Riphenex 0.5 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 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. 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

⦁ There is limited clinical experience in children and adolescents under 15 years of age. ⦁ There is limited clinical experience in children and adolescents under 15 years of age. - 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. - 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. ⦁ There is limited clinical experience in children under 5 years of age.

Caution should be exercised when administering this medication to elderly dementia patients, as the mortality risk may increase. The risk of death may be heightened particularly among elderly dementia patients when this medication is used in conjunction with furosemide, so the risks and benefits should be carefully considered prior to concomitant administration. Patients taking this medication are at risk of developing venous thrombosis, and factors that can cause thrombosis should be identified and preventive measures taken. It should not be used in patients with known allergies to this medication or its components, patients whose nervous systems are depressed due to alcohol or central nervous system depressants, patients in a comatose state, patients receiving epinephrine, and those with certain genetic lactose intolerance. Patients with a history of heart disease, seizure disorders, liver or kidney dysfunction, suicidal tendencies, Parkinson's disease or Lewy body dementia, diabetes, elderly patients, and women who are pregnant or breastfeeding should use this medication with increased caution. This medication may cause side effects, such as drowsiness, dizziness, hypotension, insomnia, anxiety, extrapyramidal symptoms like Parkinsonism, gastrointestinal disorders, skin rash, weight gain, and so forth, requiring careful monitoring of symptoms. Particularly, although rare, severe adverse effects such as blood disorders, allergic reactions, cardiac arrhythmias, liver dysfunction, and neuroleptic malignant syndrome may occur, and medical attention should be sought immediately upon the appearance of any abnormal symptoms. Caution should also be taken when co-administering this medication with other central nervous system depressants or alcohol, as they may exacerbate drowsiness or lead to a state of coma. Additionally, this medication can be affected by or influence the metabolism of certain liver enzymes (CYP2D6, CYP3A4), so interactions should be confirmed and dosage adjustments may be necessary when taken with other medications. During pregnancy, this medication can affect the fetus, so women who may become pregnant should consult medical personnel, and breastfeeding is not recommended. When using this medication in children or the elderly, special attention must be paid to dosage adjustments and monitoring for side effects. In cases of overdose, symptoms can include drowsiness, hypotension, cardiac abnormalities, seizures, and immediate emergency treatment is required, as there is no antidote for this medication, necessitating appropriate treatment based on symptoms. This medication should be stored in a place safe from children and transferring it to other containers should be avoided as it may lead to deterioration of quality or accidents.

Increased mortality, stroke, transient ischemic attack, venous thrombosis, rhinitis, upper respiratory tract infection, sinusitis, urinary tract infection, anemia, hypersensitivity reaction, insomnia, anxiety, nervousness, Parkinson's disease, akathisia, drowsiness, dizziness, sedation, tremor, muscle rigidity, hypersomnia, orthostatic dizziness, movement disorder, syncope, blurry vision, ear pain, orthostatic hypotension, tachycardia, hypotension, nasal congestion, dyspnea, epistaxis, sinus congestion, nausea, constipation, dyspepsia, vomiting, diarrhea, hypersalivation, 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, increased serum creatinine phosphokinase, increased heart rate, pneumonia, soft tissue infection, decreased appetite, confusion, transient ischemic attack, altered consciousness, drooling, cerebrovascular accident, conjunctivitis, cough, runny nose, difficulty swallowing, fecal impaction, erythema, abnormal posture, joint swelling, peripheral edema, gait disturbance, pitting edema, increased body temperature, upper respiratory tract infection, rhinitis, influenza, increased appetite, middle insomnia, weakness, headache, stuttering, attention disorder, balance disorder, hypersomnia, palpitations, pharyngeal pain, pulmonary congestion, itching, acne, myalgia, neck pain, nocturnal enuresis, increased urinary frequency, galactorrhea, mood disturbances, lethargy, chest discomfort, agitation, blunted affect, sleep disorder, decreased libido, sexual dysfunction, depression, nightmares, lack of response to stimuli, disorganized behavior, loss of consciousness, speech disorder, sensory loss, movement disorder, generalized dystonia, cerebral ischemia, cerebrovascular accident impairment, neuroleptic malignant syndrome, diabetic coma, head tremor, seizures, psychomotor agitation, tardive dyskinesia, cerebrovascular disorder, sensory disturbance, eye redness, eye discharge, eye rotation, eyelid edema, photophobia, eyelid crusting, dry eyes, increased tearing, glare, glaucoma, decreased vision, tinnitus, dizziness, bradycardia, sinus tachycardia, palpitations, I-degree atrioventricular block, left bundle branch block, right bundle branch block, atrioventricular block, flushing, conduction disorders, abnormal electrocardiogram, prolonged QT interval on electrocardiogram, venous thrombosis, bradycardia, wheezing, aspiration pneumonia, speech disturbance, wet cough, airway obstruction, crackles, respiratory disorder, nasal edema, hyperventilation, fecal incontinence, gastritis, lip edema, cheilitis, salivary deficiency, bloating, gastroenteritis, tongue edema, toothache, skin discoloration, skin lesions, skin disorders, erythematous rash, papular rash, generalized rash, papulosquamous rash, eczema, musculoskeletal chest pain, joint stiffness, muscle weakness, rhabdomyolysis, urination problems, amenorrhea, gynecomastia, vaginal discharge, erectile dysfunction, ejaculation disorder, menstrual disorders, breast engorgement, sexual dysfunction, retrograde ejaculation, nipple discharge, thirst, influenza-like syndrome, edema, malaise, facial swelling, discomfort, general edema, chills, peripheral coldness, drug withdrawal syndrome, adverse drug reactions, decreased body temperature, procedure-related pain, increased ALT, abnormal electrocardiogram, increased eosinophils, increased AST, decreased white blood cell count, increased blood sugar, decreased hemoglobin, decreased hematocrit, decreased body temperature, decreased blood pressure, increased transaminases, increased γ-glutamyl transferase, increased liver enzymes, lower respiratory tract infection, gastroenteritis, subcutaneous abscess, neutropenia, hyperglycemia, hyperuricemia, hyperinsulinemia, depression, early insomnia, delusions, hallucinations, hypomanic symptoms, persecutory delusions, suicidal ideation, increased libido, decreased libido, sexual dysfunction, sensory abnormalities, seizures, tremors, psychomotor hyperactivity, akinesia, paresthesia, head discomfort, eyelid spasms, eye movement disorders, dizziness, bradycardia, premature contractions, arrhythmia, hypertension, thromboembolism, postural orthostatic tachycardia syndrome, toothache, tongue spasms, hyperflexibility, hemorrhoids, eczema, hyperhidrosis, itching, drug rash, urticaria, hip pain, delayed menstruation, delayed ejaculation, infrequent menstruation, breast discomfort, breast engorgement, breast enlargement, pain during urination, anaphylactic reaction, pain, sclerosis, weight loss, increased γ-GT, increased liver enzymes, glucose detection in urine, falls, agranulocytosis, thrombocytopenia, abnormal secretion of antidiuretic hormone, diabetic ketoacidosis, diabetes, hypoglycemia, water intoxication, increased blood cholesterol, increased blood triglycerides, mania, dysgeusia, intraoperative syndrome of decreased iris tension, 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, abnormal liver function, hepatitis, dry mouth, oral dryness, urinary retention, polyuria, hiccups, increased sweating, urinary dysfunction, leukopenia, arrhythmia, epistaxis, anemia, diarrhea, hangover, ocular motor seizures, acne, difficulty swallowing, enuresis, tic disorder, dyspnea, Rabbit syndrome, suicidal ideation, cognitive abnormalities, delusions, hallucinations, exacerbation of auditory hallucinations, tardive dyskinesia, hyperthermia, muscle rigidity, autonomic nervous anxiety, altered consciousness, increased serum creatine phosphokinase, myoglobinuria, acute kidney failure, confusion, insensitivity, postural instability, frequent falls, hyperglycemia, diabetes, weight gain, sedative effects, leukopenia, neutropenia, agranulocytosis, intraoperative syndrome of decreased iris tension, priapism, orthostatic hypotension, syncope, decreased core temperature, acute overdose symptoms, prolonged QT interval

This medication must be stored in a tightly sealed container to protect it from air and moisture. It is important to maintain a storage temperature between 1 and 30 degrees Celsius.

Appearance

Oblong reddish-brown film-coated tablet

Package unit

30 tablets/bottle, 200 tablets/bottle