Paliperidone Dosage

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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 orally once a day
Dose range: 3 to 12 mg per day; dose increases may be made in increments of 3 mg per day and should occur at intervals of more than 5 days.
Maximum dose: 12 mg per day

Comment: Initial dose titration is not required; greater effects may be seen with higher doses, however this must be weighed against dose-related increases in adverse events; doses above 6 mg per day have not been systematically studied for additional benefit.

Extended release injectable suspension:
-Dosing of the active ingredient in the US and Canada is the same; however, paliperidone extended-release injectable suspension is dosed as paliperidone palmitate in the US and as paliperidone in Canada:

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

US dosing: (Based on paliperidone palmitate):
Initial dose: 234 mg IM on day 1 followed by 156 mg IM one week later; administer IM into deltoid muscle
Maintenance dose: 117 mg IM monthly; administer into deltoid or gluteal muscle
Dose range: 39 to 234 mg based on patient tolerability and efficacy; dose adjustments may be made monthly, although full effect may not be evident for several months

Canada dosing: (Based on paliperidone):
Initial dose: 150 mg IM on day 1 followed by 100 mg IM one week later; administer IM into deltoid muscle
Maintenance dose: 75 mg IM monthly; administer into deltoid or gluteal muscle
Dose range: 50 to 150 mg based on patient tolerability and efficacy; dose adjustments may be made monthly, although full effect may not be evident for several months

Comments:
-To avoid missed doses, patients may receive second dose 4 days before or after the 1-week time point; third and subsequent doses may be given up to 7 days before or after monthly time point.
Missed Initiation Doses:
-If second initiation dose is missed and it is less than 4 weeks since first injection, administer second injection IM into deltoid muscle as soon as possible; maintenance dose should begin 5 weeks after the first injection.
-If second initiation dose is missed and it is 4 to 7 weeks from first injection: provide 2 second dose injections (156 mg US; 100 mg Canada) administering first as soon as possible and second 1 week later, both IM into deltoid muscle, then resume normal monthly cycle.
-If second initiation dose is missed and it is more than 7 weeks from the first injection, re-initiate initial dosing schedule.
Missed Maintenance Doses:
-If less than 6 weeks have elapsed since last maintenance dose, administer as soon as possible followed by injections at monthly intervals.
-If greater than 6 weeks but less than 6 months have elapsed since last monthly maintenance dose, and dose was less than 234 mg (US) or 150 mg (Canada); administer maintenance dose IM into deltoid muscle as soon as possible and repeat same dose IM into deltoid muscle 1 week later; then resume monthly dosing
-If greater than 6 weeks but less than 6 months have elapsed since monthly maintenance dose of 234 mg (US) or 150 mg (Canada), administer 156 mg (US) or 100 mg (Canada) IM into deltoid muscle as soon as possible followed by the same dose IM into deltoid muscle one week later; then resume normal monthly cycle.
-If more than 6 months have elapsed since last maintenance injection; re-initiate initial dosing schedule.

Use: For the treatment of schizophrenia.

Usual Adult Dose for Schizoaffective Disorder

Recommended dose: 6 mg orally once a day
Dose range: 3 to 12 mg per day; dose increases may be made in increments of 3 mg per day and should occur at intervals of more than 4 days.
Maximum dose: 12 mg per day

Comment: Initial dose titration is not required; greater effects may be seen with higher doses, however this must be weighed against dose-related increases in adverse events; doses above 6 mg per day have not been systematically studied for additional benefit.

Use: Treatment of schizoaffective disorder as monotherapy and as an adjunct to mood stabilizers and/or antidepressants.

Usual Pediatric Dose for Schizophrenia

12 to 17 years old:
Recommended dose: 3 mg orally once a day
Dose range: 3 to 12 mg per day; dose increases may be made in increments of 3 mg per day and should occur at intervals of more than 5 days.
Maximum dose: 12 mg per day

Comments: Initial dose titration is not required; in the adolescent schizophrenia trials, higher doses (6 mg per day in patients weighing less than 51 kg; 12 mg per day in patients weighing 51 kg or more) did not demonstrate greater efficacy, while adverse events were dose-related.

Use: Treatment of schizophrenia

Renal Dose Adjustments

Oral formulations:
CrCl 50 mL/min to less than 80 mL/min: Initial dose: 3 mg orally once a day; may increase to a maximum of 6 mg orally once a day based on efficacy and tolerability.
CrCl 10 mL/min to less than 50 mL/min: Initial dose: 1.5 mg orally once a day; may increase to a maximum of 3 mg orally once a day based on efficacy and tolerability.
CrCl less than 10 mL/min: Use not recommended

Extended release injectable suspension:
-US dosing: (Based on paliperidone palmitate):
CrCl 50 to less than 80 mL/min:
Initial dose: 156 mg IM on day 1 followed by 117 mg IM one week later; administer IM into deltoid muscle
Maintenance dose: 78 mg IM monthly; administer IM into deltoid or gluteal muscle
CrCl less than 50 mL/min: Use not recommended

-Canada dosing: (Based on paliperidone):
CrCl 50 to less than 80 mL/min:
Initial dose: 100 mg IM on day 1 followed by 75 mg IM one week later; administer IM into deltoid muscle
Maintenance dose: 50 mg IM monthly, adjusted within the range of 50 to 100 mg based on individual efficacy and tolerability; administer IM into deltoid or gluteal muscle
CrCl less than 50 mL/min: Use not recommended

Liver Dose Adjustments

Mild to moderate hepatic impairment (Child-Pugh Class A and B): No dosage adjustments required
Severe hepatic impairment: Data not available

Dose Adjustments

Concomitant Administration with Strong CYP450 3A4/P-glycoprotein (P-gp) Inducers:
-May be necessary to increase the dose of paliperidone when coadministered with a strong inducer of both CYP450 3A4 and P-gp (e.g., carbamazepine, rifampin, St John's wort).
-May need to decrease the dose of paliperidone when a strong inducer of both CYP450 3A4 and P-gp is discontinued.

-When switching patients currently at steady-state on a long acting antipsychotic injection; initiate paliperidone extended-release injection at next scheduled injection; the 1-week initiation dosing regimen will not be necessary.

Precautions

US BOXED WARNING:
Increased Mortality in Elderly Patients with Dementia-Related Psychosis
-Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death.
-Paliperidone is not approved for the treatment of patients with dementia-related psychosis.

Safety and efficacy of the long-acting injection in patients younger than 18 years have not been established.

Safety and efficacy of paliperidone in patients younger than 12 years in the treatment of schizophrenia have not been established.

Safety and efficacy of paliperidone in patients younger than 18 years in the treatment of schizoaffective disorder have not been established

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration Advice:
Oral Extended Release Tablets:
-Swallow whole, do not chew, divide or crush
-May take with or without food, however, best to always take with food or always without food; avoid alternating between the two
-The tablet shell is eliminated from the body and patients should not be concerned if they see a tablet in their stool

Extended-release injectable suspension:
-Should be administered by a health care professional by deep IM deltoid or gluteal injection using the appropriate enclosed safety needle; administer as a single injection; do not administer subcutaneously, intravascularly, or IV.
-The manufacturer product information should be consulted.

General:
-For patients who have missed a dose, see detailed missed dose instructions in the dosing section or manufacturer product information.
-Controlled clinical trials assessing long-term use are not available; the physician who prescribes paliperidone for extended periods should periodically re-evaluate the long-term risks and benefits of the drug for the individual patient.
-No specific recommendations are available regarding switching from other antipsychotics or for the use of concomitant antipsychotics.

Monitoring:
-Cardiovascular: Orthostatic vital signs in at-risk patients
-Hematologic: CBC frequently during the first few months in patients with preexisting low WBC and/or a prior history of drug-induced leukopenia or neutropenia
-Metabolic: Monitor for increases in blood sugar, weight, and lipids

Patient Advice:
-This drug may impair judgment, thinking, or motor skills; have patient avoid driving or operating machinery until adverse effects are determined.
-Advise patient to speak to physician or health care professional if pregnant, intend to become pregnant, or are breastfeeding.
-Advise patient that this drug may cause metabolic changes such as increases in blood sugar, body weight and lipids.

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