Medication info

Riphedin Tablet 3 mg (Risperidone)

Prescription medicationTabletOralExpired
Ingredient · strength
Risperidone›3mg / 1 tablet
Manufacturer / importer
Dasan Pharmaceutical Co., Ltd.
Appearance
Yellow film-coated oval tablet
Packaging
30 tablets/bottle, 200 tablets/bottle
Approval status
Expired

MFDS item code 201906862 · Approved 2019.09.26

This product's status changed to Expired on 2024.09.26. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment of schizophrenia and mania; treatment of symptoms of Alzheimer's dementia and behavioral disorders in patients with intellectual impairment
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. 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 as appropriate according to age and symptoms. (3) No additional efficacy 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. (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 an additional sedative effect is needed. 2) Administration 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 medicine to this medicine When medically appropriate, start this medicine while gradually reducing the dose of the existing medicine. Also, when medically appropriate, when switching from an existing depot antipsychotic, 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. 2. Agitation, aggression, or psychotic symptoms in patients with dementia of the Alzheimer’s type 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 the dose may be increased to 1 mg 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. 3. Adjunctive treatment of manic episodes 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 rationale for continued use of this medicine should be evaluated. 4. Disruptive behavior disorder and other disruptive behavior disorders 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
⦁ There is limited clinical experience in children and adolescents under 15 years of age. ⦁ There is limited clinical experience in children and adolescents under 15 years of age. - 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 per day 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 necessary, depending on the patient, the dose may be increased by 0.25 mg per day 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. ⦁ There is limited clinical experience in children under 5 years of age.

Ingredients

Manufacturer
Dasan Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of schizophrenia and mania; treatment of symptoms of Alzheimer's dementia and behavioral disorders in patients with intellectual impairment

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

This medicine is used to treat schizophrenia, anxiety and aggression in patients with Alzheimer's-type dementia, mania episodes due to bipolar disorder, and behavioral problems in children and adults with behavioral disorders and disruptive behavior.

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. 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 as appropriate according to age and symptoms. (3) No additional efficacy 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. (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 an additional sedative effect is needed. 2) Administration 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 medicine to this medicine When medically appropriate, start this medicine while gradually reducing the dose of the existing medicine. Also, when medically appropriate, when switching from an existing depot antipsychotic, 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. 2. Agitation, aggression, or psychotic symptoms in patients with dementia of the Alzheimer’s type 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 the dose may be increased to 1 mg 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. 3. Adjunctive treatment of manic episodes 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 rationale for continued use of this medicine should be evaluated. 4. Disruptive behavior disorder and other disruptive behavior disorders 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

⦁ There is limited clinical experience in children and adolescents under 15 years of age. ⦁ There is limited clinical experience in children and adolescents under 15 years of age. - 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 per day 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 necessary, depending on the patient, the dose may be increased by 0.25 mg per day 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. ⦁ There is limited clinical experience in children under 5 years of age.

Precautions

This drug may increase the risk of mortality when administered to elderly dementia patients, so it should be used with particular caution. The risk of death may be further increased when this drug is used in combination with the diuretic furosemide, so the risks and benefits should be carefully considered before concurrent administration. It is also very important to manage dehydration. This drug poses a risk of thrombosis, especially venous thrombosis, so it is essential to check for risk factors for thrombosis before and during administration and take preventive measures. This drug contains the artificial sweetener aspartame, which requires caution in patients with certain genetic disorders such as phenylketonuria. This drug should not be administered to patients who are allergic to this drug or its components, patients suppressed by alcohol or central nervous system depressants, comatose patients, patients receiving epinephrine, and patients with lactose intolerance. Caution is also warranted for patients with cardiovascular diseases, reduced liver or kidney function, a history of seizures, patients at risk of suicide, diabetic patients, pregnant and nursing women, and the elderly; the dosage should be adjusted and monitored more carefully in these patients. During administration, various side effects such as drowsiness, dizziness, orthostatic hypotension, insomnia, anxiety, Parkinsonian symptoms, gastrointestinal disturbances, skin rashes may occur, and medical consultation should be sought immediately in case of symptoms. If serious neurological symptoms such as tardive dyskinesia or neuroleptic malignant syndrome occur, administration should be stopped immediately. This drug may enhance the central nervous system depressant effects when taken in combination with other central nervous system depressants or alcohol, so caution is needed in such cases. Furthermore, there can be interactions with some medications that may alter the blood concentration of this drug, so patients taking other medications should inform their healthcare providers. Pregnant and nursing women should consult their doctor before taking this medication as it may affect the fetus or newborn. In case of overdose, symptoms such as drowsiness, sedation, tachycardia, hypotension, seizures may appear, and immediate emergency treatment is required. This drug should be kept out of reach of children and it is advisable to consume it immediately after opening the package, without altering the packaging.

Side effects

Increased mortality, cerebrovascular adverse reactions, venous thrombosis, rhinitis, upper respiratory infection, sinusitis, urinary tract infection, anemia, hypersensitivity, insomnia, anxiety, nervousness, Parkinsonism, inability to sit still, drowsiness, dizziness, sedation, tremor, muscle hypertonia, somnolence, postural dizziness, dyskinesia, syncope, blurred vision, ear pain, orthostatic hypotension, tachycardia, hypotension, nasal congestion, dyspnea, nosebleed, sinus congestion, nausea, constipation, indigestion, vomiting, diarrhea, excessive salivation, dry mouth, abdominal discomfort, abdominal pain, gastrointestinal discomfort, upper abdominal pain, rash, dry skin, dandruff, seborrheic dermatitis, hyperkeratosis, back pain, arthralgia, limb pain, urinary incontinence, ejaculatory dysfunction, fatigue, weakness, fever, chest pain, elevated serum creatinine and phosphocreatine kinase, increased heart rate, pneumonia, soft tissue infection, decreased appetite, confusion, transient ischemic attack, decreased 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, middle-of-the-night insomnia, lethargy, headache, stuttering, attention deficit, balance impairment, excessive sleep, palpitations, oropharyngeal pain, pulmonary congestion, itching, acne, myalgia, neck pain, nocturia, frequent urination, hyperprolactinemia, emotional disturbances, lethargy, chest discomfort, weight gain, increased serum prolactin, anxiety, blunted affect, sleep disorders, decreased libido, sexual dysfunction, depression, nightmares, unresponsiveness to stimuli, cooperation abnormalities, loss of consciousness, speech disorders, sensory impairment, movement disorders, dyskinesia, cerebral ischemia, cerebrovascular accident disorder, neuroleptic malignant syndrome, diabetic coma, head tremors, seizures, psychomotor hyperactivity, delayed dyskinesia, cerebrovascular disorders, sensory disturbances, conjunctival hyperemia, eye discharge, eye movement, eyelid swelling, photophobia, eyelid scab, dry eyes, increased tearing, glare, glaucoma, decreased vision, tinnitus, dizziness, bradycardia, tachycardia, palpitations, AV block I, left bundle branch block, right bundle branch block, heart block, flushing, conduction disorders, abnormal electrocardiogram, prolonged QT interval on ECG, venous thrombosis, bradycardia, wheezing, aspiration pneumonia, speech impairment, productive cough, airway edema, crackles, respiratory distress, nasal cavity swelling, hyperventilation, fecal incontinence, gastritis, lip swelling, cheilitis, salivary gland deficiency syndrome, 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 disorders, menstrual disorders, breast engorgement, sexual dysfunction, retrograde ejaculation, breast discharge, thirst, influenza-like symptoms, edema, fatigue, facial swelling, malaise, systemic edema, chills, peripheral coldness, drug withdrawal syndrome, adverse drug reactions, decreased body temperature, procedure-related pain, increased ALT, electrocardiogram abnormalities, elevated eosinophil count, increased AST, decreased white blood cell count, elevated blood sugar, decreased hemoglobin, decreased hematocrit, hypothermia, hypotension, increased transaminases, increased gamma-glutamyl transferase, increased liver enzymes, ear infections, viral infections, pharyngitis, tonsillitis, bronchitis, eye infections, infections, localized infections, cystitis, otitis media, onychomycosis, scabies dermatitis, bronchopneumonia, airway infections, bronchitis, chronic otitis media, elevated eosinophil count, reduced red blood cell count, leukopenia, neutropenia, drug hypersensitivity, glucose in urine, hyperprolactinemia, acromegaly, anorexia, elevated blood cholesterol, increased triglycerides, hyperglycemia, weight loss, anxiety, blunted affect, sleep disorders, decreased libido, sexual dysfunction, depression, nightmares, suicidal ideation, thought disorders, delusions, hallucinations, exacerbation of auditory hallucinations, sensory disturbances, seizures, tremors, psychomotor agitation, immobility, paresthesia, head discomfort, eyelid spasms, eye movement disorders, dizziness, bradycardia, premature ventricular contractions, arrhythmias, hypertension, thromboembolism, postural orthostatic tachycardia syndrome, tooth pain, tongue spasms, hyperflexibility, hemorrhoids, eczema, hyperhidrosis, itching, drug rashes, urticaria, hip pain, delayed menstruation, delayed ejaculation, infrequent menstruation, breast discomfort, breast engorgement, breast enlargement, dysuria, anaphylactic reaction, pain, walking abnormalities, sclerosis, falls, agranulocytosis, thrombocytopenia, inappropriate secretion of antidiuretic hormone, diabetic ketoacidosis, diabetes, hypoglycemia, water intoxication, elevated blood cholesterol, increased 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, liver dysfunction, hepatitis, dry mouth, xerostomia, urinary retention, polyuria, hiccups, increased sweating, urinary dysfunction, leukopenia, arrhythmias, nosebleeds, anemia, diarrhea, hangover, ocular movement seizures, acne, dysphagia, enuresis, tic disorder, respiratory distress, Rabbit syndrome

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

Storage

This drug should be stored in a tightly sealed container to protect it from air and moisture, at a temperature between 1 degree and 30 degrees Celsius. Therefore, it is important to avoid direct sunlight and not to place it in excessively hot or cold places.

Appearance and packaging

Appearance

Yellow film-coated oval 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.

Questions about this medicine

No questions yet.

For anything that needs medical judgment, consult a doctor or pharmacist.

Related searches

Search tags

Suggested searches

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.