Ripenex Tablets 2 mg (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 per dose, twice daily, and increase gradually. (2) Maintenance dose: Administer 1∼3 mg per dose, 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 an individual patient are judged 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 · Older adults and patients predisposed to hypotension The initial dose is 0.5 mg per dose, twice daily. Depending on the patient’s condition, increase by 0.5 mg per dose twice daily until reaching 1～2 mg per dose twice daily. In general, increases to doses of 1.5 mg or more per dose twice daily should be made at intervals of at least 1 week. 3) Switching from an existing antipsychotic medication to this medication When medically appropriate, start this medication while gradually reducing the dose of the existing medication. Also, when switching from an existing depot antipsychotic medication, start this medication in place of the next scheduled depot injection, when medically appropriate. The need to continue any 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 per dose, twice daily. If needed, depending on the patient, the dose may be increased by 0.25 mg per dose twice daily at intervals of at least 2 days. The optimal dose for most patients is 0.5 mg per dose twice daily, but for some patients it may be increased to 1 mg per dose twice daily. 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 medication should be evaluated. 3. Adjunctive therapy for mania associated with bipolar disorder · The recommended initial dose is 2 mg once daily. Depending on the patient, the dose may be increased by up to 1 mg per day at intervals of at least 24 hours. The optimal dose for most patients is in the range of 2∼6 mg per day. 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 one-half of 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

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 medication 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 under 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. Clinical experience in children under 5 years of age is limited.

This drug should be used with caution in elderly dementia patients, as it may increase the risk of mortality. In particular, when used in conjunction with certain diuretics, such as furosemide, the mortality risk may be elevated, so the risks and benefits should be carefully considered before co-administration. Before using this medication, check for any risk factors that may induce venous thromboembolism and, if necessary, take preventive measures. This drug should not be used in cases of allergy to this medication or its components, severe CNS depression, coma, or while administering epinephrine, nor should it be administered to patients with genetic issues such as lactose intolerance. Patients with heart disease, dehydration, reduced blood volume, or cerebrovascular disease may experience side effects like hypotension when using this medication, so dosages should be adjusted slowly and administered cautiously. Patients with arrhythmias or those at risk for QT interval prolongation, a history of seizures, impaired liver or kidney function, suicidal tendencies, Parkinson's disease or certain dementia patients, diabetic patients, elderly individuals, pregnant or breastfeeding women should exercise special caution when using this drug. This medication can cause various side effects, and symptoms such as drowsiness, dizziness, anxiety, digestive disturbance, weight gain, increased blood glucose, and extrapyramidal symptoms have been reported. If any abnormal symptoms occur, consultation with a physician should be sought immediately. Use of this medication with other CNS depressants or alcohol can enhance the CNS depressant effect, so caution is necessary. Drug interactions with other medications may also occur, so any concurrent medications should be disclosed. Pregnant or breastfeeding women should consult a physician before using this drug, and breastfeeding should be discontinued if using this medication. Experience in children and adolescents is limited, so it should be used cautiously, especially in children under the age of 5. Elderly individuals are at a higher risk for impaired kidney function, so attention must be paid to dosage adjustments. In the event of overdose, symptoms such as drowsiness, hypotension, cardiopulmonary abnormalities, and seizures may occur, necessitating immediate medical attention. This medication should be kept out of the reach of children, and transferring it to other containers should be avoided as it can lead to quality degradation or accidents.

Increased mortality, cerebrovascular adverse reactions, venous thrombosis, pharyngitis, upper respiratory infections, sinusitis, urinary tract infections, anemia, hypersensitivity reactions, insomnia, anxiety, irritability, Parkinson's syndrome, akathisia, drowsiness, dizziness, sedation, tremors, muscle tone abnormalities, sleepiness, postural dizziness, movement disorders, 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, upper abdominal pain, rash, dry skin, dandruff, seborrheic dermatitis, hyperkeratosis, back pain, arthralgia, limb pain, urinary incontinence, ejaculatory dysfunction, fatigue, weakness, fever, chest pain, elevated blood creatinine and phosphokinase, increased heart rate, pneumonia, soft tissue inflammation, decreased appetite, confusion, transient ischemic attack, decreased consciousness, drooling, cerebrovascular accident, conjunctivitis, hypotension, cough, runny nose, 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 disorders, equilibrium disturbances, excessive sleep, palpitations, oropharyngeal pain, pulmonary congestion, itching, acne, myalgia, neck pain, nocturia, frequency, galactorrhea, emotional disturbances, lethargy, chest discomfort, anxiety, blunted affect, sleep disturbances, decreased libido, sexual dysfunction, depression, nightmares, unresponsiveness to stimuli, cooperation abnormalities, loss of consciousness, speech disorders, sensory deficits, movement disorders, widespread movement disorders, cerebral ischemia, cerebrovascular accident disorders, neuroleptic malignant syndrome, diabetic coma, head tremors, seizures, psychomotor hyperactivity, delayed movement disorders, cerebrovascular disorders, sensory abnormalities, conjunctival injection, eye discharge, eye movement, eyelid swelling, photophobia, eye crusting, dry eyes, increased tearing, glare, glaucoma, decreased vision, tinnitus, dizziness, sinus bradycardia, sinus tachycardia, palpitations, first-degree AV block, left bundle branch block, right bundle branch block, AV block, flushing, conduction abnormalities, ECG abnormalities, prolonged QT interval on ECG, supraventricular tachycardia, bradycardia, wheezing, aspiration pneumonia, voice disorders, productive cough, airway congestion, crackling sounds, respiratory disorders, nasal cavity swelling, hyperventilation, fecal incontinence, gastritis, lip swelling, cheilitis, salivary deficiency, distension, enteritis, tongue swelling, toothache, skin discoloration, skin lesions, skin disorders, erythematous rash, papular rash, generalized rash, papulonodular rash, eczema, musculoskeletal chest pain, joint rigidity, muscle weakness, rhabdomyolysis, urination disorders, amenorrhea, gynecomastia, vaginal discharge, erectile dysfunction, ejaculation disorders, menstrual disorders, breast enlargement, sexual dysfunction, retrograde ejaculation, breast discharge, thirst, influenza-like syndrome, edema, lethargy, facial swelling, discomfort, generalized edema, chills, peripheral coldness, drug withdrawal syndrome, adverse drug reactions, decreased body temperature, procedure-related pain, increased ALT, ECG abnormalities, increased eosinophil count, increased AST, decreased white blood cell count, increased blood glucose, decreased hemoglobin, decreased hematocrit, decreased body temperature, decreased blood pressure, increased transaminases, increased gamma-glutamyltransferase, increased liver enzymes, agranulocytosis, thrombocytopenia, abnormal secretion of antidiuretic hormone, diabetic ketoacidosis, diabetes mellitus, hypoglycemia, water intoxication, increased blood cholesterol, increased blood triglycerides, mania, dysgeusia, 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 ECG

This drug may be sensitive to air or moisture, so it should be stored in a tightly closed container. The storage temperature should be maintained between 1 and 30 degrees Celsius at room temperature. Keeping it this way will help maintain the medication's potency for a longer time.

Appearance

Oblong light orange film-coated tablets

Package unit

30 tablets/bottle, 200 tablets/bottle