Risperdal M-Tab

>10%

Somnolence (40-45%)

Insomnia (26-30%)

Agitation (20-25%)

Anxiety (10-15%)

Headache (10-15%)

Rhinitis (10-15%)

Fatigue (18-31%)

Parkinsonism (28-62%)

Akathisia (5-11%)

Increased appetite (4-44%)

Vomiting (10-20%)

Drooling (<12%)

Urinary incontinence (5-22%)

Tremor (11-24%)

Nasopharyngitis (4-19%)

Rhinorrhea (4-12%)

Enuresis (1-16%)

1-10%

Constipation (5-10%)

Dyspepsia (5-10%)

Nausea (5-10%)

Abdominal pain (1-5%)

Aggressive reaction (1-5%)

Facial edema (<4%)

QT prolongation (<4%)

Dizziness (1-5%)

Extrapyramidal symptoms (EPS; 1-5%)

Gynecomastia in children (1-5%)

Rash (1-5%)

Tachycardia (1-5%)

Syncope (1-2%)

Bradycardia (<4%)

Palpitation (<4%)

Chest pain (<4%)

Agitation (<4%)

Postural dizziness (<4%)

Pruritus (<4%)

Acne (1-2%)

Hyperprolactinemia (<4%)

Sexual dysfunction (<4%)

Xerostomia (7-10%)

<1%

Agranulocytosis

Cholesterol increased

Delirium

Ketoacidosis

Orthostatic hypotension

Seizures

Frequency Not Defined

Diabetes mellitus

Hyperthermia

Hypoglycemia

Hypothermia

Myelosuppression

Neuroleptic malignant syndrome (NMS)

Priapism

Prolonged QT interval

Tardive dyskinesia

Thrombotic thrombocytopenic purpura (TTP)

Sleep apnea syndrome

Urinary retention

Postmarketing Reports

Falls

Black Box Warnings

Not approved for dementia-related psychosis; patients with dementia-related psychosis who are treated with antipsychotic drugs are at increased risk of death, as shown in short-term controlled trials; deaths in these trials appeared to be either cardiovascular (eg, heart failure, sudden death) or infectious (eg, pneumonia) in nature

Contraindications

Documented hypersensitivity

Cautions

Increased incidence of cerebrovascular disease reported; may alter cardiac conduction; life threatening arrhythmias reported with therapeutic doses of antipsychotics

May cause anicholinergic effects including blurred vision, urinary retention, agitation, confusion, blurred vision, and xerostomia

Use with caution in patients with history of seizures, Parkinson disease, Lewy body dementia, cardiovascular disease, hypovolemia, dehydration

Leukopenia/neutropenia and agranulocytosis reported; possible risk factors for leukopenia/neutropenia include preexisting low white blood cell (WBC) count and history of drug-induced leukopenia/neutropenia

If patient has history of clinically significant low WBC count or drug-induced leukopenia/neutropenia, monitor complete blood count (CBC) frequently during first few months of therapy; discontinue drug at first sign of clinically significant WBC decline <1000/μL in absence of other causative factors, and continue monitoring WBC count until recovery

May cause somnolence, postural hypotension, motor and sensory instability, which may lead to falls and, consequently, fractures or other injuries; perform complete fall risk assessments when initiating antipsychotic treatment and recurrently for patients on long-term antipsychotic therapy

Use caution in patients at risk of pneumonia; esophageal dysmotility and aspiration reported with antipsychotic use

May cause extrapyramidal symptoms including acute dystonic reactions, akathisia, pseudoparkinsonism, and tardive dyskinesia

Intraoperative floppy iris syndrome reported in patients receiving risperidone therapy

Monitor for fever, mental status changes, muscle regidity and or autonomic instability; neuroleptic malignant syndrome associated with resperidone use

Use with caution in children <15 kg

Cases of priapism reported with therapy

Prolactin elevations occur and persist during chronic administration

Use caution when operating heavy machinery

FDA warning regarding off-label use for dementia in elderly

Metabolic changes

• Atypical antipsychotic drugs have been associated with metabolic changes that may increase cardiovascular or cerebrovascular risk (eg, hyperglycemia, dyslipidemia, and body weight gain)
• In some cases, hyperglycemia concomitant with use of atypical antipsychotics has been associated with ketoacidosis, hyperosmolar coma, or death

Risperdal M-TAB is a prescription medication used to treat schizophrenia. It is also used to treat manic or mixed episodes associated with Bipolar I Disorder. Risperdal M-TAB also is used to treat behavioral symptoms associated with autism.

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

• Risperdal M-TAB comes as an orally disintegrating tablet (tablet that dissolves quickly in the mouth) to take by mouth.
• It is usually taken once or twice a day with or without food. Take Risperdal M-TAB at around the same time(s) every day.
• Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand.
• Take Risperdal M-TAB exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Using dry hands, remove the tablet from the blister unit and immediately place the entire Risperdal M-TAB Orally Disintegrating Tablet on the tongue. The Risperdal M-TAB Orally Disintegrating Tablet should be consumed immediately, as the tablet cannot be stored once removed from the blister unit. Risperdal M-TAB Orally Disintegrating Tablets disintegrate in the mouth within seconds and can be swallowed subsequently with or without liquid. Patients should not attempt to split or to chew the tablet.

In the U.S.

• Risperdal
• Risperdal M-Tab
• RisperiDONE M-Tab

In Canada

• RisperDAL

Available Dosage Forms:

• Tablet, Disintegrating
• Tablet
• Solution

Therapeutic Class: Antipsychotic

Chemical Class: Benzisoxazole

• It is used to treat schizophrenia.
• It is used to treat bipolar problems.
• It is used to treat irritation that happens with autistic disorder.
• It may be given to you for other reasons. Talk with the doctor.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about Risperdal M-Tab, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Risperdal M-Tab. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using Risperdal M-Tab.

Review Date: October 4, 2017

10 years or older:
Initial dose: 0.5 mg orally once a day
Titration dose: May increase in increments of 0.5 mg to 1 mg per day at interval of 24 hours or more, as tolerated.
Target dose: 1 to 2.5 mg orally per day
Maximum dose: 6 mg orally per day

Comments: May be administered orally once a day or in divided doses twice a day; patients experiencing somnolence may benefit from twice a day dosing.

Use: As monotherapy or as adjunctive therapy with lithium or valproate for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder.

Oral formulations:
Severe renal impairment (CrCl less than 30 mL/min): Initial starting dose: 0.5 mg orally twice a day; increase in increments of 0.5 mg or less, administered twice a day. For doses above 1.5 mg twice a day, increase in intervals of 1 week or greater.

Long-acting IM Injection:
If a total daily oral dose of at least 2 mg once daily is well tolerated, the long acting intramuscular formulation may be used.

Initial dose: 25 mg every 2 weeks by deep IM deltoid or gluteal injection.

Comments:
-A starting dose of 12.5 mg IM may be considered when clinical factors warrant a dose adjustment; however, the efficacy of the 12.5 mg dose has not been studied in clinical trials.

US BOXED 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.
-Risperidone is not approved for the treatment of patients with dementia-related psychosis.

Safety and efficacy of the long-acting injection in patients younger than 18 years have not been established.

Safety and efficacy of risperidone in patients younger than 13 years in the treatment of schizophrenia have not been established.

Safety and efficacy of risperidone in patients younger than 10 years in the treatment of bipolar disorder have not been established

Safety and efficacy of risperidone in patients younger than 5 years in the treatment of autistic disorder have not been established.

Consult WARNINGS section for additional precautions.