Risperdal Tablets 3 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 - Adults Initial dose: Administer 1 mg of risperidone orally twice daily and increase the dose gradually. Maintenance dose: 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 to the individual patient are judged to outweigh the risks. Doses of 16 mg or more per day should not be administered because safety has not been established. If additional sedation is required, benzodiazepines may be administered concomitantly. Schizophrenia - 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

Schizophrenia - Children and adolescents under 15 years of age: Clinical experience is limited. Adjunctive treatment of mania in bipolar disorder - Children and adolescents under 15 years of age: Clinical experience is limited. Disruptive behavior disorder and other disruptive behavior disorders - 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. Disruptive behavior disorder and other disruptive behavior disorders - 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. Disruptive behavior disorder and other disruptive behavior disorders - Children under 5 years of age: Clinical experience is limited.

This medication should be used cautiously in elderly dementia patients as it may increase mortality rates. Especially, when used concurrently with certain diuretics (such as furosemide), the risk of death may be higher, hence the benefits and risks should be thoroughly considered before combination therapy. Prior to using this medication, risk factors that could induce venous thrombosis should be identified and preventive measures taken as necessary. It should not be administered to patients with allergies to this drug or its components, patients severely depressed in the central nervous system, patients in a coma, patients receiving epinephrine, and those with specific genetic lactose intolerance. Patients with heart disease, liver or kidney dysfunction, a history of seizures, suicidal risk, Parkinson's disease or Lewy body dementia, diabetes, the elderly, pregnant women, and nursing mothers should exercise special caution when using this medication. This drug can cause various side effects such as drowsiness, dizziness, hypotension, and extrapyramidal symptoms; therefore, if these symptoms occur, medical consultation should be sought immediately. Also, this drug may enhance central nervous system depression when taken with other CNS depressants or alcohol, so caution should be exercised when taken together. Taking this medication during pregnancy can affect the fetus, so women who are pregnant or may become pregnant should definitely consult with medical personnel. If breastfeeding, it is recommended to discontinue nursing as this drug may be passed into breast milk. Safety for children and adolescents has not been fully established, thus it should be administered with caution. In case of overdose, seek medical attention immediately for proper treatment and monitoring, as there is no antidote for this medication and supportive treatment according to symptoms is required. This medication should be stored in a secure place out of reach of children, and transferring it to another container is not recommended as it may compromise quality.

Increased mortality, stroke, transient ischemic attack, venous thrombosis, rhinitis, upper respiratory infection, sinusitis, urinary tract infection, anemia, hypersensitivity, insomnia, anxiety, nervous hyperexcitability, Parkinson's syndrome, akathisia, drowsiness, dizziness, sedation, tremor, muscle rigidity, sleepiness, orthostatic dizziness, movement disorder, 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, erectile dysfunction, fatigue, asthenia, fever, chest pain, elevated blood creatinine, phosphocreatine rise, increased heart rate, pneumonia, soft tissue inflammation, decreased appetite, confusion, transient ischemic attack, decreased consciousness, sialorrhea, cerebrovascular accident, conjunctivitis, cough, runny nose, dysphagia, fecaloma, erythema, abnormal posture, joint swelling, peripheral edema, gait disturbance, pitting edema, elevated body temperature, rhinitis, influenza, increased appetite, moderate insomnia, lethargy, headache, stuttering, attention deficit, balance disorder, hypersomnia, palpitations, pharyngolaryngeal pain, pulmonary congestion, itching, acne, myalgia, neck pain, nocturia, frequent urination, hyperlactation, mood disorder, apathy, chest discomfort, weight gain, elevated blood prolactin, restlessness, blunted affect, sleep disturbances, decreased libido, sexual dysfunction, depression, nightmares, non-responsiveness to stimuli, coordination disorder, loss of consciousness, speech disorder, sensory impairment, movement disorder, generalized dyskinesia, cerebral ischemia, cerebrovascular accident disorder, Neuroleptic Malignant Syndrome, diabetic coma, head tremors, seizures, psychomotor agitation, dyskinesia, cerebrovascular disorder, sensory disturbances, eye irritation, eye discharge, eye movement, eyelid swelling, photophobia, scabbing of eyelid margins, dry eyes, increased tearing, glare, glaucoma, decreased vision, tinnitus, vertigo, bradycardia, tachycardia, palpitations, I degree AV block, left bundle branch block, right bundle branch block, AV block, flushing, conduction disorder, abnormal ECG, prolonged QT interval on ECG, central venous thrombosis, bradycardia, wheezing, aspiration pneumonia, voice disorders, productive cough, airway congestion, crackles, respiratory distress, nasal swelling, hyperventilation, fecal incontinence, gastritis, lip swelling, cheilitis, salivary gland deficiency, bloating, 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 difficulties, amenorrhea, gynecomastia, vaginal discharge, erectile dysfunction, ejaculation disorders, menstrual disorders, breast engorgement, sexual dysfunction, retrograde ejaculation, nipple 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 loss, increased ALT, increased AST, elevated blood sugar, decreased hemoglobin, decreased hematocrit, lowered blood pressure, increased transaminases, increased gamma-glutamyltransferase, elevated liver enzymes, falls, agranulocytosis, thrombocytopenia, anaphylactic reaction, abnormal secretion of antidiuretic hormone, diabetic ketoacidosis, diabetes, hypoglycemia, water intoxication, tension syndrome, mania, sleepwalking, sleep-related eating disorders, dysgeusia, intraoperative pupil constriction syndrome, atrial fibrillation, deep vein thrombosis, pulmonary embolism, sleep apnea syndrome, intestinal obstruction, pancreatitis, jaundice, vascular edema, alopecia, drug reactions accompanied by eosinophilia and systemic symptoms, Stevens-Johnson syndrome, toxic epidermal necrolysis, newborn withdrawal syndrome, urinary retention, priapism, hypothermia, prolonged QT interval on ECG, chest pain, liver dysfunction, hepatitis, thirst, dry mouth, urinary retention, polyuria, pain, hiccups, increased sweating, urination difficulties, leukopenia, arrhythmia, epistaxis, anemia, diarrhea, hangover, ocular myoclonus, acne, dysphagia, nocturia, tic disorder, respiratory distress, suicidal attempts, abnormal thoughts, delusions, hallucinations, symptom exacerbation

This medication should be stored in a tightly closed container to avoid exposure to air or moisture, and it is recommended to keep it at room temperature between 1 degree and 30 degrees. By storing it this way, the drug's efficacy and safety can be maintained.

Appearance

Yellow oblong film-coated tablet

Package unit

30 tablets/bottle