Invega Extended-Release Tablet 6 mg (Paliperidone)

Adult dose

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. 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. 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. 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. 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.

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. High-dose group in clinical trials in adolescents with schizophrenia, less than 51kg: 6mg High-dose group in clinical trials in adolescents with schizophrenia, 51kg or more: 12mg

This medication should not be used in elderly patients with dementia-related psychosis as it may increase mortality. There is a risk of thrombus formation in the bloodstream when using this medication, so risk factors for venous thromboembolism should be assessed and preventive measures taken before and during use. Individuals who are allergic to this medication or its components, have severe gastrointestinal obstruction or dysphagia, are nursing mothers, or have lactose intolerance should not use this medication. Patients with heart disease, cerebrovascular disease, epilepsy, severely impaired kidney or liver function, diabetes, issues with temperature regulation, patients with Parkinson's disease or specific types of dementia, and pregnant women should use this medication with caution. This medication can cause various side effects such as heart rhythm abnormalities, headaches, dizziness, drowsiness, nausea, vomiting, weight gain, etc., so if any unusual symptoms appear, immediate consultation with a healthcare professional is recommended. Particularly, this medication affects the electrical activity of the heart and can prolong the QT interval, thus requiring caution in those taking heart-related medications or with a history of heart disease. Serious side effects may occur, such as neuroleptic malignant syndrome, tardive dyskinesia, hyperglycemia, worsening of diabetes, orthostatic hypotension, increased risk of seizures, and reproductive issues due to elevated prolactin levels, so caution is necessary. Women who are pregnant or breastfeeding should ideally avoid the use of this medication, especially breastfeeding mothers should avoid it as it may be excreted in breast milk and affect the baby. This medication can interact with other drugs, so if taking other medications, it is important to inform healthcare professionals, especially regarding heart-related drugs, central nervous system medications, and antiepileptics. Store this medication out of reach of children, avoid moisture, and direct sunlight, and swallow the tablets whole without chewing or breaking them. In case of overdose, symptoms may include drowsiness, hypotension, heart abnormalities, and severe movement disorders, which require immediate medical attention.

increased mortality, heart failure, sudden death, pneumonia, venous thromboembolism, first-degree AV block, bradycardia, bundle branch block, palpitations, sinus arrhythmia, sinus tachycardia, tachycardia, dry eyes, ocular 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 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 rigidity, neck pain, severe pain, shoulder pain, inability to sit still, dizziness, movement disorders, abnormal muscle tone, extrapyramidal symptoms, headache, excessive tension, Parkinsonism, sedation, drowsiness, syncope, tremors, aggression, anxiety, depression, nightmares, suicidal thoughts, cough, nasal congestion, pruritus, hypotension, orthostatic hypotension, agranulocytosis, thrombocytopenia, inappropriate secretion of antidiuretic hormone, diabetes mellitus, diabetic ketoacidosis, hypoglycemia, water intoxication, tension syndrome, mania, sleepwalking, sleep-related eating disorder, taste disturbance, delayed movement disorder, intraoperative iris hypotension syndrome, atrial fibrillation, deep vein thrombosis, pulmonary embolism, obstructive sleep apnea syndrome, pancreatitis, bowel obstruction, jaundice, angioedema, alopecia, drug reactions accompanied by eosinophilia and systemic symptoms, Stevens-Johnson syndrome, toxic epidermal necrolysis, urinary retention, urinary incontinence, neonatal drug withdrawal symptoms, priapism, hypothermia, anaphylactic reaction, edema, nightmares, amenorrhea, breast secretion, mastitis, breast pain, erectile dysfunction, galactorrhea, gynecomastia, irregular menstruation, ischemia, bradykinesia, sensory impairment, breastfeeding issues, athlete's foot, flushing, itching, hypertension, abnormal liver function, chest pain, sore throat, pharyngodynia, decreased exercise tolerance, generalized tonic-clonic seizures, hypersomnia, position-related dizziness, speech disorder, dysphagia, gastroesophageal reflux, amnesia, worsening depression, impaired concentration, frequent urination, dysuria, psychomotor agitation, facial edema, chest tightness, pain, gastric ulcer, sensory abnormalities, intentional tremor, rigidity in joints

Store this medication in a tightly closed container to protect it from air and moisture. It is preferable to maintain a storage temperature between 15 to 30 degrees Celsius to preserve its efficacy.

Appearance

Pale yellow, capsule-shaped extended-release film-coated tablets

Package unit

30 tablets/bottle