Paliperidone Extended Release Tablet 9 mg (Paliperidone)

Adult dose

Adults (18 years and older) Administer 6 mg of paliperidone orally once daily in the morning. Take this medicine consistently either with food or on an empty stomach; do not alternate between these conditions. No initial dose adjustment is needed. A lower or higher dose within the range of 3-12mg of paliperidone once daily may be beneficial for some patients. Dose adjustments should be made only after clinical reassessment. If a dose increase is needed, it is recommended to increase by 3mg per day at intervals of at least 5 days. Schizoaffective disorder - Adults (18 years and older) Administer 6 mg of paliperidone orally once daily in the morning. Take this medicine consistently either with food or on an empty stomach; do not alternate between these conditions. No initial dose adjustment is needed. A lower or higher dose within the range of 3-12mg of paliperidone once daily may be beneficial for some patients. Dose adjustments should be made only after clinical reassessment. If a dose increase is needed, it is recommended to increase by 3mg per day at intervals of at least 4 days. Swallow this medicine whole with liquid; do not chew, cut, or crush it. The medicine is contained within a non-dissolvable membrane designed to release the drug at a controlled rate. The tablet-shaped membrane, along with insoluble core components, is eliminated from the body. There is no need for concern if tablet-shaped material is seen in the stool. No dose adjustment is needed in patients with mild to moderate hepatic impairment (Child-Pugh Classification A and B). Patients with severe hepatic impairment have not been studied. Dosing should be individualized according to the patient's renal function. Patients with mild renal impairment (creatinine clearance 50ml/min or more and less than 80ml/min): The recommended initial dose is 3mg once daily. Following clinical reassessment, the dose may be increased to a maximum of 6mg daily. Patients with moderate or severe renal impairment (creatinine clearance 10ml/min or more and less than 50ml/min): The recommended initial dose is 1.5mg once daily. Following clinical reassessment, the dose may be increased to a maximum of 3mg daily. This medicine has not been studied in patients with creatinine clearance below 10ml/min; therefore, its use in these patients is not recommended. Renal function may be reduced in elderly patients, so dose adjustment may be needed based on renal function. In general, the recommended dose for elderly patients with normal renal function is the same as that for adults with normal renal function. In patients with moderate or severe renal impairment (creatinine clearance 10ml/min or more and less than 50ml/min), the maximum recommended dose of this medicine is 3mg once daily (see the 'Patients with renal impairment' section under Dosage and Administration).

Child dose

Adolescents (12 to 17 years) Administer 3mg of paliperidone orally once daily in the morning. Take this medicine consistently either with food or on an empty stomach; do not alternate between these conditions. No initial dose adjustment is needed. A higher dose within the range of 6-12mg of paliperidone once daily may be beneficial for some patients. Dose adjustments should be made only after clinical reassessment. If a dose increase is needed, increase by 3mg per day at intervals of at least 5 days. Under 51kg: 6mg 51kg or more: 12mg

This drug is not approved for use in elderly patients with dementia due to increased risk of death. There is a risk of developing thrombus in the blood vessels, so it is essential to evaluate risk factors for thrombosis before using this drug. It should not be administered to patients who have allergies to this drug or any of its components, or who are hypersensitive to risperidone. Patients with severe gastrointestinal stenosis, difficulties swallowing, nursing mothers, and patients with lactose intolerance should not use this medication. Great caution is required for patients with cardiovascular diseases, epilepsy, liver and kidney dysfunction, diabetes, febrile conditions, Parkinson's disease, certain types of dementia, elderly dementia patients with a risk of seizures, aspiration pneumonia risk, and pregnant women. This drug can cause various side effects such as heart rhythm abnormalities, dizziness, drowsiness, headaches, vomiting, dry mouth, weight gain, etc., so any unusual symptoms should lead to immediate consultation with a doctor or pharmacist. It may cause QT interval prolongation, leading to cardiac arrhythmias, and should be avoided by patients with a history of cardiac arrhythmias or those taking QT prolonging medications; cardiac monitoring is necessary. Serious side effects like neuroleptic malignant syndrome, tardive dyskinesia, hyperglycemia and worsened diabetes, orthostatic hypotension, increased seizure risk, hyperprolactinemia, etc., may also occur and should be taken seriously. The safety of this drug during pregnancy has not been established; it should only be used when the benefits outweigh the risks, and it should not be taken while breastfeeding. Safety in children and adolescents is limited, so it should be used cautiously in patients under 12 years of age or specific conditions under 18 years of age. Overdose can result in drowsiness, sedation, heart rhythm abnormalities, hypotension, and extrapyramidal symptoms, requiring immediate medical treatment. This drug should be stored out of reach of children, protected from moisture, and not transferred to other containers.

Increased mortality, heart failure, sudden death, pneumonia, venous thromboembolism, first-degree heart block, bradycardia, bundle branch block, palpitations, arrhythmia, tachycardia, increased heart rate, dry eyes, eye movement, blurred vision, abdominal pain, upper abdominal pain, diarrhea, dry mouth, dyspepsia, nausea, excessive salivation, gastric discomfort, toothache, vomiting, weakness, fatigue, fever, bronchitis, nasopharyngitis, rhinitis, upper respiratory tract infection, viral infection, falls, increased alanine aminotransferase, increased serum creatinine phosphokinase, increased serum insulin, increased blood pressure, elevated blood triglycerides, prolonged QT interval on ECG, abnormal T waves on ECG, T wave inversion on ECG, abnormal ECG, increased heart rate, increased insulin C-peptide, weight loss, weight gain, decreased appetite, increased appetite, arthralgia, low back pain, muscle stiffness, neck pain, severe pain, shoulder pain, inability to sit still, dizziness, movement disorders, dystonia, extrapyramidal symptoms, headache, excessive tension, Parkinsonism, sedation, drowsiness, syncope, tremors, aggression, anxiety, depression, nightmares, suicidal thoughts, cough, nasal congestion, pruritus, hypotension, orthostatic hypotension, tongue swelling, speech disorder, edema, anaphylactic reaction, positional dizziness, generalized tonic-clonic seizures, hypersomnia, nightmares, amenorrhea, breast discharge, mastitis, breast pain, erectile dysfunction, excessive lactation, gynecomastia, irregular menstruation, ischemia, atrial fibrillation, deep vein thrombosis, pulmonary embolism, sleep apnea syndrome, pancreatitis, bowel obstruction, jaundice, vascular edema, hair loss, DRESS syndrome, urinary retention, incontinence, neonatal drug withdrawal symptoms, priapism, hypothermia, tension symptoms, mania, somnambulism, sleep-related eating disorders, taste disturbances, delayed motor disorders, intraoperative pupillary hypotonic syndrome, hyperglycemia, diabetes, diabetic ketoacidosis, hypoglycemia, water intoxication, amnesia, worsening depression, impaired concentration, dysphagia, gastroesophageal reflux, hyperlipidemia, frequent urination, suicide, asthenia, intracerebral hemorrhage, aspiration pneumonia, psychomotor agitation, facial edema, chest tightness, pain, gastric ulcer, sensory abnormalities, intention tremor, joint rigidity

This drug should be stored in a tightly sealed container to prevent air and moisture from entering. Additionally, it is recommended to keep it in a cool place between 15 and 30 degrees Celsius. Proper storage can help maintain the efficacy of the medication.

Appearance

Pink round extended-release film-coated tablet

Package unit

30 tablets/bottle