IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

PROCHLORPERAZINE - ORAL

(pro-klor-PAIR-uh-zeen)

COMMON BRAND NAME(S): Compazine

WARNING: There may be a slightly increased risk of serious, possibly fatal side effects (such as pneumonia, heart failure) when this medication is used in older adults with dementia. This medication is not approved for the treatment of dementia-related behavior problems. Discuss the risks and benefits of this medication with your doctor.

USES: This medication is used to treat severe nausea and vomiting from various causes (e.g., anti-cancer treatment, migraine headaches, after surgery).

Prochlorperazine is a phenothiazine medication that works by affecting the balance of natural chemicals (neurotransmitters) in the brain to reduce nausea and the urge to vomit.

This medication is not recommended for use in children under 2 years old or during surgery on children.

HOW TO USE: Take this medication by mouth with or without food as directed by your doctor.

For the syrup, use a medication measuring device to carefully measure the prescribed dose. Avoid getting the syrup on the skin since it may rarely cause skin reactions.

The dosage is based on your age, medical condition, and response to therapy. Do not increase your dose or use this medication more often without your doctor's approval. Your condition will not improve any faster, and the risk of serious side effects may be increased.

If you are taking this medication on a prescribed schedule, use it regularly in order to get the most benefit from it. To help you remember, take it at the same time(s) each day.

Inform your doctor if your condition persists or worsens.

SIDE EFFECTS: Constipation, drowsiness, dizziness, blurred vision, or dry mouth may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

To relieve dry mouth, suck on (sugarless) hard candy or ice chips, chew (sugarless) gum, drink water, or use a saliva substitute.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: agitation/restlessness, face/muscle twitching, uncontrolled movements, drooling, trouble swallowing, difficulty talking, enlarged/tender breasts, unusual breast milk production, shaking (tremors), trouble urinating.

Tell your doctor immediately if any of these rare but very serious side effects occur: dark urine, persistent nausea/vomiting, signs of infection (e.g., fever, persistent sore throat), severe abdominal pain, unusual bleeding/bruising, weakness, yellowing eyes/skin.

This drug may infrequently cause a very serious (rarely fatal) nervous system disorder (neuroleptic malignant syndrome). If you notice any of the following unlikely but very serious side effects, stop taking this medication and seek immediate medical attention: severe muscle stiffness, mental/mood changes (e.g., confusion, extreme drowsiness), very high fever, seizures, irregular/fast heartbeat, increased sweating.

In the unlikely event you have an allergic reaction to this drug, seek immediate medical attention. Symptoms of an allergic reaction include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking prochlorperazine, tell your doctor or pharmacist if you are allergic to it; or to other phenothiazines (e.g., chlorpromazine); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used to treat patients who are unconscious or taking large amounts of any drug that causes drowsiness and slow/shallow breathing (e.g., alcohol, barbiturates, narcotics).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood disorders (e.g., bone marrow depression), ongoing breathing problems (e.g., asthma, emphysema), certain heart rhythm problems (e.g., prolonged QTc interval, irregular heartbeat), low blood pressure, glaucoma, liver problems (e.g., cirrhosis), Reye's syndrome, seizures, urination problems (e.g., trouble urinating due to enlarged prostate, urinary retention).

This drug may make you dizzy or drowsy or cause blurred vision. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely. Limit alcoholic beverages.

To minimize dizziness and light-headedness, get up slowly when rising from a sitting or lying position.

This medication may make you more sensitive to the sun. Avoid prolonged sun exposure, tanning booths, and sunlamps. Use a sunscreen and wear protective clothing when outdoors.

This medication may decrease your body's ability to adjust to either very hot or very cold temperatures. Due to the risk of fainting, avoid being alone if exposed to temperature extremes (e.g., swimming in cold water). In hot weather, fever and heatstroke may occur due to decreased sweating. Avoid strenuous work/exercise, drink plenty of fluids, and dress lightly while in hot weather.

The elderly may be more sensitive to the effects of this drug, especially low blood pressure, constipation, urinary problems, and nerve/muscle problems.

Children may be at greater risk for nerve/muscle side effects while using this drug. Therefore, this medication is not recommended for use in children who are in surgery or have a short-term illness (e.g., chickenpox, flu) or in children under 2 years old.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. Do not stop taking this medication unless directed by your doctor. Babies born to mothers who have used this medication during pregnancy may rarely have liver problems with symptoms including yellowing eyes/skin or dark urine. When this drug is used during the last 3 months of pregnancy, babies born to these mothers may infrequently develop symptoms including muscle stiffness or shakiness, drowsiness, feeding/breathing difficulties, or constant crying. If you notice any of these symptoms in your newborn anytime during their first month, tell the doctor right away.

Based on information from related drugs, this medication may pass into breast milk. Therefore, breast-feeding while using this medication is not recommended. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Your healthcare professionals (e.g., doctor or pharmacist) may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop or change the dosage of any medicine before checking with them first.

This drug should not be used with the following medications because very serious interactions may occur: dofetilide, certain drugs that increase dopamine activity (e.g., cabergoline, pergolide), certain drugs that may affect the heart rhythm (e.g., cisapride, halofantrine, sparfloxacin, pimozide), epinephrine for low blood pressure, metrizamide, sibutramine.

If you currently using any of these medications listed above, tell your doctor or pharmacist before starting this medication.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially: alpha blockers (e.g., prazosin), anticholinergics (e.g., atropine, scopolamine), anti-seizure drugs (e.g., carbamazepine), guanethidine/guanadrel, narcotic pain relievers (e.g., codeine).

Also report the use of drugs which might increase seizure risk when combined with prochlorperazine such as bupropion, isoniazid (INH), other phenothiazines (e.g., thioridazine), theophylline, tramadol, tricyclic antidepressants (e.g., amitriptyline) among others. Consult your doctor or pharmacist for details.

Check the labels on all your medicines (e.g., cough-and-cold products) because they may contain drowsiness-causing ingredients. Ask your pharmacist about the safe use of those products.

This medication can affect the results of certain lab tests (e.g., phenylketonuria, certain pregnancy tests, certain urine tests such as amylase). Make sure laboratory personnel and all your doctors know you use this drug.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly. Symptoms of overdose may include restlessness, muscle spasms, deep sleep/loss of consciousness, seizures, irregular heartbeat.

NOTES: Do not share this medication with others.

Laboratory and/or medical tests may be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

MISSED DOSE: If you are taking this medication on a prescribed schedule and miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store at room temperature between 59-86 degrees F (15-30 degrees C) away from light and moisture. Do not store in the bathroom. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised February 2011 Copyright(c) 2011 First DataBank, Inc.