RVP

Drug Catalog - Product Detail

RISPERIDONE TB 1MG 500

NDC Mfr Size Str Form
68382-0114-05 ZYDUS PHARMACEUTICALS (USA) 500 1MG TABLET
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Description
DESCRIPTION RISPERIDONE contains risperidone, an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. The chemical designation is 3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one. Its molecular formula is C 23 H 27 FN 4 O 2 and its molecular weight is 410.49. The structural formula is: Risperidone, USP 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. Each risperidone tablet intended for oral administration contains 0.25 mg or 0.5 mg or 1 mg or 2 mg or 3 mg or 4 mg of risperidone. Additionally each tablet also contains the following inactive ingredients: corn starch, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, propylene glycol, sodium lauryl sulfate, and titanium dioxide. Additionally each 0.25 mg tablet contains iron oxide red and iron oxide yellow, 0.5 mg tablet contains iron oxide red, 2 mg tablet contains FD&C yellow # 6/sunset yellow FCF aluminum lake, 3 mg tablet contains D&C yellow # 10 aluminum lake and 4 mg tablet contains D&C yellow # 10 aluminum lake and FD&C blue # 2/ indigo carmine aluminum lake. MM1
How Supplied
HOW SUPPLIED Risperidone Tablets USP, 0.25 mg are dark yellow, round, biconvex film-coated tablets debossed with "Z" on one side and "4" on the other side and are supplied as follows: NDC 68382-112-06in bottle of 30 tablets NDC 68382-112-14 in bottle of 60 tablets NDC 68382-112-16 in bottle of 90 tablets NDC 68382-112-01 in bottle of 100 tablets NDC 68382-112-05 in bottle of 500 tablets NDC 68382-112-10 in bottle of 1000 tablets Risperidone Tablets USP, 0.5 mg are red-brown colored, round, biconvex film-coated tablets debossed with "Z" on one side and "6" on other side and are supplied as follows: NDC 68382-113-06 in bottle of 30 tablets NDC 68382-113-14 in bottle of 60 tablets NDC 68382-113-16 in bottle of 90 tablets NDC 68382-113-01 in bottle of 100 tablets NDC 68382-113-05 in bottle of 500 tablets NDC 68382-113-10 in bottle of 1000 tablets Risperidone Tablets USP, 1 mg are white to off-white, round, biconvex film-coated tablets debossed with "ZC 75" on one side and plain on other side and are supplied as follows: NDC 68382-114-06 in bottle of 30 tablets NDC 68382-114-14 in bottle of 60 tablets NDC 68382-114-16 in bottle of 90 tablets NDC 68382-114-01 in bottle of 100 tablets NDC 68382-114-05 in bottle of 500 tablets NDC 68382-114-10 in bottle of 1000 tablets Risperidone Tablets USP, 2 mg are orange, round, biconvex film-coated tablets debossed with "ZC 76" on one side and plain on other side and are supplied as follows: NDC 68382-115-06 in bottle of 30 tablets NDC 68382-115-14 in bottle of 60 tablets NDC 68382-115-16 in bottle of 90 tablets NDC 68382-115-01 in bottle of 100 tablets NDC 68382-115-05 in bottle of 500 tablets NDC 68382-115-10 in bottle of 1000 tablets Risperidone Tablets USP, 3 mg are yellow, round, biconvex film-coated tablets debossed with "ZC 77"on one side and plain on other side and are supplied as follows: NDC 68382-116-06 in bottle of 30 tablets NDC 68382-116-14 in bottle of 60 tablets NDC 68382-116-16 in bottle of 90 tablets NDC 68382-116-01 in bottle of 100 tablets NDC 68382-116-05 in bottle of 500 tablets NDC 68382-116-10 in bottle of 1000 tablets Risperidone Tablets USP, 4 mg are green, round, biconvex film-coated tablets debossed with "ZC 78" on one side and plain on other side and are supplied as follows: NDC 68382-117-06 in bottle of 30 tablets NDC 68382-117-14 in bottle of 60 tablets NDC 68382-117-16 in bottle of 90 tablets NDC 68382-117-01 in bottle of 100 tablets NDC 68382-117-05 in bottle of 500 tablets NDC 68382-117-10 in bottle of 1000 tablets Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from light and moisture. Dispense in a tight, light-resistant container. Keep out of reach of children. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Indications & Usage
INDICATIONS & USAGE RISPERIDONE is an atypical antipsychotic indicated for: Treatment of schizophrenia ( 1.1 ) As monotherapy or adjunctive therapy with lithium or valproate, for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder ( 1.2 ) Treatment of irritability associated with autistic disorder ( 1.3 ) RISPERIDONE (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 ) ]. Monotherapy RISPERIDONE 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 RISPERIDONE 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 ) ]. Pediatrics RISPERIDONE 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 ) ].
Dosage and Administration
DOSAGE & ADMINISTRATION Recommended daily dosage: Summary of Heart Protection Study Results Initial Dose Target Dose Effective Dose Range Schizophrenia: adults (2.1) 2 mg 4 to 8 mg 4 to 16 mg Schizophrenia: adolescents (2.1) 0.5 mg 3 mg 1 to 6 mg Bipolar mania: Adults (2.2) 2 to 3 mg 1 to 6 mg 1 to 6 mg Bipolar mania: in children and adolescents (2.2) 0.5 mg 1 to 2.5 mg 1 to 6 mg Irritability associated with autistic disorder 0.25 mg (Weight < 20 kg) 0.5 mg (<20 kg) 0.5 to 3 mg (2.3) 1 mg 0.5 mg (Weight ≥ 20 kg) (≥ 20 kg) 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) Table 1Recommended 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 1mg 1 to 6mg 1 to 6 mg Bipolar mania : children and adolescents ( 2 . 2 ) 0.5 mg 0.5 to 1mg 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 at one week or longer Adults Usual Initial Dose RISPERIDONE 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. 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 trials [see Clinical Studies ( 14.1 ) ]. Adolescents The initial dose is 0.5 mg once daily, administered as a single-daily dose in the morning or evening. The dose may be adjusted at intervals of 24 hours or greater, in increments of 0.5 mg or 1 mg per day, as tolerated, to a recommended dose of 3 mg per day. Although efficacy has been demonstrated in studies of adolescent patients with schizophrenia at doses between 1 mg to 6 mg per day, no additional benefit was observed above 3 mg per day, and higher doses were associated with more adverse events. Doses higher than 6 mg per day have not been studied. Patients experiencing persistent somnolence may benefit from administering half the daily dose twice daily. Maintenance Therapy While it is unknown how long a patient with schizophrenia should remain on RISPERIDONE, the effectiveness of RISPERIDONE 2 mg per day to 8 mg per day at delaying relapse was demonstrated in a controlled trial in adult patients who had been clinically stable for at least 4 weeks and were then followed for a period of 1 to 2 years [see Clinical Studies (14.1) ]. Both adult and adolescent patients who respond acutely should generally be maintained on their effective dose beyond the acute episode. Patients should be periodically reassessed to determine the need for maintenance treatment. Reinitiation of Treatment in Patients Previously Discontinued Although there are no data to specifically address reinitiation of treatment, it is recommended that after an interval off RISPERIDONE, the initial titration schedule should be followed. Switching From Other Antipsychotics There are no systematically collected data to specifically address switching schizophrenic patients from other antipsychotics to RISPERIDONE, or treating patients with concomitant antipsychotics. Usual Dose Adults The initial dose range is 2 mg to 3 mg per day. The dose may be adjusted at intervals of 24 hours or greater, in increments of 1 mg per day. The effective dose range is 1 mg to 6 mg per day, as studied in the short-term, placebo-controlled trials. In these trials, short-term (3 week) anti-manic efficacy was demonstrated in a flexible dosage range of 1 mg to 6 mg per day [see Clinical Studies ( 14.2 , 14.3 ) ]. RISPERIDONE doses higher than 6 mg per day were not studied. Pediatrics The initial dose is 0.5 mg once daily, administered as a single-daily dose in the morning or evening. The dose may be adjusted at intervals of 24 hours or greater, in increments of 0.5 mg or 1 mg per day, as tolerated, to the recommended target dose of 1mg to 2.5 mg per day. Although efficacy has been demonstrated in studies of pediatric patients with bipolar mania at doses between 0.5 mg and 6 mg per day, no additional benefit was observed above 2.5 mg per day, and higher doses were associated with more adverse events. Doses higher than 6 mg per day have not been studied. Patients experiencing persistent somnolence may benefit from administering half the daily dose twice daily. Maintenance Therapy There is no body of evidence available from controlled trials to guide a clinician in the longer-term management of a patient who improves during treatment of an acute manic episode with RISPERIDONE. While it is generally agreed that pharmacological treatment beyond an acute response in mania is desirable, both for maintenance of the initial response and for prevention of new manic episodes, there are no systematically obtained data to support the use of RISPERIDONE in such longer-term treatment (i.e., beyond 3 weeks). The physician who elects to use RISPERIDONE for extended periods should periodically re-evaluate the long-term risks and benefits of the drug for the individual patient. The dosage of RISPERIDONE should be individualized according to the response and tolerability of the patient. The total daily dose of RISPERIDONE can be administered once daily, or half the total daily dose can be administered twice daily. For patients with body weight less than 20 kg, initiate dosing at 0.25 mg per day. For patients with body weight greater than or equal to 20 kg, initiate dosing at 0.5 mg per day. After a minimum of four days, the dose may be increased to the recommended dose of 0.5 mg per day for patients less than 20 kg and 1 mg per day for patients greater than or equal to 20 kg. Maintain this dose for a minimum of 14 days. In patients not achieving sufficient clinical response, the dose may be increased at intervals of 2 weeks or greater, in increments of 0.25 mg per day for patients less than 20 kg, or increments of 0.5 mg per day for patients greater than or equal to 20 kg. The effective dose range is 0.5 mg to 3 mg per day. No dosing data are available for children who weigh less than 15 kg. Once sufficient clinical response has been achieved and maintained, consider gradually lowering the dose to achieve the optimal balance of efficacy and safety. The physician who elects to use RISPERIDONE for extended periods should periodically re-evaluate the long-term risks and benefits of the drug for the individual patient. Patients experiencing persistent somnolence may benefit from a once-daily dose administered at bedtime or administering half the daily dose twice daily, or a reduction of the dose. For patients with severe renal impairment (CLcr < 30 mL/min) or hepatic impairment (10 to 15 points on Child Pugh System), the initial starting dose is 0.5 mg twice daily. The dose may be increased in increments of 0.5 mg or less, administered twice daily. For doses above 1.5 mg twice daily, increase in intervals of one week or greater [see Use in Specific Populations ( 8.6 and 8.7 ) ]. When RISPERIDONE is coadministered with enzyme inducers (e.g., carbamazepine), the dose of RISPERIDONE should be increased up to double the patient's usual dose. It may be necessary to decrease the RISPERIDONE dose when enzyme inducers such as carbamazepine are discontinued [see Drug Interactions ( 7.1 ) ]. Similar effect may be expected with coadministration of RISPERIDONE with other enzyme inducers (e.g., phenytoin, rifampin, and phenobarbital). When fluoxetine or paroxetine is coadministered with RISPERIDONE, the dose of RISPERIDONE should be reduced. The RISPERIDONE dose should not exceed 8 mg per day in adults when coadministered with these drugs. When initiating therapy, RISPERIDONE should be titrated slowly. It may be necessary to increase the RISPERIDONE dose when enzyme inhibitors such as fluoxetine or paroxetine are discontinued [see Drug Interactions ( 7.1 ) ].