Prochlorperazine (Oral route)
- Capsule, 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 deaths appeared to be either cardiovascular (eg, heart failure, sudden death) or infectious (eg, pneumonia) in nature. Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. It is unclear from these studies to what extent the mortality findings may be attributed to the antipsychotic drug as opposed to patient characteristics. Prochlorperazine maleate is not approved for the treatment of patients with dementia-related psychosis .
Uses of This Medicine:
Prochlorperazine is used to treat nervous, emotional, and mental conditions (eg, schizophrenia) and non-psychotic anxiety. It is also used to control severe nausea and vomiting. This medicine should not be used to treat behavioral problems in older adult patients who have dementia.
This medicine is available only with your doctor's prescription.
Before Using This Medicine:
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:
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.
Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of prochlorperazine in children 2 years of age and older or weighing 9 kilograms (kg) (20 pounds (lbs)) and over. Use in children younger than 2 years of age or weighing under 9 kg (20 lbs) is not recommended.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of prochlorperazine in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require caution and an adjustment in the dose for patients receiving this medicine.
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.
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.
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.
- Aripiprazole Lauroxil
- Arsenic Trioxide
- Chloral Hydrate
- Inotuzumab Ozogamicin
- Morphine Sulfate Liposome
- Secretin Human
- Sodium Phosphate
- Sodium Phosphate, Dibasic
- Sodium Phosphate, Monobasic
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.
- Aminolevulinic Acid
- Belladonna Alkaloids
- Betel Nut
- Evening Primrose
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. 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 may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of 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:
- Allergy to phenothiazine, history of or
- Comatose state (unconscious)—Should not be used in patients with these conditions.
- Blood or bone marrow problems (eg, agranulocytosis, leukopenia, neutropenia) or
- Breast cancer, history of or
- Glaucoma or
- Liver disease or
- Hypotension (low blood pressure) or
- Seizures—Use with caution. May make these conditions worse.
- Bowel blockage or
- Brain tumor or
- Reye's syndrome—This medicine may mask symptoms in patients with these conditions.
- Dehydration or
- Heart disease or
- Infections (eg, chickenpox, CNS infection, gastroenteritis, measles) or
- Pheochromocytoma (adrenal problem)—May cause side effects to become worse.
Proper Use of This Medicine:
Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.
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 (tablets):
- For severe nausea and vomiting:
- Adults and children 2 years of age and older and weighs more than 39 kilograms (kg) (85 pounds (lbs))—At first, 5 or 10 milligrams (mg) 3 or 4 times a day. Your doctor may adjust your dose if needed. However, the dose is usually not more than 40 mg per day.
- Children 2 years of age and older and weighs 18 to 39 kg (40 to 85 lbs)—Dose is based on body weight and must be determined by your doctor. At first, 2.5 mg 3 times a day or 5 mg 2 times a day. Your doctor may adjust your dose if needed. However, the dose is usually not more than 15 mg per day.
- Children 2 years of age and older and weighs 14 to 18 kg (30 to 39 lbs)—Dose is based on body weight and must be determined by your doctor. At first, 2.5 mg 2 or 3 times a day. Your doctor may adjust your dose if needed. However, the dose is usually not more than 10 mg per day.
- Children 2 years of age and older and weighs 9 to 13 kg (20 to 29 lbs)—Dose is based on body weight and must be determined by your doctor. At first, 2.5 mg 1 or 2 times a day. Your doctor may adjust your dose if needed. However, the dose is usually not more than 7.5 mg per day.
- Children younger than 2 years of age and weighs under 9 kg (20 lbs)—Use is not recommended.
- For non-psychotic anxiety:
- Adults—At first, 5 milligrams (mg) 3 or 4 times a day. Your doctor may adjust your dose if needed. However, the dose is usually not more than 20 mg per day or longer than 12 weeks.
- Children—Use and dose must be determined by your doctor.
- For schizophrenia:
- Adults—5 to 10 milligrams (mg) 3 or 4 times a day. Your doctor may adjust your dose if needed. However, the dose is usually not more than 150 mg per day.
- Children 6 to 12 years of age—At first, 2.5 mg 2 or 3 times a day. Your doctor may adjust your dose if needed. However, the dose is usually not more than 10 mg on the first day and 25 mg per day.
- Children 2 to 5 years of age—At first, 2.5 mg 2 or 3 times a day. Your doctor may adjust your dose if needed. However, the dose is usually not more than 10 mg on the first day and 20 mg per day.
- Children younger than 2 years of age—Use and dose must be determined by your doctor.
- For severe nausea and vomiting:
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
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.
Precautions While Using This Medicine:
It is very important that your doctor should check the progress of you and your child at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.
Check with your doctor before using this medicine with alcohol or other medicines that affect the central nervous system (CNS). The use of alcohol or other medicines that affect the CNS with risperidone may worsen the side effects of this medicine, such as dizziness, poor concentration, drowsiness, unusual dreams, and trouble with sleeping. Some examples of medicines that affect the CNS are antihistamines or medicine for allergies or colds, sedatives, tranquilizers, or sleeping medicines, medicine for depression, medicine for anxiety, prescription pain medicine or narcotics, medicine for attention deficit and hyperactivity disorder, medicine for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics.
This medicine may cause extrapyramidal symptoms. Check with your doctor right away if you have difficulty in speaking, drooling, loss of balance control, muscle trembling, jerking, or stiffness, restlessness, shuffling walk, stiffness of the limbs, twisting movements of the body, or uncontrolled movements, especially of the face, neck, and back.
This medicine may cause drowsiness, trouble with thinking, or trouble with controlling body movements, which may lead to falls, fractures or other injuries. Make sure you know how you react to this medicine before you drive, use machines, or do other jobs that require you to be alert, well-coordinated, or able to think or see well.
Dizziness, lightheadedness, or fainting may occur, especially when you get up suddenly from a lying or sitting position. Getting up slowly may help. If this problem continues or gets worse, check with your doctor.
This medicine 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 receiving risperidone injection. If you become too cold, you may feel drowsy, confused, or clumsy.
Make sure any doctor or dentist who treats you knows that you are using this medicine. This medicine may affect the results of certain medical tests.
This medicine may cause tardive dyskinesia (a movement disorder). Check with your doctor right away if you have any of the following symptoms while using this medicine: 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.
Check with your doctor right away if you have any of the following symptoms while using this medicine: 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).
Prochlorperazine 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.
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.
Side Effects of This Medicine:
- Incidence not known
- black, tarry stools
- chest pain
- clay-colored stools
- dark urine
- decrease in how much or how often you urinate
- difficulty in swallowing and breathing
- dizziness, faintness, or lightheadedness when suddenly getting up from a lying or sitting position
- dryness of the mouth
- fever and chills
- inability to have or keep an erection
- loss of appetite
- mask-like face
- nasal congestion
- painful or difficult urination
- shuffling walk
- sore throat
- sores, ulcers, or white spots on the lips or in the mouth
- stomach pain
- swollen glands
- tightness of the throat
- trembling and shaking of the fingers and hands
- uncontrolled chewing movements and movements of the arms and legs
- unpleasant breath odor
- unusual bleeding or bruising
- unusual tiredness or weakness
- vomiting of blood
- yellow eyes or skin
- Symptoms of overdose
- Change in consciousness
- fast, slow, or irregular heartbeat
- loss of consciousness
- severe sleepiness
- Incidence not known
- Blurred vision
- increased sensitivity of the skin to sunlight
- irregular menstrual periods
- itching, rash, redness, or discoloration of the skin
- trouble sleeping
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 immediately if any of the following side effects occur:
Get emergency help immediately if any of the following symptoms of overdose occur:
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:
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.
Last Updated: 9/4/2017