Risperdal Consta

Risperdal Consta is a prescription medication used to treat schizophrenia. It is also used to treat manic or mixed episodes associated with Bipolar I Disorder. Risperdal Consta belongs to a group of drugs called atypical antipsychotics. It is not fully known how it works, but it is believed to work by changing the activity of natural substances in the brain.

Risperdal Consta comes as a long-acting injectable and is given into the muscle once every two weeks. It is injected into the upper arm or buttock by a healthcare provider.

Common side effects of Risperdal Consta are headache, weight gain, restlessness, dry mouth, and tremors.

Risperdal Consta can cause headache, dizziness, and make you feel tired. Do not drive or operate heavy machinery until you know how Risperdal Consta affects you.

Risperdal Consta is a prescription medication used to manage symptoms of schizophrenia. Risperdal Consta is also given alone or in combination with valproate or lithium for the maintenance treatment of Bipolar I Disorder.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Janssen Pharmaceuticals, Inc.

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 Consta, the most common side effects in the treatment of bipolar disorder:

• were weight gain (when used alone) 
• tremors (when used with lithium or valproate)

If you are taking Risperdal Consta and think you are having any side effects, talk to your doctor immediately.

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.

• 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.
• Neuroleptic Malignant Syndrome (NMS) is a rare and potentially fatal side effect reported with Risperdal Consta and similar medicines. Call your doctor immediately if the person being treated develops symptoms such as high fever; stiff muscles; shaking; confusion; sweating; changes in pulse, heart rate, or blood pressure; or muscle pain and weakness. Treatment should be stopped if the person being treated has NMS.
• Tardive Dyskinesia (TD) is a serious, sometimes permanent side effect reported with Risperdal Consta and similar medications. TD includes uncontrollable movements of the face, tongue, and other parts of the body. The risk of developing TD and the chance that it will become permanent is thought to increase with the length of therapy and the overall dose taken by the patient. This condition can develop after a brief period of therapy at low doses, although this is much less common. There is no known treatment for TD, but it may go away partially or completely if therapy is stopped.
• 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.
• Some people taking Risperdal Consta may feel faint or lightheaded when they stand up or sit up too quickly. By standing up or sitting up slowly and following your healthcare professional’s dosing instructions, this side effect can be reduced or it may go away over time.
• Blood problems such as low numbers of white blood cells have been reported in patients using Risperdal Consta 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.
• 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.
• Painful, long-lasting erections have been reported with the use of Risperdal Consta. Call your doctor immediately if you think you are having this problem.
• Extrapyramidal Symptoms (EPS) are usually persistent movement disorders or muscle disturbances, such as restlessness, tremors, and muscle stiffness. If you observe any of these symptoms, talk to your healthcare professional.
• 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.

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 this medication.

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
• a history of seizures
• kidney disease
• liver disease
• diabetes

Be sure to tell your doctor if you are pregnant or breastfeeding.

Tell your doctor if you are allergic to any ingredient in Risperdal Consta.

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 pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

This medication falls into category C. In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

Tell your doctor if you are breastfeeding or plan to breastfeed. Risperdal Consta can cross into human breast milk. It may harm your baby.

If your doctor has decided that Risperdal Consta 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.

Injectable:

• If you have taken risperidone before, and you can tolerate it, you may get your first injection right away. After the first injection, you will keep taking the oral medicine you're already on for 3 weeks to give the injection 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 Consta, he or she may offer you a choice of where you want to get the medicine. Risperdal Consta can be given as an injection in the upper arm or the upper buttock.
• Risperdal Consta is given by a doctor or nurse every 2 weeks. In most cases, you may only have to expose a small area of skin.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your weight
• your height
• your age
• your gender

Injectable:

• 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. 
• 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.

If this medication is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

Injectable:

• 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.

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 Consta is not approved for the treatment of patients with dementia-related psychosis.