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Paliperidone
Overview
What is Paliperidone?
Paliperidone, the active ingredient in Paliperidone Extended-Release Tablets, is a psychotropic agent belonging to the chemical class of benzisoxazole derivatives. Paliperidone Extended-Release Tablets contain a racemic mixture of (+)- and (-)- paliperidone. The chemical name is (±)-3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-9-hydroxy-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one. Its molecular formula is CHFNO and its molecular weight is 426.49. The structural formula is:
Paliperidone is sparingly soluble in 0.1N HCl and methylene chloride; practically insoluble in water, 0.1N NaOH, and hexane; and slightly soluble in N,N-dimethylformamide.
Paliperidone Extended-Release Tablets are available in 1.5 mg (orange-brown), 3 mg (white), 6 mg (beige), and 9 mg (pink) strengths. Paliperidone Extended-Release Tablets utilizes OROS osmotic drug-release technology .
Inactive ingredients are carnauba wax, cellulose acetate, hydroxyethyl cellulose, propylene glycol, polyethylene glycol, polyethylene oxides, povidone, sodium chloride, stearic acid, butylated hydroxytoluene, hypromellose, titanium dioxide, and iron oxides. The 3 mg tablets also contain lactose monohydrate and triacetin.
What does Paliperidone look like?
What are the available doses of Paliperidone?
Tablets: 1.5 mg, 3 mg, 6 mg, and 9 mg ()
What should I talk to my health care provider before I take Paliperidone?
How should I use Paliperidone?
Paliperidone Extended-Release Tablets are indicated for the treatment of schizophrenia .
The efficacy of Paliperidone Extended-Release Tablets in schizophrenia was established in three 6-week trials in adults and one 6-week trial in adolescents, as well as one maintenance trial in adults.
Tablet should be swallowed whole and should not be chewed, divided, or crushed. ()
What interacts with Paliperidone?
Sorry No Records found
What are the warnings of Paliperidone?
Sorry No Records found
What are the precautions of Paliperidone?
Sorry No Records found
What are the side effects of Paliperidone?
Sorry No records found
What should I look out for while using Paliperidone?
Paliperidone Extended-Release Tablets are contraindicated in patients with a known hypersensitivity to either paliperidone or risperidone, or to any of the excipients in the Paliperidone Extended-Release Tablets formulation. Hypersensitivity reactions, including anaphylactic reactions and angioedema, have been reported in patients treated with risperidone and in patients treated with paliperidone. Paliperidone is a metabolite of risperidone.
Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analyses of 17 placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in drug-treated patients of between 1.6 to 1.7 times the risk of death in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patients is not clear. Paliperidone Extended-Release Tablets are not approved for the treatment of patients with dementia-related psychosis.
What might happen if I take too much Paliperidone?
How should I store and handle Paliperidone?
Store at 20º to 25ºC (68º to 77ºF); excursions permitted to 15º to 30ºC (59º to 86ºF) [see USP Controlled Room Temperature].Paliperidone Extended-Release Tablets are available in the following strengths and packages. All tablets are capsule-shaped.1.5 mg tablets are orange-brown and imprinted with "PAL 1.5", and are available in bottles of 30 (NDC 10147-0951-3).3 mg tablets are white and imprinted with "PAL 3", and are available in bottles of 30 (NDC 10147-0952-3) and hospital unit dose packs of 100 (NDC 10147-0952-1).6 mg tablets are beige and imprinted with "PAL 6", and are available in bottles of 30 (NDC 10147-0953-3) and hospital unit dose packs of 100 (NDC 10147-0953-1).9 mg tablets are pink and imprinted with "PAL 9", and are available in bottles of 30 (NDC 10147-0954-3) and hospital unit dose packs of 100 (NDC 10147-0954-1).Paliperidone Extended-Release Tablets are available in the following strengths and packages. All tablets are capsule-shaped.1.5 mg tablets are orange-brown and imprinted with "PAL 1.5", and are available in bottles of 30 (NDC 10147-0951-3).3 mg tablets are white and imprinted with "PAL 3", and are available in bottles of 30 (NDC 10147-0952-3) and hospital unit dose packs of 100 (NDC 10147-0952-1).6 mg tablets are beige and imprinted with "PAL 6", and are available in bottles of 30 (NDC 10147-0953-3) and hospital unit dose packs of 100 (NDC 10147-0953-1).9 mg tablets are pink and imprinted with "PAL 9", and are available in bottles of 30 (NDC 10147-0954-3) and hospital unit dose packs of 100 (NDC 10147-0954-1).Paliperidone Extended-Release Tablets are available in the following strengths and packages. All tablets are capsule-shaped.1.5 mg tablets are orange-brown and imprinted with "PAL 1.5", and are available in bottles of 30 (NDC 10147-0951-3).3 mg tablets are white and imprinted with "PAL 3", and are available in bottles of 30 (NDC 10147-0952-3) and hospital unit dose packs of 100 (NDC 10147-0952-1).6 mg tablets are beige and imprinted with "PAL 6", and are available in bottles of 30 (NDC 10147-0953-3) and hospital unit dose packs of 100 (NDC 10147-0953-1).9 mg tablets are pink and imprinted with "PAL 9", and are available in bottles of 30 (NDC 10147-0954-3) and hospital unit dose packs of 100 (NDC 10147-0954-1).Paliperidone Extended-Release Tablets are available in the following strengths and packages. All tablets are capsule-shaped.1.5 mg tablets are orange-brown and imprinted with "PAL 1.5", and are available in bottles of 30 (NDC 10147-0951-3).3 mg tablets are white and imprinted with "PAL 3", and are available in bottles of 30 (NDC 10147-0952-3) and hospital unit dose packs of 100 (NDC 10147-0952-1).6 mg tablets are beige and imprinted with "PAL 6", and are available in bottles of 30 (NDC 10147-0953-3) and hospital unit dose packs of 100 (NDC 10147-0953-1).9 mg tablets are pink and imprinted with "PAL 9", and are available in bottles of 30 (NDC 10147-0954-3) and hospital unit dose packs of 100 (NDC 10147-0954-1).Paliperidone Extended-Release Tablets are available in the following strengths and packages. All tablets are capsule-shaped.1.5 mg tablets are orange-brown and imprinted with "PAL 1.5", and are available in bottles of 30 (NDC 10147-0951-3).3 mg tablets are white and imprinted with "PAL 3", and are available in bottles of 30 (NDC 10147-0952-3) and hospital unit dose packs of 100 (NDC 10147-0952-1).6 mg tablets are beige and imprinted with "PAL 6", and are available in bottles of 30 (NDC 10147-0953-3) and hospital unit dose packs of 100 (NDC 10147-0953-1).9 mg tablets are pink and imprinted with "PAL 9", and are available in bottles of 30 (NDC 10147-0954-3) and hospital unit dose packs of 100 (NDC 10147-0954-1).
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Paliperidone is the major active metabolite of risperidone. The mechanism of action of paliperidone, as with other drugs having efficacy in schizophrenia, is unknown, but it has been proposed that the drug's therapeutic activity in schizophrenia is mediated through a combination of central dopamine Type 2 (D) and serotonin Type 2 (5HT) receptor antagonism.
Non-Clinical Toxicology
Paliperidone Extended-Release Tablets are contraindicated in patients with a known hypersensitivity to either paliperidone or risperidone, or to any of the excipients in the Paliperidone Extended-Release Tablets formulation. Hypersensitivity reactions, including anaphylactic reactions and angioedema, have been reported in patients treated with risperidone and in patients treated with paliperidone. Paliperidone is a metabolite of risperidone.Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analyses of 17 placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in drug-treated patients of between 1.6 to 1.7 times the risk of death in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patients is not clear. Paliperidone Extended-Release Tablets are not approved for the treatment of patients with dementia-related psychosis.
The renal effects of nephrotoxic compounds may be potentiated by carboplatin.
Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Paliperidone Extended-Release Tablets are not approved for the treatment of dementia-related psychosis .
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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