Medication info
Ripendon Tablet 2 mg (Risperidone)

Ripendon Tablet 2 mg (Risperidone)

Prescription medicationTabletOral
Ingredient · strength
Risperidone›2mg / 1 tablet
Manufacturer / importer
Poonglim Pharmaceutical Co., Ltd.
Appearance
Pale orange, oblong film-coated tablet
Packaging
30 tablets/bottle, 300 tablets/bottle
Approval status
Active

MFDS item code 202002353 · Approved 2020.04.03 · Insurance code 649002330

Summary

Main use
Treatment of psychiatric disorders (schizophrenia and mania), behavioral and psychological symptoms of dementia, and disruptive behavior disorders
Who takes it
Adults · Children
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; once it disintegrates within a few seconds, swallow it with or without water (for orally disintegrating tablets only). Initial dose for adults with schizophrenia: Administer risperidone 1 mg per dose orally twice daily and increase the dose gradually. Maintenance dose for adults with schizophrenia: Administer 1∼3 mg per dose twice daily. Adjust as appropriate according to age and symptoms. No additional benefit was observed with doses of 10 mg or more daily compared with lower doses, and the risk of extrapyramidal symptoms may increase. Doses of 10 mg or more daily should be administered only when the benefits to the individual patient are judged to outweigh the risks. Do not administer doses of 16 mg or more daily, as safety has not been established. A benzodiazepine may be administered concomitantly if additional sedation is needed. Older adults and patients predisposed to hypotension: The initial dose is 0.5 mg per dose twice daily. Depending on the patient's condition, increase by 0.5 mg per dose twice daily until a dose of 1~2 mg per dose twice daily is reached. In general, increases to doses of 1.5 mg or more per dose twice daily should be made at intervals of at least 1 week. Switching from another antipsychotic to this medicine: When medically appropriate, start treatment with this medicine while gradually reducing the dose of the existing medicine. Also, when switching from an existing depot antipsychotic, if medically appropriate, start this medicine in place of the next scheduled injection of the depot formulation. The need to continue concomitant antiparkinsonian medication should be reassessed regularly. Agitation, aggression, or psychotic symptoms in patients with dementia of the Alzheimer type: The initial dose is 0.25 mg per dose twice daily. If necessary, depending on the patient, the dose may be increased by 0.25 mg per dose twice daily at intervals of at least 2 days. The optimal dose for most patients is 0.5 mg per dose twice daily, although the dose may be increased to 1 mg per dose twice daily depending on the patient. Once the patient reaches the optimal dose, once-daily administration may also be considered. As with symptomatic treatment, the rationale for continued use of this medicine should be evaluated. Adjunctive treatment of mania in bipolar disorder: An initial dose of 2 mg once daily is recommended. Depending on the patient, the dose may be increased by 1 mg daily at intervals of at least 24 hours. The optimal dose for most patients is within the range of 2∼6 mg daily. As with symptomatic treatment, the rationale for continued use of this medicine should be evaluated. Renal and hepatic impairment: In 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
Schizophrenia: There is limited clinical experience in children and adolescents under 15 years of age. Adjunctive treatment of mania in bipolar disorder: There is limited clinical experience in children and adolescents under 15 years of age. Disruptive behavior disorders and other disruptive behavior disorders, body weight 50 kg or more: The initial dose is 0.5 mg of this medicine once daily. If necessary, depending on the patient, the dose may be increased by 0.5 mg daily at intervals of at least 2 days. The optimal dose for most patients is 1 mg once daily. Depending on the patient, 0.5∼1.5 mg may be administered once daily. Disruptive behavior disorders and other disruptive behavior disorders, body weight less than 50 kg: The initial dose is 0.25 mg once daily. If necessary, depending on the patient, the dose may be increased by 0.25 mg daily at intervals of at least 2 days. The optimal dose for most patients is 0.5 mg once daily. Depending on the patient, 0.25∼0.75 mg may be administered once daily. Disruptive behavior disorders and other disruptive behavior disorders: There is limited clinical experience in children under 5 years of age.

Ingredients

Manufacturer
Poonglim Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of psychiatric disorders (schizophrenia and mania), behavioral and psychological symptoms of dementia, and disruptive behavior disorders

  • Schizophrenia
  • agitation
  • aggression
  • psychotic symptoms
  • manic episodes
  • disruptive behavior
  • aggression
  • impulsivity
  • self-harm behavior
  • behavioral disorders
View approved original text

This medication helps alleviate symptoms in patients with schizophrenia. It is also used for short-term treatment in moderate to severe Alzheimer's type dementia patients who exhibit agitation, aggression, or psychotic symptoms. It can be used alongside mood stabilizers for the treatment of manic episodes in bipolar disorder. Additionally, it is effective for the control of aggression, impulsivity, and self-harming behaviors in children, adolescents, and adults with behavioral disorders or conduct disorders. This drug is widely used to improve various psychiatric symptoms.

How to take

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; once it disintegrates within a few seconds, swallow it with or without water (for orally disintegrating tablets only). Initial dose for adults with schizophrenia: Administer risperidone 1 mg per dose orally twice daily and increase the dose gradually. Maintenance dose for adults with schizophrenia: Administer 1∼3 mg per dose twice daily. Adjust as appropriate according to age and symptoms. No additional benefit was observed with doses of 10 mg or more daily compared with lower doses, and the risk of extrapyramidal symptoms may increase. Doses of 10 mg or more daily should be administered only when the benefits to the individual patient are judged to outweigh the risks. Do not administer doses of 16 mg or more daily, as safety has not been established. A benzodiazepine may be administered concomitantly if additional sedation is needed. Older adults and patients predisposed to hypotension: The initial dose is 0.5 mg per dose twice daily. Depending on the patient's condition, increase by 0.5 mg per dose twice daily until a dose of 1~2 mg per dose twice daily is reached. In general, increases to doses of 1.5 mg or more per dose twice daily should be made at intervals of at least 1 week. Switching from another antipsychotic to this medicine: When medically appropriate, start treatment with this medicine while gradually reducing the dose of the existing medicine. Also, when switching from an existing depot antipsychotic, if medically appropriate, start this medicine in place of the next scheduled injection of the depot formulation. The need to continue concomitant antiparkinsonian medication should be reassessed regularly. Agitation, aggression, or psychotic symptoms in patients with dementia of the Alzheimer type: The initial dose is 0.25 mg per dose twice daily. If necessary, depending on the patient, the dose may be increased by 0.25 mg per dose twice daily at intervals of at least 2 days. The optimal dose for most patients is 0.5 mg per dose twice daily, although the dose may be increased to 1 mg per dose twice daily depending on the patient. Once the patient reaches the optimal dose, once-daily administration may also be considered. As with symptomatic treatment, the rationale for continued use of this medicine should be evaluated. Adjunctive treatment of mania in bipolar disorder: An initial dose of 2 mg once daily is recommended. Depending on the patient, the dose may be increased by 1 mg daily at intervals of at least 24 hours. The optimal dose for most patients is within the range of 2∼6 mg daily. As with symptomatic treatment, the rationale for continued use of this medicine should be evaluated. Renal and hepatic impairment: In 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

Schizophrenia: There is limited clinical experience in children and adolescents under 15 years of age. Adjunctive treatment of mania in bipolar disorder: There is limited clinical experience in children and adolescents under 15 years of age. Disruptive behavior disorders and other disruptive behavior disorders, body weight 50 kg or more: The initial dose is 0.5 mg of this medicine once daily. If necessary, depending on the patient, the dose may be increased by 0.5 mg daily at intervals of at least 2 days. The optimal dose for most patients is 1 mg once daily. Depending on the patient, 0.5∼1.5 mg may be administered once daily. Disruptive behavior disorders and other disruptive behavior disorders, body weight less than 50 kg: The initial dose is 0.25 mg once daily. If necessary, depending on the patient, the dose may be increased by 0.25 mg daily at intervals of at least 2 days. The optimal dose for most patients is 0.5 mg once daily. Depending on the patient, 0.25∼0.75 mg may be administered once daily. Disruptive behavior disorders and other disruptive behavior disorders: There is limited clinical experience in children under 5 years of age.

Precautions

Caution is needed when administering this medication to elderly patients with dementia, as it may increase mortality rates. Particularly, combining this drug with certain diuretics like furosemide may heighten the risk of death, so the risks and benefits should be carefully considered before combination treatment. This medication may increase the risk of venous thrombosis, so thromboembolic risk factors should be checked and preventive measures should be taken before and during administration. Additionally, the drug contains the artificial sweetener aspartame, which requires caution in patients with phenylketonuria. Patients with hypersensitivity to this medication, those in a comatose state, users of alcohol or central nervous system depressants that suppress the CNS, those using epinephrine, and patients with lactose intolerance should not take this medication. Patients with cardiovascular disease or liver/kidney dysfunction should use this medication cautiously, and particularly those with a history of hypotension or arrhythmia should have their dosage carefully adjusted. Women who are pregnant or breastfeeding should use this medication very cautiously due to potential effects on the fetus and newborn, with recommendations to cease breastfeeding if using the drug. This medication may cause drowsiness, dizziness, and hypotension, so activities requiring alertness, such as driving or operating machinery, should be avoided during treatment. Furthermore, this medication may induce metabolic abnormalities such as weight gain, increased blood sugar levels, and aggravated diabetes, thus regular monitoring of blood sugar and weight is important. Overdose can result in severe side effects requiring immediate medical assistance, as there is no antidote for this drug, so appropriate treatment based on symptoms is necessary. This medication may interact with other central nervous system depressants, antihypertensives, or drugs that prolong the QT interval, so it's essential to discuss any concomitant medications with a physician. Finally, store out of reach of children, take immediately after opening the package, and avoid mixing with tea or cola.

Side effects

Increased mortality, stroke, transient ischemic attack, venous thrombosis, rhinitis, upper respiratory infection, sinusitis, urinary tract infection, anemia, hypersensitivity reaction, insomnia, anxiety, nervous irritability, Parkinsonism, akathisia, drowsiness, dizziness, sedation, tremor, muscle rigidity, hypersomnia, orthostatic dizziness, motor disorders, syncope, blurry vision, ear pain, 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, ejaculatory failure, fatigue, weakness, fever, chest pain, increased blood creatinine phosphokinase, increased heart rate, pneumonia, soft tissue infection, decreased appetite, confusion, transient ischemic attack, decreased level of consciousness, drooling, cerebrovascular accident, conjunctivitis, hypotension, cough, rhinorrhea, dysphagia, fecal impaction, erythema, abnormal posture, joint swelling, peripheral edema, gait disturbance, pituitary edema, increased body temperature, rhinitis, influenza, increased appetite, moderate insomnia, lethargy, headache, stuttering, attention deficit, equilibrium disorder, excessive sleep, palpitations, oropharyngeal pain, pulmonary congestion, itching, acne, myalgia, neck pain, nocturia, increased urinary frequency, galactorrhea, emotional disturbances, lethargy, chest discomfort, weight gain, increased blood prolactin, restlessness, diminished affect, sleep disturbances, decreased libido, sexual dysfunction, depression, nightmares, unresponsiveness to stimuli, cooperation abnormalities, loss of consciousness, speech disorders, sensory loss, movement disorders, widespread movement disorders, cerebral ischemia, cerebrovascular accident dysfunction, neuroleptic malignant syndrome, diabetic coma, head tremors, seizures, psychomotor hyperactivity, delayed movement disorders, cerebrovascular disorders, sensory disturbances, eye congestion, eye discharge, eye rolling, eyelid edema, photophobia, eyelid crusts, dry eyes, increased tearing, glare, glaucoma, decreased vision, tinnitus, vertigo, bradycardia, tachycardia, palpitations, I-degree atrioventricular block, left bundle branch block, right bundle branch block, heart block, flushing, conduction disorders, abnormal electrocardiogram, prolonged QT interval in electrocardiogram, inferior vena cava, bradycardia, wheezing, aspiration pneumonia, voice disorders, wet cough, airway congestion, wheezing sounds, respiratory disorders, nasal swelling, hyperventilation, fecal incontinence, gastritis, lip swelling, cheilitis, salivary deficiency, abdominal distension, gastroenteritis, tongue swelling, tooth pain, skin discoloration, skin lesions, skin disorders, erythematous rash, papular rash, generalized rash, annular papular rash, eczema, musculoskeletal chest pain, joint stiffness, muscle weakness, rhabdomyolysis, urination disorders, amenorrhea, gynecomastia, vaginal discharge, erectile dysfunction, ejaculatory disorders, menstrual disorders, breast engorgement, sexual dysfunction, retrograde ejaculation, breast discharge, thirst, influenza-like syndrome, edema, malaise, facial swelling, discomfort, generalized edema, chills, peripheral coldness, drug withdrawal syndrome, adverse drug reactions, decreased body temperature, procedural-related pain, increased ALT, abnormal electrocardiogram, increased eosinophil count, increased AST, decreased white blood cell count, increased blood glucose, decreased hemoglobin, decreased hematocrit, decreased body temperature, decreased blood pressure, increased transaminases, increased gamma-glutamyltransferase, increased liver enzymes, agranulocytosis, thrombocytopenia, abnormal secretion of antidiuretic hormone, diabetic ketoacidosis, diabetes, hypoglycemia, water intoxication, increased blood cholesterol levels, increased blood triglycerides, mania, taste disturbances, intraoperative iris tension decrease syndrome, atrial fibrillation, deep vein thrombosis, pulmonary embolism, sleep apnea syndrome, intestinal obstruction, pancreatitis, jaundice, vascular edema, hair loss, neonatal drug withdrawal syndrome, urinary retention, persistent erection, hypothermia, prolonged QT interval in electrocardiogram, restlessness, insomnia, akathisia, movement disorders, muscle rigidity, Parkinsonism, hypertension, musculoskeletal pain, gait abnormalities, edema, pain, falls, suicide attempts, accident abnormalities, delusions, hallucinations, exacerbation of auditory hallucinations, delayed chorea, neuroleptic malignant syndrome exacerbation, extrapyramidal symptom exacerbation, hyperglycemia, worsening of diabetes, weight gain, orthostatic hypotension, syncope, decreased deep body temperature, drug withdrawal syndrome, persistent erection

Not everyone experiences these, and they can vary from person to person.

Storage

This medication may be sensitive to air or moisture, so it should be stored in a tightly sealed container. The recommended storage temperature is between 1°C and 30°C. Proper storage will help maintain the medication's efficacy for a longer period.

Appearance and packaging

Appearance

Pale orange, oblong film-coated tablet

Package unit

30 tablets/bottle, 300 tablets/bottle

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.