Medication info

Junghun Risperidone Tablets 2 mg

Prescription medicationTabletOralExpired
Ingredient · strength
Risperidone›2mg / 1 tablet
Manufacturer / importer
Junghun Pharmaceutical Co., Ltd.
Appearance
This medicine is an orange, oval-shaped film-coated tablet.
Packaging
30 tablets/bottle, 200 tablets/bottle
Approval status
Expired

MFDS item code 201903635 · Approved 2019.05.31

This product's status changed to Expired on 2024.05.31. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment of psychiatric disorders (schizophrenia and mania), 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 and, once it disintegrates within a few seconds, swallow it without water or with water (for orally disintegrating tablets only.). Initial dose for adults with schizophrenia: Administer 1 mg of risperidone orally twice daily and gradually increase the dose. Maintenance dose for adults with schizophrenia: Administer 1∼3 mg twice daily. Adjust the dose appropriately according to age and symptoms. 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 to the individual patient are considered to outweigh the risks. The safety of doses of 16 mg or more per day has not been established; do not administer such doses. If additional sedation is needed, a benzodiazepine may be administered concomitantly. Schizophrenia, 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. Increases to doses of 1.5 mg or more twice daily should generally be made at intervals of at least 1 week. Switching from another antipsychotic medicine to this medicine: When medically appropriate, initiate this medicine while gradually reducing the dose of the existing medicine. Also, when switching from an existing depot antipsychotic medicine, if medically appropriate, initiate 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 Alzheimer's-type dementia: The initial dose is 0.25 mg of this medicine twice daily. If necessary, depending on 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 administration may also be considered. As with symptomatic treatment, the appropriateness of continued use of this medicine should be evaluated. Adjunctive treatment for 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 within the range of 2∼6 mg per day. As with symptomatic treatment, the appropriateness of 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 (refer to 5. General precautions).
Child dose
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, 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. 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, 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. Schizophrenia: Clinical experience in children and adolescents younger than 15 years of age is limited. Adjunctive therapy for manic episodes associated with bipolar disorder: Clinical experience in children and adolescents younger than 15 years of age is limited. Disruptive behavior disorders and other disruptive behavior disorders: Clinical experience in children younger than 5 years of age is limited.

Ingredients

Manufacturer
Junghun Pharmaceutical Co., Ltd.

Efficacy & effects

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

  • Schizophrenia
  • agitation
  • aggression
  • psychotic symptoms
  • manic episodes
  • disruptive behavior
  • aggression
  • impulsiveness
  • self-harming behavior
  • behavioral disorders
  • disruptive behavioral disorder
View approved original text

This medication is used to improve symptoms in patients with schizophrenia. It is also effective in the short-term (up to 6 weeks) treatment of agitation, aggression, and psychotic symptoms in patients with moderate to severe Alzheimer-type dementia. Additionally, it is used as an adjunctive therapy for mood stabilizers in the treatment of manic episodes associated with bipolar disorder. Furthermore, it is applicable in treating behavioral disorders and disruptive behaviors characterized by aggression, impulsiveness, and self-harm in patients with intellectual disabilities and children, adolescents, and adults with developmental delays. This medicine helps improve symptoms of various mental and behavioral disorders.

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 and, once it disintegrates within a few seconds, swallow it without water or with water (for orally disintegrating tablets only.). Initial dose for adults with schizophrenia: Administer 1 mg of risperidone orally twice daily and gradually increase the dose. Maintenance dose for adults with schizophrenia: Administer 1∼3 mg twice daily. Adjust the dose appropriately according to age and symptoms. 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 to the individual patient are considered to outweigh the risks. The safety of doses of 16 mg or more per day has not been established; do not administer such doses. If additional sedation is needed, a benzodiazepine may be administered concomitantly. Schizophrenia, 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. Increases to doses of 1.5 mg or more twice daily should generally be made at intervals of at least 1 week. Switching from another antipsychotic medicine to this medicine: When medically appropriate, initiate this medicine while gradually reducing the dose of the existing medicine. Also, when switching from an existing depot antipsychotic medicine, if medically appropriate, initiate 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 Alzheimer's-type dementia: The initial dose is 0.25 mg of this medicine twice daily. If necessary, depending on 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 administration may also be considered. As with symptomatic treatment, the appropriateness of continued use of this medicine should be evaluated. Adjunctive treatment for 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 within the range of 2∼6 mg per day. As with symptomatic treatment, the appropriateness of 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 (refer to 5. General precautions).

Child dose

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, 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. 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, 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. Schizophrenia: Clinical experience in children and adolescents younger than 15 years of age is limited. Adjunctive therapy for manic episodes associated with bipolar disorder: Clinical experience in children and adolescents younger than 15 years of age is limited. Disruptive behavior disorders and other disruptive behavior disorders: Clinical experience in children younger than 5 years of age is limited.

Precautions

This medication should be used very cautiously in elderly dementia patients as it may increase mortality. Careful consideration of risks and benefits should be made, especially when used in combination with furosemide as it may elevate the risk of death. There is a risk of developing venous thrombosis, so risk factors for thrombosis should be checked and preventative measures taken before and during administration. Because this medication contains aspartame, caution is advised for patients with specific genetic disorders, such as phenylketonuria. It should not be administered to patients with hypersensitivity to this drug, patients whose central nervous system is inhibited due to alcohol or central nervous system depressants, patients in a coma, those undergoing epinephrine administration, and patients with genetic issues like lactose intolerance. Patients with cardiovascular diseases or dehydration, those at risk of arrhythmias or QT interval prolongation, patients with impaired liver or kidney function, those at risk of suicide, patients with Parkinson's disease or Lewy body dementia, diabetes patients, elderly patients, and pregnant or breastfeeding women should use this medication cautiously. This medication may cause various side effects, particularly neurologic symptoms, low blood pressure, gastrointestinal symptoms, skin rashes, and muscle and joint pain. Immediate consultation with healthcare providers is necessary if adverse effects occur. Moreover, caution is advised when using this medication with other central nervous system drugs or alcohol as it may enhance CNS depressant effects. It should also be used cautiously in combination with specific antihypertensive drugs or drugs that prolong the QT interval. During pregnancy, it should only be administered after consulting a physician due to potential effects on the fetus, and if breastfeeding, discontinuation of breastfeeding is recommended. Dose adjustment and monitoring of condition are required when administering this medication to children and the elderly. In case of overdose, immediate medical attention is necessary, as there is no specific antidote for this medication and supportive treatment according to symptoms should be undertaken. This drug is fragile and should not be crushed or cut, and should be taken immediately after opening. It should also not be mixed with tea or cola as this may reduce efficacy. Lastly, it should be stored out of reach of children and should not be transferred to another container.

Side effects

Increased mortality, stroke, transient ischemic attack, venous thrombosis, rhinitis, upper respiratory infection, sinusitis, urinary tract infection, anemia, hypersensitivity, insomnia, anxiety, neurosensitivity, Parkinsonism, akathisia, drowsiness, dizziness, sedation, tremor, muscle tone abnormalities, hypersomnia, orthostatic dizziness, dyskinesia, syncope, blurred vision, ear pain, orthostatic hypotension, tachycardia, hypotension, nasal congestion, dyspnea, epistaxis, sinus congestion, nausea, constipation, dyspepsia, vomiting, diarrhea, hypersalivation, 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 serum creatinine phosphokinase, increased heart rate, pneumonia, soft tissue infection, decreased appetite, confusion, transient ischemic attack, altered consciousness, drooling, cerebrovascular accident, conjunctivitis, hypotension, cough, runny nose, dysphagia, fecal impaction, erythema, abnormal posture, joint swelling, peripheral edema, walking difficulties, pitting edema, elevated body temperature, upper respiratory infection, rhinitis, influenza, increased appetite, moderate insomnia, lethargy, headache, stuttering, attention disorder, balance disorder, hypersomnia, palpitations, pharyngolaryngeal pain, pulmonary congestion, itching, acne, myalgia, neck pain, nocturia, increased frequency of urination, galactorrhea, emotional disturbances, apathy, chest discomfort, weight gain, elevated serum prolactin, anxiety, flattened affect, sleep disorder, decreased libido, sexual dysfunction, depression, nightmares, unresponsiveness to stimuli, coordination abnormalities, loss of consciousness, speech disorder, sensory loss, movement disorders, generalized dyskinesia, cerebral ischemia, cerebrovascular accident disorders, neuroleptic malignant syndrome, diabetic coma, head tremor, seizures, psychomotor hyperactivity, tardive dyskinesia, cerebrovascular disorders, sensory disturbances, conjunctival injection, eye discharge, eye movement, eyelid edema, photophobia, crusting of eyelid margin, 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, atrioventricular block, flushing, conduction disorders, abnormal electrocardiogram, prolonged QT interval on electrocardiogram, venous return, bradycardia, wheezing, aspiration pneumonia, voice disorders, productive cough, airway congestion, crackles, respiratory difficulties, nasal mucosa edema, hyperventilation, fecal incontinence, gastritis, lip swelling, cheilitis, salivary deficiency, bloating, gastroenteritis, tongue swelling, dental pain, skin discoloration, 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 disorders, menstrual disorders, breast enlargement, sexual dysfunction, retrograde ejaculation, breast discharge, thirst, influenza-like syndrome, edema, malaise, facial swelling, discomfort, generalized edema, chills, peripheral coldness, withdrawal syndrome, adverse drug reactions, decreased body temperature, procedure-related pain, elevated ALT, abnormal electrocardiogram, eosinophilia, elevated AST, leukopenia, elevated blood glucose, decreased hemoglobin, decreased hematocrit, hypothermia, decreased blood pressure, elevated transaminases, elevated gamma-glutamyl transferase, increased liver enzymes, agranulocytosis, thrombocytopenia, abnormal secretion of antidiuretic hormone, diabetic ketoacidosis, diabetes, hypoglycemia, water intoxication, elevated serum cholesterol, elevated serum triglycerides, mania, dysgeusia, intraoperative iris hypotension syndrome, atrial fibrillation, deep vein thrombosis, pulmonary embolism, obstructive sleep apnea, intestinal obstruction, pancreatitis, jaundice, vascular edema, hair loss, neonatal withdrawal syndrome, urinary retention, persistent erection, hypothermia, chest pain, liver dysfunction, hepatitis, dry mouth, oral dryness, urinary retention, polyuria, pain, hiccups, increased sweating, urination disorders, leukopenia, arrhythmia, epistaxis, anemia, diarrhea, hangover, ocular motor seizures, acne, dysphagia, enuresis, tic disorder, dyspnea, Rabbit syndrome, suicide attempts, accident abnormalities, delusions, hallucinations, exacerbation of auditory hallucinations, tardive dyskinesia, hyperthermia, muscle rigidity, autonomic nervous system anxiety, altered consciousness, elevated serum creatine phosphokinase, myoglobinuria, acute renal failure, delirium, bluntness, postural instability, falls, weight loss, elevated gamma-GT, elevated liver enzymes, urinary glucose detection, falls

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

Storage

This medication is sensitive to air and moisture and should be stored in a tightly closed container. The storage temperature should be maintained between 1 to 30 degrees Celsius.

Appearance and packaging

Appearance

This medicine is an orange, oval-shaped 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.