Ujedion M 50mg (Risperidone)

Adult dose

1. Adults: For patients who have never received risperidone, establish tolerability with oral risperidone before administering this medication. This medication must be administered by a healthcare professional as a subcutaneous injection into the abdomen or upper arm and must not be administered by any other route. (See “9. Instructions for Use” under Precautions for Use.) For patients receiving a stable dose of oral risperidone, start this medication by administering one injection every 1 month, beginning the day after the last oral dose. • Switching patients receiving oral risperidone Refer to Table 1 below for switching from oral risperidone to this medication. A loading dose or supplemental oral risperidone is not recommended when switching. Switching to this medication has not been studied in patients previously treated with oral risperidone at a daily dose exceeding 5mg. Table 1. Recommended doses when switching from daily oral risperidone to this medication Previous treatment (daily oral risperidone dose) 2mg → Dose of this medication (administered once every 1 month) 50mg Previous treatment (daily oral risperidone dose) 3mg → Dose of this medication (administered once every 1 month) 75mg Previous treatment (daily oral risperidone dose) 4mg → Dose of this medication (administered once every 1 month) 100mg Previous treatment (daily oral risperidone dose) 5mg → Dose of this medication (administered once every 1 month) 125mg • Switching patients receiving a long-acting risperidone injection Switching between this medication and the risperidone injection administered once every 2 months (see Table 2) is possible. In this case, administer the first dose of the new regimen on the next scheduled administration date of the original regimen. Adjust the dosing schedule to reflect the change. Table 2. Doses for switching between this medication and the risperidone injection administered once every 2 months Dose of this medication (administered once every 1 month) 75mg → Dose of Yuje Ditum Injection (risperidone) (administered once every 2 months) 150mg Dose of this medication (administered once every 1 month) 100mg → Dose of Yuje Ditum Injection (risperidone) (administered once every 2 months) 200mg Dose of this medication (administered once every 1 month) 125mg → Dose of Yuje Ditum Injection (risperidone) (administered once every 2 months) 250mg If a dose is missed, administer the next dose as soon as possible. Do not administer more frequently than the recommended regimen. The dose may be administered within 1 week before or after the date it is due every 1 month; however, the safety and efficacy of administration more than 1 week outside this window have not been established. 2. Patients with renal or hepatic impairment This medication has not been studied in patients with renal or hepatic impairment. Before starting this medication in patients with renal or hepatic impairment, titrate oral risperidone to at least 2 mg once daily. Following oral titration, based on clinical response and tolerability, administration of 50 mg of this medication once every 1 month is recommended. 3. Dosage adjustment for concomitant use with strong CYP2D6 inhibitors and strong CYP3A4 inducers [See Precautions for Use, Section 6. Interactions] 1) Concomitant use with strong CYP2D6 inhibitors In patients receiving this medication, starting a strong CYP2D6 inhibitor (e.g., fluoxetine or paroxetine) may increase plasma risperidone concentrations; therefore, administration of a lower dose of this medication is recommended before concomitant use of a CYP2D6 inhibitor. For patients receiving the lowest dose of this medication (50mg once every 1 month), if a strong CYP2D6 inhibitor is started, continue treatment at that dose unless discontinuation of treatment is considered clinically necessary. The effect of discontinuing a strong CYP2D6 inhibitor on the pharmacokinetics of risperidone and 9-hydroxyrisperidone has not been studied. 2) Concomitant use with strong CYP3A4 inducers When treatment with a strong CYP3A4 inducer (e.g., carbamazepine) is started, closely monitor the patient, as dose adjustment of this medication may be necessary during the first 4~8 weeks. For patients receiving this medication at a particular dose, consider increasing the dose by one level. In patients receiving 125 mg of this medication once every 1 month, supplemental oral risperidone may be considered. If treatment with a strong CYP3A4 inducer is discontinued, plasma risperidone concentrations may increase; therefore, reassess the dose of this medication and any supplemental oral risperidone dose, and reduce the dose of this medication if necessary. For patients receiving 50mg of this medication once every 1 month, continue treatment at that dose unless discontinuation of treatment is considered clinically necessary.

This drug may increase mortality risk when used in elderly patients with dementia. Caution is particularly warranted as deaths are often due to cardiovascular diseases or infections; therefore, it is not to be used for treating dementia-related psychosis. There is a risk of venous thromboembolism, necessitating the assessment and prevention of thrombotic risk factors before and during administration. It must not be administered to patients with allergies to risperidone or any components of this drug. It should be used cautiously in patients with cardiovascular diseases, cerebrovascular diseases, renal or liver dysfunction, the elderly, or those with a history of seizures. Patients with Parkinson's disease or Lewy body dementia may be more sensitive to this drug; symptoms such as confusion, postural instability, and falls should be monitored closely. Pregnant women, lactating mothers, or women who may become pregnant should carefully assess risks and benefits before administration. Various adverse reactions such as drowsiness, dizziness, weight gain, gastrointestinal disturbances, and symptoms of Parkinsonism may occur, so consultation with healthcare professionals is advisable in case of symptom onset. Regular monitoring is required due to the risk of ECG abnormalities, hypotension, and fainting. This drug can cause severe side effects such as neuroleptic malignant syndrome, thus immediate notification to healthcare professionals is needed if high fever, muscle rigidity, or changes in mental state occur. There is a risk of tardive dyskinesia with long-term use, thus monitoring for symptoms is important. Diabetic patients or those at risk of metabolic disorders should regularly check blood glucose and lipid levels. This medication can increase prolactin levels and cause reproductive dysfunction; hence, attention should be paid to associated symptoms. There is a risk of falls due to orthostatic hypotension, so extra caution is warranted in the elderly or those with hypotension. Regular blood tests are recommended due to possible hematological abnormalities such as leukopenia. This drug can cause drowsiness and decreased motor function, so caution is advised while driving or operating hazardous machinery. Caution should be exercised in patients with a history of seizures or those at high risk for seizures. In pregnancy, the newborn may exhibit extrapyramidal symptoms and withdrawal symptoms, thus careful monitoring of the newborn's condition is necessary. For breastfeeding women, medication may pass through breast milk, so monitoring for abnormal symptoms in the infant is crucial. This medication may interact with other drugs, so it's essential to inform healthcare professionals if any concomitant medications are being taken and to closely monitor for interactions. In cases of overdose, symptoms such as drowsiness, hypotension, and extrapyramidal symptoms may occur, necessitating appropriate emergency treatment.

Increased mortality, heart failure, sudden death, pneumonia, anaphylactic reaction, angioedema, Parkinsonism, inability to sit still, muscle tone abnormalities, tremor, sedation, dizziness, anxiety, blurred vision, nausea, vomiting, abdominal pain, gastric discomfort, dyspepsia, diarrhea, excessive salivation, constipation, dry mouth, increased appetite, weight gain, fatigue, rash, nasal congestion, upper respiratory infection, nasopharyngitis, pharyngolaryngeal pain, tachycardia, abdominal discomfort, increased blood creatine phosphokinase, increased heart rate, back pain, arthralgia, limb pain, insomnia, chest pain, muscle weakness, epistaxis, dry skin, orthostatic hypotension, nasopharyngitis, upper respiratory infection, sinusitis, urinary tract infection, increased blood creatine phosphokinase, increased heart rate, back pain, arthralgia, limb pain, Parkinsonism, inability to sit still, sedation, dizziness, muscle tone abnormalities, tremor, postural dizziness, insomnia, anxiety, nasal congestion, dyspnea, epistaxis, rash, dry skin, orthostatic hypotension, drowsiness, chest pain, muscle weakness, agitation, abdominal pain, orthostatic hypotension, inability to sit still, pneumonia, influenza, ear infection, viral infection, pharyngitis, tonsillitis, bronchitis, eye infection, localized infection, cystitis, soft tissue infection, otitis media, onychomycosis, peripheral dermatitis, bronchopneumonia, respiratory infection, tracheobronchitis, chronic otitis media, increased body temperature, increased serum prolactin, increased alanine aminotransferase, abnormal ECG, eosinophilia, leukopenia, hyperglycemia, decreased hemoglobin, decreased hematocrit, decreased body temperature, decreased blood pressure, increased aminotransferase, decreased appetite, asthenia, poor appetite, joint swelling, joint stiffness, musculoskeletal chest pain, postural abnormalities, myalgia, neck pain, muscle weakness, muscle rigidity, rhabdomyolysis, balance disorders, attention disorders, speech disorders, unresponsiveness to stimuli, decreased level of consciousness, movement disorders, transient ischemic attack, coordination abnormalities, cerebrovascular accident, language impairment, syncope, loss of consciousness, sensory loss, tardive dyskinesia, cerebral ischemia, cerebrovascular disorders, neuroleptic malignant syndrome, diabetic coma, head tremor, agitation, flat affect, confusion, sleep interruption, nervousness, sleep disorders, indifference, decreased libido, hyperesthesia, polyuria, dysuria, frequency, urinary incontinence, irregular menstrual cycle, amenorrhea, gynecomastia in men, enuresis, vaginal discharge, menstrual disorders, erectile dysfunction, retrograde ejaculation, ejaculation disorders, sexual dysfunction, breast enlargement, wheezing, aspiration pneumonia, sinus congestion, voice disorders, wet cough, pulmonary congestion, respiratory congestion, stridor, respiratory distress, nasal edema, erythema, skin discoloration, skin lesions, pruritus, skin disorders, erythematous rash, papular rash, acne, hyperkeratosis, seborrheic dermatitis, generalized rash, maculopapular rash, hypotension, flushing, hair loss, atrial fibrillation, cardiopulmonary arrest, tension, glucose metabolism disorders, diabetic ketoacidosis, taste disturbances, hypoglycemia, hypothermia, intestinal obstruction, inappropriate secretion of antidiuretic hormone, bowel obstruction, jaundice, mania, pancreatitis, pituitary adenoma, precocious puberty, pulmonary embolism, QT prolongation, sleep apnea syndrome, somnambulism, Stevens-Johnson syndrome, toxic epidermal necrolysis, sudden death, thrombocytopenia, thrombotic thrombocytopenic purpura, urinary retention, water intoxication, stroke, transient ischemic attack, neuroleptic malignant syndrome, tardive dyskinesia, hyperglycemia, dyslipidemia, weight gain, hyperprolactinemia, orthostatic hypotension, syncope, drowsiness, seizures, dysphagia, persistent erection, hyperthermia, hypothermia, intraoperative iris hypotension syndrome

This medication should be stored in a sealed container to prevent exposure to air and light, and it is advisable to keep it refrigerated at a temperature between 2 and 8 degrees Celsius. This helps maintain the medication's efficacy over time.

Appearance

A white to light gray opaque solid under refrigerated conditions, and a white to light gray opaque suspension in a colorless and transparent prefilled syringe at room temperature, intended for slow-release injection.

Package unit

1 prefilled syringe/box [prefilled syringe (50mg/0.14mL)] - 50mg/prefilled syringe [prefilled syringe (50mg/0.14mL)]