Ujedivone M Injection 75 milligrams (Risperidone)

Adult dose

1. Adults: For patients who have not previously received risperidone, establish tolerability with oral risperidone before administering this drug. This drug 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. Instructions for Use.”) In patients receiving a stable dose of oral risperidone, initiate this drug when switching; administer this drug once every 1 month, starting the day after the last oral dose. • Switching from oral risperidone For instructions on switching from oral risperidone to this drug, see Table 1 below. A loading dose or additional oral risperidone is not recommended when switching. Switching to this drug 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 drug Previous treatment (daily dose of oral risperidone) 2mg → Dose of this drug (administered once every 1 month) 50mg Previous treatment (daily dose of oral risperidone) 3mg → Dose of this drug (administered once every 1 month) 75mg Previous treatment (daily dose of oral risperidone) 4mg → Dose of this drug (administered once every 1 month) 100mg Previous treatment (daily dose of oral risperidone) 5mg → Dose of this drug (administered once every 1 month) 125mg • Switching from a long-acting injectable risperidone product Patients may be switched between this drug and the risperidone injection administered once every 2 months (see Table 2). In this case, administer the first dose of the new regimen on the date the next dose of the original regimen was scheduled. Adjust the dosing schedule to reflect the change. Table 2. Switching doses between this drug and the risperidone injection administered once every 2 months Dose of this drug (administered once every 1 month) 75mg → Dose of Yujedito M Injection (risperidone) (administered once every 2 months) 150mg Dose of this drug (administered once every 1 month) 100mg → Dose of Yujedito M Injection (risperidone) (administered once every 2 months) 200mg Dose of this drug (administered once every 1 month) 125mg → Dose of Yujedito M 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 scheduled date for the 1-month dose; however, the safety and efficacy of administration more than 1 week outside this interval have not been established. 2. Patients with renal or hepatic impairment This drug has not been studied in patients with renal or hepatic impairment. Before initiating this drug in patients with renal or hepatic impairment, titrate oral risperidone to at least 2 mg once daily. Based on clinical response and tolerability following oral titration, administration of 50 mg of this drug once every 1 month is recommended. 3. Dosage adjustment when coadministered with strong CYP2D6 inhibitors and strong CYP3A4 inducers [See Precautions for Use, “6. Interactions.”] 1) Concomitant use with strong CYP2D6 inhibitors When initiating a strong CYP2D6 inhibitor (e.g., fluoxetine or paroxetine) in patients receiving this drug, plasma risperidone concentrations may increase; therefore, administration of a lower dose of this drug is recommended before concomitant use of a CYP2D6 inhibitor. When initiating a strong CYP2D6 inhibitor in patients receiving the lowest dose of this drug (50mg once every 1 month), 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 initiating treatment with a strong CYP3A4 inducer (e.g., carbamazepine), closely monitor the patient, as dosage adjustment of this drug may be necessary during the first 4~8 weeks. For patients receiving a particular dose of this drug, consider increasing the dose by one dose level. In patients receiving 125 mg of this drug once every 1 month, additional 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 drug and any additional oral risperidone, and reduce the dose of this drug if necessary. For patients receiving 50mg of this drug once every 1 month, continue treatment at that dose unless discontinuation of treatment is considered clinically necessary.

This medication may increase the risk of death when used in elderly patients with dementia-related psychosis, and is not recommended for treating dementia-related psychosis. Risk factors for venous thromboembolism must be checked before administering this drug, and necessary preventive measures should be taken. Patients allergic to risperidone or any components of this drug should not be administered this medication as hypersensitivity reactions may occur. Patients with cardiovascular disease, cerebrovascular disease, hypotension, renal or liver dysfunction, and a history of seizures should use this drug with caution. Pregnant or breastfeeding women as well as those who could become pregnant should consult with healthcare providers before using this medication. This medication can cause side effects such as drowsiness, dizziness, weight gain, gastrointestinal disturbances, muscle spasms. Patients should report any unusual symptoms immediately. Local reactions such as pain or itching at the injection site may occur, so caution is needed. This medication affects the central nervous system and may impair judgment and motor function; caution is advised when driving or operating hazardous machinery. In case of overdose, symptoms such as hypotension, sedation, heart rate changes, and seizures may occur; urgent medical attention is required. This medication should only be administered subcutaneously by healthcare professionals, as other routes of administration may be dangerous. Interactions may occur when this drug is combined with other medications, so patients should inform healthcare providers of any other medications they are taking. Regular monitoring of blood glucose, lipids, blood pressure, and blood tests should be performed during treatment to check for abnormalities. This medication may cause serious side effects such as neuroleptic malignant syndrome, tardive dyskinesia, and hyperprolactinemia, and patients must consult healthcare providers immediately if symptoms occur. Elderly patients may require dosage adjustment and monitoring due to potential renal function decline. Newborns exposed to this medication during pregnancy may exhibit extrapyramidal symptoms and withdrawal symptoms, necessitating close observation of the newborn's condition.

Increased mortality, heart failure, sudden death, pneumonia, anaphylactic reactions, angioedema, Parkinsonism, akathisia, muscle tension disorders, tremors, sedation, dizziness, anxiety, blurred vision, nausea, vomiting, upper abdominal pain, gastric discomfort, dyspepsia, diarrhea, hypersalivation, constipation, dry mouth, increased appetite, weight gain, fatigue, rash, nasal congestion, upper respiratory infections, nasopharyngitis, oropharyngeal pain, tachycardia, chest pain, weakness, epistaxis, dry skin, orthostatic hypotension, back pain, arthralgia, limb pain, increased serum creatine phosphokinase, increased heart rate, nasopharyngitis, upper respiratory infections, sinusitis, urinary tract infections, increased serum creatine phosphokinase, sinus bradycardia, sinus tachycardia, first-degree atrioventricular block, left bundle branch block, right bundle branch block, complete heart block, ear pain, tinnitus, hyperprolactinemia, conjunctival hyperemia, eye discharge, conjunctivitis, eye rotation, eyelid edema, eye swelling, eyelid crusting, dry eyes, increased tear secretion, photophobia, glaucoma, vision impairment, dysphagia, fecal incontinence, gastritis, lip edema, cheilitis, xerostomia, peripheral edema, thirst, walking difficulties, chest discomfort, chest pain, influenza-like illness, pitting edema, edema, chills, lethargy, malaise, facial edema, discomfort, generalized edema, drug withdrawal syndrome, peripheral coldness, strange sensations, drug hypersensitivity, pneumonia, influenza, ear infections, viral infections, pharyngitis, tonsillitis, bronchitis, eye infections, localized infections, cystitis, soft tissue infections, otitis media, onychomycosis, distal dermatitis, bronchopneumonia, respiratory infections, tracheobronchitis, chronic otitis media, increased body temperature, increased serum prolactin, increased alanine aminotransferase, electrocardiogram abnormalities, increased eosinophils, decreased white blood cells, increased blood glucose, decreased hemoglobin, decreased hematocrit, decreased body temperature, decreased blood pressure, increased aminotransferases, decreased appetite, paroxysmal dyskinesia, loss of appetite, joint swelling, joint stiffness, musculoskeletal chest pain, postural abnormalities, myalgia, neck pain, muscle weakness, muscle rigidity, rhabdomyolysis, balance disorders, attention deficits, speech disorders, unresponsiveness to stimuli, decreased level of consciousness, movement disorders, transient ischemic attacks, coordination abnormalities, cerebrovascular accidents, language impairment, syncope, loss of consciousness, sensory deficits, delayed motor dyskinesia, cerebral ischemia, cerebrovascular disorders, neuroleptic malignant syndrome, diabetic coma, head tremors, restlessness, blunted affect, confusional state, middle-of-the-night insomnia, neurosensitivity, sleep disorders, apathy, decreased libido, paraphilia, nocturia, dysuria, frequent urination, urinary incontinence, menstrual irregularities, amenorrhea, gynecomastia in males, urinary incontinence, 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, tracheobronchitis, breathing difficulties, respiration, nasal swelling, erythema, skin discoloration, skin lesions, pruritus, skin disorders, erythematous rash, papular rash, acne, hyperkeratosis, seborrheic dermatitis, generalized rash, maculopapular rash, hypotension, flushing, hair loss, anaphylactic reactions, angioedema, atrial fibrillation, cardiac arrest, tension disorders, glucose metabolism disorders, diabetic ketoacidosis, taste disorders, hypoglycemia, hypothermia, bowel obstruction, inappropriate antidiuretic hormone secretion, 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 retention, water intoxication, neuroleptic malignant syndrome, delayed motor dyskinesia, hyperglycemia, dyslipidemia, weight gain, hyperprolactinemia, orthostatic hypotension, syncope, drowsiness, seizures, aspiration pneumonia, priapism, hyperthermia, hypothermia, injection site nodules, pruritus, erythema, tumors, edema

This medication should be stored in a sealed container to protect it from air and light, and kept at refrigeration temperatures between 2 degrees and 8 degrees Celsius. Proper storage can help maintain the drug's effectiveness over time.

Appearance

An opaque solid that is white to light gray under refrigerated conditions, and an opaque suspension that is white to light gray in a colorless and transparent prefilled syringe at room temperature.

Package unit

1 prefilled syringe/box [prefilled syringe (75mg/0.21mL)] - 75 milligrams/prefilled syringe [prefilled syringe (75mg/0.21mL)]