Risperdal Consta may make you drowsy. Do not drive a car or operate machinery until you know how it will affect you.
Do not drink alcohol while taking this medicine. Alcohol can add to the drowsiness caused by Risperdal Consta.
Risperdal Consta may cause dizziness, lightheadedness, and fainting when you get up too quickly from a lying position (orthostatic hypotension). This is more common when you first start taking it. To avoid this problem, get out of bed slowly, resting your feet on the floor for a few minutes before standing up.
Tell your doctor if you are pregnant or plan to become pregnant while taking Risperdal Consta and for at least 12 weeks after the last injection of Risperdal Consta.
You should not breastfeed during treatment and for at least 12 weeks after the last Risperdal Consta injection.
Risperdal Consta is a prescription medication used to manage symptoms of schizophrenia and bipolar disorder.
This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.
No cases of overdose were reported in premarketing studies with Risperdal Consta. Because Risperdal Consta is to be administered by health care professionals, the potential for overdosage by patients is low.
In premarketing experience with oral Risperdal, there were eight reports of acute Risperdal overdosage, with estimated doses ranging from 20 to 300 mg and no fatalities. In general, reported signs and symptoms were those resulting from an exaggeration of the drug’s known pharmacological effects, i.e., drowsiness and sedation, tachycardia and hypotension, and extrapyramidal symptoms.
Postmarketing experience with oral Risperdal includes reports of acute overdose, with estimated doses of up to 360 mg. In general, the most frequently reported signs and symptoms are those resulting from an exaggeration of the drug’s known pharmacological effects, i.e., drowsiness, sedation, tachycardia, hypotension, and extrapyramidal symptoms. Other adverse reactions reported since market introduction related to oral Risperdal overdose include prolonged QT interval and convulsions.
In case of acute overdosage, establish and maintain an airway and ensure adequate oxygenation and ventilation. Cardiovascular monitoring should commence immediately and should include continuous electrocardiographic monitoring to detect possible arrhythmias.
In a study of people taking Risperdal Consta, the most common side effects in the treatment of schizophrenia were:
- Headache
- Tremors
- Dizziness
- Restlessness
- Tiredness
- Constipation
- Indigestion
- Sleepiness
- Weight gain
- Pain in the limbs
- Dry mouth
In a study of people taking Risperdal , the most common side effects in the treatment of bipolar disorder were:
- Weight gain (when used alone)
- Tremors (when used with lithium or valproate)
The most common adverse reactions that were associated with discontinuation from clinical trials in patients with schizophrenia were agitation, depression, anxiety, and akathisia. Adverse reactions that were associated with discontinuation from bipolar disorder trials were hyperglycemia (one subject monotherapy trial) and hypokinesia and tardive dyskinesia (one subject each in adjunctive therapy trial).
If your doctor has decided that Risperdal is right for you, and you have never taken risperidone, he or she may give you a test dose of an oral version to ensure that you can tolerate the medicine.
If you have taken risperidone before, and you can tolerate it, you may get your first injection of Risperdal right away. After the first injection, you will keep taking the oral medicine you’re already on for 3 weeks to give Risperdal a chance to start working. After that, you will come back to your healthcare professional every 2 weeks for your next dose.
Once your doctor has prescribed Risperdal, he or she may offer you a choice of where you want to get the medicine. Risperdal can be given as an injection in the upper arm or the upper buttock.
Risperdal is given by a doctor or nurse every 2 weeks. In most cases, you may only have to expose a small area of skin.
Risperdal may affect your alertness or driving ability; therefore, do not drive or operate machinery before talking to your healthcare professional. Avoid alcohol while taking Risperdal Consta.
Inform your healthcare professional if you become pregnant or intend to become pregnant during therapy with Risperdal Consta . Caution should be used when administering Risperdal Consta to a nursing woman.
Some medications interact with Risperdal Consta. Please inform your healthcare professional of any medications or supplements that you are taking.
Risperdal Consta may make you more sensitive to heat. You may have trouble cooling off, or be more likely to become dehydrated, so take care when exercising or when doing things that make you warm.
Risperdal Consta should be used cautiously in people with a seizure disorder, who have had seizures in the past, or who have conditions that increase their risk for seizures.
High blood sugar and diabetes have been reported with Risperdal Consta and similar medications. If the person being treated has diabetes or risk factors such as being overweight or a family history of diabetes, blood sugar testing should be performed at the beginning and throughout treatment with Risperdal Consta. Complications of diabetes can be serious and even life-threatening. If signs of high blood sugar or diabetes develop, such as being thirsty all the time, going to the bathroom a lot, or feeling weak or hungry, contact your doctor.
Risperdal Consta and similar medications can raise the blood levels of a hormone known as prolactin, causing a condition known as hyperprolactinemia. Blood levels of prolactin remain elevated with continued use. Some side effects seen with these medications include the absence of a menstrual period; breasts producing milk; the development of breasts by males; and the inability to achieve an erection.
Blood problems such as low numbers of white blood cells have been reported in patients taking risperidone and similar medications. In some cases it has been serious and life-threatening. Depending upon your medical condition, your doctor may choose to test your blood as you start therapy with Risperdal Consta.
Storage and Handling
The entire dose pack should be stored in the refrigerator (36°– 46°F; 2°– 8°C) and protected from light.
If refrigeration is unavailable, Risperdal Consta can be stored at temperatures not exceeding 77°F (25°C) for no more than 7 days prior to administration. Do not expose unrefrigerated product to temperatures above 77°F (25°C).
Keep out of reach of children.
Before receiving Risperdal Consta, tell your doctor about all of your medical conditions including if you have:
- Parkinson’s Disease
- breast cancer
- heart disease (angina, irregular heartbeat, heart failure, heart attack, stroke)
- high blood pressure
- low blood pressure
- seizures
- kidney disease
- liver disease
- diabetes
Tell your doctor if you are allergic to any ingredient in Risperdal Consta.
Be sure to tell your doctor if you are pregnant or breastfeeding.
Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.
Tell your doctor if you are breastfeeding or plan to breastfeed. Risperdal Consta is excreted in human breast milk. It may harm your baby.
Schizophrenia
The recommended dose for the treatment of schizophrenia is 25 mg IM (injected into muscle) every 2 weeks. Some patients not responding to 25 mg may benefit from a higher dose of 37.5 mg or 50 mg. The maximum dose should not exceed 50 mg Risperdal Consta every 2 weeks.
The efficacy of Risperdal Consta in the treatment of schizophrenia has not been evaluated in controlled clinical trials for longer than 12 weeks. Although controlled studies have not been conducted to answer the question of how long patients with schizophrenia should be treated with Risperdal Consta, oral risperidone has been shown to be effective in delaying time to relapse in longer-term use. It is recommended that responding patients be continued on treatment with Risperdal Consta at the lowest dose needed. The physician who elects to use Risperdal Consta for extended periods should periodically re-evaluate the long-term risks and benefits of the drug for the individual patient.
Bipolar Disorder
The recommended dose for monotherapy or adjunctive therapy to lithium or valproate for the maintenance treatment of Bipolar I Disorder is 25 mg IM every 2 weeks. Some patients may benefit from a higher dose of 37.5 mg or 50 mg. Dosages above 50 mg have not been studied.
Risperdal Consta (risperidone) is is an oral medication used primarily to treat schizophrenia and bipolar disorder. Most recently it has been approved to treat symptoms if irritability and aggression in children with autism. It is part of a class of medications called atypical antipsychotics.
Atypical antipsychotics were developed to be different from the older antipsychotic drugs that tended to cause extrapryimidal side effects (involuntary muscle contractions, tremor, slurred speech, restlessness, anxiety, distress, paranoia, and slowed thought) and increased the levels of a hormone called prolactin, which caused sexual and fertility side effects.
The mechanism of action of atypical antipsychotics has not been fully elucidated, but it is believed that all of them have some action on the dopamine receptors in the brain. Atypical antipsychotics have become the first line therapy for schizophrenia and bipolar disorder, and have generally replaced the old typical antipsychotics due to having a higher response rate, lower risk of suicide, and a better quality of life and functionality for patients. However, atypical antipsychotics still carry the risk of serious side effects, including the development of a movement disorder called tardive dyskinesia, neuroleptic malignant syndrome, and increased risks of developing stroke, blood clots, and diabetes.
Tell your doctor if you are pregnant or plan to become pregnant. It is not known if Risperdal Consta will harm your unborn baby.
WARNING: 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. Risperdal® Consta® is not approved for use in patients with dementia-related psychosis.
WARNING: 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. RISPERDAL® (risperidone) is not approved for the treatment of patients with dementia-related psychosis.
Risperdal Consta (risperidone) is available in dosage strengths of 12.5 mg, 25 mg, 37.5 mg, or 50 mg risperidone. It is provided as a dose pack, consisting of a vial containing the risperidone microspheres, a pre-filled syringe containing 2 mL of diluent for Risperdal Consta, a SmartSite Needle-Free Vial Access Device, and two Needle-Pro safety needles for intramuscular injection (a 21 G UTW 1-inch needle with needle protection device for deltoid administration and a 20 G TW 2-inch needle with needle protection device for gluteal administration).
12.5-mg vial/kit (NDC 50458-309-11): 41 mg (equivalent to 12.5 mg of risperidone) of a white to off-white powder provided in a vial with a violet flip-off cap (NDC 50458-309-01).
25-mg vial/kit (NDC 50458-306-11): 78 mg (equivalent to 25 mg of risperidone) of a white to off-white powder provided in a vial with a pink flip-off cap (NDC 50458-306-01).
37.5-mg vial/kit (NDC 50458-307-11): 116 mg (equivalent to 37.5 mg of risperidone) of a white to off-white powder provided in a vial with a green flip-off cap (NDC 50458-307-01).
50-mg vial/kit (NDC 50458-308-11): 152 mg (equivalent to 50 mg of risperidone) of a white to off-white powder provided in a vial with a blue flip-off cap (NDC 50458-308-01).
Risperidone Microspheres: risperidone microencapsulated in polylac-tide-co-glycolide. The microspheres contain no inactive ingredients.
Diluent Ingredients (note: there is no active ingredient in the diluent formulation): Polysorbate 20, Sodium Carboxymethylcellulose,
Disodium Hydrogen Phosphate Dihydrate, Citric Acid Anhydrous, Sodium Chloride, Sodium Hydroxide, Water for Injection.
Risperdal Consta is an atypical antipsychotic indicated:
- for the treatment of schizophrenia.
- as monotherapy or as adjunctive therapy to lithium or valproate for the maintenance treatment of Bipolar I Disorder.
Risperdal Consta can help manage the symptoms that are part of Bipolar I Disorder and schizophrenia. This may help people feel more like themselves.
The symptoms of Bipolar I Disorder and schizophrenia are thought to be caused by chemical imbalances in the brain. Although it is unclear exactly how Risperdal Consta works, it seems to help balance the chemicals in the brain. While it is not a cure, Risperdal Consta has helped many people manage the symptoms of Bipolar I Disorder and schizophrenia.
Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Risperdal Consta there are no specific foods that you must exclude from your diet when receiving Risperdal Consta.
Active Ingredients:
Risperidone
For more information on the conditions Risperdal Consta treats go to :
1-800-Therapist Bipolar Encyclopedia
1-800-Therapist Schizophrenia Encyclopedia
It is important to keep a list of all medications you are currently taking. This should include all prescription, over the counter, and supplemental medications. This list should be kept with you at all times. Whenever you are beginning a new medication, be sure to consult your doctor and provide him or her with your list of medications.
For further information on Risperdal Consta speak with a pharmacist.
If your doctor has decided that Risperdal is right for you, and you have never taken risperidone, he or she may give you a test dose of an oral version to ensure that you can tolerate the medicine. If you have taken risperidone before, and you can tolerate it, you may get your first injection of Risperdal right away.
After the first injection, you will keep taking the oral medicine you’re already on for 3 weeks to give Risperdal a chance to start working. After that, you will come back to your healthcare professional every 2 weeks for your next dose. Once your doctor has prescribed Risperdal , he or she may offer you a choice of where you want to get the medicine. Risperdal can be given as an injection in the upper arm or the upper buttock.
Risperdal is given by a doctor or nurse every 2 weeks. In most cases, you may only have to expose a small area of skin. Plus, it may not take very long. You may be able to bring a family member or caregiver with you. Remember, Bipolar I Disorder and schizophrenia are lifelong illnesses. It is important that the person who is ill gets Risperdal every 2 weeks.
Tell your doctor about the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:
- antidepressants
- carbamazepine (Tegretol)
- cimetidine (Tagamet)
- clozapine (Clozaril)
- dopamine agonists such as bromocriptine (Parlodel), cabergoline (Dostinex), levodopa (Dopar, Larodopa), pergolide (Permax), and ropinirole (Requip)
- medications for anxiety, high blood pressure, or seizures
- other medications for mental illness
- paroxetine (Paxil)
- phenobarbital (Luminal, Solfoton)
- phenytoin (Dilantin)
- quinidine (Quinaglute, Quinidex)
- ranitidine (Zantac)
- rifampin (Rifadin, Rimactane)
- sedatives
- sleeping pills
- tranquilizers
- valproic acid (Depakote, Depakene)
This is not a complete list of Risperdal Consta drug interactions. Ask your doctor or pharmacist for more information.