Paliperidone Dosage
This dosage information may not include all the information needed to use Paliperidone safely and effectively. See additional information for Paliperidone.
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Usual Adult Dose for:
Usual Pediatric Dose for:
Additional dosage information:
Usual Adult Dose for Schizophrenia
Extended Release Tablets:
Recommended dose: 6 mg once daily, administered in the morning.
Initial dose titration is not required.
Paliperidone can be taken with or without food.
Extended Release Injectable Suspension:
For patients who have never taken oral paliperidone or oral or injectable risperidone, tolerability should be established with oral paliperidone or oral risperidone prior to initiating treatment with paliperidone extended-release injectable suspension.
Initial dose: 234 mg on treatment day 1 followed by 156 mg one week later. Both of these doses should be administered by intramuscular injection in the deltoid muscle. Following the second dose, monthly maintenance doses can be administered in either the deltoid or gluteal muscle.
The recommended monthly maintenance dose is 117 mg. Some patients may benefit from lower or higher maintenance doses within the recommended range of 39 mg to 234 mg based on individual patient tolerability and/or efficacy.
Usual Adult Dose for Schizoaffective Disorder
Extended Release Tablets:
Recommended dose: 6 mg once daily, administered in the morning.
Initial dose titration is not required.
Paliperidone can be taken with or without food.
Extended Release Injectable Suspension:
For patients who have never taken oral paliperidone or oral or injectable risperidone, tolerability should be established with oral paliperidone or oral risperidone prior to initiating treatment with paliperidone extended-release injectable suspension.
Initial dose: 234 mg on treatment day 1 followed by 156 mg one week later. Both of these doses should be administered by intramuscular injection in the deltoid muscle. Following the second dose, monthly maintenance doses can be administered in either the deltoid or gluteal muscle.
The recommended monthly maintenance dose is 117 mg. Some patients may benefit from lower or higher maintenance doses within the recommended range of 39 mg to 234 mg based on individual patient tolerability and/or efficacy.
Usual Pediatric Dose for Schizophrenia
12 years to 17 years:
Weight less than 51 kg:
Initial Dose: 3 mg orally per day. Recommended Dose: 3 to 6 mg orally per day. Maximum Dose: 6 mg/day.
Weight 51 kg or more:
Initial Dose: 3 mg orally per day. Recommended Dose: 3 to 12 mg orally per day. Maximum Dose: 12 mg/day.
Renal Dose Adjustments
Extended Release Injectable Suspension:
Based on a limited number of observations with paliperidone extended-release injectable suspension in subjects with mild renal impairment and pharmacokinetic simulations, the recommended initiation of paliperidone extended-release injectable suspension for patients with mild renal impairment is with a dose of 156 mg by intramuscular injection on treatment day one and 117 mg by intramuscular injection on treatment day eight. This may be followed by monthly injections of 78 mg by intramuscular injection.
Extended Release Tablets:
Dosing must be individualized according to the patient's renal function status. For patients with mild renal impairment (creatinine clearance greater than or equal to 50 to less than 80 mL/min), the maximum recommended dose is 6 mg once daily. For patients with moderate to severe renal impairment (creatinine clearance 10 to less than 50 mL/min), the maximum recommended dose of paliperidone is 3 mg once daily.
Liver Dose Adjustments
For patients with mild to moderate hepatic impairment, (Child-Pugh Classification A and B), no dose adjustment is recommended. The effect of severe hepatic impairment is unknown.
Dose Adjustments
Extended Release Injectable Suspension:
Adjustment of the maintenance dose may be made monthly. When making dose adjustments, the prolonged release characteristics of the extended-release injectable suspension should be considered, as the full effect of the dose adjustment may not be evident for several months.
Extended Release Tablets:
Although it has not been systematically established that doses above 6 mg have additional benefit, there was a general trend for greater effects with higher doses. This must be weighed against the dose-related increase in adverse effects. Thus, some patients may benefit from a higher dosage; up to 12 mg/day, and for some patients, a lower dose of 3 mg/day may be sufficient. Dose increases above 6 mg/day should be made only after clinical reassessment and generally should occur at intervals of more than 5 days in the treatment of schizophrenia and intervals more than 4 days in the treatment of schizoaffective disorder. When dose increases are indicated, small increments of 3 mg/day are recommended. The maximum recommended dose is 12 mg/day.
Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.
No dosage adjustment is recommended based on race. No differences in pharmacokinetics were observed in a pharmacokinetic study conducted in Japanese and Caucasians.
No dosage adjustment is recommended based on gender. No differences in pharmacokinetics were observed in a pharmacokinetic study conducted in men and women.
No dosage adjustment is recommended based on smoking status. Based on in vitro studies utilizing human liver enzymes, paliperidone is not a substrate for CYP450 1A2; smoking should, therefore, not have an effect on the pharmacokinetics of paliperidone.
Precautions
Elderly patients with dementia related psychosis treated with atypical antipsychotic drugs are at an increased risk of death compared to placebo. Paliperidone extended-release tablets are not approved for the treatment of patients with dementia related psychosis.
Because the paliperidone tablet is nondeformable and does not appreciably change in shape in the gastrointestinal tract, paliperidone should ordinarily not be administered to patients with preexisting severe gastrointestinal narrowing (pathologic or iatrogenic, for example: esophageal motility disorders, small bowel inflammatory disease, "short gut" syndrome due to adhesions or decreased transit time, past history of peritonitis, cystic fibrosis, chronic intestinal pseudoobstruction, or Meckel's diverticulum). There have been rare reports of obstructive symptoms in patients with known strictures in association with the ingestion of drugs in nondeformable controlled-release formulations. Because of the controlled-release design of the tablet, paliperidone should only be used in patients who are able to swallow the tablet whole. A decrease in transit time, e.g., as seen with diarrhea, would be expected to decrease bioavailability and an increase in transit time, e.g., as seen with gastrointestinal neuropathy, diabetic gastroparesis, or other causes, would be expected to increase bioavailability. These changes in bioavailability are more likely when the changes in transit time occur in the upper GI tract.
Like other antipsychotic drugs, paliperidone should be used cautiously in patients with a history of seizures or other conditions that potentially lower the seizure threshold. Conditions that lower the seizure threshold may be more prevalent in patients 65 years or older. Paliperidone should be used cautiously in patients at risk for aspiration pneumonia and avoided in patients with congenital long QT syndrome.
The possibility of suicide attempt is inherent in psychotic illnesses, and close supervision of high-risk patients should accompany drug therapy. Prescriptions for paliperidone should be written for the smallest quantity of tablets consistent with good patient management in order to reduce the risk of overdose.
Patients undergoing treatment with paliperidone should be monitored for changes in QT interval, clinical manifestations of neuroleptic malignant syndrome, signs and symptoms of tardive dyskinesia, symptoms of hyperglycemia, and hypotension.
Safety and effectiveness have not been established in pediatric patients (less than 18 years of age).
Dialysis
Dosing must be individualized according to the patient's renal function status. For patients with moderate to severe renal impairment (creatinine clearance 10 to less than 50 mL/min), the maximum recommended dose of paliperidone is 3 mg once daily. No specific recommendations are currently available regarding the use of paliperidone in the treatment of dialysis patients.
Other Comments
The extended-release injectable suspension should be administered by intramuscular injection only, using appropriate needle sizes. For deltoid injection, use a 1 and half inch 22 G needle for patients 90 kg (200 lb) or over or a 1 inch 23 G needle for patients less than 90 kg (200 lb). For gluteal injection, use a 1 and half inch 22 G needle regardless of the patient's weight.
Extended Release Tablets:
Paliperidone must be swallowed whole with the aid of liquids. Tablets should not be chewed, divided, or crushed. The medication is contained within a nonabsorbable shell designed to release the drug at a controlled rate. The tablet shell, along with insoluble core components, is eliminated from the body; patients should not be concerned if they occasionally notice in their stool something that looks like a tablet.
Paliperidone may be administered with or without food, but high fat meals can increase absorption by 50% or greater.
Although the long-term efficacy of paliperidone has been established, physicians who elect to use paliperidone for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient.
