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 daily in the morning
Initial dose titration is not required

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.

Note: Although dosing of the active ingredient in the US and Canada is the same, paliperidone extended-release injectable suspension is dosed as paliperidone palmitate in the US and as paliperidone in Canada:

US dosing: (Based on paliperidone palmitate):
-Initial dose: 234 mg IM on day 1 followed by 156 mg IM one week later (on day 8). 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 monthly maintenance dose is 117 mg IM. Some patients may benefit from lower or higher maintenance doses within the recommended range of 39 mg to 234 mg based on patient tolerability and efficacy.

Canada dosing: (Based on paliperidone):
-Initial dose: 150 mg IM on day 1 followed by 100 mg IM one week later (on day 8). 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 monthly maintenance dose is 75 mg IM. Some patients may benefit from lower or higher maintenance doses within the recommended range of 50 mg to 150 mg based on patient tolerability and efficacy.

Approved indication: For the acute and maintenance treatment of schizophrenia and for the acute treatment of schizoaffective disorder both as monotherapy and as an adjunct to mood stabilizers and/or antidepressants.

Usual Adult Dose for Schizoaffective Disorder

Extended Release Tablets:
Recommended dose: 6 mg orally once daily in the morning
Initial dose titration is not required

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.

Note: Although dosing of the active ingredient in the US and Canada is the same, paliperidone extended-release injectable suspension is dosed as paliperidone palmitate in the US and as paliperidone in Canada:

US dosing: (Based on paliperidone palmitate):
-Initial dose: 234 mg IM on day 1 followed by 156 mg IM one week later (on day 8). 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 monthly maintenance dose is 117 mg IM. Some patients may benefit from lower or higher maintenance doses within the recommended range of 39 mg to 234 mg based on patient tolerability and efficacy.

Canada dosing: (Based on paliperidone):
-Initial dose: 150 mg IM on day 1 followed by 100 mg IM one week later (on day 8). 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 monthly maintenance dose is 75 mg IM. Some patients may benefit from lower or higher maintenance doses within the recommended range of 50 mg to 150 mg based on patient tolerability and efficacy.

Approved indication: For the acute and maintenance treatment of schizophrenia and for the acute treatment of schizoaffective disorder both as monotherapy and as an adjunct to mood stabilizers and/or antidepressants.

Usual Pediatric Dose for Schizophrenia

12 years to 17 years:
Weight less than 51 kg:
Initial Dose: 3 mg orally once daily in the morning
Recommended Dose: 3 to 6 mg orally once daily in the morning
Maximum Dose: 6 mg daily
Weight 51 kg or more:
Initial Dose: 3 mg orally daily in the morning
Recommended Dose: 3 to 12 mg orally daily in the morning
Maximum Dose: 12 mg daily

Approved indication: For the acute and maintenance treatment of schizophrenia.

Renal Dose Adjustments

Extended Release Tablets:
Dosing must be individualized according to the patient renal function status:
-Mild renal impairment (CrCl 50 to 80 mL/min):
Initial dose: 3 mg orally daily in the morning
Maximum dose: 6 mg orally once daily in the morning
-Moderate to severe renal impairment (CrCl 10 to less than 50 mL/min):
Initial dose 1.5 mg orally daily in the morning
Maximum dose: 3 mg orally once daily in the morning

Extended release injectable suspension:
-US dosing: (Based on paliperidone palmitate):
Mild renal impairment (CrCl 50 to 80 mL/min):
Initial dose: 156 mg IM on treatment day one and 117 mg IM on treatment day eight. This may be followed by monthly injections of 78 mg IM.
-Canada dosing: (Based on paliperidone):
Mild renal impairment (CrCl 50 to 80 mL/min):
Initial dose: 100 mg IM on treatment day one and 75 mg IM on treatment day eight. This may be followed by monthly injections of 50 mg IM.

Liver Dose Adjustments

-Mild or moderate hepatic impairment (Child-Pugh A or B): No adjustment recommended
-Severe hepatic impairment: Data not available

Dose Adjustments

Care should be taken in dose selection for elderly patients because they may have reduced renal function. Renal function may require monitoring in this population.

Extended Release Tablets:
-It has not been established that doses above 6 mg daily have additional benefit; however, some patients may benefit from a dose up to 12 mg daily. A dose of 3 mg daily may be sufficient for other patients. Dose increases above 6 mg daily should be made only after careful patient assessment and should occur at intervals of more than 5 days in the treatment of schizophrenia and more than 4 days in the treatment of schizoaffective disorder. Small increments of 3 mg daily are recommended. The maximum recommended dose is 12 mg daily.

For dose adjustments for paliperidone extended release injectable solution consult the package insert or local treatment guidelines.

Precautions

Consult WARNINGS section for dosing related precautions.

Dialysis

Data not available

Other Comments

Paliperidone may be administered with or without food, but high fat meals can increase absorption by 50% or greater.

Tablets must be swallowed whole with the aid of liquids. Tablets should not be chewed, divided, or crushed.

The tablet shell is eliminated from the body. Patients should not be concerned if they notice something that looks like a tablet in their stool.

The extended-release injectable suspension should be administered IM 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 a half inch 22 G needle regardless patient weight.

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.

Paliperidone extended-release injectable is intended for intramuscular use only. Inject slowly, deep into the muscle. Care should be taken to avoid inadvertent injection into a blood vessel. Each injection should be administered by a health care professional. Administration should be in a single injection, not in divided injections. Do not administer intravascularly or subcutaneously.

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