Rispen Tablet 0.5 mg (Risperidone)

Adult dose

The therapeutic dose of this medicine should be adjusted according to the patient's clinical condition, and the lowest effective dose possible should be administered. Place this medicine on the tongue and, once it disintegrates within a few seconds, swallow it with or without water (for orally disintegrating tablets only). 1. Schizophrenia 1) Adults (1) Initial dose: Administer 1 mg of risperidone orally twice daily and increase the dose gradually. (2) Maintenance dose: Administer 1∼3 mg twice daily. Adjust the dose appropriately according to the patient's age and symptoms. (3) No additional benefit was observed with doses of 10 mg or more per day compared with lower doses, and such doses 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 their safety has not been established. (5) A benzodiazepine may be administered concomitantly if additional sedation is required. 2) Dosing 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 a dose of 1～2 mg twice daily is reached. 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 an existing antipsychotic to this medicine When medically appropriate, start treatment with this medicine while gradually reducing the dose of the existing medicine. Also, when medically appropriate, when switching from an existing depot antipsychotic, start treatment with this medicine in place of the next scheduled depot injection. The need to continue concomitant antiparkinsonian medication should be reassessed regularly. 2. Agitation, aggression, or psychotic symptoms in patients with dementia of the Alzheimer type The initial dose is 0.25 mg of this medicine twice daily. If necessary for 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 has reached the optimal dose, once-daily dosing may also be considered. As with symptomatic treatment, the rationale for continued use of this medicine should be evaluated. 3. Adjunctive treatment of mania in bipolar disorder ⦁ The recommended initial dose is 2 mg of this medicine once daily. Depending on the patient, the dose may be increased by 1 mg per day at intervals of 24 hours or more. The optimal dose for most patients is in the range of 2∼6 mg per day. As with symptomatic treatment, the rationale for continued use of this medicine should be evaluated. Renal and hepatic impairment For patients with renal or hepatic impairment, administer half the initial and maintenance doses and adjust the dose more gradually. Use this medicine with caution in these patients (see 5. General Precautions).

Child dose

⦁ Clinical experience in children and adolescents under 15 years of age is limited. ⦁ Clinical experience in children and adolescents under 15 years of age is limited. - Body weight 50 kg or more: The initial dose is 0.5 mg of this drug once daily. If necessary, the dose may be increased by 0.5 mg per day at intervals of at least 2 days, depending on the patient. For most patients, the optimal dose 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, the dose may be increased by 0.25 mg per day at intervals of at least 2 days, depending on the patient. For most patients, the optimal dose is 0.5 mg once daily. Depending on the patient, 0.25∼0.75 mg may be administered once daily. ⦁ Clinical experience in children under 5 years of age is limited.

Caution is required when administering this drug to elderly dementia patients as it may increase mortality rates. In particular, the co-administration of this drug and a diuretic called furosemide may further elevate the risk of death, warranting careful judgment before combined use. Furthermore, this drug may increase the risk of venous thrombosis, so patients with thrombotic risk factors should verify this before use and take preventive measures. This medication contains the artificial sweetener aspartame, which patients with certain genetic disorders like phenylketonuria must disclose before taking. This medication should not be administered to patients with specific allergies or hypersensitivities, patients in a state of central nervous system depression, comatose patients, patients receiving epinephrine, and patients with lactose intolerance. Caution should also be exercised for patients with cardiovascular diseases, impaired liver or kidney function, a history of seizures, patients at risk of suicide, patients with Parkinson's disease, diabetes, elderly patients, and pregnant or breastfeeding women. Various side effects such as drowsiness, dizziness, orthostatic hypotension, insomnia, anxiety, Parkinsonism, nausea, constipation, and weight gain may occur, necessitating close observation of symptoms during treatment. In particular, due to the central nervous system suppressive effects of this medication, caution should be taken when used with alcohol or other sedatives as CNS suppression may be exacerbated. Pregnant or breastfeeding women must consult a physician when taking this medication as it may affect the fetus or newborn. It is advisable to avoid activities requiring concentration, such as driving or operating machinery, while taking this medication. In case of overdose, immediate medical attention should be sought as there is no antidote for this medication, and supportive care based on symptoms will be necessary. Finally, this medication should be stored out of reach of children, not transferred to other containers, and taken immediately after opening for safety purposes.

Increased mortality, cerebrovascular adverse reactions, venous thrombosis, rhinitis, upper respiratory infection, sinusitis, urinary tract infection, anemia, hypersensitivity, insomnia, anxiety, nervousness, Parkinson's disease, inability to sit still, drowsiness, dizziness, sedation, tremor, muscle spasticity, excessive somnolence, orthostatic dizziness, abnormal movements, syncope, blurred vision, earache, orthostatic hypotension, tachycardia, hypotension, nasal congestion, dyspnea, epistaxis, sinus congestion, nausea, constipation, dyspepsia, vomiting, diarrhea, excessive salivation, dry mouth, abdominal discomfort, abdominal pain, gastrointestinal discomfort, epigastric pain, rash, dry skin, dandruff, seborrheic dermatitis, hyperkeratosis, back pain, arthralgia, limb pain, urinary incontinence, ejaculation failure, fatigue, asthenia, fever, chest pain, elevated serum creatinine phosphokinase, increased heart rate, pneumonia, soft tissue infection, reduced appetite, confusion, transient ischemic attack, decreased consciousness, drooling, cerebrovascular accident, conjunctivitis, hypotension, cough, runny nose, dysphagia, stool mass, erythema, abnormal posture, joint swelling, peripheral edema, gait disturbance, pituitary edema, elevated temperature, rhinitis, influenza, increased appetite, mid-stage insomnia, fatigue, headache, stuttering, attention deficit, balance disorders, hypersomnia, palpitations, oropharyngeal pain, pulmonary congestion, itching, acne, myalgia, neck pain, nocturia, polyuria, galactorrhea, mood disturbances, lethargy, chest discomfort, weight gain, elevated blood prolactin, anxiety, flattened affect, sleep disorders, decreased libido, sexual dysfunction, depression, nightmares, unresponsiveness to stimuli, cooperation abnormalities, loss of consciousness, speech impairment, sensory loss, movement disorders, generalized hyperkinesia, cerebral ischemia, cerebrovascular accident disorder, neuroleptic malignant syndrome, diabetic coma, head tremors, convulsions, psychomotor agitation, akathisia, cerebrovascular disorders, sensory disturbances, conjunctival injection, eye discharge, eye movements, eyelid edema, photophobia, crusting of eyelid margins, dry eyes, increased tearing, glare, glaucoma, decreased vision, tinnitus, dizziness, bradycardia, tachycardia, palpitations, I-degree atrioventricular block, left bundle branch block, right bundle branch block, heart block, flushing, conduction disorders, electrocardiogram abnormalities, prolonged QT interval on electrocardiogram, right-sided venous thrombosis, bradycardia, wheezing, aspiration pneumonia, voice disorders, wet cough, airway congestion, crackles, respiratory disorders, nasal cavity edema, hyperventilation, fecal incontinence, gastritis, lip swelling, cheilitis, salivary deficiency syndrome, abdominal distention, gastroenteritis, tongue swelling, dental pain, skin hyperpigmentation, skin lesions, skin disorders, erythematous rash, papular rash, generalized rash, papulopustular rash, eczema, musculoskeletal chest pain, joint stiffness, muscle weakness, rhabdomyolysis, urinary disorders, amenorrhea, gynecomastia, vaginal discharge, erectile dysfunction, ejaculation disorder, menstrual disorders, breast engorgement, sexual function disorder, retrograde ejaculation, breast discharge, thirst, influenza-like syndrome, edema, malaise, facial swelling, discomfort, generalized edema, chills, peripheral coldness, drug withdrawal syndrome, drug adverse reactions, reduced body temperature, procedure-related pain, weight loss, elevated γ-GT, increased liver enzymes, glycosuria, decreased blood pressure, elevated transaminases, increased γ-glutamyltransferase, liver enzyme increase, falls, agranulocytosis, thrombocytopenia, anaphylactic reaction, abnormal secretion of antidiuretic hormone, diabetic ketoacidosis, diabetes, hypoglycemia, water intoxication, mania, altered taste, intraoperative pupil constriction syndrome, atrial fibrillation, deep vein thrombosis, pulmonary embolism, sleep apnea syndrome, intestinal obstruction, pancreatitis, jaundice, angioedema, hair loss, neonatal drug withdrawal syndrome, urinary retention, priapism, hypothermia, chest pain, liver dysfunction, hepatitis, thirst, dry mouth, urinary retention, polyuria, hiccups, increased sweating, leukopenia, arrhythmia, hangover, ocular motor seizures, acne, dysphagia, nocturia, tic disorders, difficulty breathing, Rabbit syndrome, suicidal attempts, abnormal thoughts, delusions, hallucinations, exacerbation of auditory symptoms

This medication may be sensitive to air and moisture, so it should be stored in a tightly closed container. The storage temperature should be maintained between 1 and 30 degrees Celsius. Doing so will help to preserve the medication's efficacy and safety for a longer period.

Appearance

Brownish-red oblong film-coated tablets

Package unit

30 tablets/bottle, 200 tablets/bottle