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

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چکیده

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, magnesium stearate, microcrystalline cellulose, propylene glycol, sodium lauryl sulfate, and starch (corn). Tablets of 0.25, 0.5, 2, 3, and 4 mg also contain talc and titanium dioxide. The 0.25 mg tablets contain yellow iron oxide; the 0.5 mg tablets contain red iron oxide; the 2 mg tablets contain FD&C Yellow No. 6 Aluminum Lake; the 3 mg and 4 mg tablets contain D&C Yellow No. 10; the 4 mg tablets contain FD&C Blue No. 2 Aluminum Lake. RISPERDAL® is also available as a 1 mg/mL oral solution. The inactive ingredients for this solution are tartaric acid, benzoic acid, sodium hydroxide, and purified water. RISPERDAL® M-TAB Orally Disintegrating Tablets are available in 0.5 mg (light coral), 1 mg (light coral), 2 mg (light coral), 3 mg (coral), and 4 mg (coral) strengths. RISPERDAL® M-TAB Orally Disintegrating Tablets contain the following inactive ingredients: Amberlite® resin, gelatin, mannitol, glycine, simethicone, carbomer, sodium hydroxide, aspartame, red ferric oxide, and peppermint oil. In addition, the 3 mg and 4 mg RISPERDAL® M-TAB Orally Disintegrating Tablets contain xanthan gum.

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منابع مشابه

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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Comparative pharmacokinetics and bioequivalence of two tablet formulations of 2 mg risperidone in healthy Thai male volunteers.

BACKGROUND Risperidone is an atypical antipsychotic drug with potent serotonin and moderate dopamine antagonistic properties. It possesses good bioavailability following oral administration. Risperidone is primarily converted by the cytochrome P450 2D6 (CYP2D6) and 3A4 (CYP3A4) enzymes to 9-hydroxyrisperidone, its active metabolite with equivalent potency to the parent compound. OBJECTIVE Thi...

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New Modified UPLC/Tandem Mass Spectrometry Method for Determination of Risperidone and Its Active Metabolite 9-Hydroxyrisperidone in Plasma: Application to Dose-Dependent Pharmacokinetic Study in Sprague-Dawley Rats

Sensitive and specific liquid-chromatography tandem mass spectrometry (UPLC-MS/MS) assay has been developed and validated for simultaneous quantification of risperidone (RIS) and its active metabolite 9-hydroxyrisperidone (9-OH-RIS) in rat plasma using olanzapine (OLA) as internal standard (IS). Pharmacokinetics of risperidone and its active metabolite 9-hydroxyrisperidone was compared across d...

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Low-Dose Antipsychotics for Relapse Prevention

A recall has been issued by Ortho-McNeil-Janssen Pharmaceuticals for specific lots of 3-mg Risperdal (risperidone) tablets and 2-mg generic risperidone tablets because of an uncharacteristic musty odor thought to come from trace amounts of 2,4,6-tribromoanisole (TBA), the metabolite of a chemical fungicide used to treat wooden pallets on which the products are stored.1 McNeil Consumer Health ha...

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Induction of Drug Transporters Alters Disposition of Risperidone - A Study in Mice

Pharmacokinetic interactions, e.g. modulation of drug transporters like P-glycoprotein at the blood-brain barrier, can be a reason for treatment non-response. This study focuses on the influence of induction of drug transporters on the disposition of the antipsychotic drugs risperidone and 9-hydroxyrisperidone. Brain and serum concentrations of risperidone and its active metabolite 9-hydroxyris...

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تاریخ انتشار 2006