Author: Charles Frank

Risperdal Uses, Dosages, Formulas & Drug Interactions

Pooled data from 7 placebo-controlled, 3-to 8-week, fixed-or flexible-dose studies in adult subjects with schizophrenia or bipolar mania are presented in Table 4. Patients with an established diagnosis of diabetes mellitus who are started on atypical antipsychotics, including RISPERDAL®, should be monitored regularly for worsening of glucose control. Any patient treated with atypical antipsychotics, including RISPERDAL®, should be monitored for symptoms of hyperglycemia including polydipsia, polyuria, polyphagia, and weakness. Patients who develop symptoms of hyperglycemia during treatment with atypical antipsychotics, including RISPERDAL®, should undergo fasting blood glucose testing. In some cases, hyperglycemia has resolved when the atypical antipsychotic, including RISPERDAL®, was discontinued; however, some patients required continuation of anti-diabetic treatment despite discontinuation of RISPERDAL®.

However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Talk to your care team about the use of this medication in children. While this medication may be prescribed for children as young as 5 years of age for selected conditions, precautions do apply. This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

Although appropriate studies on the relationship of age to the effects of risperidone have not been performed in the geriatric population, geriatric-specific problems are not expected to limit the usefulness of risperidone in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require caution and an adjustment in the dose for patients receiving risperidone. Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals.

Advise patients and caregivers to inform their physiciansif the patient is taking, or plans to take, any prescription orover-the-counter drugs, because there is a potential for interactions [see DRUGINTERACTIONS]. The pharmacokinetics of risperidone and 9-hydroxyrisperidone in children were similar to those in adults after correcting for the difference in body weight. CYP 2D6, also called debrisoquin hydroxylase, is the enzyme responsible for metabolism of many neuroleptics, antidepressants, antiarrhythmics, and other drugs.

A survey of treatment recommendations from top experts emphasizes that medication should not replace behavioral therapy. Most experts, including Dr. Nash, stress the importance of thoroughly investigating the causes of aggressive behavior as part of the evaluation for medication. Behavior problems can have many different sources, including undiagnosed anxiety, ADHD, learning disorders, trauma and medical problems. Treating those problems may allieviate the behavior issues in a more effective (and lasting) way than giving the child antipsychotic medication. Risperdal can be especially useful for times when a child is in crisis, such as when they have an extreme or dangerous outburst.

In plasma, risperidone is bound to albumin and α1-acid glycoprotein. The plasma protein binding of risperidone is approximately 90%, and that of its major metabolite, 9-hydroxyrisperidone, is 77%. Neither risperidone nor 9-hydroxyrisperidone displaces each other from plasma binding sites. RISPERDAL® is contraindicated in patients with a known hypersensitivity to either risperidone or paliperidone, or to any of the excipients in the RISPERDAL® formulation.

In clinical trials in 1885 children and adolescents treated with RISPERDAL®, 2 (0.1%) patients were reported to have tardive dyskinesia, which resolved on discontinuation of RISPERDAL® treatment [see also WARNINGS AND PRECAUTIONS]. Antipsychotic drugs have been shown to chronically elevate prolactin levels in rodents. An increase in mammary, pituitary, and endocrine pancreas neoplasms has been found in rodents after chronic administration of other antipsychotic drugs and is considered to be prolactin-mediated. The relevance for human risk of the findings of prolactin-mediated endocrine tumors in rodents is unclear [see WARNINGS AND PRECAUTIONS]. In a long-term, open-label extension study in adolescent patients with schizophrenia, weight increase was reported as a treatment-emergent adverse event in 14% of patients.

Drug Interactions for Risperdal

Be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). To reduce your risk of side effects, your doctor may direct you to start this medication at a low dose and gradually increase your dose. The efficacy of RISPERDAL® in the treatment of acute manic or mixed episodes was established in two short-term (3-week) placebo-controlled trials in patients who met the DSM-IV criteria for Bipolar I Disorder with manic or mixed episodes.

QT prolongation can rarely cause serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away. Rarely, males may have a painful or prolonged erection lasting 4 or more hours. If this occurs, stop using this drug and get medical help right away, or permanent problems could occur. Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

If signs and symptoms of tardive dyskinesia appear in a patient on RISPERDAL®, drug discontinuation should be considered. However, some patients may require treatment with RISPERDAL® despite the presence of the syndrome. RISPERDAL® (risperidone) is not approved for the treatment of dementia-related psychosis [see BOX WARNING]. Given the primary CNS effects of risperidone, caution should be used when RISPERDAL® is taken in combination with other centrally acting drugs and alcohol. RISPERDAL® M-TAB® (risperidone) Orally Disintegrating Tablets are etched on one side with “R0.5”, “R1”, “R2”, “R3”, or “R4” according to their respective strengths. RISPERDAL® MTAB® Orally Disintegrating Tablets 0.5 mg, 1 mg, and 2 mg are packaged in blister packs of 4 (2 X 2) tablets.

Risperidone Tablets

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Tardive dyskinesia may remit, partially or completely, if antipsychotic treatment is discontinued. Antipsychotic treatment, itself, however, may suppress (or partially suppress) the signs and symptoms of the syndrome, possibly masking the underlying process.

1. Prolactin levels should be measured frequently during the first few months of treatment.
2. It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements.
3. Caution is advised when prescribing for patients who will be exposed to temperature extremes.
4. Following oral administration of solution or tablet, mean peak plasma concentrations of risperidone occurred at about 1 hour.

In addition, the Positive and Negative Syndrome Scale (PANSS) and the Scale for Assessing Negative Symptoms (SANS) were employed. Rat offspring mortality increased during the first 4 days of lactation when pregnant rats were dosed throughout gestation at 0.16 to 5 mg/kg/day which are 0.1 to 3 times the MRHD of 16 mg/day based on mg/m2 body surface area. It is not known whether these deaths were due to a direct effect on the fetuses or pups or to effects on the dams; a no-effect dose could not be determined.

Description for Risperdal

Take this medication by mouth with or without food as directed by your doctor, usually once or twice daily.

To help you remember, take it at the same time(s) each day. Do not stop taking this medication without consulting your doctor. Inform patients with Phenylketonuria and caregivers thatRISPERDAL® M-TAB® Orally DisintegratingTablets contain phenylalanine. Infants exposed to RISPERDAL® through breastmilk should be monitored for excess sedation, failure to thrive, jitteriness, and extrapyramidal symptoms (tremors and abnormal muscle movements).

Death in Elderly Patients

Drowsiness, dizziness, lightheadedness, drooling, nausea, weight gain, or tiredness may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly. Advise patients and caregivers about the risk of orthostatic hypotension, especially during the period of initial dose titration[see WARNINGS AND PRECAUTIONS]. In vitro studies demonstrated that drugs metabolized by other CYP isozymes, including 1A1, 1A2, 2C9, 2C19, and 3A4, are only weak inhibitors of risperidone metabolism.

For children with disruptive behavior problems that haven’t reached a crisis stage, experts’ first choice  for treatment is behavioral therapy, including parent training, to rein things in. Depending on the level of risk, Dr. Nash says she might recommend a first trial of behavioral therapy, or medication together with behavioral therapy. The BPRS psychosis cluster (conceptual disorganization, hallucinatory behavior, suspiciousness, and unusual thought content) is considered a particularly useful subset for assessing actively psychotic schizophrenic patients. A second traditional assessment, the Clinical Global Impression (CGI), reflects the impression of a skilled observer, fully familiar with the manifestations of schizophrenia, about the overall clinical state of the patient.

A lot of doctors think kids who have behavior problems but are not in crisis should be treated with behavioral therapy instead of Risperdal. Behavioral therapy is aimed at changing aggressive and angry behavior. Pros and cons of this medication, used to treat children with severe behavior problems. Taking Risperdal with other drugs that make you sleepy or slow your breathing can cause dangerous or life-threatening side effects.