Paliperidone Dosage

This dosage information may not include all the information needed to use Paliperidone safely and effectively. See additional information for Paliperidone.

The information at Drugs.com is not a substitute for medical advice. ALWAYS consult your doctor or pharmacist.

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

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, gender, or smoking status.

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.

Extended Release Injectable Suspension:
It is recommended that the second initiation dose be given one week after the first dose. To avoid a missed dose, the second dose may be given 4 days before or after the one week time point. The third and subsequent injections after the initiation regimen are recommended to be given monthly. To avoid a missed monthly dose, patients may be given the injection up to 7 days before or after the monthly time point.

If the target date for the second injection (one week plus or minus 4 days) is missed, the recommended reinitiation depends on the length of time which has elapsed since the first injection:

Missed second initiation dose (less than 4 weeks from first injection): The second injection of 156 mg should be given in the deltoid muscle as soon as possible. A third injection of 117 mg is recommended in either the deltoid or gluteal muscle administered 5 weeks after the first injection (regardless of the timing of the second injection). The normal monthly cycle of injections in either the deltoid or gluteal muscle of 39 mg to 234 mg based on individual patient tolerability and/or efficacy should be followed thereafter.

Missed second initiation dose (4 to 7 weeks from first injection):
If 4 to 7 weeks have elapsed since the first injection, dosing is resumed with two injections of 156 mg in the following manner: a deltoid injection as soon as possible followed by another deltoid injection one week later, then resumption of the normal monthly cycle of injections in either the deltoid or gluteal muscle of 39 mg to 234 mg based on individual patient tolerability and/or efficacy.

Missed second initiation dose (greater than 7 weeks from first injection):
If more than 7 weeks have elapsed since the first injection, dosing is started over at the initial dosing.

Missed Maintenance Dose (4 to 6 weeks):
After initiation, the recommended injection cycle is monthly. If less than 6 weeks have elapsed since the last injection, then the previously stabilized dose should be administered as soon as possible, followed by injections at monthly intervals.

Missed Maintenance Dose (greater than 6 weeks to 6 months):
If more than 6 weeks have elapsed since the last injection, resume the same dose the patient was previously stabilized on (unless the patient was stabilized on a dose of 234 mg, then the first two injections should each be 156 mg) in the following manner: 1) a deltoid injection as soon as practically possible, followed by 2) another deltoid injection (same dose) one week later, and 3) resumption of either deltoid or gluteal dosing at monthly intervals.

Missed Maintenance Dose (greater than 6 months):
If more than 6 months have elapsed since the first injection, dosing is started over at the initial dosing.

Precautions

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.

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