Pregnant or nursing women should consult with a physician before taking this medication, as adverse effects may occur in the fetus or newborn; discontinuing nursing is recommended. The safety and efficacy of this medication in children and adolescents have not been sufficiently established, so caution is necessary when used. In cases of overdose, symptoms such as drowsiness, hypotension, arrhythmia, and seizures may occur, requiring immediate emergency care. This medication is fragile; do not crush tablets or open the packaging forcefully, and take it immediately after opening. It is advisable not to mix with tea or cola. It should be stored in a safe place out of reach of children, and transferring it to another container poses a risk of accidents or quality degradation.

Increased mortality, cerebrovascular adverse reactions, venous thrombosis, rhinitis, upper respiratory infection, sinusitis, urinary tract infection, anemia, hypersensitivity reactions, insomnia, anxiety, nervousness, Parkinson's syndrome, inability to sit still, drowsiness, dizziness, sedation, tremors, muscle rigidity, sleepiness, 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, gastrointestinal discomfort, epigastric pain, rash, dry skin, dandruff, seborrheic dermatitis, hyperkeratosis, back pain, joint pain, limb pain, incontinence, ejaculation failure, fatigue, weakness, fever, chest pain, elevated blood creatinine phosphokinase, increased heart rate, pneumonia, soft tissue infection, decreased appetite, confusional state, transient ischemic attack, decreased consciousness, drooling, cerebrovascular accident, conjunctivitis, hypotension, cough, runny nose, dysphagia, fecal lump, erythema, abnormal posture, joint swelling, peripheral edema, gait disturbance, dependent edema, elevated body temperature, upper respiratory infection, rhinitis, influenza, increased appetite, mid-insomnia, lethargy, headache, stuttering, attention disorder, balance disorder, hypersomnia, palpitations, pharyngolaryngeal pain, pulmonary congestion, itching, acne, myalgia, neck pain, nocturia, increased frequency of urination, galactorrhea, emotional disturbances, lethargy, chest discomfort, weight gain, elevated blood prolactin, anxiety, blunted affect, sleep disorders, decreased libido, sexual dysfunction, depression, nightmares, unresponsiveness to stimuli, coordination disorders, loss of consciousness, speech disorders, sensory loss, movement disorders, generalized dyskinesia, cerebral ischemia, cerebrovascular accident dysfunction, neuroleptic malignant syndrome, diabetic coma, head tremors, seizures, psychomotor hyperactivity, delayed dyskinesia, cerebrovascular disorders, sensory disturbances, conjunctival injection, eye discharge, eye movement, eyelid edema, photophobia, crusting of eyelids, dry eyes, increased tearing, glare, glaucoma, decreased vision, tinnitus, dizziness, bradycardia, dextrocardia, palpitations, type I atrioventricular block, left bundle branch block, right bundle branch block, heart block, flushing, conduction disorders, electrocardiogram abnormalities, QT interval prolongation on electrocardiogram, right pulmonary vein, bradycardia, wheezing, aspiration pneumonia, voice disorders, wet cough, airway congestion, rales, respiratory disorders, nasal cavity swelling, hyperventilation, fecal incontinence, gastritis, lip swelling, cheilitis, salivary gland deficiency, abdominal distension, gastroenteritis, tongue swelling, dental pain, 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, ejaculation disorders, menstrual disorders, breast engorgement, sexual dysfunction, retrograde ejaculation, breast secretion, thirst, influenza-like syndrome, swelling, malaise, facial swelling, discomfort, generalized edema, chills, peripheral coldness, drug withdrawal syndrome, drug adverse reactions, decreased body temperature, procedure-related pain, increased ALT, electrocardiogram abnormalities, eosinophilia, increased AST, leukopenia, elevated blood glucose, decreased hemoglobin, decreased hematocrit, hypothermia, decreased blood pressure, increased transaminases, increased gamma-glutamyl transferase, elevated liver enzymes, agranulocytosis, thrombocytopenia, abnormal secretion of antidiuretic hormone, diabetic ketoacidosis, diabetes mellitus, hypoglycemia, water intoxication, increased blood cholesterol, increased blood triglycerides, mania, dysgeusia, intraoperative iris hypotension 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 function abnormalities, hepatitis, thirst, dry mouth, urinary retention, polyuria, pain, hiccups, increased sweating, urination disorders, leukopenia, arrhythmia, nosebleed, anemia, diarrhea, hangover, oculomotor seizures, acne, dysphagia, enuresis, tic disorder, dyspnea, Rabbit syndrome, suicidal ideation, thought disorder, delusions, hallucinations, exacerbation of auditory hallucinations, delayed dyskinesia, neuroleptic malignant syndrome, exacerbation of extrapyramidal symptoms, hyperglycemia, diabetes mellitus, weight gain, falls, priapism, orthostatic hypotension, syncope, decreased core body temperature, drug withdrawal syndrome

Store this medication in a tightly sealed container to protect it from air and moisture. It is recommended to keep it at room temperature between 1 to 30 degrees Celsius. This way, the medication's effectiveness and safety can be maintained for a long time.

Appearance

Oblong pale orange film-coated tablet

Package unit

30 tablets/bottle