risperidone (Intramuscular route)

Pronunciation

ris-PER-i-done

Intramuscular route(Powder for Suspension, Extended Release)

Elderly patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk of death compared with placebo. Although the causes of death in clinical trials were varied, most of the deaths appeared to be either cardiovascular (eg, heart failure, sudden death) or infectious (eg, pneumonia) in nature. Observational studies suggest that antipsychotic drugs may increase mortality. It is unclear from the observational studies to what extent these mortality findings may be attributed to the antipsychotic drug as opposed to patient characteristics. Risperidone is not approved for the treatment of patients with dementia-related psychosis .

Commonly used brand name(s)

In the U.S.

  • Risperdal Consta

Available Dosage Forms:

  • Powder for Suspension, Extended Release

Therapeutic Class: Antipsychotic

Chemical Class: Benzisoxazole

Uses For risperidone

Risperidone injection is used to treat the symptoms of psychotic (mental) disorders, such as schizophrenia. It may be used alone or together with other medicines (e.g., lithium or valproate) to treat patients with bipolar disorder. risperidone should not be used to treat behavioral problems in older adult patients who have dementia.

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risperidone is available only with your doctor's prescription.

Before Using risperidone

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 risperidone, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to risperidone 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 injection in the pediatric population. Safety and efficacy have not been established.

Geriatric

Elderly people may be especially sensitive to the effects of risperidone. This may increase the chance of having side effects during treatment. risperidone should not be used for behavioral problems in older adults with dementia.

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of risperidone injection in the elderly. However, elderly patients are more likely to have age-related heart problems, which may require caution and an adjustment in the dose for patients receiving risperidone injection.

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 receiving risperidone, 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 risperidone 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
  • Bepridil
  • Cisapride
  • Levomethadyl
  • Mesoridazine
  • Metoclopramide
  • Pimozide
  • Piperaquine
  • Terfenadine
  • Thioridazine

Using risperidone 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
  • Amisulpride
  • Amitriptyline
  • Aprindine
  • Arsenic Trioxide
  • Asenapine
  • Astemizole
  • Azimilide
  • Bretylium
  • Bupropion
  • Chloral Hydrate
  • Chloroquine
  • Chlorpromazine
  • Citalopram
  • Clarithromycin
  • Crizotinib
  • Desipramine
  • Dibenzepin
  • Disopyramide
  • Dofetilide
  • Dolasetron
  • Doxepin
  • Droperidol
  • Encainide
  • Enflurane
  • Erythromycin
  • Flecainide
  • Fluconazole
  • Fluoxetine
  • Foscarnet
  • Gemifloxacin
  • Ginkgo Biloba
  • Halofantrine
  • Haloperidol
  • Hydromorphone
  • Hydroquinidine
  • Ibutilide
  • Imipramine
  • Ivabradine
  • Linezolid
  • Lithium
  • Lorcainide
  • Mefloquine
  • Milnacipran
  • Nortriptyline
  • Octreotide
  • Ondansetron
  • Pazopanib
  • Pentamidine
  • Probucol
  • Procainamide
  • Prochlorperazine
  • Propafenone
  • Protriptyline
  • Quetiapine
  • Sematilide
  • Sertindole
  • Simvastatin
  • Sotalol
  • Spiramycin
  • Sulfamethoxazole
  • Sultopride
  • Tedisamil
  • Telithromycin
  • Tetrabenazine
  • Tramadol
  • Trifluoperazine
  • Trimethoprim
  • Trimipramine
  • Vemurafenib
  • Vinflunine
  • Zotepine

Using risperidone 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
  • Itraconazole
  • Ketoconazole
  • Lamotrigine
  • Midodrine
  • Paroxetine
  • 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 risperidone. Make sure you tell your doctor if you have any other medical problems, especially:

  • Alzheimer's 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
  • Bone problems (e.g., osteodystrophy) 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's disease or
  • Priapism (painful or prolonged erection of the penis) or
  • Seizures, history of—Use with caution. May make these conditions worse.
  • Brain tumor or
  • Intestinal blockage or
  • Reye's syndrome—Risperidone injection may prevent vomiting and hide these medical problems from you or your doctor.
  • Kidney disease or
  • Liver disease—Effects may be increased because of slower removal of the medicine from the body.

Proper Use of risperidone

A nurse or other trained health professional will give you risperidone. risperidone is given as a shot into one of your muscles.

Precautions While Using risperidone

It is very important that your doctor check your progress at regular visits to make sure risperidone is working properly. Blood tests may be needed to check for unwanted effects.

Stop taking risperidone and check with your doctor right away if you have any of the following symptoms while using risperidone: convulsions (seizures), difficulty with breathing, a fast heartbeat, a high fever, high or low blood pressure, increased sweating, loss of bladder control, severe muscle stiffness, unusually pale skin, or tiredness. These could be symptoms of a serious condition called neuroleptic malignant syndrome (NMS).

risperidone may cause tardive dyskinesia (a movement disorder). Check with your doctor right away if you have any of the following symptoms while taking risperidone: lip smacking or puckering, puffing of the cheeks, rapid or worm-like movements of the tongue, uncontrolled chewing movements, or uncontrolled movements of the arms and legs.

risperidone may increase the amount of sugar in your blood. Check with your doctor right away if you have increased thirst or increased urination. If you have diabetes, you may notice a change in the results of your urine or blood sugar tests. If you have any questions, check with your doctor.

Dizziness, lightheadedness, or fainting may occur, especially when you get up from a lying or sitting position suddenly. Getting up slowly may help. If this problem continues or gets worse, check with your doctor.

Risperidone injection can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.

risperidone may cause drowsiness, trouble with thinking, or trouble with controlling body movements. Make sure you know how you react to risperidone before you drive, use machines, or do other jobs that require you to be alert, well-coordinated, or able to think or see well.

risperidone may make it more difficult for your body to cool itself down. Use care not to become overheated during exercise or hot weather since overheating may result in heat stroke. Also, use extra care not to become too cold while you are taking risperidone injection. If you become too cold, you may feel drowsy, confused, or clumsy.

Risperidone injection may cause some people to be agitated, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. If you or your caregiver notice any of these side effects, tell your doctor right away.

risperidone may increase your weight. Your doctor may need to check your weight on a regular basis while you are using risperidone.

risperidone will add to the effects of alcohol and other CNS depressants (medicines that make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for allergies or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicines including other narcotics; medicine for seizures (e.g., barbiturates); muscle relaxants; or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the above while you are taking risperidone.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

risperidone Side Effects

Along with its needed effects, a medicine 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 or nurse immediately if any of the following side effects occur:

More common
  • Difficulty with swallowing
  • drowsiness
  • inability to sit still
  • loss of balance control
  • mask-like face
  • need to keep moving
  • relaxed and calm
  • restlessness
  • shuffling walk
  • sleepiness
  • slowed movements
  • slurred speech
  • stiffness of the arms and legs
  • tic-like (jerky) movements of the head, face, mouth, and neck
  • trembling and shaking of the fingers and hands
Less common
  • Abdominal or stomach pain
  • abnormal or decreased touch sensation
  • absence of or decrease in body movement
  • anxiety
  • back pain
  • black, tarry, stools
  • bladder pain
  • bloating or swelling of the face, arms, hands, lower legs, or feet
  • bloody or cloudy urine
  • blurred vision
  • body aches or pain
  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • change in walking and balance
  • changes in patterns and rhythms of speech
  • chest pain or discomfort
  • clumsiness or unsteadiness
  • cold flu-like symptoms
  • cold sweats
  • convulsions
  • cough or hoarseness
  • cough producing mucus
  • depression
  • diarrhea
  • difficult or labored breathing
  • difficult, burning, or painful urination
  • difficulty with breathing
  • difficulty with moving
  • disturbed attention
  • dizziness
  • dizziness, faintness, or lightheadedness when getting up from lying or sitting position
  • dry mouth
  • ear congestion
  • fainting
  • fast, irregular, pounding, or racing heartbeat or pulse
  • fever or chills
  • flushed, dry skin
  • frequent urge to urinate
  • fruit-like breath odor
  • general feeling of discomfort or illness
  • hard lump
  • headache
  • hyperventilation
  • inability to move the eyes
  • increased blinking or spasms of the eyelid
  • increased hunger
  • increased thirst
  • increased urination
  • irritability
  • joint pain
  • lip smacking or puckering
  • loss of appetite
  • loss of bladder control
  • loss of voice
  • lower back or side pain
  • muscle aches and pains
  • muscle stiffness
  • muscle weakness
  • nasal congestion
  • nausea
  • neck pain
  • pain
  • pale skin
  • pounding in the ears
  • pounding, slow heartbeat
  • puffing of the cheeks
  • rapid or worm-like movements of the tongue
  • rapid weight gain
  • shivering
  • shortness of breath
  • slow or fast heartbeat
  • sneezing
  • sore throat
  • sticking out of the tongue
  • stuffy or runny nose
  • sweating
  • swelling or puffiness of the face
  • swollen joints
  • tightness in the chest
  • trouble with breathing, speaking, or swallowing
  • trouble with sleeping
  • troubled breathing with exertion
  • ulcers, sores, or white spots in the mouth
  • uncontrolled chewing movements
  • uncontrolled twisting movements of the neck, trunk, arms, or legs
  • unexplained weight loss
  • unusual bleeding or bruising
  • unusual facial expressions
  • unusual tiredness or weakness
  • unusual weight gain or loss
  • vomiting
  • wheezing
Incidence not known
  • Abnormal growth filled with fluid or semisolid material
  • accumulation of pus
  • actions that are out of control
  • bleeding gums
  • blood in the urine or stools
  • bluish lips or skin
  • break in the skin, especially associated with blue-black discoloration, swelling, or drainage of fluid
  • change in vision
  • clay-colored stools
  • clumsiness
  • collection of blood under the skin
  • coma
  • confusion
  • constipation
  • dark urine
  • deep, dark purple bruise
  • drowsiness
  • fever with or without chills
  • flushed, dry skin
  • fruit-like breath odor
  • indigestion
  • itching
  • itching, pain, redness, or swelling
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • loss of consciousness
  • low body temperature
  • not breathing
  • painful or prolonged erection of the penis
  • pains in the stomach, side, or abdomen, possibly radiating to the back
  • pinpoint red spots on the skin
  • rash
  • severe constipation
  • swollen, red, tender area of infection
  • talking, feeling, and acting with excitement
  • tiredness
  • unexplained weight loss
  • unpleasant breath odor
  • vomiting of blood
  • weak or feeble pulse
  • weight gain
  • yellow eyes or skin

Some side effects 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
  • Acid or sour stomach
  • belching
  • heartburn
  • stomach discomfort, upset, or pain
Less common
  • Abnormal ejaculation
  • absent missed or irregular menstrual periods
  • bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
  • blemishes on the skin
  • burning, dry, or itching eyes
  • change in hearing
  • decreased interest in sexual intercourse
  • decreased sexual performance or desire
  • decreased vision
  • discharge, excessive tearing
  • dry skin
  • ear drainage
  • ear pain
  • feeling of constant movement of self or surroundings
  • inability to have or keep an erection
  • increased watering of the mouth
  • loss in sexual ability, desire, drive, or performance
  • pain or tenderness around the eyes and cheekbones
  • pimples
  • redness, pain, swelling of the eye, eyelid, or inner lining of the eyelid
  • sensation of spinning
  • skin rash, encrusted, scaly and oozing
  • sleeplessness
  • sluggishness
  • stopping of menstrual bleeding
  • swelling of the breasts or unusual milk production
  • swelling of the breasts or breast soreness in both females and males
  • tender, swollen glands in the neck
  • tenderness in the stomach area
  • toothache
  • unable to sleep
  • unexpected or excess milk flow from breasts
  • voice changes
  • weight gain
  • weight loss
Incidence not known
  • Hair loss or thinning of the hair

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

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