Generic equivalent of PALIPERIDONE
11 SKUs available · In stock · NABP accredited · DSCSA compliant
Paliperidone is the generic equivalent of the brand-name drug PALIPERIDONE. Licensed pharmacies, clinics, doctor's offices, and veterinary practices can source wholesale Paliperidone through Premier Pharma with same-day fulfillment on in-stock SKUs.
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 extended-release tablets are not approved for the treatment of patients with dementia-related psychosis. [see Warnings and Precautions (5.1) ] WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS See full prescribing information for complete boxed warning. 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 use in patients with dementia-related psychosis. ( 5.1 )
Source: FDA prescribing information. For licensed professionals only.
1 INDICATIONS AND USAGE Paliperidone is an atypical antipsychotic agent indicated for Treatment of schizophrenia ( 1.1 ) Adults: Efficacy was established in three 6-week trials and one maintenance trial. ( 14.1 ) Adolescents (ages 12 to 17): Efficacy was established in one 6-week trial. ( 14.1 ) Treatment of schizoaffective disorder as monotherapy and as an adjunct to mood stabilizers and/or antidepressants. ( 1.2 ) Efficacy was established in two 6-week trials in adult patients. ( 14.2 ) 1.1 Schizophrenia Paliperidone extended-release tablets are indicated for the treatment of schizophrenia [see Clinical Studies (14.1) ] . The efficacy of paliperidone extended-release tablets in schizophren…
12.1 Mechanism of Action Paliperidone is the major active metabolite of risperidone. The mechanism of action of paliperidone in schizophrenia is unclear. However, the drug's therapeutic effect in schizophrenia could be mediated through a combination of central dopamine Type 2 (D 2 ) and serotonin Type 2 (5HT 2A ) receptor antagonism.
12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action Paliperidone is the major active metabolite of risperidone. The mechanism of action of paliperidone in schizophrenia is unclear. However, the drug's therapeutic effect in schizophrenia could be mediated through a combination of central dopamine Type 2 (D 2 ) and serotonin Type 2 (5HT 2A ) receptor antagonism. 12.2 Pharmacodynamics In vitro , paliperidone acts as an antagonist at the central dopamine Type 2 (D 2 ) and serotonin Type 2 (5HT 2A ) receptors, with binding affinities (Ki values) of 1.6 nM to 2.8 nM for D 2 and 0.8 nM to 1.2 nM for 5HT 2A receptors. Paliperidone is also active as an antagonist at the α 1 and α 2 adrenergic receptors…
4 CONTRAINDICATIONS 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. Known hypersensitivity to paliperidone, risperidone, or to any excipients in paliperidone extended-release tablets. ( 4 )
6 ADVERSE REACTIONS The following adverse reactions are discussed in more detail in other sections of the labeling: Increased mortality in elderly patients with dementia-related psychosis [see Boxed Warning and Warnings and Precautions (5.1)] Cerebrovascular adverse reactions, including stroke, in elderly patients with dementia-related psychosis [see Warnings and Precautions (5.2)] Neuroleptic malignant syndrome [see Warnings and Precautions (5.3)] QT prolongation [see Warnings and Precautions (…
7 DRUG INTERACTIONS Centrally-acting drugs: Due to CNS effects, use caution in combination. Avoid alcohol. ( 7.1 ) Drugs that may cause orthostatic hypotension: An additive effect may be observed when co-administered with paliperidone extended-release tablets. ( 7.1 ) Strong CYP3A4/P-glycoprotein (P-gp) inducers: It may be necessary to increase the dose of paliperidone extended-release tablets when a strong inducer of both CYP3A4 and P-gp (e.g., carbamazepine) is co-administered. Conversely, on…
2 DOSAGE AND ADMINISTRATION Initial Dose Recommended Dose Maximum Dose Schizophrenia - adults ( 2.1 ) 6 mg/day 3 mg/day to 12 mg/day 12 mg/day Schizophrenia-adolescents ( 2.1 ) Weight < 51 kg 3 mg/day 3 mg/day to 6 mg/day 6 mg/day Weight ≥ 51 kg 3 mg/day 3 mg/day to 12 mg/day 12 mg/day Schizoaffective disorder - adults ( 2.2 ) 6 mg/day 3 mg/day to 12 mg/day 12 mg/day Tablet should be swallowed whole and should not be chewed, divided, or crushed. ( 2.3 ) 2.1 Schizophrenia Adults The recommended d…
17 PATIENT COUNSELING INFORMATION Physicians are advised to discuss the following issues with patients for whom they prescribe paliperidone extended-release tablets. Neuroleptic Malignant Syndrome (NMS) Counsel patients about a potentially fatal adverse reaction, Neuroleptic Malignant Syndrome (NMS), that has been reported in association with administration of antipsychotic drugs. Advise patients, family members, or caregivers to contact their healthcare provider or report to the emergency room if they experience signs and symptoms of NMS, including hyperpyrexia, muscle rigidity, altered menta…
Source: FDA. For professional use only. Not a substitute for prescribing information.
| Name | Status |
|---|---|
| PALIPERIDONE ER 3MG 30 TAB | In Stock |
| PALIPERIDONE ER 6MG 30 TAB | In Stock |
| PALIPERIDONE ER 9MG 30 TAB | In Stock |
| PALIPERIDONE ER 1.5 MG 30 TAB | 2-Day |
| PALIPERIDONE ER 1.5MG 30 TAB ANI Pharmaceuticals, Inc. | 2-Day |
| PALIPERIDONE ER 3 MG 30 TAB | 2-Day |
| PALIPERIDONE ER 3MG 30 TAB ANI Pharmaceuticals, Inc. | 2-Day |
| PALIPERIDONE ER 6 MG 30 TAB | 2-Day |
| PALIPERIDONE ER 6MG 30 TAB ANI Pharmaceuticals, Inc. | 2-Day |
| PALIPERIDONE ER 9 MG 30 TAB | 2-Day |
| PALIPERIDONE ER 9MG 30 TAB ANI Pharmaceuticals, Inc. | 2-Day |
Premier Pharma stocks 11 Paliperidone SKUs — 3 currently in stock — available to licensed pharmacies, clinics, doctor's offices, and veterinary practices. Paliperidone is the generic equivalent of PALIPERIDONE. Create a free account to see live wholesale pricing and place orders with same-day fulfillment for in-stock items.
Premier Pharma carries Paliperidone in 1.5 mg/1, 3 mg/1, 6 mg/1, 9 mg/1 and TABLET, EXTENDED RELEASE, TABLET, FILM COATED, EXTENDED RELEASE. Available from manufacturers including ANI Pharmaceuticals, Inc..
Paliperidone carries an FDA Orange Book TE code of AB. Therapeutically equivalent — meets FDA bioequivalence requirements; may be substituted for the reference listed drug. Always verify substitution with the current Orange Book before dispensing.
12.1 Mechanism of Action Paliperidone is the major active metabolite of risperidone. The mechanism of action of paliperidone in schizophrenia is unclear. However, the drug's therapeutic effect in schizophrenia could be mediated through a combination of central dopamine Type 2 (D 2 ) and serotonin Type 2 (5HT 2A ) receptor antagonism.
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