Risperdal M-Tab

Name: Risperdal M-Tab

Risperdal M-TAB Overview

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. Risperdal M-TAB 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 M-TAB comes as an orally disintegrating tablet. It is usually taken once or twice a day with or without food. 

Risperdal M-TAB is placed under the tongue. Risperdal M-TAB can be swallowed with or without liquid.

Common side effects of Risperdal M-TAB are headache, increased appetite, and tremors.

Risperdal M-TAB can cause dizziness. Do not drive or operate heavy machinery until you know how Risperdal M-TAB affects you.

Manufacturer

  • Janssen Pharmaceuticals, Inc.

Risperdal M-TAB Interactions

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 M-TAB drug interactions. Ask your doctor or pharmacist for more information.

What do I need to tell my doctor BEFORE I take Risperdal M-Tab?

  • If you have an allergy to risperidone or any other part of this medicine.
  • If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If you are breast-feeding or plan to breast-feed.

This medicine may interact with other drugs or health problems.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Risperdal M-Tab with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Risperdal M-Tab?

  • Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
  • Avoid driving and doing other tasks or actions that call for you to be alert until you see how Risperdal M-Tab affects you.
  • To lower the chance of feeling dizzy or passing out, rise slowly if you have been sitting or lying down. Be careful going up and down stairs.
  • It may take several weeks to see the full effects.
  • High blood sugar or diabetes, high cholesterol, and weight gain have happened with drugs like this one. These changes may raise the chance of heart and brain blood vessel disease. Talk with the doctor.
  • If you have high blood sugar (diabetes), you will need to watch your blood sugar closely.
  • Have blood work checked as you have been told by the doctor. Talk with the doctor.
  • Avoid drinking alcohol while taking this medicine.
  • Talk with your doctor before you use other drugs and natural products that slow your actions.
  • Dizziness, sleepiness, and feeling less stable may happen with Risperdal M-Tab. These may lead to falling. Broken bones or other health problems can happen from falling. Talk with the doctor.
  • Low white blood cell counts have happened with drugs like this one. This may lead to a higher chance of getting an infection. Deadly infections have rarely happened. Tell your doctor if you have ever had a low white blood cell count. Call your doctor right away if you have signs of infection like fever, chills, or sore throat. Talk with your doctor.
  • Some people who take this medicine may get a very bad muscle problem called tardive dyskinesia. This muscle problem may not go away even if Risperdal M-Tab is stopped. Sometimes, signs may lessen or go away over time after this medicine is stopped. The risk of tardive dyskinesia may be greater in people with diabetes and in older adults, especially older women. The risk is also greater the longer you take Risperdal M-Tab or with higher doses. Muscle problems may also occur after short-term use with low doses. Call your doctor right away if you have trouble controlling body movements or if you have muscle problems with your tongue, face, mouth, or jaw like tongue sticking out, puffing cheeks, mouth puckering, or chewing.
  • Older adults with dementia taking drugs like this one have had a higher number of strokes. Sometimes these strokes have been deadly. This drug is not approved to treat mental problems caused by dementia. Talk with your doctor.
  • If you have phenylketonuria (PKU), talk with your doctor. Some products have phenylalanine.
  • If you are 65 or older, use this medicine with care. You could have more side effects.
  • Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using Risperdal M-Tab while you are pregnant.
  • Taking this medicine in the third trimester of pregnancy may lead to muscle movements that cannot be controlled and withdrawal in the newborn. Talk with the doctor.

If OVERDOSE is suspected

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.

For the Consumer

Applies to risperidone: oral solution, oral tablet, oral tablet disintegrating

Other dosage forms:

  • intramuscular powder for suspension extended release

Along with its needed effects, risperidone (the active ingredient contained in Risperdal M-Tab) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking risperidone:

More common
  • Aggressive behavior
  • agitation
  • anxiety
  • changes in vision, including blurred vision
  • difficulty concentrating
  • difficulty speaking or swallowing
  • inability to move the eyes
  • increase in amount of urine
  • loss of balance control
  • mask-like face
  • memory problems
  • muscle spasms of the face, neck, and back
  • problems with urination
  • restlessness or need to keep moving (severe)
  • shuffling walk
  • skin rash or itching
  • stiffness or weakness of the arms or legs
  • tic-like or twitching movements
  • trembling and shaking of the fingers and hands
  • trouble sleeping
  • twisting body movements
Less common
  • Back pain
  • chest pain
  • speech or vision problems
  • sudden weakness or numbness in the face, arms, or legs
Rare
  • Confusion
  • dizziness
  • drowsiness
  • extreme thirst
  • fast, shallow breathing
  • fast, weak heartbeat
  • headache
  • increased thirst
  • lip smacking or puckering
  • loss of appetite
  • muscle cramps
  • pale, clammy skin
  • poor coordination
  • prolonged, painful, inappropriate erection of the penis
  • puffing of the cheeks
  • rapid or worm-like movements of the tongue
  • shivering
  • talking, feeling, and acting with excitement and activity that cannot be controlled
  • uncontrolled chewing movements
  • uncontrolled twisting movements of neck, trunk, arms, or legs
  • unusual bleeding or bruising
  • unusual facial expressions or body positions

Some side effects of risperidone may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Constipation
  • cough
  • diarrhea
  • dry mouth
  • headache
  • heartburn
  • increased dream activity
  • increased length of sleep
  • nausea
  • sleepiness or unusual drowsiness
  • sore throat
  • stuffy or runny nose
  • unusual tiredness or weakness
  • weight gain
Less common
  • Absent, missed, or irregular menstrual periods
  • body aches or pain
  • breast swelling or soreness
  • chills
  • dandruff
  • darkening of skin color
  • decreased interest in sexual intercourse
  • dry skin
  • ear congestion
  • fever
  • inability to have or keep an erection
  • increase in body movements
  • increased watering of the mouth
  • joint pain
  • loss in sexual ability, desire, drive, or performance
  • loss of voice
  • oily skin
  • pain or tenderness around the eyes and cheekbones
  • shortness of breath or troubled breathing
  • sneezing
  • stomach pain
  • stopping of menstrual bleeding
  • tightness in the chest
  • toothache
  • unusual breast milk production
  • vomiting
  • weight loss

Usual Adult Dose for Bipolar Disorder

Oral formulations:
Initial dose: 2 to 3 mg orally per day
Titration dose: May increase in increments of 1 mg per day at interval of 24 hours or more, as tolerated.
Effective dose range: 1 to 6 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.

Long-acting IM Injection:

For patients who have never taken oral risperidone, it is recommended to establish tolerability with oral formulation prior to initiating treatment with long acting injection.

Initial dose: 25 mg IM every 2 weeks
Titration dose: May increase to 37.5 mg or 50 mg if needed; dose titration should occur no more frequently than every 4 weeks as expected drug release starts 3 weeks after injection.
Maximum dose: 50 mg IM every 2 weeks


Comments:
-Should be administered by a health care professional as deep IM deltoid or gluteal injection; do not administer IV.
-To ensure adequate therapeutic plasma concentrations are maintained prior to the main release phase of drug from the injection, oral risperidone (or another antipsychotic drug) should be given for 3 weeks following the first injection.
-Some patients not responding to the 25 mg dose may benefit from a 37.5 mg or 50 mg dose, and some patients who have a history of poor tolerability to psychotropic medications may benefit from a lower initial dose of 12.5 mg, however, the efficacy of the 12.5 mg dose has not been studied in clinical trials.

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

Usual Pediatric Dose for Schizophrenia

13 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: 3 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.
-Doses greater than 6 mg per day have not been studied

Use: Treatment of schizophrenia

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