Jungheon Risperidone Tablet 1 mg

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 has disintegrated within a few seconds, swallow it with or without water (for orally disintegrating tablets only.). Initial dose for adults with schizophrenia: Administer 1 mg of risperidone orally twice daily, and increase the dose gradually. Maintenance dose for adults with schizophrenia: Administer 1∼3 mg twice daily. Adjust the dose appropriately according to age and symptoms. 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 for the individual patient are considered to outweigh the risks. Doses of 16 mg or more per day should not be administered because their safety has not been established. A benzodiazepine may be coadministered if additional sedation is needed. For elderly 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. When switching from an existing antipsychotic medicine to this medicine, if medically appropriate, start treatment with this medicine while gradually reducing the dose of the existing medicine. Also, if 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 any concomitant antiparkinsonian medicine should be reassessed regularly. 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 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 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. Adjunctive treatment of manic episodes 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 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. 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 medicine to 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 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. Clinical experience in children under 5 years of age with conduct disorder and other disruptive behavior disorders is limited.

This medication can increase mortality in elderly dementia patients, so caution should be exercised, especially. When using this medication in conjunction with the diuretic furosemide, the risk of death may increase, so the risks and benefits should be carefully considered before concurrent administration. Caution is necessary to avoid dehydration, and since there is a risk of venous thromboembolism, all risk factors that may induce venous thromboembolism should be assessed and preventive measures implemented before and during the use of this medication. In the case of certain genetic disorders such as phenylketonuria, the artificial sweetener aspartame contained in this medication may cause issues, so caution is warranted. This medication should not be administered to patients with hypersensitivity, central nervous system suppression, comatose states, those receiving epinephrine, or patients with specific genetic lactose intolerance. Patients with cardiovascular diseases, hepatic or renal dysfunction, a history of seizures, or suicidal risks, as well as diabetic patients and the elderly, should be administered this medication with care. Women who are pregnant or breastfeeding may face risks when using this medication and should consult a doctor. This medication can cause various side effects, particularly neurological symptoms (drowsiness, dizziness, Parkinsonism, etc.), gastrointestinal disturbances, skin rashes, cardiovascular abnormalities, etc., so any atypical symptoms should be reported to a healthcare professional immediately. This medication may lead to increased central nervous system depression when taken with other central nervous system depressants or alcohol, so caution is advised. Additionally, there may be interactions with certain antibiotics, antifungals, antidepressants, anticonvulsants, etc., so it is essential to inform the healthcare provider about other medications being taken. The risks to the fetus when administered to pregnant women are not fully understood; particularly, administration during late pregnancy may lead to extrapyramidal symptoms or withdrawal symptoms in newborns, so it should be used only when necessary. This medication can pass to the baby through breast milk, so discontinuing breastfeeding is recommended while using this medication. Safety in children and adolescents has not been adequately established, especially in infants under 5 years of age, so it should be used with caution. Elderly patients are more likely to experience reduced renal function, necessitating careful monitoring of dosage and administration. In cases of overdose, serious symptoms such as drowsiness, hypotension, and electrocardiogram abnormalities may occur, and immediate medical treatment should be sought. This medication is fragile; therefore, do not press to open the package or cut the tablets, and take them immediately after opening without mixing them with tea or cola. Keep out of reach of children and do not transfer to other containers to maintain quality.

Death, stroke, transient ischemic attack, venous thrombosis, pharyngitis, upper respiratory infection, sinusitis, urinary tract infection, anemia, hypersensitivity, insomnia, anxiety, nervousness, Parkinsonism, akathisia, drowsiness, dizziness, sedation, tremor, muscle rigidity, somnolence, orthostatic dizziness, dyskinesia, 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, epigastric pain, rash, dry skin, dandruff, seborrheic dermatitis, hyperkeratosis, back pain, arthralgia, limb pain, urinary incontinence, ejaculatory dysfunction, fatigue, weakness, fever, chest pain, elevated serum creatinine phosphokinase, increased heart rate, pneumonia, soft tissue infection, decreased appetite, confusion, transient ischemic attack, decreased consciousness, drooling, cerebrovascular accident, conjunctivitis, cough, runny nose, dysphagia, fecal impaction, erythema, abnormal posture, joint swelling, peripheral edema, gait abnormalities, pitting edema, elevated temperature, rhinitis, influenza, increased appetite, middle insomnia, lethargy, headache, stuttering, attention deficit, equilibrium disorder, hypersomnia, palpitations, oropharyngeal pain, pulmonary congestion, itching, acne, myalgia, neck pain, nocturia, frequency of urination, galactorrhea, mood disturbances, lethargy, chest discomfort, weight gain, elevated prolactin, anxiety, diminished affect, sleep disorders, decreased libido, sexual dysfunction, depression, nightmares, unresponsiveness to stimuli, cooperation abnormalities, loss of consciousness, speech disorders, sensory deficits, movement disorders, focal dystonia, cerebral ischemia, cerebellar stroke disorder, neuroleptic malignant syndrome, diabetic coma, tremors, seizures, psychomotor hyperactivity, delayed motor disorders, cerebrovascular disorders, sensory abnormalities, conjunctival injection, eye discharge, eye movement, eyelid edema, photophobia, eyelid crusting, dry eyes, increased tearing, glare, glaucoma, decreased vision, tinnitus, dizziness, bradycardia, tachycardia, palpitations, type I atrioventricular block, left bundle branch block, right bundle branch block, atrioventricular block, flushing, conduction disorders, ECG abnormalities, prolonged QT interval on ECG, inferior vena cava, bradycardia, wheezing, aspiration pneumonia, voice disorders, wet cough, airway edema, rales, respiratory disorders, nasal swelling, hyperventilation, fecal incontinence, gastritis, lip swelling, cheilitis, salivary deficiency, abdominal distension, enteritis, 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, ejaculation disorders, menstrual disorders, breast engorgement, sexual dysfunction, retrograde ejaculation, breast secretion, thirst, influenza-like syndrome, edema, fatigue, facial edema, malaise, generalized edema, chills, peripheral coldness, drug withdrawal syndrome, drug adverse reactions, decreased body temperature, procedure-related pain, elevated ALT, ECG abnormalities, eosinophilia, elevated AST, leukopenia, elevated blood glucose, decreased hemoglobin, decreased hematocrit, hypothermia, decreased blood pressure, elevated transaminases, elevated gamma-glutamyl transferase, increased liver enzymes, agranulocytosis, thrombocytopenia, abnormal secretion of antidiuretic hormone, diabetic ketoacidosis, diabetes, hypoglycemia, water intoxication, mania, taste disturbances, intraoperative iris hypotension syndrome, atrial fibrillation, deep vein thrombosis, pulmonary embolism, obstructive 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, tic disorder, dyspnea, suicidal ideation, abnormal accidents, delusions, hallucinations, exacerbation of auditory hallucinations, falls, drug hypersensitivity reactions, hypertension, musculoskeletal pain, gait abnormalities, pain, falls, anaphylaxis, angioedema, laryngeal edema, laryngealtracheobronchial edema, ocular respiratory syndrome, oral edema, orbital septal edema, small bowel vascular edema, tongue edema, priapism, hypothermia

This medication should be stored in a tightly sealed container to protect it from air and moisture. It is best to store the medication at a normal room temperature between 1 to 30 degrees Celsius, away from extreme heat or cold.

Appearance

Oval white film-coated tablets

Package unit

30 tablets/bottle, 200 tablets/bottle