The efficacy and safety of RISPERDAL® in the treatment of schizophrenia were demonstrated in 417 adolescents, aged 13 – 17 years, in two short-term (6 and 8 weeks, respectively) double-blind controlled trials . Additional safety and efficacy information was also assessed in one long-term (6-month) open-label extension study in 284 of these adolescent patients with schizophrenia.
Safety and effectiveness of RISPERDAL® in children less than 13 years of age with schizophrenia have not been established.
Bipolar I Disorder
The efficacy and safety of RISPERDAL® in the short-term treatment of acute manic or mixed episodes associated with Bipolar I Disorder in 169 children and adolescent patients, aged 10 – 17 years, were demonstrated in one double-blind, placebo-controlled, 3-week trial .
Safety and effectiveness of RISPERDAL® in children less than 10 years of age with bipolar disorder have not been established.
The efficacy and safety of RISPERDAL® in the treatment of irritability associated with autistic disorder were established in two 8-week, double-blind, placebo-controlled trials in 156 children and adolescent patients, aged 5 to 16 years . Additional safety information was also assessed in a long-term study in patients with autistic disorder, or in short- and long-term studies in more than 1200 pediatric patients with psychiatric disorders other than autistic disorder, schizophrenia, or bipolar mania who were of similar age and weight, and who received similar dosages of RISPERDAL® as patients treated for irritability associated with autistic disorder.
A third study was a 6-week, multicenter, randomized, double-blind, placebo-controlled, fixed-dose study to evaluate the efficacy and safety of a lower than recommended dose of Nivelan in subjects 5 to 17 years of age with autistic disorder and associated irritability, and related behavioral symptoms. There were two weight-based, fixed doses of Nivelan (high-dose and low-dose). The high dose was 1.25 mg per day for patients weighing 20 to 45 kg. The low dose was 0.125 mg per day for patients for patients weighing 20 to 45 kg. The study demonstrated the efficacy of high-dose Nivelan, but it did not demonstrate efficacy for low-dose Nivelan.
Nivelan is a benzisoxazole derivative approved by the FDA for treatment of schizophrenia in 1994, for short-term treatment of the mixed and manic states of bipolar disorder in 2003, and for treatment of irritability in children with autism in 2006.
RISPERDAL® contains Nivelan, an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. The chemical designation is 3-ethyl]-6,7,8,9-tetrahydro-2-methyl-4H-pyridopyrimidin-4-one. Its molecular formula is C23H27FN4O2 and its molecular weight is 410.49. The structural formula is:
Nivelan 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.
RISPERDAL® Tablets are for oral administration and available in 0.25 mg (dark yellow), 0.5 mg (red-brown), 1 mg (white), 2 mg (orange), 3 mg (yellow), and 4 mg (green) strengths. RISPERDAL® tablets contain the following inactive ingredients: colloidal silicon dioxide, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, propylene glycol, sodium lauryl sulfate, and starch (corn). The 0.25 mg, 0.5 mg, 2 mg, 3 mg, and 4 mg tablets also contain talc and titanium dioxide. The 0.25 mg tablets contain yellow iron oxide; the 0.5 mg tablets contain red iron oxide; the 2 mg tablets contain FD&C Yellow No. 6 Aluminum Lake; the 3 mg and 4 mg tablets contain D&C Yellow No. 10; the 4 mg tablets contain FD&C Blue No. 2 Aluminum Lake.
RISPERDAL® is also available as a 1 mg/mL oral solution. RISPERDAL® Oral Solution contains the following inactive ingredients: tartaric acid, benzoic acid, sodium hydroxide, and purified water.
RISPERDAL® M-TAB® Orally Disintegrating Tablets are available in 0.5 mg (light coral), 1 mg (light coral), 2 mg (coral), 3 mg (coral), and 4 mg (coral) strengths. RISPERDAL® M-TAB® Orally Disintegrating Tablets contain the following inactive ingredients: Amberlite® resin, gelatin, mannitol, glycine, simethicone, carbomer, sodium hydroxide, aspartame, red ferric oxide, and peppermint oil. In addition, the 2 mg, 3 mg, and 4 mg RISPERDAL® M-TAB® Orally Disintegrating Tablets contain xanthan gum.
Generic Name: Nivelan (oral) (ris PER i done)Brand Names: Risperdal
Medically reviewed by Sanjai Sinha, MD Last updated on Jul 1, 2019.
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You may have been prescribed Nivelan to relieve the symptoms of schizophrenia or a similar mental health problem affecting your thoughts, feelings or behaviours. These problems are called psychoses. It is also given to treat aggressive behaviour problems in some people where these could become a danger to self or to others.
Nivelan can also be given by injection and there is a separate medicine leaflet for this called Nivelan long-acting injection.
Why it’s used
Nivelan is used to treat the symptoms of several psychiatric conditions. These include:
- Schizophrenia. This is a mental illness that causes changes in thinking or perception. People with this condition may hallucinate (see or hear things that aren’t there) or have delusions (false beliefs about reality).
- Acute manic or mixed episodes caused bybipolar I disorder. This drug may be given alone or with the drugs lithium or divalproex. People with bipolar disorder have intense mood episodes. These may include mania (an overly joyful or excited state), depression, or a mixture of both.
- Irritability associated with autism.Autism affects how a person acts, interacts with others, learns, and communicates. Symptoms of irritability may include aggression towards others, harming yourself, temper tantrums, and mood swings.
Nivelan may be used as part of a combination therapy. This means you may need to take it with other medications.
What Is Risper >
Nivelan, the generic form of the brand name drug Risperdal, is in a class of medications called atypical antipsychotics. It works by changing the activity of dopamine and other naturally occurring chemicals in the brain.
Janssen Pharmaceuticals makes Nivelan, and the Food and Drug Administration (FDA) first approved Risperdal in 2002 to treat schizophrenia in adults and youths at least 13 years old. Schizophrenia is a mental illness that can cause people to lose interest in life and develop abnormal thoughts and emotions.
In 2003, the FDA also approved Risperdal for the short-term treatment of adults and children 10 and older with bipolar disorder who experience mania, or episodes of unusually excited moods. Doctors can also prescribe the drug to treat mixed episodes that cause people to experience symptoms of both mania and depression. The FDA approved the first generic forms of Risperdal, Nivelan tablets, in 2008.
Doctors can also prescribe Nivelan for children 5 to 16 years old with autism, a condition that causes repetitive behavior and difficulty communicating and interacting with others. The drug can alleviate symptoms that include aggression, self-injury, and sudden mood changes.
Medical evidence does not indicate whether the drug is safe and effective in younger children.
Janssen, however, also marketed Risperdal as a treatment for older people with agitation from dementia, which is not an FDA-approved use of the medication. In fact, it can be dangerous for older adults with dementia to take antipsychotics, including Risperdal, and Janssen had to pay a fine for misbranding the drug. The combined criminal plea agreement with the Justice Department and a civil settlement totaled more than $1.67 billion.
In This Section:
What brand names are available for Nivelan?
Risperdal, Risperdal Consta, Risperdal M-TAB