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Paliperidone extended-release tablets
INVEGA™ |
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FDA Approval: |
December 19, 2006 |
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Indication: |
Schizophrenia |
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Pharmacology: |
Benzisoxazole psychotropic (active metabolite of risperidone) |
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Usual Dose: |
6 mg orally once a day in the morning |
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Contraindications: |
Hypersensitivity to paliperidone, risperidone or any ingredients |
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Warnings: |
Antipsychotics have been associated with an increased risk of
cardiovascular events and mortality in elderly patients with
dementia-related psychosis, neuroleptic malignant syndrome, tardive
dyskinesia, hyperglycemia, dysphagia, and disruption of body
temperature regulation Paliperidone has been associated with
increased QTc interval, orthostatic hypotension, syncope, seizures,
hyperprolactinemia, somnolence, sedation, priapism, and antiemetic
effects
Caution is recommended in patients with recent myocardial
infarction, unstable heart disease, or other carvdiovascular disease
Tablets should not be cut, chewed, or crushed
Safety and efficacy have not been established in pediatric
patients or patients with severe hepatic impairment
Dose reduction is recommended in patients with renal impairment (CrCl
10 to 50 mL/min)
Mothers should not breastfeed during treatment |
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Pregnancy Category: |
C |
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Side Effects: |
Common: Akathisia, extrapyramidal disorder Dose-related:
Somnolence, orthostatic hypotension, salivary hypersecretion,
akathisia, dystonia, extrapyramidal disorder, hypertonia,
Parkinsonism |
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Drug Interactions: |
Alcohol CNS-active drugs
Dopamine agonists
Levodopa
Other drugs that may cause orthostatic hypotension
QT-prolonging drugs |
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