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MICROMEDEX® Healthcare Series MICROMEDEX®Case 3:09-cv-00080-TMB Healthcare Series :Document Document 78-31 Filed 03/24/2010 Page 1 Paofg 209e 1 of 127 DRUGDEX® Evaluations RISPERIDONE 0.0 Overview 1) Class a) This drug is a member of the following class(es): Antipsychotic Benzisoxazole 2) Dosing Information a) Adult 1) if overlapping of antipsychotics is necessary, in all cases, the period of overlapping should be minimized; if swi antipsychotics and if medically appropriate, initiate risperidone therapy in place of the next scheduled injection (Pr RISPERDAL M-TAB(R) tablets, oral solution, orally disintegrating tablets, 2005) 2) previous oral antipsychotics should be continued for 3 weeks following the initiation of therapy with risperidone that adequate therapeutic concentrations are maintained until the main release phase of risperidone from the injec RISPERDAL(R) CONSTA(R) long acting injection, 2009) a) Bipolar I disorder 1) (oral, monotherapy or in combination with lithium or valproate) initial, 2 to 3 mg ORALLY once a day ( tablets, 2007; Prod Info RISPERDAL(R) M-TAB orally disintegrating tablets, 2007; Prod Info RISPERDA 2) (oral, monotherapy or in combination with lithium or valproate) maintenance, dosage adjustments sho mg/day at intervals of at least 24 hours; doses higher than 6 mg/day have not been evaluated in clinical t oral tablets, 2007; Prod Info RISPERDAL(R) M-TAB orally disintegrating tablets, 2007; Prod Info RISPER 3) (intramuscular, monotherapy or in combination with lithium or valproate) initiation of therapy, recomm oral risperidone prior to initiation of treatment with the risperidone long-acting IM injection; oral risperidon medication should be given with the initial injection and should be continued for 3 weeks and then discon (R) CONSTA(R) long acting injection, 2009) 4) initial, 25 mg IM every 2 weeks (Prod Info RISPERDAL(R) CONSTA(R) long acting injection, 2009) 5) (intramuscular, monotherapy or in combination with lithium or valproate) maintenance, dose may be i at intervals of at least 4 weeks; clinical effects of dose adjustment should not be expected earlier than 3 w higher dose; MAX 50 mg IM every 2 weeks (Prod Info RISPERDAL(R) CONSTA(R) long acting injection b) Schizophrenia 1) (oral) initial, 1 mg ORALLY twice daily, with increases in increments of 1 mg twice daily on the second target dose of 3 mg twice daily on the third day OR 1 mg ORALLY once daily, with increases to 2 mg dai dose of 4 mg once daily on the third day (Prod Info RISPERDAL(R), RISPERDAL M-TAB(R) tablets, ora tablets, 2005) 2) (oral) maintenance, small, ORAL dose increments/decrements of 1 to 2 mg are recommended at inte Maximal effect is usually seen within a range of 4 to 8 mg/day. Doses above 6 mg/day for twice-daily dos efficacious than lower doses; the safety of doses above 16 mg/day has not been evaluated in clinical tria RISPERDAL M-TAB(R) tablets, oral solution, orally disintegrating tablets, 2005) 3) (intramuscular) initiation of therapy, recommended to establish tolerability to oral risperidone prior to i risperidone long-acting IM injection; oral risperidone or another antipsychotic medication should be given should be continued for 3 weeks and then discontinued (Prod Info RISPERDAL(R) CONSTA(R) long act 4) initial, 25 mg IM every 2 weeks (Prod Info RISPERDAL(R) CONSTA(R) long acting injection, 2009) 5) (intramuscular) maintenance, dose may be increased to 37.5 mg or 50 mg IM at intervals of at least 4 adjustment should not be expected earlier than 3 weeks after the injection of the higher dose; MAX 50 m RISPERDAL(R) CONSTA(R) long acting injection, 2009) b) Pediatric 1) safety and effectiveness of long-acting risperidone injection has not been established in pediatric patients unde RISPERDAL(R) CONSTA(R) long acting injection, 2009) 2) safety and effectiveness of oral risperidone in pediatric patients less than 13 years of age with schizophrenia o mania have not been established (Prod Info RISPERDAL(R) oral tablets, 2007; Prod Info RISPERDAL(R) M-TAB 2007; Prod Info RISPERDAL(R) oral solution, 2007) 3) safety and effectiveness or oral risperidone in pediatric patients less than 5 years of age with autistic disorder h Info RISPERDAL(R) oral tablets, 2007; Prod Info RISPERDAL(R) M-TAB orally disintegrating tablets, 2007; Prod solution, 2007) a) Autistic disorder - Irritability 1) dosing individualized according to the response and tolerability (Prod Info RISPERDAL(R) oral tablets disintegrating tablets, 2006) 2) (weight less than 20 kg) initial, 0.25 mg ORALLY once a day or half the total daily dose given twice da minimum of 4 days to 0.5 mg/day (Prod Info RISPERDAL(R) oral tablets, oral solution, orally-disintegrati 3) (weight less than 20 kg) maintenance, 0.5 mg ORALLY once a day or half the total daily dose given tw a minimum of 14 days and may increase doses at 2-week intervals or longer, in increments of 0.25 mg p clinical response; use with caution in children weighing less than 15 kg (Prod Info RISPERDAL(R) oral ta disintegrating tablets, 2006) Exhibit E.23, page 1 http://www.thomsonhc.com/hcs/librarian/PFDefaultActionId/pf.PrintReady 7/1/2009 MICROMEDEX®Case 3:09-cv-00080-TMB Healthcare Series :Document Document 78-31 Filed 03/24/2010 Page 2 Paofg 209e 2 of 127 4) (weight 20 kg or greater) initial, 0.5 mg ORALLY once a day or half the total daily dose given twice da minimum of 4 days to 1 mg/day (Prod Info RISPERDAL(R) oral tablets, oral solution, orally-disintegrating 5) (weight 20 kg or greater) maintenance, 1 mg ORALLY once a day or half the total daily dose given tw minimum of 14 days; may increase doses at 2-week intervals or longer, in increments of 0.5 mg per day response (Prod Info RISPERDAL(R) oral tablets, oral solution, orally-disintegrating tablets, 2006) 6) in patients with persistent somnolence, a once-daily dose at bedtime or half the daily dose twice daily be considered (Prod Info RISPERDAL(R) oral tablets, oral solution, orally-disintegrating tablets, 2006) b) Bipolar I disorder 1) (10 years and older) initial, 0.5 mg ORALLY once daily as a single dose in the morning or evening; ad than 24 hours and in increments of 0.5 to 1 mg/day up to a maximum recommended dose of 2.5 mg/day tablets, 2007; Prod Info RISPERDAL(R) M-TAB orally disintegrating tablets, 2007; Prod Info RISPERDA c) Schizophrenia 1) (13 years and older) initial, 0.5 mg ORALLY once daily as a single dose in the morning or evening; ad than 24 hours and in increments of 0.5 to 1 mg/day up to a recommended dose of 3 mg/day (Prod Info R Prod Info RISPERDAL(R) M-TAB orally disintegrating tablets, 2007; Prod Info RISPERDAL(R) oral solut 3) Contraindications a) hypersensitivity to risperidone or to any product component (Prod Info RISPERDAL(R) CONSTA(R) long acting inje RISPERDAL(R) oral tablets, solution, RISPERDAL(R) M-TAB(R) orally disintegrating tablets, 2008) 4) Serious Adverse Effects a) Agranulocytosis b) Death c) Diabetic ketoacidosis d) Hypothermia e) Leukopenia f) Neuroleptic malignant syndrome g) Neutropenia h) Pancreatitis i) Priapism j) Purpura k) Seizure l) Sudden cardiac death m) Syncope n) Tardive dyskinesia o) Thrombocytopenia p) Thrombotic thrombocytopenic purpura 5) Clinical Applications a) FDA Approved Indications 1) Autistic disorder - Irritability 2) Bipolar I disorder 3) Schizophrenia 1.0 Dosing Information Drug Properties Storage and Stability Adult Dosage Pediatric Dosage 1.1 Drug Properties A) Information on specific products and dosage forms can be obtained by referring to the Tradename List (Product Ind B) Synonyms Risperidone C) Physicochemical Properties 1) Molecular Weight a) 410.49 (Canada, 1997) 2) pKa a) pKa1: 8.24 ; pKa2: 3.11 (Prod Info Risperdal, 93) 1.2 Storage and Stability A) Preparation 1) Intramuscular route Exhibit E.23, page 2 http://www.thomsonhc.com/hcs/librarian/PFDefaultActionId/pf.PrintReady 7/1/2009 MICROMEDEX®Case 3:09-cv-00080-TMB Healthcare Series :Document Document 78-31 Filed 03/24/2010 Page 3 Paofg 209e 3 of 127 a) Preparation 1) Risperidone long-acting injection must only be suspended in the diluent supplied by the manufacturer and diluent to come to room temperature prior to reconstitution. After injecting the diluent into the vial, sh minimum of 10 seconds. The suspension should appear uniform, thick, and milky in color. The particles w particle should remain. It should be used immediately after suspension and must be used within 6 hours pass before injection, resuspend by shaking vigorously, as settling will occur over time once the product RISPERDAL(R) CONSTA(R) long acting injection, 2009). b) Administration 1) Do NOT inject intravenously. Administer by deep intramuscular injection into the deltoid or gluteal mu arms or two buttocks. Use a 1-inch 21 gauge needle for deltoid injection and a 2-inch 20 gauge needle fo combine different dosage strengths in a single administration (Prod Info RISPERDAL(R) CONSTA(R) lon 2) Oral route a) Orally Disintegrating Tablets 1) Oral disintegrating tablets are supplied in blister packs and should not be opened until ready for use. do NOT push the tablet through the foil backing because this could damage the tablet. Use dry hands to unit and immediately place the entire tablet on the tongue. The tablet should be consumed immediately o unit. Tablets disintegrate in the mouth within seconds and can be swallowed subsequently with or withou tablet (Prod Info RISPERDAL(R), RISPERDAL M-TAB(R) tablets, oral solution, orally disintegrating table b) Oral Solution 1) Calibrated dispensing-pipettes are provided with risperidone oral solution.
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