Invega Extended-Release Tablet 9 mg (Paliperidone)

Adult dose

1. Schizophrenia Adults (18 years and older) This medicine is administered orally as paliperidone 6mg once daily in the morning. Administer this medicine consistently either with food or on an empty stomach; do not alternate between the two. No initial dose adjustment is necessary. Some patients may benefit from a lower or higher dose within the range of 3-12mg of paliperidone once daily. Dose adjustments should be made only after clinical reassessment. If dose escalation is needed, it is recommended to increase the dose by 3mg per day at intervals of at least 5 days. 2. Schizoaffective disorder Adults (18 years and older) This medicine is administered orally as paliperidone 6mg once daily in the morning. Administer this medicine consistently either with food or on an empty stomach; do not alternate between the two. No initial dose adjustment is necessary. Some patients may benefit from a lower or higher dose within the range of 3-12mg of paliperidone once daily. Dose adjustments should be made only after clinical reassessment. If dose escalation is needed, it is recommended to increase the dose by 3mg per day at intervals of at least 4 days. This medicine should be swallowed whole with liquid and must not be chewed, cut, or crushed. The drug is contained within a non-absorbable membrane designed to release the drug at a controlled rate. The tablet-shaped membrane, together with insoluble core components, is excreted from the body. There is no need to be concerned if you find tablet-shaped material in your stool. 3. Patients with hepatic impairment No dose adjustment is necessary in patients with mild or moderate hepatic impairment (Child-Pugh Classification A and B). This medicine has not been studied in patients with severe hepatic impairment. 4. Patients with renal impairment Dosing should be individualized according to the patient's renal function. Patients with mild renal impairment (creatinine clearance of 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 up to a maximum of 6mg per day. Patients with moderate or severe renal impairment (creatinine clearance of 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 up to a maximum of 3mg per day. This medicine has not been studied in patients with creatinine clearance below 10ml/min; therefore, administration of this medicine to these patients is not recommended. 5. Older adults Renal function may be decreased in older adults, and dose adjustment may be needed based on renal function. In general, the recommended dose for older adults 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 of 10ml/min or more and less than 50ml/min), the maximum recommended dose of this medicine is 3mg once daily (see “Patients with renal impairment” under Dosage and Administration).

Child dose

Adolescents (12-17 years) This medicine is administered orally as paliperidone 3mg once daily in the morning. Administer this medicine consistently either with food or on an empty stomach; do not alternate between the two. No initial dose adjustment is necessary. Some patients may benefit from a higher dose within the range of 6-12mg of paliperidone once daily. Dose adjustments should be made only after clinical reassessment. If dose escalation is needed, the dose should be increased by 3mg per day at intervals of at least 5 days. It should be noted that in clinical trials in adolescents with schizophrenia, adverse reactions were dose-related in the high-dose groups (less than 51kg: 6mg; 51kg or more: 12mg), whereas efficacy was not clearly improved. Maintenance treatment has not been evaluated in adolescent patients with schizophrenia. Patients should be reassessed regularly to determine the need for maintenance treatment. As long-term safety has not been established with regard to the onset of suicidal symptoms, growth, maturation, and cognitive and behavioral development, patients should be carefully monitored regularly.

Caution is needed when administering this drug to elderly patients with dementia-related psychosis, as it may increase the risk of death. Before using this medication, it is necessary to evaluate the risk factors for venous thromboembolism and take preventive measures. This medication should not be administered to patients with allergies to this drug or its components, those with certain gastrointestinal obstructions, swallowing difficulties, breastfeeding mothers, or those with lactose intolerance. Patients with cardiovascular disease, cerebrovascular disease, hypotension, epilepsy, renal and liver function impairment, and diabetes should use this medication with caution. This medication can prolong the QT interval, thus patients with heart disease or those at risk of QT prolongation should exercise particular caution. Serious side effects such as Neuroleptic Malignant Syndrome, tardive dyskinesia, and extrapyramidal symptoms may occur, requiring immediate consultation with healthcare professionals upon symptom onset. During the treatment with this drug, glucose levels, weight, and blood pressure should be monitored regularly, and patients with a history of seizures should be especially cautious. Women who are pregnant or breastfeeding should avoid using this medication, and those planning to become pregnant should consult with a healthcare provider. This medication may affect the central nervous system; therefore, caution is advised when driving or operating machinery. Severe side effects may occur in case of overdose, so it is important to adhere to the prescribed dosage, and to seek medical attention immediately if any side effects occur. Store this medication out of the reach of children, and keep it away from moisture.

increased mortality, heart failure, sudden death, pneumonia, venous thromboembolism, first-degree atrioventricular block, bradycardia, bundle branch block, palpitations, arrhythmia, tachycardia, increased heart rate, dry eyes, eye movement, blurred vision, abdominal pain, epigastric 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 creatine phosphokinase, increased serum insulin, increased blood pressure, increased blood triglycerides, prolonged QT interval on electrocardiogram, abnormal T wave on electrocardiogram, T wave inversion on electrocardiogram, abnormal electrocardiogram, 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, muscle tone disorders, extrapyramidal disorders, headache, excessive tension, Parkinsonism, sedation, drowsiness, fainting, tremors, aggression, anxiety, depression, nightmares, suicidal ideation, cough, nasal congestion, itching, hypotension, orthostatic hypotension, tongue swelling, oral ulcer, edema, anaphylactic reaction, weight gain, increased appetite, muscle rigidity, positional dizziness, grand mal seizure, hypersomnia, nightmares, amenorrhea, breast discharge, mastitis, breast pain, erectile dysfunction, galactorrhea, gynecomastia, irregular menstruation, ischemia, neonatal drug withdrawal syndrome, priapism, hypothermia, agranulocytosis, thrombocytopenia, inappropriate antidiuretic hormone secretion, diabetes, diabetic ketoacidosis, hypoglycemia, water intoxication, tension syndrome, mania, sleepwalking, sleep-related eating disorder, taste disorders, delayed motor disturbances, intraoperative iris hypotension syndrome, atrial fibrillation, deep vein thrombosis, pulmonary embolism, sleep apnea syndrome, pancreatitis, intestinal obstruction, jaundice, angioedema, hair loss, drug reactions accompanied by eosinophilia and systemic symptoms, urinary retention, incontinence, neonatal drug withdrawal syndrome, priapism, hypothermia, suicide attempt, depression, death, vomiting, cerebral hemorrhage, aspiration pneumonia, urinary difficulty, psychomotor agitation, runny nose, dysphagia, facial swelling, chest tightness, pain, hair loss, gastric ulcer, sensory disturbances, intentional tremors, arthrogryposis

This medication should be stored in a tightly sealed container to prevent exposure to air and moisture. It is advisable to keep it in a cool place between 15 to 30 degrees Celsius. Avoid storing it in humid places to maintain its efficacy.

Appearance

Pink capsule-shaped extended-release film-coated tablets

Package unit

30 tablets/bottle