Epiduron M Injection 100 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 month 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) / Dose of this medicine (administered once every month) 2mg / 50mg 3mg / 75mg 4mg / 100mg 5mg / 125mg • Switching patients receiving a long-acting risperidone injection Patients may be switched between this medicine and a risperidone injection administered once every 2 months (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 2 months Dose of this medicine (administered once every month) / Dose of Yujedi 2M Injection (risperidone) (administered once every 2 months) 75mg / 150mg 100mg / 200mg 125mg / 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 scheduled monthly administration date; however, the safety and efficacy of administration more than 1 week outside this period have not been established. 2. Patients with renal or hepatic impairment This medicine has not been studied in patients with renal or hepatic impairment. Before starting this medicine in patients with renal or hepatic impairment, titrate oral risperidone to at least 2 mg once daily. Based on clinical response and tolerability after oral titration, a dose of 50 mg of this medicine once every month is recommended. 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. If a strong CYP2D6 inhibitor is initiated in a patient receiving the lowest dose of this medicine (50mg once every month), continue treatment at that dose unless treatment discontinuation 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 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 125 mg of this medicine once every month, 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. For patients receiving 50mg of this medicine once every month, continue treatment at that dose unless treatment discontinuation is considered clinically necessary.

This medication is not approved for the treatment of psychosis related to dementia in elderly patients as it may increase the risk of death. It is essential to check for thrombosis risk factors before using this medication, and appropriate venous thromboembolism prevention measures must be taken. Patients with allergies to risperidone or any of the components of this medication should not use it. Use with caution in patients with cardiovascular diseases, cerebrovascular diseases, hypotension, renal or liver dysfunction, history of seizures, Parkinson's disease, or Lewy body dementia, and in pregnant or nursing women. This medication can cause various side effects, such as muscle rigidity, tremors, drowsiness, dizziness, nausea, vomiting, and weight gain. If any unusual symptoms appear, immediate consultation with a healthcare professional is necessary. During treatment, blood glucose and lipid levels should be regularly monitored to detect and manage metabolic abnormalities early. This drug can increase prolactin levels and may affect the reproductive function in both men and women, so related symptoms should be closely observed. There is a risk of hypotension or fainting during treatment, so caution is needed, especially in the elderly. This medication should only be used during pregnancy when necessary due to potential effects on the fetus, and during breastfeeding, any unusual symptoms in the baby should be monitored. Overdose may cause drowsiness, hypotension, increased heart rate, and seizures, necessitating immediate medical attention. This medication must be administered as a subcutaneous injection only by a healthcare professional and should be kept at room temperature before administration. There may be interactions when used with other medications, so it is essential to inform healthcare providers of any concurrent medications, especially when used together with CYP2D6 inhibitors or CYP3A4 inducers, as careful dose adjustments and monitoring may be necessary. This medication may cause drowsiness, so caution is needed when driving or operating dangerous machinery. Severe side effects such as neuroleptic malignant syndrome or tardive dyskinesia may occur during the treatment process, so any emergence of symptoms should be reported immediately to healthcare professionals for appropriate action.

Increased mortality rate, heart failure, sudden death, pneumonia, anaphylactic reactions, angioedema, Parkinsonism, inability to sit still, muscle tone abnormality, tremors, 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, nasal hemorrhage, dry skin, orthostatic hypotension, nasopharyngitis, upper respiratory infection, sinusitis, urinary tract infection, increased serum creatine phosphokinase activity, increased heart rate, back pain, arthralgia, limb pain, insomnia, dyspnea, rash, increased serum creatine phosphokinase activity, sinus bradycardia, sinus tachycardia, first-degree AV block, left bundle branch block, right bundle branch block, AV block, ear pain, tinnitus, hyperprolactinemia, conjunctival hyperemia, ocular discharge, conjunctivitis, eye motility, eyelid edema, eye swelling, eyelid margin crust, dry eyes, increased tear secretion, photophobia, glaucoma, vision deterioration, dysphagia, fecal incontinence, gastritis, lip edema, cheilitis, xerostomia, peripheral edema, thirst, gait disturbance, chest discomfort, influenza-like illness, pit 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 infection, otitis media, onychomycosis, distal dermatitis, bronchopneumonia, respiratory infection, bronchitis, chronic otitis media, increased body temperature, increased serum prolactin, elevated alanine aminotransferase, ECG abnormalities, eosinophilia, leukopenia, increased blood glucose, decreased hemoglobin, decreased hematocrit, decreased body temperature, decreased blood pressure, increased aminotransferase, decreased appetite, next symptoms, appetite loss, joint swelling, joint stiffness, musculoskeletal chest pain, postural abnormalities, myalgia, neck pain, muscle weakness, muscle rigidity, rhabdomyolysis, balance disorders, attention deficits, speech disorders, non-responsiveness to stimuli, decreased level of consciousness, movement disorders, transient ischemic attack, coordination problems, cerebrovascular accident, language impairment, syncope, loss of consciousness, sensory deficit, delayed movement disorders, cerebral ischemia, cerebrovascular disorders, neuroleptic malignant syndrome, diabetic coma, head tremors, agitation, affective flattening, confusion, intermediate insomnia, neurogenic hyperreflexia, sleep disorders, apathy, decreased libido, paraphilia, nocturia, dysuria, increased urination, urinary incontinence, menstrual irregularities, amenorrhea, gynecomastia in males, hypergalactorrhea, vaginal discharge, menstrual disorders, erectile dysfunction, retrograde ejaculation, ejaculation disorders, sexual dysfunction, breast enlargement, wheezing, aspiration pneumonia, sinus congestion, vocal disorders, productive cough, pulmonary congestion, respiratory congestion, bronchitis, respiratory distress, breathing, nasal edema, erythema, skin discoloration, skin lesions, pruritus, skin disorders, erythematous rash, papular rash, acne, excessive keratinization, seborrheic dermatitis, generalized rash, maculopapular rash, hypotension, flushing, drowsiness, fainting, seizures, persistent erection, hyperthermia, hypothermia, neuroleptic malignant syndrome, delayed movement disorders, hair loss, atrial fibrillation, cardiac arrest, tension, glucose metabolism disorder, diabetic ketoacidosis, dysgeusia, hypoglycemia, 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 retention, water intoxication

This medication should be stored in a sealed container to protect it from air and light, at a temperature maintaining refrigeration between 2 degrees and 8 degrees Celsius. Storing it this way helps preserve the medication's efficacy for a longer time.

Appearance

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

Package unit

1 prefilled syringe/box [Prefilled syringe (100mg/0.28mL)] - 100 milligrams/prefilled syringe [Prefilled syringe (100mg/0.28mL)]