Risperdal 0.5 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. 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 appropriately 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 judged to outweigh the risks. (4) Doses of 16 mg or more per day should not be administered because safety has not been established. (5) If additional sedation is required, benzodiazepines may be administered concomitantly. 2) Dosing 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 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. 3) Switching from another antipsychotic medicine to this medicine When medically appropriate, start this medicine while gradually reducing the dose of the previous medicine. Also, when medically appropriate, when switching from a depot antipsychotic medicine, start this medicine in place of the next scheduled injection of the depot formulation. 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 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 depending on the patient, the dose may be increased up to 1 mg twice daily. Once the patient has reached the optimal dose, once-daily dosing may also be considered. As with all symptomatic treatments, the continued use of this medicine should be regularly assessed and justified. 3. Adjunctive treatment of mania 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 all symptomatic treatments, the continued use of this medicine should be regularly assessed and justified. Renal and hepatic impairment For 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

• Clinical experience in children and adolescents under 15 years of age is limited. • 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 medicine 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. As with all symptomatic treatments, the continued use of this medicine should be regularly assessed and justified. • Clinical experience in children under 5 years of age is limited.

Caution is required when administering this medication to elderly dementia patients due to an increased risk of death. In particular, the mortality rate may be higher when used with certain diuretics, so it is essential to carefully evaluate the risks and benefits before co-administration. Since there is a risk of venous thrombosis, risk factors for thrombosis should be evaluated and preventive measures taken before and during the use of this medication. It should not be administered to patients who have allergies to this medication or its components, or who are in a state of central nervous system depression or coma. Additionally, it should not be used with alcohol or specific central nervous system depressants, and patients receiving epinephrine should be avoided. Patients with genetic issues such as lactose intolerance should also avoid this medication. Patients with cardiovascular disease or with impaired liver and kidney function, patients with a history of seizures, and those at risk of suicide should use this medication with caution. Pregnant or breastfeeding women should consult with their doctor before using this medication, as it may affect the fetus or newborn. This medication may cause side effects such as drowsiness, dizziness, hypotension, weight gain, and worsened diabetes, so medical personnel should be notified immediately if symptoms arise. There may also be drug interactions, so it is important to inform healthcare professionals of any other medications being taken. Activities requiring caution, such as driving or operating machinery, should be avoided during this medication's use. Serious side effects may arise from overdosing, hence it is crucial to adhere to the prescribed dosage and regimen. Lastly, keep this medication out of reach of children and avoid transferring it to other containers.

Increased mortality, stroke, transient ischemic attack, venous thrombosis, sinusitis, upper respiratory infection, sinusitis, urinary tract infection, anemia, hypersensitivity reaction, insomnia, anxiety, neurovascular irritability, Parkinson's disease, akathisia, drowsiness, dizziness, sedation, tremor, muscle rigidity, somnolence, orthostatic dizziness, dyskinesia, syncope, blurry vision, ear pain, orthostatic hypotension, tachycardia, hypotension, nasal congestion, respiratory distress, 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, ejaculation failure, fatigue, weakness, fever, chest pain, elevated blood 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, stool mass, erythema, abnormal posture, joint swelling, peripheral edema, gait disturbance, pitting edema, elevated temperature, rhinitis, influenza, increased appetite, mid-insomnia, fatigue, headache, stuttering, attention deficit, balance disorder, hypersomnia, palpitations, oropharyngeal pain, pulmonary congestion, itching, acne, myalgia, neck pain, nocturnal enuresis, frequent urination, excessive lactation, emotional disturbances, lethargy, chest discomfort, weight gain, elevated blood prolactin, anxiety, flattened affect, sleep disorders, decreased libido, sexual dysfunction, depression, nightmares, unresponsive to stimuli, cooperative disorders, loss of consciousness, speech disorders, sensory deficits, movement disorders, generalized dyskinesia, cerebral ischemia, cerebrovascular accident disabilities, neuroleptic malignant syndrome, diabetic coma, head tremors, spasms, psychomotor hyperactivity, delayed dyskinesia, cerebrovascular disorders, sensory abnormalities, conjunctival injection, eye discharge, eye movement, eyelid edema, photophobia, eyelid crusting, dry eyes, increased tearing, glare, glaucoma, decreased vision, tinnitus, vertigo, bradycardia, tachycardia, palpitations, flushing, wheezing, aspiration pneumonia, vocal disorders, wet cough, airway congestion, rales, respiratory distress, nasal edema, hyperventilation, fecal incontinence, gastritis, lip swelling, cheilitis, salivary deficiency, abdominal distension, gastroenteritis, 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 discharge, thirst, influenza-like syndrome, edema, malaise, facial swelling, discomfort, generalized edema, chills, peripheral hypothermia, drug withdrawal syndrome, drug adverse reactions, hypothermia, procedure-related pain, increased ALT, ECG abnormalities, eosinophilia, increased AST, leukopenia, increased blood glucose, decreased hemoglobin, decreased hematocrit, low body temperature, hypotension, increased transaminases, increased gamma-glutamyl transferase, increased liver enzymes, agranulocytosis, thrombocytopenia, anaphylaxis, abnormal secretion of antidiuretic hormone, diabetic ketoacidosis, diabetes, hypoglycemia, water intoxication, elevated cholesterol levels, elevated triglyceride levels, tension disorder, mania, sleepwalking, sleep-related eating disorder, altered taste, intraoperative pupillary atony syndrome, atrial fibrillation, deep vein thrombosis, pulmonary embolism, sleep apnea syndrome, intestinal obstruction, pancreatitis, jaundice, vascular edema, hair loss, drug reactions accompanying eosinophilia and systemic symptoms, Stevens-Johnson syndrome, toxic epidermal necrolysis, neonatal drug withdrawal syndrome, urinary retention, priapism, hypothermia, QT prolongation on ECG, chest pain, liver dysfunction, hepatitis, thirst, dry mouth, urinary retention, polyuria, hiccups, increased sweating, leukopenia, arrhythmia, hangover, ocular movement seizures, tic disorders, respiratory distress, Rabbit syndrome, suicide attempt, abnormal thoughts, delusions, hallucinations, worsening of auditory hallucinations, falls, priapism

This medication may be sensitive to air or moisture, so it should be stored in a tightly closed container. The storage temperature should be maintained at room temperature between 1 to 30 degrees Celsius.

Appearance

Reddish-brown, oblong film-coated tablet

Package unit

30 tablets/bottle