Ripenex 3mg Tablet (Risperidone)

Adult dose

The therapeutic dose of this medication 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 gradually increase the dose. (2) Maintenance dose: Administer 1∼3 mg twice daily. Adjust the dose appropriately according to age and symptoms. (3) Administration of 10 mg or more per day has not shown additional efficacy compared with lower doses and 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. (4) Do not administer doses of 16 mg or more per day, as safety has not been established. (5) A benzodiazepine may be administered concomitantly if additional sedation is needed. 2) Administration 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 reaching 1～2 mg twice daily. 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 medication to this medication When medically appropriate, start this medication while gradually reducing the dose of the previous medication. Also, when switching from a depot antipsychotic medication, if medically appropriate, start this medication 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’s type The initial dose is 0.25 mg 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 depending on the patient, the dose may be increased to 1 mg twice daily. Once the patient reaches the optimal dose, once-daily dosing may also be considered. As with symptomatic treatment, the appropriateness of continued use of this medication should be evaluated. 3. Adjunctive treatment of mania in bipolar disorder ⦁ The recommended initial dose is 2 mg 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 appropriateness of continued use of this medication should be evaluated. 4. Conduct disorder and other disruptive behavior disorders As with symptomatic treatment, the appropriateness of continued use of this medication 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 medication 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 mania in bipolar disorder: There is limited clinical experience in children and adolescents under 15 years of age. Conduct disorder and other disruptive behavior disorders, body weight 50 kg or more: The initial dose is 0.5 mg 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. Conduct 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. Conduct disorder and other disruptive behavior disorders: There is limited clinical experience in children under 5 years of age.

This drug should be used with caution as it may increase mortality when administered to elderly dementia patients. Particularly, the risk of death may be higher when used in combination with furosemide, so the risks and benefits must be considered before co-administration. There is a risk of venous thromboembolism, so thromboembolic risk factors should be assessed and preventive measures taken before and during administration. It should not be used in patients with known allergies to this drug or its components, severe central nervous system depression, coma, current epinephrine treatment, or lactose intolerance. Special caution is required for patients with cardiovascular diseases or those at risk of arrhythmia and QT interval prolongation, patients with impaired liver or kidney function, patients at risk for suicide, patients with Parkinson's disease, diabetic patients, the elderly, pregnant women, and nursing mothers. This medication can cause various side effects in multiple systems, such as the nervous system, gastrointestinal system, and cardiovascular system. Commonly observed side effects may include drowsiness, dizziness, hypotension, insomnia, anxiety, and symptoms of Parkinsonism. During treatment, it is crucial to monitor for serious neurological side effects such as tardive dyskinesia or neuroleptic malignant syndrome. Additionally, as this medication can affect blood sugar control, diabetic patients should consistently monitor their blood sugar levels, and weight gain should be monitored, necessitating dietary adjustments. Caution is advised when taken in conjunction with central nervous system depressants or alcohol, as it may intensify sedation or drowsiness. This medication is primarily metabolized by the liver, thus caution is needed when co-administering with drugs that inhibit or induce CYP2D6 or CYP3A4 enzymes, particularly in patients with liver impairment. Safety for fetal exposure during pregnancy has not been established, especially in late pregnancy, as withdrawal symptoms or extrapyramidal symptoms may occur in newborns, therefore pregnant women should use it with caution. If breastfeeding, as this drug is excreted in breast milk, it is recommended to discontinue breastfeeding. In the case of overdose, symptoms such as drowsiness, hypotension, arrhythmia, and seizures may appear, requiring immediate emergency care and cardiac monitoring. This medication should be kept out of the reach of children, and transferring to another container should be avoided as it may compromise quality.

Increased mortality, cerebrovascular adverse reactions, venous thrombosis, nasopharyngitis, upper respiratory infection, sinusitis, urinary tract infection, anemia, hypersensitivity, insomnia, anxiety, nervousness, Parkinsonism, akathisia, drowsiness, dizziness, sedation, tremor, muscle tone abnormality, somnolence, orthostatic dizziness, movement disorders, syncope, blurred vision, ear pain, orthostatic hypotension, tachycardia, hypotension, nasal congestion, dyspnea, nosebleeds, sinus congestion, nausea, constipation, indigestion, vomiting, diarrhea, excessive salivation, dry mouth, abdominal discomfort, abdominal pain, gastrointestnial discomfort, epigastric pain, rash, dry skin, dandruff, seborrheic dermatitis, hyperkeratosis, back pain, joint pain, limb pain, urinary incontinence, ejaculatory dysfunction, fatigue, asthenia, fever, chest pain, increased blood creatinine phosphokinase, increased heart rate, pneumonia, soft tissue infection, decreased appetite, confusional state, transient ischemic attack, decreased level of consciousness, drooling, cerebrovascular accident, conjunctivitis, cough, rhinorrhea, dysphagia, fecal impaction, erythema, abnormal posture, joint swelling, peripheral edema, gait disturbance, edema, increased body temperature, rhinitis, influenza, increased appetite, middle insomnia, lethargy, headache, stuttering, attention deficit, balance disorders, excessive sleepiness, palpitations, oropharyngeal pain, pulmonary congestion, pruritus, acne, myalgia, neck pain, nocturia, frequent urination, hypergalactorrhea, affective disorders, apathy, chest discomfort, weight gain, elevated blood prolactin, anxiety, blunted affect, sleep disorders, decreased libido, anorgasmia, depression, nightmares, lack of response to stimuli, cooperative disorders, loss of consciousness, speech disorders, sensory impairment, movement disorders, manifest movement abnormalities, cerebral ischemia, cerebrovascular accident complications, neuroleptic malignant syndrome, diabetic coma, head tremors, seizures, 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, sinus bradycardia, sinus tachycardia, palpitations, I-degree atrioventricular block, left bundle branch block, right bundle branch block, complete block, flushing, conduction disorders, ECG abnormalities, ECG QT interval prolongation, sinoatrial node dysfunction, bradycardia, wheezing, aspiration pneumonia, dysphonia, wet cough, airway congestion, crackles, respiratory distress, nasal mucosa edema, 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, urinary dysfunction, amenorrhea, gynecomastia, vaginal discharge, erectile dysfunction, ejaculation disorders, menstrual disorders, breast engorgement, sexual dysfunction, retrograde ejaculation, breast discharge, thirst, influenza-like symptoms, edema, lethargy, facial swelling, discomfort, generalized edema, chills, peripheral coldness, drug withdrawal syndrome, drug adverse reactions, decreased body temperature, procedure-related pain, ALT elevation, ECG abnormalities, eosinophilia, AST elevation, leukopenia, increased blood sugar, decreased hemoglobin, decreased hematocrit, hypothermia, hypotension, transaminase elevation, γ-glutamyl transferase elevation, liver enzyme elevation, agranulocytosis, thrombocytopenia, antidiuretic hormone secretion disorders, diabetic ketoacidosis, diabetes, hypoglycemia, water intoxication, increased blood cholesterol, increased blood triglycerides, mania, dysgeusia, intraoperative iris tension decrease 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, ECG QT prolongation, chest pain, liver function abnormalities, hepatitis, dry mouth, xerostomia, urinary retention, polyuria, hiccup, increased sweating, urinary dysfunction, leukopenia, arrhythmia, hangover, oculomotor seizures, tic disorders, respiratory distress, Rabbit syndrome, suicide attempt, accident abnormalities, delusion, hallucinations, exacerbation of auditory hallucinations

This medication should be stored in a tightly sealed container as it may be sensitive to air or moisture. Additionally, avoid storing in extremely hot or cold environments, and it is recommended to maintain a storage temperature between 1 to 30 degrees Celsius.

Appearance

Oblong yellow film-coated tablets

Package unit

30 tablets/bottle, 200 tablets/bottle