Ripadin Tablets 2 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 as appropriate according to age and symptoms. No additional efficacy 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 considered to outweigh the risks. Do not administer doses of 16 mg or more per day, as their safety has not been established. A benzodiazepine may be administered concomitantly if an additional sedative effect is needed. Administration in special populations with 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. Switching from an existing antipsychotic medicine 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 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’s 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 reaches the optimal dose, once-daily administration may also be considered. As with symptomatic treatment, the rationale for continued use of this medicine should be evaluated. 3. 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 rationale for continued use of this medicine 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 medicine with caution in these patients (see 5. General Precautions)

Child dose

Schizophrenia: There is limited clinical experience in children and adolescents under 15 years of age. Adjunctive treatment of manic episodes in bipolar disorder: There is limited clinical experience in children and adolescents under 15 years of age. 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 necessary, 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 necessary, 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. Disruptive behavior disorder and other disruptive behavior disorders: As with symptomatic treatment, the rationale for continued use of this medicine should be evaluated. There is limited clinical experience in children under 5 years of age.

Caution is required when administering this drug to elderly dementia patients as it may increase mortality rates. Especially, the risk of death may be higher if this drug is used in combination with furosemide, so the risks and benefits should be carefully considered before concomitant administration. Additionally, this drug may cause venous thrombosis, therefore thrombosis risk factors should be identified and preventive measures should be taken before and during administration. This medication contains the artificial sweetener aspartame and should not be administered to patients with certain genetic disorders such as phenylketonuria. Moreover, this drug should not be used in patients with hypersensitivity to this drug or its components, patients with central nervous system depression, comatose patients, patients receiving epinephrine, and lactose-intolerant patients. Careful administration is warranted in patients with cardiovascular diseases, decreased renal and liver function, history of seizures, patients at risk of suicide, patients with Parkinson's disease or Lewy body dementia, diabetes patients, and elderly patients, etc., and pregnant or lactating women should consider the effects on the fetus and newborn before administration. This medication may cause various adverse reactions including insomnia, dizziness, drowsiness, orthostatic hypotension, nausea, constipation, skin rash, etc., so any abnormal symptoms should be promptly discussed with a healthcare professional. Furthermore, co-administration with other central nervous system depressants or alcohol may enhance CNS depression, hence caution is needed during concurrent use. If a pregnant woman takes this medication, extrapyramidal disorders or withdrawal symptoms may occur in the newborn, so administration during pregnancy should be decided carefully, and in the case of breastfeeding, discontinuation of breastfeeding is recommended. In case of overdose, symptoms such as drowsiness, hypotension, seizures may occur, so immediate emergency treatment should be obtained, and this medication is fragile, so it should not be pressed open or cut, and should be taken immediately after opening. Additionally, this drug may have reduced effectiveness when mixed with tea or cola, so it should not be mixed. Finally, it is safe to keep this medication out of reach of children and not to transfer it to another container, and it is advisable to avoid activities requiring mental focus, such as driving or operating machinery, while taking this medication.

Increased mortality, cerebrovascular adverse reactions, venous thrombosis, pharyngitis, upper respiratory infection, sinusitis, urinary tract infection, anemia, hypersensitivity, insomnia, anxiety, nervousness, Parkinsonism, akathisia, drowsiness, dizziness, sedation, tremor, muscle hypertonia, somnolence, orthostatic dizziness, dyskinesia, syncope, blurred vision, ear pain, orthostatic hypotension, tachycardia, hypotension, nasal congestion, dyspnea, nosebleed, sinus congestion, nausea, constipation, dyspepsia, vomiting, diarrhea, excessive salivation, dry mouth, abdominal discomfort, abdominal pain, gastric discomfort, epigastric pain, rash, dry skin, dandruff, seborrheic dermatitis, hyperkeratosis, back pain, arthralgia, limb pain, urinary incontinence, ejaculatory dysfunction, fatigue, asthenia, fever, chest pain, elevated blood creatinine phosphokinase, increased heart rate, pneumonia, soft tissue infections, decreased appetite, confusion, transient ischemic attack, altered consciousness, drooling, cerebrovascular accident, conjunctivitis, hypotension, cough, rhinorrhea, dysphagia, fecal impaction, erythema, abnormal posture, joint swelling, peripheral edema, gait disturbance, pitting edema, elevated body temperature, upper respiratory infection, rhinitis, influenza, increased appetite, middle insomnia, lethargy, headache, stuttering, attention disorder, balance disorder, excessive sleep, palpitations, pharyngolaryngeal pain, pulmonary congestion, itching, acne, myalgia, neck pain, nocturnal enuresis, frequency of urination, excessive milk secretion, mood disorders, lethargy, chest discomfort, weight gain, elevated blood prolactin, anxiety, flattened affect, sleep disorders, decreased libido, sexual dysfunction, depression, nightmares, unresponsiveness to stimuli, cooperative disorders, loss of consciousness, speech disorders, sensory loss, movement disorders, generalized dyskinesia, cerebral ischemia, cerebrovascular accident disorder, neuroleptic malignant syndrome, diabetic coma, head tremors, convulsions, psychomotor agitation, delayed dyskinesia, cerebrovascular disorders, sensory abnormalities, conjunctival injection, ocular discharge, eye movement, eyelid swelling, photophobia, crust on eyelid margin, dry eyes, increased tearing, glare, glaucoma, decreased vision, tinnitus, vertigo, bradycardia, tachycardia, palpitations, I-degree atrioventricular block, left bundle branch block, right bundle branch block, atrioventricular block, flushing, conduction disturbance, abnormal electrocardiogram, prolonged QT interval on electrocardiogram, venous thrombosis, bradycardia, wheezing, aspiration pneumonia, vocal cord dysfunction, productive cough, airway congestion, crackles, respiratory distress, nasal cavity 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 disorders, amenorrhea, gynecomastia, vaginal discharge, erectile dysfunction, ejaculatory dysfunction, menstrual disorders, breast engorgement, sexual dysfunction, retrograde ejaculation, breast discharge, thirst, influenza-like syndrome, edema, lethargy, facial swelling, malaise, generalized edema, chills, peripheral coldness, drug withdrawal syndrome, adverse drug reactions, decreased body temperature, procedure-related pain, elevated ALT, electrocardiogram abnormality, eosinophilia, elevated AST, leukopenia, increased blood glucose, decreased hemoglobin, decreased hematocrit, hypothermia, decreased blood pressure, elevated transaminases, increased γ-glutamyl transferase, increased liver enzymes, agranulocytosis, thrombocytopenia, abnormal secretion of antidiuretic hormone, diabetic ketoacidosis, diabetes, hypoglycemia, water intoxication, increased blood cholesterol, increased blood triglycerides, mania, taste disorders, intraoperative iris hypotonia 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, prolonged QT interval on electrocardiogram, chest pain, altered liver function, hepatitis, dry mouth, xerostomia, urinary retention, polyuria, pain, hiccups, increased sweating, urination disorders, leukopenia, arrhythmia, nosebleed, anemia, diarrhea, hangover, ocular movement seizures, acne, dysphagia, nocturnal enuresis, tic disorder, respiratory distress, suicide attempt, thought disorder, delusions, hallucinations, exacerbation of auditory hallucinations, falls, extrapyramidal symptoms, hyperthermia, muscle rigidity, autonomic nervous system anxiety disorders, altered consciousness, elevated serum creatine phosphokinase, myoglobinuria, acute renal failure, delirium, insensitivity, postural instability, frequent falls, weight gain, orthostatic hypotension, syncope, decreased core temperature, drug withdrawal syndrome, intraoperative iris hypotonia syndrome, priapism

This medication should be stored in a tightly closed container to avoid exposure to air or moisture. Additionally, it should be safely stored at room temperature between 1 degree and 30 degrees.

Appearance

Oblong light orange film-coated tablet

Package unit

30 tablets/bottle, 200 tablets/bottle