Risperidone 0.25 MG Disintegrating Oral Tablet
1 INDICATIONS AND USAGE Risperidone orally disintegrating tablets are 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 orally disintegrating tablets are indicated for the treatment of schizophrenia. Efficacy was established in four short-term trials in adults, two 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 orally disintegrating tablets are indicated for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder. Efficacy was established in two 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 orally disintegrating tablet 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 orally disintegrating tablets are 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 three short-term trials in children and adolescents (ages 5 to 17 years) [see Clinical Studies (14.4) ] .
Mylan Pharmaceuticals Inc.
ROUND WHITE M R25
DISCLAIMER:
"This tool does not provide medical advice, and is for informational and educational purposes only, and is not a substitute for professional medical advice, treatment or diagnosis. Call your doctor to receive medical advice. If you think you may have a medical emergency, please dial 911."
"Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service."
"This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product."
PillSync may earn a commission via links on our site
16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied Risperidone Orally Disintegrating Tablets, USP are available containing 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg or 4 mg of risperidone, USP. The 0.25 mg tablets are white, round, unscored tablets debossed with M on one side of the tablet and R25 on the other side. They are available as follows: NDC 0378-6042-28 bottles of 28 tablets The 0.5 mg tablets are white, round, unscored tablets debossed with M over RN on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-6043-28 bottles of 28 tablets The 1 mg tablets are white, round, unscored tablets debossed with M over RN1 on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-6044-28 bottles of 28 tablets The 2 mg tablets are peach, round, unscored tablets debossed with M over RN2 on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-6045-28 bottles of 28 tablets The 3 mg tablets are green, round, unscored tablets debossed with M over RN3 on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-6046-28 bottles of 28 tablets The 4 mg tablets are blue, round, unscored tablets debossed with M over RN4 on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-6047-28 bottles of 28 tablets 16.2 Storage and Handling Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light and moisture. Keep this and all medication out of the reach of children. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.
More pills like ROUND M R25