Risperger tablets

Risperger

  • Active Ingredient: Risperidone
  • 4 mg, 2 mg, 1 mg
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What is Risperger?

The active ingredient of Risperger brand is risperidone. Risperidone is a antipsychotic medicine. It works by changing the effects of chemicals in the brain. 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 tablets, USP are for oral administration and available in 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg strengths. Inactive ingredients are lactose monohydrate, microcrystalline cellulose, colloidal silicon dioxide, magnesium stearate, hypromellose, titanium dioxide and polyethylene glycol 400. The 0.25 mg, 0.5 mg, 3 mg and 4 mg tablets contain D&C Yellow # 10 aluminum lake. The 0.5 mg and 4 mg tablets also contain FD&C Blue # 2 aluminum lake. The 2 mg tablets contain iron oxide yellow, iron oxide red, and iron oxide black.

Used for

Risperger is used to treat diseases such as: Agitation, Anxiety, Asperger Syndrome, Autism, Bipolar Disorder, Body Dysmorphic Disorder, Borderline Personality Disorder, Depression, Head Injury, Mania, Nightmares, Paranoid Disorder, Post Traumatic Stress Disorder, Schizoaffective Disorder, Schizophrenia, Severe Mood Dysregulation, Social Anxiety Disorder, Tic Disorder.

Side Effect

Possible side effects of Risperger include: difficulty concentrating; diarrhea; sleepiness or unusual drowsiness; increase in amount of urine; decreased interest in sexual intercourse.

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2.1.1 Autism Spectrum Disorder

Risperger has received a great deal of attention for its potential therapeutic effects on serious behavior problems in youth with ASD. In 2002, the National Institute of Mental Health Research Units on Pediatric Psychopharmacology Autism Network (RUPP) identified 101 children for the presence of high parent-rated Irritability subscale scores (≥18) on the Aberrant Behavior Checklist (ABC; Aman, Singh, Stewart, & Field, 1985 ; RUPP, 2002 ). A double-blind, placebo-controlled, parallel-groups design was used to compare behavior over 8 weeks. Risperger, given in doses from 0.5 to 3.5 mg/day, resulted in a 57% reduction in Irritability subscale ratings as compared with a 14% reduction for placebo. Substantial improvements were also seen on the Stereotypic Behavior and the Hyperactivity/Noncompliance subscales and nominally significant changes occurred for the social withdrawal and inappropriate speech subscales with Risperger treatment. Weight was significantly increased in the Risperger group as were appetite, fatigue, drowsiness, dizziness, and drooling. Seventy-five percent of the Risperger participants were rated as much or very much improved in the Clinical Global Impressions-Improvement (CGI-I) scale as compared with 11% of placebo subjects.

Risperger responders from this trial were followed for an additional 16 weeks and then enrolled in a discontinuance study ( RUPP Autism, 2005 ). Sixteen participants were eventually assigned to placebo substitution, whereas another 16 were assigned to risper >

Shea et al. (2004) treated 79 children (5–12 years) with ASD with either placebo or Risperger for 8 weeks in a double-blind, parallel-groups study. Statistically significant improvements were seen on the Irritability, Hyperactivity/Noncompliance, and Lethargy/Social Withdrawal subscales of the ABC and on the Conduct Problem subscale of the Nisonger Child Behavior Rating Form (NCBRF) as rated by the children’s parents. Fifty-four percent of Risperger-treated subjects were rated as much or very much improved on the CGI-I as compared with 18% of placebo-treated subjects. Somnolence, abdominal pain, headache, and constipation were more frequent in the Risperger group than the placebo group, and subjects gained more weight with Risperger.

No specific pharmacokinetic study was conducted to investigate race and gender effects, but a population pharmacokinetic analysis did not identify important differences in the disposition of Risperger due to gender (whether corrected for body weight or not) or race.

COMMON BRAND(S): Risperdal

GENERIC NAME(S): Risperger

There may be a slightly increased risk of serious, possibly fatal side effects (such as stroke, heart failure, fast/irregular heartbeat, pneumonia) when this medication is used by older adults with dementia. This medication is not approved for the treatment of dementia-related behavior problems. Discuss the risks and benefits of this medication, as well as other effective and possibly safer treatments for dementia-related behavior problems, with the doctor.

If you are using Risperger in combination with other medication to treat depression, also carefully read the drug information for the other medication.

Risperger is used to treat certain mental/mood disorders (such as schizophrenia, bipolar disorder, irritability associated with autistic disorder). This medication can help you to think clearly and take part in everyday life.

Risperger belongs to a class of drugs called atypical antipsychotics. It works by helping to restore the balance of certain natural substances in the brain.

Why is this medication prescribed?

Risperger is used to treat the symptoms of schizophrenia (a mental illness that causes disturbed or unusual thinking, loss of interest in life, and strong or inappropriate emotions) in adults and teenagers 13 years of age and older. It is also used to treat episodes of mania (frenzied, abnormally excited, or irritated mood) or mixed episodes (symptoms of mania and depression that happen together) in adults and in teenagers and children 10 years of age and older with bipolar disorder (manic depressive disorder; a disease that causes episodes of depression, episodes of mania, and other abnormal moods). Risperger is also used to treat behavior problems such as aggression, self-injury, and sudden mood changes in teenagers and children 5 to 16 years of age who have autism (a condition that causes repetitive behavior, difficulty interacting with others, and problems with communication). Risperger is in a class of medications called atypical antipsychotics. It works by changing the activity of certain natural substances in the brain.

What Are the Most Common and Serious Side Effects of Risperger?

Common side effects of Risperger (Risperdal) include:

  • Sleepiness
  • Dizziness
  • Nausea or vomiting
  • Diarrhea
  • Constipation
  • Heartburn
  • Dry mouth
  • Increased saliva
  • Increased appetite
  • Weight gain
  • Stomach pain
  • Anxiety
  • Agitation
  • Restlessness
  • More frequent dreaming
  • Trouble sleeping
  • Low sex drive or sexual problems
  • Unusual breast milk production
  • Vision problems
  • Muscle or joint pain
  • Dry or discolored skin
  • Trouble urinating

Serious side effects can also occur while taking Risperger. If you have any of these side effects, call your doctor immediately:

  • Fever
  • Muscle stiffness
  • Confusion
  • Fast or irregular pulse
  • Sweating
  • Abnormal movements of your face or body that you cannot control
  • Lightheadedness
  • Seizures
  • Slow movements or shuffling walk
  • Rash
  • Hives
  • Itching
  • Trouble breathing or swallowing
  • Painful erection that lasts for hours

Juvenile Animal Studies

Juvenile dogs were treated for 40 weeks with oral Risperger doses of 0.31, 1.25, or 5 mg/kg/day. Decreased bone length and density were seen, with a no-effect dose of 0.31 mg/kg/day. This dose produced plasma levels (AUC) of Risperger plus its active metabolite paliperidone (9-hydroxy-Risperger) which were similar to those in children and adolescents receiving the maximum recommended human dose (MRHD) of 6 mg/day. In addition, a delay in sexual maturation was seen at all doses in both males and females. The above effects showed little or no reversibility in females after a 12 week drug-free recovery period.

In a study in which juvenile rats were treated with oral Risperger from days 12 to 50 of age, a reversible impairment of performance in a test of learning and memory was seen, in females only, with a no-effect dose of 0.63 mg/kg/day. This dose produced plasma levels (AUC) of Risperger plus paliperidone about half those observed in humans at the MRHD. No other consistent effects on neurobehavioral or reproductive development were seen up to the highest testable dose (1.25 mg/kg/day). This dose produced plasma levels (AUC) of Risperger plus paliperidone which were about two thirds of those observed in humans at the MRHD.

IMPORTANT WARNING:

Studies have shown that older adults with dementia (a brain disorder that affects the ability to remember, think clearly, communicate, and perform daily activities and that may cause changes in mood and personality) who take antipsychotics (medications for mental illness) such as Risperger have an increased risk of death during treatment. Older adults with dementia may also have a greater chance of having a stroke or ministroke during treatment. Tell your doctor and pharmacist if you are taking furosemide (Lasix).

Risperger is not approved by the Food and Drug Administration (FDA) for the treatment of behavior problems in older adults with dementia. Talk to the doctor who prescribed this medication if you, a family member, or someone you care for has dementia and is taking Risperger. For more information visit the FDA website: http://www.fda.gov/Drugs

Outcome and Management

The serum aminotransferase elevations that occur on Risperger therapy are usually self-limited and often do not require dose modification or discontinuation of therapy. No instances of acute liver failure or vanishing bile duct syndrome have been attributed to Risperger. A single case of autoimmune hepatitis due to Risperger has been published. There may be some cross reactivity to liver injury between Risperger and quetiapine, but usually not with clozapine and olanzapine.

What is Risperger, and how does it work (mechanism of action)?

Risperger is an atypical antipsychotic drug that is used for treating schizophrenia, bipolar mania, and autism. Other atypical antipsychotic drugs include olanzapine (Zyprexa), quetiapine (Seroquel), ziprasidone (Geodon), aripiprazole (Abilify) and paliperidone (Invega). Atypical antipsychotics differ from typical antipsychotics because they cause a lesser degree of movement (extrapyramidal) side effects and constipation. Risperdal Consta is an injectable, long-acting form of Risperger.

The exact mechanism of action of Risperger is not known, but, like other anti-psychotics, it is believed that Risperger affects the way the brain works by interfering with communication among the brain's nerves. Nerves communicate with each other by making and releasing chemicals called neurotransmitters. The neurotransmitters travel to other nearby nerves where they attach to receptors on the nerves. The attachment of the neurotransmitters either stimulates or inhibits the function of the nearby nerves. Risperger blocks several of the receptors on nerves including dopamine type 2, serotonin type 2, and alpha 2 adrenergic receptors. It is believed that many psychotic illnesses are caused by abnormal communication among nerves in the brain and that by altering communication through neurotransmitters, Risperger can alter the psychotic state. Risperger was approved by the FDA in December 1993.

Getting the most from your treatment

  • Remember to keep your regular doctor's appointments so that your progress can be checked. If you are taking Risperger long-term, you may need to have some tests from time to time.
  • If you drink alcohol, ask your doctor for advice about drinking while you are on Risperger. Alcohol will increase the chance that you experience side-effects and is unlikely to be recommended for you.
  • If you are having an operation, tell the person carrying out the treatment which medicines you are taking. This is important because Risperger may interfere with any anaesthetic you receive. If you are having cataract surgery, it is particularly important that you tell your surgeon you are on Risperger. This is because an eye problem known as 'floppy iris syndrome' has developed in some people and your doctor will want to advise you about the risk of this.
  • If you buy or take any 'over-the-counter' medicines, check with a pharmacist that they are suitable to take with Risperger.
  • If you have diabetes you may need to check your blood glucose more frequently as Risperger can affect the levels of sugar in your blood. Your doctor will advise you about this.
  • When Risperger has been taken for a while, stopping treatment suddenly can cause problems. If you have been taking it regularly for a year or so, your doctor will probably want you to reduce your dose gradually if this becomes necessary.

Risper >About Risperger
  • Before taking Risperger
  • How to take Risperger
  • Getting the most from your treatment
  • Can Risperger cause problems?
  • How to store Risperger
  • Important information about all medicines
  • Risper > Risperger 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. In 2007 it was approved as a treatment for schizophrenia and bipolar disorder in children. Its pharmacology is characterized by binding affinity for 5-HT 2A receptors that is 20 times that for D2-dopamine receptors. D2-receptor affinity is approximately 50 times, and 5-HT2A receptor affinity approximately 20 times that of clozapine. Risperger also has strong affinity for α1-/α2-adrenergic and H1-histamine receptors. Affinity for D1 receptors is low, and it has no affinity at muscarinic receptors. Protein binding is 90%, and it is metabolized by CYP 2D6. D2-receptor occupancy at therapeutic doses is 63% to 89%, which would be expected to be associated with a significant incidence of EPS. 110 The addition of strong serotonergic antagonism, with a 5-HT2 receptor occupancy of 95%, is thought to confer protection against D2 antagonist effects on the nigrostriatal pathway, and the incidence of EPS is low. Nonetheless, unlike other SGAs with relatively lower affinities for D2 receptors that permit dynamic responses to surges in dopamine, Risperger is tightly bound and does cause significant hyperprolactinemia. 111,112 It can also cause orthostatic hypotension during early treatment. Risperger does not cause prolongation of the QTc and is less arrhythmogenic than other antipsychotics. It carries a boxed warning for increased risk of death in older patients receiving antipsychotics for dementia-related psychosis.

    Increased Mortality In Elderly Patients With Dementia-Related Psychosis

    Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analyses of 17 placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in drug-treated patients of between 1.6 to 1.7 times the risk of death in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patients is not clear.

    In two of four placebo-controlled trials in elderly patients with dementia-related psychosis, a higher incidence of mortality was observed in patients treated with furosemide plus RISPERDAL® when compared to patients treated with RISPERDAL® alone or with placebo plus furosemide. No pathological mechanism has been identified to explain this finding, and no consistent pattern for cause of death was observed.

    RISPERDAL® (Risperger) is not approved for the treatment of dementia-related psychosis .


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