RisperiDONE M-Tab

Name: RisperiDONE M-Tab

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For oral dosage forms (solution, tablets, or orally disintegrating tablets):
    • For bipolar disorder:
      • Adults—At first, 2 to 3 milligrams (mg) once a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 6 mg per day.
      • Older adults—At first, 0.5 mg two times a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 6 mg per day.
      • Children 10 to 17 years—At first, 0.5 mg once a day, in the morning or evening. Your doctor may adjust your dose as needed. However, the dose is usually not more than 6 mg per day.
      • Children younger than 10 years—Use and dose must be determined by your doctor.
    • For irritability associated with autistic disorder:
      • Children 5 to 16 years weighing 20 kilograms (kg) or greater—At first, 0.5 milligrams (mg) per day. Your doctor may adjust your dose as needed.
      • Children 5 to 16 years weighing less than 20 kg—At first, 0.25 mg per day. Your doctor may adjust your dose as needed.
      • Children younger than 5 years—Use and dose must be determined by your doctor.
    • For schizophrenia:
      • Adults—At first, 2 milligrams (mg) per day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 16 mg per day.
      • Older adults—At first, 0.5 mg two times a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 6 mg per day.
      • Children 13 to 17 years—At first, 0.5 mg once a day, in the morning or evening. Your doctor may adjust your dose as needed. However, the dose is usually not more than 6 mg per day.
      • Children younger than 13 years—Use and dose must be determined by your doctor.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Commonly used brand name(s)

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

Before Using RisperiDONE M-Tab

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of risperidone in children younger than 13 years with schizophrenia, in children younger than 10 years with bipolar disorder, or in children younger than 5 years with autistic disorder. Safety and efficacy have not been established.

Geriatric

Although appropriate studies on the relationship of age to the effects of risperidone have not been performed in the geriatric population, geriatric-specific problems are not expected to limit the usefulness of risperidone in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require an adjustment in the dose for patients receiving risperidone.

Pregnancy

Pregnancy Category Explanation
All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

  • Amifampridine
  • Amisulpride
  • Bepridil
  • Bromopride
  • Cisapride
  • Dronedarone
  • Levomethadyl
  • Mesoridazine
  • Metoclopramide
  • Pimozide
  • Piperaquine
  • Saquinavir
  • Sparfloxacin
  • Terfenadine
  • Thioridazine
  • Ziprasidone

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Acecainide
  • Ajmaline
  • Amiodarone
  • Amitriptyline
  • Anagrelide
  • Aprindine
  • Aripiprazole
  • Aripiprazole Lauroxil
  • Arsenic Trioxide
  • Asenapine
  • Astemizole
  • Azimilide
  • Bretylium
  • Bupropion
  • Buserelin
  • Chloral Hydrate
  • Chloroquine
  • Chlorpromazine
  • Citalopram
  • Clarithromycin
  • Clozapine
  • Crizotinib
  • Dabrafenib
  • Degarelix
  • Delamanid
  • Desipramine
  • Deslorelin
  • Deutetrabenazine
  • Dibenzepin
  • Disopyramide
  • Dofetilide
  • Dolasetron
  • Domperidone
  • Donepezil
  • Doxepin
  • Droperidol
  • Efavirenz
  • Encainide
  • Enflurane
  • Erythromycin
  • Escitalopram
  • Flecainide
  • Fluconazole
  • Fluoxetine
  • Foscarnet
  • Gemifloxacin
  • Ginkgo Biloba
  • Gonadorelin
  • Goserelin
  • Halofantrine
  • Haloperidol
  • Histrelin
  • Hydroquinidine
  • Hydroxychloroquine
  • Hydroxyzine
  • Ibutilide
  • Imipramine
  • Itraconazole
  • Ivabradine
  • Ketoconazole
  • Leuprolide
  • Levofloxacin
  • Linezolid
  • Lithium
  • Lorcainide
  • Mefloquine
  • Methadone
  • Metronidazole
  • Milnacipran
  • Moxifloxacin
  • Nafarelin
  • Nortriptyline
  • Octreotide
  • Ondansetron
  • Panobinostat
  • Paroxetine
  • Pasireotide
  • Pazopanib
  • Pentamidine
  • Pimavanserin
  • Pitolisant
  • Posaconazole
  • Probucol
  • Procainamide
  • Prochlorperazine
  • Propafenone
  • Protriptyline
  • Quetiapine
  • Remifentanil
  • Ribociclib
  • Sematilide
  • Sertindole
  • Sertraline
  • Sevoflurane
  • Simvastatin
  • Sotalol
  • Spiramycin
  • Sulfamethoxazole
  • Sulpiride
  • Sultopride
  • Tacrolimus
  • Tedisamil
  • Telithromycin
  • Tetrabenazine
  • Trifluoperazine
  • Trimethoprim
  • Trimipramine
  • Triptorelin
  • Vandetanib
  • Vemurafenib
  • Vinflunine
  • Zotepine
  • Zuclopenthixol

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Carbamazepine
  • Cimetidine
  • Fosphenytoin
  • Lamotrigine
  • Levorphanol
  • Midodrine
  • Phenobarbital
  • Phenytoin
  • Ranitidine
  • Ritonavir
  • Valproic Acid

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Allergic reaction to paliperidone (Invega®), history of—Should not be used in patients with this condition.
  • Alzheimer disease or
  • Dehydration or
  • Heart attack, recent or history of or
  • Heart or blood vessel disease or
  • Heart failure, history of or
  • Heart rhythm problem, or a history of or
  • Hypotension (low blood pressure) or
  • Hypovolemia (low amount of blood) or
  • Stroke, history of or
  • Trouble with swallowing—May cause side effects to become worse.
  • Blood or bone marrow problems or
  • Breast cancer, prolactin-dependent or
  • Diabetes or
  • Hyperglycemia (high blood sugar) or
  • Hyperprolactinemia (high prolactin in the blood) or
  • Neuroleptic malignant syndrome (NMS), history of or
  • Parkinson disease or
  • Priapism (painful or prolonged erection of the penis) or
  • Seizures, history of—Use with caution. May make these conditions worse.
  • Kidney disease or
  • Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.
  • Phenylketonuria (PKU)—The oral disintegrating tablets may contain aspartame, which can make this condition worse.
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