Ujedito M Injection 200 Milligrams (Risperidone)

Adult dose

1. Adults: For patients who have never received risperidone, establish tolerability with oral risperidone before administering this medicine. This medicine 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 Precautions for Use, “9. Precautions for Administration.”) When switching patients receiving a stabilized dose of oral risperidone to this medicine, start treatment by administering this medicine once every 2 months on the day after the last oral dose. • Switching patients receiving oral risperidone See Table 1 below for how to switch from oral risperidone to this medicine. A loading dose or additional oral risperidone is not recommended when switching. Switching to this medicine has not been studied in patients previously treated with an oral risperidone daily dose exceeding 5mg. Table 1. Recommended doses when switching from daily oral risperidone to this medicine Previous treatment (daily oral risperidone dose) 3mg → Dose of this medicine (administered once every 2 months) 150mg Previous treatment (daily oral risperidone dose) 4mg → Dose of this medicine (administered once every 2 months) 200mg Previous treatment (daily oral risperidone dose) 5mg → Dose of this medicine (administered once every 2 months) 250mg • Switching patients receiving a long-acting risperidone injection Patients may be switched between this medicine and a risperidone injection administered once every month (see Table 2). 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 medicine and a risperidone injection administered once every month Dose of Yujedi 1M Injection (administered once every month) 75mg → Dose of this medicine (administered once every 2 months) 150mg Dose of Yujedi 1M Injection (administered once every month) 100mg → Dose of this medicine (administered once every 2 months) 200mg Dose of Yujedi 1M Injection (administered once every month) 125mg → Dose of this medicine (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 schedule. It may be administered within 1 week before or after the last administration date; however, the safety and efficacy of administration more than 1 week outside this period have not been established. 2. Dose adjustment in patients with renal or hepatic impairment This medicine has not been studied in patients with renal or hepatic impairment. 3. Dose adjustment with concomitant use of strong CYP2D6 inhibitors and strong CYP3A4 inducers [See Precautions for Use 6. Drug Interactions] 1) Concomitant use with strong CYP2D6 inhibitors If a strong CYP2D6 inhibitor (e.g., fluoxetine or paroxetine) is initiated in a patient receiving this medicine, risperidone plasma concentrations may increase; therefore, administration of a lower dose of this medicine is recommended before concomitant use of a CYP2D6 inhibitor. 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 initiated, closely monitor the patient, as dose adjustment of this medicine may be necessary during the first 4~8 weeks. For patients receiving a particular dose of this medicine, consider increasing the dose by one dose level. For patients receiving 250 mg of this medicine once every 2 months, additional oral risperidone may be considered. If treatment with a strong CYP3A4 inducer is discontinued, risperidone plasma concentrations may increase; therefore, reassess the dose of this medicine and any additional oral risperidone dose, and reduce the dose of this medicine if necessary.

This medication may increase the risk of death in elderly patients with dementia-related psychosis, therefore caution is warranted. Particularly, the risk is higher due to cardiovascular disease or infections, so it is advisable not to administer this medication to such patients. This medication can increase the risk of venous thromboembolism, and risk factors for thrombosis should be confirmed and managed beforehand. Patients with hypersensitivity to risperidone or any component of this medication should not use it, as hypersensitivity reactions may occur. It should be administered with caution in patients with cardiovascular diseases, cerebrovascular diseases, renal or liver impairment, and those with a history of seizures. Elderly patients, as well as those with Parkinson’s disease or Lewy body dementia, may also be more sensitive to this medication, hence caution is necessary. Pregnant women, women of childbearing potential, and nursing mothers should carefully assess the potential effects on the fetus and neonate when using this medication. During treatment with this medication, side effects such as drowsiness, dizziness, weight gain, gastrointestinal disturbances, and extrapyramidal symptoms may occur, so symptoms should be closely monitored. Cardiac-related adverse reactions, including changes in electrocardiograms, may occur, hence periodic assessments of cardiac condition are important. Local reactions at the injection site may occur, necessitating monitoring of the site after administration. Serious neurological adverse reactions such as neuroleptic malignant syndrome and tardive dyskinesia may occur, thus immediate discontinuation and treatment is required if symptoms are suspected. Metabolic abnormalities may lead to changes in blood glucose and lipid levels, requiring regular testing and management. There is a risk of reproductive dysfunction and decreased bone density due to hyperprolactinemia, requiring caution with long-term use. Orthostatic hypotension and the risk of syncope necessitate caution, particularly in elderly patients, to reduce the risk of falls. Hematological abnormalities such as leukopenia may occur, so regular blood tests are recommended. This medication may cause drowsiness and impaired judgment, hence caution is advised when driving or operating hazardous machinery. Patients with a history of seizures may experience increased seizure risk when using this medication, thus careful use is necessary. Caution should be exercised when administering this medication to patients with aspiration risk, and priapism and thermoregulation disorders have been reported. Patients scheduled for cataract surgery should inform their physician considering the risk of intraoperative pupillary dilation syndrome. Patients with suicidal risk require close monitoring alongside pharmacotherapy. This medication may interact with other drugs, so dosing adjustments and monitoring are needed, especially when used with CYP2D6 inhibitors or CYP3A4 inducers. Caution is especially warranted when used with central nervous system depressants or alcohol, as side effects such as drowsiness may be intensified. Pregnant and nursing mothers should consider the effects on the fetus and infant during the use of this medication and monitor particularly for extrapyramidal and withdrawal symptoms in neonates. Safety in pediatric patients has not been established, thus use in children is not recommended. Elderly patients require careful dosage adjustment and monitoring due to potential renal function decline. In case of overdose, there is no specific antidote, hence appropriate treatment and support depending on symptoms are necessary. This medication must be administered only as a subcutaneous injection by a healthcare professional and should be kept at room temperature before administration.

Increased mortality, heart failure, sudden death, pneumonia, anaphylactic reactions, angioedema, Parkinsonism, immobility, muscle tone abnormality, tremor, sedation, dizziness, anxiety, blurred vision, nausea, vomiting, upper 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, chest pain, weakness, epistaxis, dry skin, orthostatic hypotension, back pain, arthralgia, limb pain, nasopharyngitis, upper respiratory infection, sinusitis, urinary tract infection, increased blood creatine phosphokinase, increased heart rate, rash, blood and lymphatic system disorders, anemia, granulocytopenia, neutropenia, sinus bradycardia, sinus tachycardia, first-degree atrioventricular block, left bundle branch block, right bundle branch block, heart block, ear pain, tinnitus, hyperprolactinemia, eye congestion, eye discharge, conjunctivitis, eye rotation, eyelid edema, eye swelling, eyelid margin crust, dry eyes, increased tear production, photophobia, glaucoma, decreased vision, dysphagia, fecal impaction, fecal incontinence, gastritis, lip swelling, cheilitis, xerostomia, peripheral edema, thirst, gait disturbance, chest discomfort, influenza-like illness, pituitary edema, edema, chill, lethargy, sense of illness, facial swelling, discomfort, generalized edema, drug withdrawal syndrome, peripheral coldness, strange sensation, drug hypersensitivity, pneumonia, influenza, ear infection, viral infection, pharyngitis, tonsillitis, bronchitis, eye infection, localized infection, cystitis, soft tissue infection, otitis media, onychomycosis, distal dermatitis, bronchopneumonia, respiratory infection, tracheobronchitis, chronic otitis media, increased body temperature, increased serum prolactin, increased alanine aminotransferase, electrocardiogram abnormalities, eosinophilia, leukopenia, increased blood glucose, decreased hemoglobin, decreased hematocrit, decreased body temperature, decreased blood pressure, increased aminotransferase, decreased appetite, nystagmus, anorexia, joint swelling, joint stiffness, musculoskeletal chest pain, abnormal posture, 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 disorders, cerebrovascular accident, language impairment, syncope, loss of consciousness, sensory disturbance, delayed motor hyperactivity, cerebral ischemia, cerebrovascular disorders, neuroleptic malignant syndrome, diabetic coma, head tremor, restlessness, blunted affect, confusion, insomnia, hyperactivity, sleep disorders, apathy, decreased libido, paraphilia, nocturia, dysuria, frequent urination, urinary incontinence, irregular menstruation, amenorrhea, gynecomastia in males, urinary urgency, vaginal discharge, menstrual disorders, erectile dysfunction, retrograde ejaculation, ejaculation disorders, sexual dysfunction, breast hypertrophy, wheezing, aspiration pneumonia, sinus congestion, voice disorders, productive cough, pulmonary congestion, respiratory congestion, wheezing, respiratory distress, respiratory failure, nasal edema, erythema, skin discoloration, skin lesions, pruritus, skin disorders, erythematous rash, papular rash, acne, hyperkeratosis, seborrheic dermatitis, generalized rash, maculopapular rash, hypotension, flushing, dizziness, nausea, vomiting, drowsiness, agitation, abdominal pain, persistent erection, high fever, muscle rigidity, delirium, autonomic instability, sweating, cardiac rhythm disorders, increased creatine phosphokinase, myoglobinuria, acute renal failure, hair loss, atrial fibrillation, cardiopulmonary arrest, tension, glucose metabolism disorder, diabetic ketoacidosis, taste disturbance, hypoglycemia, hypothermia, bowel obstruction, inappropriate secretion of antidiuretic hormone, intestinal 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 stasis, water intoxication, convulsions, hyponatremia, hypokalemia, QT prolongation, QRS widening, seizures, drowsiness, sedation, tachycardia, hypotension, extrapyramidal symptoms

This medication should be stored in a sealed container to avoid exposure to air, protected from light, and refrigerated between 2 to 8 degrees Celsius. Proper storage will maintain the efficacy of the medication and prevent deterioration.

Appearance

An opaque solid that is white to light gray under refrigeration, and a white to light gray opaque suspension contained in a colorless clear prefilled syringe at room temperature, designed as a prolonged-release injection.

Package unit

1 prefilled syringe/box [prefilled syringe (200mg/0.56mL)] - 200 milligrams/prefilled syringe [prefilled syringe (200mg/0.56mL)]