Retrovir

Retrovir

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Questions & Answers

Side Effects & Adverse Reactions

There is currently no warning information available for this product. We apologize for any inconvenience.

Legal Issues

There is currently no legal information available for this drug.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

1.1 Schizophrenia

Risperidone oral solution, USP 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 oral solution, USP 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 oral solution, USP 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 oral solution, USP 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)].

History

There is currently no drug history available for this drug.

Other Information

Risperidone oral solution, USP contains risperidone, USP, 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 C23H27FN4O2 and its molecular weight is 410.49. The structural formula is:

6d47971f-figure-01

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.

Risperidone oral solution, USP is available as a 1 mg/mL oral solution. Risperidone oral solution, USP contains the following inactive ingredients: benzoic acid and purified water.

Retrovir Manufacturers


  • Viiv Healthcare Company
    Retrovir (Zidovudine) Capsule Retrovir (Zidovudine) Tablet, Film Coated Retrovir (Zidovudine) Syrup [Viiv Healthcare Company]
  • Viiv Healthcare Company
    Retrovir (Zidovudine) Injection, Solution [Viiv Healthcare Company]

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