Author: Alex Thompson

Risperdal Oral: Uses, Side Effects, Interactions, Pictures, Warnings & Dosing

Although not all of these side effects may occur, if they do occur they may need medical attention. Do not stop taking this medicine without first checking with your doctor. Your doctor may want you to gradually reduce the amount you are taking before stopping it completely. This is to prevent side effects and to keep your condition from becoming worse. It is very important that your doctor check your or your child’s progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.

The above effects showed little or no reversibility in females after a 12 week drug-free recovery period. No pathological mechanism has been identified to explain this finding, and no consistent pattern for cause of death was observed. Both adult and adolescent patients who respond acutely should generally be maintained on their effective dose beyond the acute episode.

1. CYP 2D6, also called debrisoquin hydroxylase, is the enzyme responsible for metabolism of many neuroleptics, antidepressants, antiarrhythmics, and other drugs.
2. If directed, you may mix the measured dose with a small amount of liquid (3 to 4 ounces/about 100 milliliters) such as water, coffee, orange juice, or low-fat milk.
3. Dose adjustment is not recommended for RISPERDAL® when co-administered with ranitidine, cimetidine, amitriptyline, or erythromycin [see Table 18].
4. Rarely, males may have a painful or prolonged erection lasting 4 or more hours.
5. RISPERDAL® MTAB® Orally Disintegrating Tablets 0.5 mg, 1 mg, and 2 mg are packaged in blister packs of 4 (2 X 2) tablets.

Use the dosing syringe provided, or use a medicine dose-measuring device (not a kitchen spoon). Risperidone can pass into breast milk and may cause side effects in the baby. If you breast-feed while using Risperdal, tell your doctor if the baby has symptoms such as drowsiness, tremors, or involuntary muscle movements. While you are taking this medicine, you may be more sensitive to temperature extremes such as very hot or cold conditions. Avoid getting too cold, or becoming overheated or dehydrated.

International Patients

Weight gain has been observed with atypical antipsychotic use. Pooled data from three double-blind, placebo-controlled schizophrenia studies and four double-blind, placebo-controlled bipolar monotherapy studies are presented in Table 2. The risk of developing tardive dyskinesia and the likelihood that it will become irreversible increase with the duration of treatment and the cumulative dose. The syndrome can develop after relatively brief treatment periods, even at low doses. When fluoxetine or paroxetine is co-administered with RISPERDAL®, the dose of RISPERDAL® should be reduced.

Get your prescription refilled before you run out of medicine completely. Follow all directions on your prescription label and read all medication guides or instruction sheets. Stop using Risperdal and call your doctor at once if you have fever, stiff muscles, confusion, sweating, fast or uneven heartbeats, restless muscle movements in your face or neck, tremor (uncontrolled shaking), trouble swallowing, feeling light-headed, or fainting. Risperdal is not approved for use in older adults with dementia-related psychosis.

DRUGS AND MEDICATIONS CENTER

Limited data from published literature reports the presence of risperidone and its metabolite, 9-hydroxyrisperidone, in human breast milk at relative infant dose ranging between 2.3% and 4.7% of the maternal weight-adjusted dosage. There are reports of sedation, failure to thrive, jitteriness, and extrapyramidal symptoms (tremors and abnormal muscle movements) in breastfed infants exposed to risperidone (see Clinical Considerations). There is no information on the effects of risperidone on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for RISPERDAL® and any potential adverse effects on the breastfed child from RISPERDAL® or from the mother’s underlying condition. Antipsychotic drugs have been shown to chronically elevate prolactin levels in rodents.

If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco. Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. 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. For non-prescription products, read the label or package ingredients carefully.

Risperidone oral tablet can interact with other medications, vitamins, or herbs you may be taking. If these effects are mild, they may go away within a few days or a couple of weeks. If they’re more severe or don’t go away, talk with your doctor or pharmacist.

Be sure to tell your doctor about all medications, vitamins, or herbs you’re taking. To find out how this drug might interact with something else you’re taking, talk with your doctor or pharmacist. It’s thought that people with schizophrenia, bipolar disorder, and autism have an imbalance of certain neurotransmitters. Older adults may be more sensitive to the side effects of this drug, especially drowsiness, dizziness, lightheadedness, and QT prolongation (see above). Drowsiness, dizziness, and lightheadedness can increase the risk of falling.

Consequently, patients should be evaluated carefully for a history of drug abuse, and such patients should be observed closely for signs of RISPERDAL® misuse or abuse (e.g., development of tolerance, increases in dose, drug-seeking behavior). The following additional adverse reactions occurred across all placebo-controlled, active-controlled, and open-label studies of RISPERDAL® in adults and pediatric patients. RISPERIDONE (ris PER i done) treats schizophrenia, bipolar disorder, and autism spectrum disorder. It works by balancing the levels of dopamine and serotonin in your brain, substances that help regulate mood, behaviors, and thoughts.

FDA warning: Increased risk of death in seniors with dementia

The dose of RISPERDAL® should be adjusted when used in combination with CYP2D6 enzyme inhibitors (e.g., fluoxetine, and paroxetine) and enzyme inducers (e.g., carbamazepine) [see Table 18 and DOSAGE AND ADMINISTRATION]. Dose adjustment is not recommended for RISPERDAL® when co-administered with ranitidine, cimetidine, amitriptyline, or erythromycin [see Table 18]. Patients experiencing persistent somnolence may benefit from a once-daily dose administered at bedtime or administering half the daily dose twice daily, or a reduction of the dose. Patients experiencing persistent somnolence may benefit from administering half the daily dose twice daily.

Highlights for risperidone

It belongs to a group of medications called antipsychotics. Antipsychotic medications can be used to treat several kinds of mental health conditions. Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Risperidone

It also comes as an injection that’s only given by a healthcare provider. Oral risperidone (0.16 to 5 mg/kg) impaired mating, but not fertility, in rat reproductive studies at doses 0.1 to 3 times the MRHD of 16 mg/day based on mg/m2 body surface area. The effect appeared to be in females, since impaired mating behavior was not noted in the male fertility study. In a subchronic study in Beagle dogs in which risperidone was administered orally at doses of 0.31 to 5 mg/kg, sperm motility and concentration were decreased at doses 0.6 to 10 times the MRHD based on mg/m2 body surface area.

Get medical help right away, if you have any of the symptoms listed above. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medication affects you. Do not stand or sit up quickly, especially if you are an older patient.

In these trials, approximately 33% of the RISPERDAL® group had weight gain ≥7%, compared to 7% in the placebo group. In longer-term, uncontrolled, open-label pediatric studies, the mean weight gain was 5.5 kg at Week 24 and 8 kg at Week 48 [see WARNINGS AND PRECAUTIONS and ADVERSE REACTIONS]. Cerebrovascular adverse reactions (e.g., stroke, transient ischemic attack), including fatalities, were reported in patients (mean age 85 years; range 73-97) in trials of risperidone in elderly patients with dementia-related psychosis.