Medication info
Respiridone 2 mg Tablet

Respiridone 2 mg Tablet

Prescription medicationTabletOral
Ingredient · strength
Risperidone›2mg / 1 tablet
Manufacturer / importer
Myungin Pharmaceutical Co., Ltd.
Appearance
Pale orange, elongated film-coated tablet
Packaging
30 tablets/bottle, 200 tablets/bottle
Approval status
Active

MFDS item code 200300918 · Notified 2003.08.02 · Insurance code 651900390

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 drug should be adjusted according to the patient's clinical condition, and the lowest effective dose possible should be administered. Place this drug 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 per dose 2 times daily and increase gradually. (2) Maintenance dose: Administer 1∼3 mg per dose 2 times daily. Adjust as appropriate according to age and symptoms. (3) 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 for the individual patient are judged to outweigh the risks. (4) Do not administer doses of 16 mg or more daily because safety has not been established. (5) A benzodiazepine may be administered concomitantly if additional sedation is needed. 2) Administration in specific populations • Elderly patients and patients predisposed to hypotension The initial dose is 0.5 mg per dose 2 times daily. Depending on the patient's condition, increase by 0.5 mg per dose 2 times daily until the dose is 1~2 mg per dose 2 times daily. In general, increases to doses of 1.5 mg or more per dose 2 times daily should be made at intervals of at least 1 week. 3) Switching from existing antipsychotic medication to this drug When medically appropriate, start treatment with this drug while gradually reducing the dose of the existing medication. Also, when switching from an existing depot antipsychotic medication, when medically appropriate, start this drug in place of the next scheduled depot injection. Regularly reassess whether concomitant antiparkinsonian medication needs to be continued. 2. Agitation, aggression, or psychotic symptoms in patients with dementia of the Alzheimer type The initial dose is 0.25 mg of this drug per dose 2 times daily. If needed, depending on the patient, the dose may be increased by 0.25 mg per dose 2 times daily at intervals of at least 2 days. The optimal dose for most patients is 0.5 mg per dose 2 times daily, but depending on the patient, the dose may be increased to 1 mg per dose 2 times 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 drug should be evaluated. 3. Adjunctive treatment of manic episodes associated with bipolar disorder • The recommended initial dose is 2 mg of this drug once daily. 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 drug 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 drug with caution in these patients (see 5. General Precautions).
Child dose
Schizophrenia: Clinical experience in children and adolescents under 15 years of age is limited. Adjunctive treatment of manic episodes associated with bipolar disorder: 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 needed, 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. Body weight less than 50 kg: The initial dose is 0.25 mg once daily. If needed, 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. Children under 5 years of age: Clinical experience is limited.

Ingredients

Manufacturer
Myungin 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
  • destructive behaviors
  • impulsivity
  • self-harming behaviors
  • behavioral disorders
  • disruptive behavior disorders
View approved original text

This medication is used for the treatment of schizophrenia and helps in the short-term management of agitation, aggression, or psychotic symptoms in patients with moderate to severe Alzheimer's-type dementia. It is also used as an add-on therapy in mood stabilization for manic episodes resulting from bipolar disorder. Additionally, it is used to improve destructive behaviors arising from behavioral disorders or other disruptive behavioral disorders in children, adolescents, and adults.

How to take

Adult dose

The therapeutic dose of this drug should be adjusted according to the patient's clinical condition, and the lowest effective dose possible should be administered. Place this drug 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 per dose 2 times daily and increase gradually. (2) Maintenance dose: Administer 1∼3 mg per dose 2 times daily. Adjust as appropriate according to age and symptoms. (3) 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 for the individual patient are judged to outweigh the risks. (4) Do not administer doses of 16 mg or more daily because safety has not been established. (5) A benzodiazepine may be administered concomitantly if additional sedation is needed. 2) Administration in specific populations • Elderly patients and patients predisposed to hypotension The initial dose is 0.5 mg per dose 2 times daily. Depending on the patient's condition, increase by 0.5 mg per dose 2 times daily until the dose is 1~2 mg per dose 2 times daily. In general, increases to doses of 1.5 mg or more per dose 2 times daily should be made at intervals of at least 1 week. 3) Switching from existing antipsychotic medication to this drug When medically appropriate, start treatment with this drug while gradually reducing the dose of the existing medication. Also, when switching from an existing depot antipsychotic medication, when medically appropriate, start this drug in place of the next scheduled depot injection. Regularly reassess whether concomitant antiparkinsonian medication needs to be continued. 2. Agitation, aggression, or psychotic symptoms in patients with dementia of the Alzheimer type The initial dose is 0.25 mg of this drug per dose 2 times daily. If needed, depending on the patient, the dose may be increased by 0.25 mg per dose 2 times daily at intervals of at least 2 days. The optimal dose for most patients is 0.5 mg per dose 2 times daily, but depending on the patient, the dose may be increased to 1 mg per dose 2 times 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 drug should be evaluated. 3. Adjunctive treatment of manic episodes associated with bipolar disorder • The recommended initial dose is 2 mg of this drug once daily. 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 drug 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 drug with caution in these patients (see 5. General Precautions).

Child dose

Schizophrenia: Clinical experience in children and adolescents under 15 years of age is limited. Adjunctive treatment of manic episodes associated with bipolar disorder: 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 needed, 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. Body weight less than 50 kg: The initial dose is 0.25 mg once daily. If needed, 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. Children under 5 years of age: Clinical experience is limited.

Precautions

This medication may increase mortality in elderly dementia patients; caution is needed. In particular, the combined use of this medication with a specific diuretic, furosemide, may heighten the risk of death, hence careful consideration of risk versus benefit is necessary before co-administration. There is a risk of thrombus formation in the veins known as venous thromboembolism; therefore, thrombus risk factors should be assessed and preventive measures taken before and during treatment with this medication. This medication contains the artificial sweetener aspartame; patients with phenylketonuria, a specific genetic disorder, should be cautious when taking it. This medication should not be used in patients with certain allergies or hypersensitivities, those in a state of central nervous system depression, coma patients, patients receiving epinephrine, and patients with lactose intolerance. Patients with cardiovascular diseases or liver/kidney dysfunction require careful observation and dosage adjustments when receiving this medication. This medication may cause various side effects such as drowsiness, dizziness, orthostatic hypotension, Parkinsonian symptoms, insomnia, and weight gain; if symptoms occur, consultation with a healthcare provider is advised. Women who are pregnant or breastfeeding should consult a physician before using this medication, as it may affect both the fetus and the newborn. Caution is required as the central nervous system depressive effects may be intensified when using this medication in combination with other central nervous system depressants or alcohol. It is advisable to refrain from activities requiring alertness, such as driving a car or operating machinery, while taking this medication. Severe side effects may occur in cases of overdose, so the prescribed dosages must be maintained, and immediate medical attention should be sought if adverse symptoms appear. Keep out of reach of children, do not open packaging arbitrarily or cut the tablets, and do not mix liquid formulations with tea or cola.

Side effects

Death, stroke, transient ischemic attack, venous thrombosis, nasopharyngitis, upper respiratory infection, sinusitis, urinary tract infection, anemia, hypersensitivity reaction, insomnia, anxiety, nervous irritability, Parkinson's disease, inability to remain seated, drowsiness, dizziness, sedation, tremor, muscle rigidity, somnolence, orthostatic dizziness, dyskinesia, syncope, blurred 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 dysfunction, fatigue, asthenia, fever, chest pain, elevated blood creatinine phosphokinase, increased heart rate, urinary tract infection, pneumonia, soft tissue infection, decreased appetite, confusion, transient ischemic attack, decreased level of consciousness, drooling, cerebrovascular accident, conjunctivitis, hypotension, cough, runny nose, dysphagia, fecal impaction, erythema, abnormal posture, joint swelling, peripheral edema, gait disturbance, pitting edema, elevated body temperature, upper respiratory infection, rhinitis, influenza, increased appetite, mid-insomnia, lethargy, headache, stuttering, attention disorder, balance disorder, hypersomnia, palpitations, oropharyngeal pain, pulmonary congestion, itching, acne, myalgia, neck pain, nocturia, polyuria, galactorrhea, emotional disturbance, lethargy, chest discomfort, weight gain, elevated blood prolactin, anxiety, blunted affect, sleep disorder, decreased libido, sexual dysfunction, depression, nightmares, unresponsiveness to stimuli, abnormal cooperation, loss of consciousness, speech disorder, sensory impairment, movement disorder, tardive dyskinesia, cerebral ischemia, cerebrovascular accident disorder, neuroleptic malignant syndrome, diabetic coma, head tremors, seizures, psychomotor hyperactivity, delayed dyskinesia, cerebrovascular disorder, sensory disturbances, eye redness, ocular discharge, eye movements, eyelid swelling, photophobia, eyelid crusting, dry eyes, increased tearing, glare, glaucoma, decreased vision, tinnitus, vertigo, bradycardia, tachycardia, palpitations, I degree AV block, left bundle branch block, right bundle branch block, AV block, flushing, conduction disorder, ECG abnormality, prolonged QT interval on ECG, inferior vena cava syndrome, bradycardia, wheezing, aspiration pneumonia, voice disorder, moist cough, airway congestion, rales, respiratory distress, nasal cavity edema, hyperventilation, fecal incontinence, gastritis, lip swelling, cheilitis, salivary deficiency, abdominal distension, gastroenteritis, tongue swelling, toothache, skin discoloration, skin lesions, skin disorders, erythematous rash, papular rash, generalized rash, papulopustular rash, eczema, musculoskeletal chest pain, joint stiffness, muscle weakness, rhabdomyolysis, urinary dysfunction, amenorrhea, gynecomastia, vaginal discharge, erectile dysfunction, ejaculation disorder, menstrual disorder, breast engorgement, sexual dysfunction, retrograde ejaculation, breast secretion, thirst, influenza-like syndrome, edema, fatigue, facial edema, discomfort, generalized edema, chills, peripheral coldness, drug withdrawal syndrome, adverse drug reactions, decreased body temperature, procedure-related pain, weight loss, neutropenia, decreased hematocrit, leukopenia, neutropenia, drug hypersensitivity reactions, glucosuria, hyperprolactinemia, somnolence, anorexia, increased blood cholesterol, increased blood triglycerides, hyperglycemia, weight loss, anxiety, blunted affect, sleep disorder, decreased libido, sexual dysfunction, depression, nightmares, suicidal thoughts, thought disorder, delusions, hallucinations, auditory hallucinations, suicidal thoughts, suicide, falls, agranulocytosis, thrombocytopenia, antidiuretic hormone secretion abnormalities, diabetic ketoacidosis, diabetes, hypoglycemia, water intoxication, increased blood cholesterol, increased blood triglycerides, mania, dysgeusia, intraoperative iris tension reduction 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, priapism, hypothermia, chest pain, abnormal liver function, hepatitis, thirst, dry mouth, urinary retention, polyuria, pain, hiccups, increased sweating, urinary dysfunction, leukopenia, arrhythmia, epistaxis, anemia, diarrhea, hangover, eye movement seizures, acne, dysphagia, nocturnal enuresis, tic disorder, respiratory distress, Rabbit syndrome, suicidal thoughts, thought disorder, delusions, hallucinations, auditory hallucinations, symptom exacerbation

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

Storage

This medication may be sensitive to air and moisture, so it should be stored in a tightly closed container. It's important to maintain the storage temperature at room temperature between 1 degree and 30 degrees Celsius.

Appearance and packaging

Appearance

Pale orange, elongated film-coated tablet

Package unit

30 tablets/bottle, 200 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.