While the pharmacokinetics of Sizodon in subjects with liver disease were comparable to those in young healthy subjects, the mean free fraction of Sizodon in plasma was increased by about 35% because of the diminished concentration of both albumin and α1-acid glycoprotein. RISPERDAL® doses should be reduced in patients with liver disease .
Sizodon is a prescription drug. It comes as an oral tablet, an orally disintegrating tablet, and an oral solution. It also comes as an injection that’s only given by a healthcare provider.
Sizodon oral tablet is available as the brand-name drug Risperdal. It’s also available as a generic drug. Generic drugs usually cost less than the brand-name version. In some cases, the brand-name drug and the generic version may be available in different forms and strengths.In one of the 8-week, placebo-controlled trials, children and adolescents with autistic disorder (n=101), aged 5 to 16 years, received twice daily doses of placebo or RISPERDAL® 0.5-3.5 mg/day on a weight-adjusted basis. RISPERDAL®, starting at 0.25 mg/day or 0.5 mg/day depending on baseline weight (
There were two weight-based, fixed doses of Sizodon (high-dose and low-dose). The high dose was 1.25 mg per day for patients weighing 20 to 45 kg. The low dose was 0.125 mg per day for patients weighing 20 to 45 kg. The dose was administered once daily in the morning, or in the evening if sedation occurred.
The primary efficacy endpoint was the mean change in the Aberrant Behavior Checklist – Irritability subscale (ABC-I) score from baseline to the end of Week 6. The study demonstrated the efficacy of high-dose risper >
The sections below will provide you with more specific information and guidelines related to Sizodon and its correct use. Please read them carefully.
In December 2003, physicians treating patients with bipolar mania gained a new treatment option with the FDA-approval of Sizodon (Risperdal®) used alone or in combination with lithium or valproate. The FDA approved Sizodon for the short-term treatment of acute manic or mixed episodes associated with bipolar disorder.
Sizodon is now the most commonly prescribed antipsychotic medication in the United States.
However, Sizodon has received a “not approved” letter from the FDA for use in autism.
Please visit the official site of the FDA for further information.
Why is this medication prescribed?
Sizodon is used for the treatment of psychotic disorders, for example, schizophrenia. It also is used in combination with lithium or valproate for the treatment of acute manic or mixed episodes associated with bipolar I disorder.
This medication works by interfering with the communication among nerves in the brain. The nerves communicate with one another by producing and releasing chemicals called neurotransmitters. The neurotransmitters attach to receptors on other nearby nerves, and the attachment of the neurotransmitter causes changes in the cells that have the receptor on them. Sizodon blocks several of the receptors on nerves including dopamine type 2, serotonin type 2, and alpha 2 adrenergic receptors and this blocks communication among nerves.
Sizodon is a relatively new antipsychotic medication that probably has fewer side effects than many of the older medications.
Other uses for this medicine
Sizodon has also been used to treat severe behavioral problems in children and teenagers, as well as in the treatment of irritability associated with autistic disorders. However, it is important to note that the FDA has warned that the safety of Sizodon in children has actually never been established.
Moreover, it is important that you talk to your doctor about the possible risks of using this drug for your particular condition.
Dosage and using this medicine
Sizodon comes as a tablet, a solution (liquid), and an orally disintegrating tablet to take by mouth.
It is usually taken once or twice a day with or without food.
Take Sizodon exactly as directed by your doctor. Do not take more or less of it or take it more often than prescribed by your doctor.
Use the dropper provided to measure your dose of Sizodon oral solution. You can take the oral solution with water, orange juice, coffee, or low-fat milk. Do not take the solution with tea or cola.
To take the orally disintegrating tablet, use dry hands to separate one blister unit at the perforation. Peel back the foil and remove the tablet. Do not push the tablet through the foil. Immediately place the entire tablet on your tongue but do not chew it. The tablet will quickly dissolve and may be swallowed with or without water.
Additionally, your doctor will probably start you on a low dose of Sizodon and gradually increase your dose every day for several days, and then not more than once every week.
Please note that Sizodon controls schizophrenia but does not cure it. It may take several weeks or longer before you feel the full benefit of Sizodon. Continue to take Sizodon even if you feel well, and never take Sizodon without first talking with your doctor. If you suddenly stop taking Sizodon, your symptoms may return and your illness may become harder to treat.
What special precautions should I follow?
Pharmacologic class: Benzisoxazole derivative
Therapeutic class: Antipsychotic
Pregnancy risk category C
RISPERDAL® is contraindicated in patients with a known hypersensitivity to either Sizodon or paliperidone, or to any of the excipients in the RISPERDAL® formulation. Hypersensitivity reactions, including anaphylactic reactions and angioedema, have been reported in patients treated with Sizodon and in patients treated with paliperidone. Paliperidone is a metabolite of Sizodon.
What Are Side Effects Associated with Using Sizodon?
Common side effects of Sizodon include:
Less common side effects of Sizodon include:
Other side effects of Sizodon include:
This is not a complete list of side effects and other serious side effects may occur. Call your doctor for information and medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Is There Anything Special I Should Discuss With My Doctor Before Taking Sizodon (Risperdal)?
Sizodon could cause certain side effects and can interfere with many medications. If you have certain medical conditions, take Sizodon with caution. Always tell your doctor if you have allergies to any medications and discuss the risks and benefits of Sizodon.
Tell your doctor if you use or have ever used illegal or "street" drugs, or if you are a heavy drinker. Also let your doctor know if you have ever abused prescription drugs.
Because it may be more difficult for your body to warm up or cool down while taking Sizodon, let your doctor know if you plan to engage in vigorous exercise or if you will be in a place where temperatures are very hot or very cold.
Your doctor should also know if you ever developed severe side effects from a medication to treat mental illness.
Tell your doctor if you are pregnant, particularly if you are in your third trimester. Sizodon may be harmful for newborns right after delivery. This is particularly true if women take the drug during the final few months of pregnancy.
Your doctor should also know if you might become pregnant or if you are breastfeeding. Women who are nursing shouldn't take Sizodon or should stop breastfeeding.
Also tell your doctor if you have ever had:
Older people with liver disease or low blood pressure should receive a lower initial dose of Sizodon.
Sizodon (0.16 to 5 mg/kg) was shown to impair mating, but not fertility, in Wistar rats in three reproductive studies (two Segment I and a multigenerational study) at doses 0.1 to 3 times the maximum recommended human dose (MRHD) on a mg/m² body surface area basis. The effect appeared to be in females, since impaired mating behavior was not noted in the Segment I study in which males only were treated. In a subchronic study in Beagle dogs in which Sizodon 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 on a mg/m² body surface area basis. Dose-related decreases were also noted in serum testosterone at the same doses. Serum testosterone and sperm parameters partially recovered, but remained decreased after treatment was discontinued. A no-effect dose could not be determined in either rat or dog.
GENERIC NAME(S): Sizodon
OTHER NAME(S): Risperdal Solution
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 Sizodon in combination with other medication to treat depression, also carefully read the drug information for the other medication.
Sizodon 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.
Sizodon belongs to a class of drugs called atypical antipsychotics. It works by helping to restore the balance of certain natural substances in the brain.
Dosing In Patients With Severe Renal Or Hepatic Impairment
For patients with severe renal impairment (CLcr RISPERDAL® (Sizodon) 1 mg/mL Oral Solution (NDC 50458-305-03) is supplied in 30 mL bottles with a calibrated (in milligrams and milliliters) pipette. The minimum calibrated volume is 0.25 mL, while the maximum calibrated volume is 3 mL.
WHAT IS RISPERIDONE?
Sizodon is an atypical antipsychotic medication. It is most often used to treat delusional psychosis (including schizophrenia).
This medication is also used to treat some forms of bipolar disorder and psychotic depression.
Sizodon works by changing the effects of chemicals in the brain. Some of the brand names of Sizodon is the US are Belivon®, Rispen®, Risperdal®.
Why is this medication prescribed?
Sizodon 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). Sizodon 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). Sizodon is in a class of medications called atypical antipsychotics. It works by changing the activity of certain natural substances in the brain.
Serious side effects
Call your doctor right away if you have serious side effects. Call 911 if your symptoms feel life-threatening or if you think you’re having a medical emergency. Serious side effects and their symptoms can include the following:
- Death from infection and stroke in seniors with dementia
- high fever (above 100.4°F, or 38°C)
- heavy sweating
- stiff muscles
- changes in your breathing, heart rhythm, and blood pressure
- kidney failure, with symptoms such as weight gain, lethargy, or urinating less than normal or not at all
Disclaimer: Our goal is to provide you with the most relevant and current information. However, because drugs affect each person differently, we cannot guarantee that this information includes all possible side effects. This information is not a substitute for medical advice. Always discuss possible side effects with a healthcare provider who knows your medical history.
Sizodon oral tablet can interact with other medications, vitamins, or herbs you may be taking. An interaction is when a substance changes the way a drug works. This can be harmful or prevent the drug from working well.
To help avoid interactions, your doctor should manage all of your medications carefully. 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 to your doctor or pharmacist.
Examples of drugs that can cause interactions with Sizodon are listed below.