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New Dosages of Risperdal (Risperidone) Now Available

TITUSVILLE, N.J. -- March 24, 20006 -- Physicians treating people with schizophrenia or bipolar mania now have expanded treatment options: Two additional dosages (3 mg and 4 mg) of Risperdal(R) M-TAB(R), the fast- dissolving form of one of the most prescribed antipsychotic medications, Risperdal(R) (risperidone), are now available by prescription.

Risperdal M-Tabs are easy for patients to use because they dissolve in seconds when placed on the tongue. This is an alternative for healthcare professionals who may have patients who hide medication in their mouths to avoid taking it. Additionally, for patients who have difficulty or do not like swallowing pills, Risperdal M-Tabs can be an important alternative. The new delivery option offers benefits to healthcare professionals because there is no mixing, measuring or beverage required for administration. The two new dosages are now available.

Schizophrenia affects more than two million Americans(1) and is characterized by symptoms such as hallucinations, delusions, social withdrawal and a diminished capacity for organized thought.(2)

Bipolar mania is one aspect of bipolar disorder. People with bipolar mania may experience high levels of energy, unrealistic thoughts or ideas, and reckless and/or impulsive behavior. Of the more than three million Americans believed to suffer from bipolar disorder, two-thirds are often under-diagnosed and under-treated, according to the National Alliance for the Mentally Ill, the leading advocacy organization for people with mental illness.(3)

Risperdal has been marketed in tablet form in the United States since 1994. It is available as a standard, oral tablet in 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg and 4 mg doses; a quick-dissolving tablet (Risperdal M-TAB) in 0.5 mg, 1 mg and 2 mg doses (new 3 mg and 4 mg doses are now available); and an oral solution in a 1.0 mg/mL dose. Risperdal Consta(R) (risperidone) Long-Acting Injection is also available in 25 mg, 37.5 mg and 50 mg strengths, and is given by intramuscular injection every two weeks.

Risperdal(R) is indicated for the treatment of schizophrenia and for the short term treatment of bipolar mania in acute manic or mixed episodes of Bipolar I Disorder (manic depression). As with all other psychotropic medications, Risperdal(R) is associated with side effects.

Elderly patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk of death compared to placebo. Neither Risperdal nor Risperdal(R) Consta(R) is approved for the treatment of patients with Dementia-Related Psychosis.

The most common side effects that occurred with Risperdal in the treatment of Schizophrenia were: anxiety, sleepiness, restlessness, tremors, and muscle stiffness; dizziness, constipation, nausea, indigestion, runny nose, rash, and rapid heartbeat; in the treatment of Bipolar Mania either alone or in combination with a mood stabilizer (lithium or valproate) were: sleepiness, muscle stiffness, restlessness, tremor, indigestion, nausea, abnormal vision, muscle aches, dizziness, runny nose, diarrhea, increased saliva, stomach pain, and urinary incontinence. In a study of people taking Risperdal(R) Consta(R), most common side effects were: sleepiness, restlessness, tremors and muscle stiffness, stomach upset, constipation, dry mouth, feeling tired, and weight increase.

Studies suggest an increased risk of elevated blood sugar-related side effects, and sometimes potentially fatal, in patients treated with this class of medications, including Risperdal(R). Some people may need regular blood sugar testing.

Some people may have heard the term "tardive dyskinesia." These are usually persistent, uncontrollable, slow or jerky facial or body movements that can be caused by all medications of this type. A rare but serious side effect that has been reported with this kind of medicine, including Risperdal(R), is known as NMS or neuroleptic malignant syndrome. NMS is characterized by muscle rigidity, fever and can be serious.

Phenylketonurics: Risperdal M-TAB(R) contains phenylalanine

Risperdal M-TAB(R) is bioequivalent to Risperdal(R) Tablets


REFERENCES:
(1) Schizophrenia Research Fact Sheet. National Institute of Mental Health, Washington, D.C. http://nimh.gov/publicat/NIMHschizresfact.pdf
(2) Schizophrenia. National Institute of Mental Health, Washington, D.C. http://www.nimh.nih.gov/publicat/HIMHschizoph.pdf
(3) The National Alliance for the Mentally Ill, "Understanding Bipolar Disorder," page 1


SOURCE: Janssen, L.P.

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