Risperidone Orally Disintegrating Tablets

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---------------------------------------------------RECENT MAJOR CHANGES-------------------------------------------------­ Indications and Usage, Schizophrenia/Adolescents (1.1) 08/2007 Indications and Usage, Bipolar Mania/Pediatrics (1.2) 08/2007 Dosage and Administration, Schizophrenia/Adolescents (2.1) 08/2007 Dosage and Administration, Bipolar Mania/Pediatrics (2.2) 08/2007 ----------------------------------------------------INDICATIONS AND USAGE------------------------------------------------Risperidone is an atypical antipsychotic agent indicated for: � � Treatment of schizophrenia in adults (1.1) Alone, or in combination with lithium or valproate, for the short-term treatment of acute manic or mixed episodes associated with Bipolar I Disorder in adults (1.2)

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RISPERDAL (risperidone) tablets, for oral use RISPERDAL (risperidone) oral solution RISPERDAL M-TAB (risperidone) orally disintegrating tablets Initial U.S. Approval: 1993 WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS

 Severe Renal or Hepatic Impairment in Adults: Use a lower starting dose of 0.5 mg twice daily. May increase to dosages above 1.5 mg twice daily at intervals of at least one week. (2.4)  Oral Solution: Can be administered directly from calibrated pipette or mixed with beverage (water, coffee, orange juice, or low-fat milk). (2.6)  M-TAB Orally Disintegrating Tablets: Open the blister only wh...

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Acceptability and disintegration rates of orally disintegrating risperidone tablets in patients with schizophrenia or schizoaffective disorder.

OBJECTIVE To investigate the disintegration profile, acceptability, and tolerability of orally disintegrating risperidone tablets in patients with schizophrenia or schizoaffective disorder. METHOD Ten patients stable for at least 10 days on monotherapy with oral risperidone 2 mg to 4 mg taken once daily were switched for 7 days to an equivalent dosage of orally disintegrating risperidone. Vis...

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Pharmacokinetic studies showed that RISPERDAL® M-TAB Orally Disintegrating Tablets and RISPERDAL® Oral Solution are bioequivalent to RISPERDAL® Tablets. Plasma concentrations of risperidone, its major metabolite, 9–hydroxyrisperidone, and risperidone plus 9–hydroxyrisperidone are dose

Risperidone is a white to slightly beige powder. It is practically insoluble in water, freely soluble in methylene chloride, and soluble in methanol and 0.1 N HCl. RISPERDAL® tablets are available in 0.25 mg (dark yellow), 0.5 mg (red-brown), 1 mg (white), 2 mg (orange), 3 mg (yellow), and 4 mg (green) strengths. Inactive ingredients are colloidal silicon dioxide, hypromellose, lactose, magnesi...

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Pharmacokinetic comparison of orally disintegrating, β-cyclodextrin inclusion complex and conventional tablets of nicardipine in rats

The goal of this study was to compare the pharmacokinetics of nicardipine hydrochloride orally disintegrating tablets and β-cyclodextrin inclusion complex with its conventional tablets. Forty-five rats were divided into three groups evaluating the effect of dosage forms on the pharmacokinetics of nicardipine hydrochloride. Blood samples were taken at predefined sampling points 0–24h after medic...

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Development and evaluation of orally disintegrating tablets of Pramipexole using full factorial design

Pramipexole is the mostly prescribed drug in patients with Parkinson disease. The incidence of Parkinson disease is related to aging and mostly developed in elderly people with difficulty in swallowing or dysphagia. In the current study we aimed to develop an orally fast disintegrating tablet (ODT) of pramipexole as a preferable alternative in geriatric patients. Hence, the fast disintegration ...

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تاریخ انتشار 2009