Risperidone 1 MG Oral Tablet
1 INDICATIONS AND 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 ) 1.1 schizophrenia 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 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 )] . 1.3 Irritability Associated with Autistic Disorder 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 )].
Solco Healthcare US, LLC
ROUND WHITE HH 223
HH 223 ROUND WHITE
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16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied
RISPERIDONE Tablets
RISPERIDONE Tablets, USP are imprinted with "HH" on one side and either "221","222","223","224","225", or "226" on the other side according to their respective strengths. 0.25 mg dark yellow, round, biconvex film-coated tablets: NDC 43547-339-06 Bottles of 60 NDC 43547-339-50 Bottles of 500 0.5 mg red brown, round, biconvex film-coated tablets: NDC 43547-340-06 Bottles of 60 NDC 43547-340-50 Bottles of 500 1 mg white, round, biconvex film-coated tablets: NDC 43547-341-06 Bottles of 60 NDC 43547-341-50 Bottles of 500 2 mg red, round, biconvex film-coated tablets: NDC 43547-342-06 Bottles of 60 NDC 43547-342-50 Bottles of 500 3 mg yellow, round, biconvex film-coated tablets: NDC 43547-343-06 Bottles of 60 NDC 43547-343-50 Bottles of 500 4 mg white, round, biconvex film-coated tablets: NDC 43547-344-06 Bottles of 60 NDC 43547-344-50 Bottles of 500 16.2 Storage and Handling
RISPERIDONE Tablets should be stored at controlled room temperature 15°-25°C (59°-77°F). Protect from light and moisture. Keep out of reach of children.
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