Rx Item-Risperidone 0.5Mg ODT Tab 30 By Jubilant Cadista Pharma Gen Risperdal

Clinical Information
Gen. Code and Des.
52049 risperidone ORAL TAB RAPDIS 0.5 MG
GCN and Des.
19541 risperidone ORAL TAB RAPDIS 0.5 MG
Strength
0.5MG ODT
Dose Form
TABLET,DISINTEGRATING
Product Category
RX Pharmaceuticals
Fine Line Class
850085008510 All Rx Products
DEA Class
NC
OMP Family

AHFS Class
28160804 ATYPICAL ANTIPSYCHOTICS
28280000 ANTIMANIC AGENTS
Active Ingredients
4392 risperidone 106266062
Inactive Ingredients
2272 mannitol 69658
2605 aspartame 22839470
6364 magnesium aluminum silicate 1327431
7989 peppermint




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. RISPERDAL � (risperidone) is not approved for the treatment of patients with dementia-related psychosis. [See Warnings and Precautions (5.1)]

1 INDICATIONS AND USAGE

1.1 Schizophrenia


RISPERDAL � (risperidone) is indicated for the treatment of schizophrenia. Efficacy was established in 4 short-term trials in adults, 2 short-term trials in adolescents (ages 13 to 17 years), and one long-term maintenance trial in adults [see Clinical Studies (14.1)] .

1.2 Bipolar Mania
Monotherapy

RISPERDAL � is indicated for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder. Efficacy was established in 2 short-term trials in adults and one short-term trial in children and adolescents (ages 10 to 17 years) [see Clinical Studies (14.2)] .

Adjunctive Therapy

RISPERDAL � adjunctive therapy with lithium or valproate is indicated for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder. Efficacy was established in one short-term trial in adults [see Clinical Studies (14.3)] .

1.3 Irritability Associated with Autistic Disorder
RISPERDAL � is indicated for the treatment of irritability associated with autistic disorder, including symptoms of aggression towards others, deliberate self-injuriousness, temper tantrums, and quickly changing moods. Efficacy was established in 3 short-term trials in children and adolescents (ages 5 to 17 years) [see Clinical Studies (14.4)] .

2 DOSAGE AND ADMINISTRATION

Table 1. Recommended Daily Dosage by Indication
Initial Dose Titration (Increments) Target Dose Effective Dose Range
Schizophrenia: adults (2.1) 2 mg 1 to 2 mg 4 to 8 mg 4 to 16 mg
Schizophrenia: adolescents (2.2) 0.5 mg 0.5 to 1 mg 3 mg 1 to 6 mg
Bipolar mania: adults (2.2) 2 to 3 mg 1 mg 1 to 6 mg 1 to 6 mg
Bipolar mania: children and adolescents (2.2) 0.5 mg 0.5 to 1 mg 1 to 2.5 mg 1 to 6 mg
Irritability in autistic disorder (2.3) 0.25 mg Can increase to 0.5 mg by Day 4: (body weight less than 20 kg) 0.5 mg Can increase to 1 mg by Day 4: (body weight greater than or equal to 20 kg) After Day 4, at intervals of > 2 weeks: 0.25 mg (body weight less than 20 kg) 0.5 mg (body weight greater than or equal to 20 kg) 0.5 mg: (body weight less than 20 kg) 1 mg: (body weight greater than or equal to 20 kg) 0.5 to 3 mg
Severe Renal and 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 one week or longer.

2.1 Schizophrenia
Adults

Usual Initial Dose

RISPERDAL � can be administered once or twice daily. Initial dosing is 2 mg per day. May increase the dose at intervals of 24 hours or greater, in increments of 1 to 2 mg per day, as tolerated, to a recommended dose of 4 to 8 mg per day. In some patients, slower titration may be appropriate. Efficacy has been demonstrated in a range of 4 mg to 16 mg per day. However, doses above 6 mg per day for twice daily dosing were not demonstrated to be more efficacious than lower doses, were associated with more extrapyramidal symptoms and other adverse effects, and are generally not recommended. In a single study supporting once-daily dosing, the efficacy results were generally stronger for 8 mg than for 4 mg. The safety of doses above 16 mg per day has not been evaluated in clinical trial

Risperidone 0.5Mg ODT Tab 30 B
Item No.:RX218014/b, Item No. RX218014, 218014, NDC No.: 59746-0010-32, 59746-010-32, 5974601032, 59746001032, 0010-32, 001032 UPC No. 3-59746-01032-4, 359746-010324, 359746010324

Risperidone 0.5Mg ODT Tab 30 B
Item No.:RX218014/b, Item No. RX218014, 218014, NDC No.: 59746-0010-32, 59746-010-32, 5974601032, 59746001032, 0010-32, 001032 UPC No. 3-59746-01032-4, 359746-010324, 359746010324

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RX ITEM-Risperidone 0.5Mg ODT Tab 30 By
Item No.:RX218014/b, Item No. RX218014, 218014, NDC No.: 59746-0010-32, 59746-010-32, 5974601032, 59746001032, 0010-32, 001032 UPC No. 3-59746-01032-4, 359746-010324, 359746010324

Risperidone 0.5Mg ODT Tab 30 By Jubilan
Item No.:RX218014/b, Item No. RX218014, 218014, NDC No.: 59746-0010-32, 59746-010-32, 5974601032, 59746001032, 0010-32, 001032 UPC No. 3-59746-01032-4, 359746-010324, 359746010324

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