Promethazine (patient information)

IMPORTANT WARNING:

Promethazine may cause breathing to slow or stop, and may cause death in children. Promethazine should not be given to babies or children who are younger than 2 years old and should be given with caution to children who are 2 years of age or older. Promethazine should not routinely be used to treat vomiting in children; it should only be used in specific cases when a doctor decides that it is needed. Tell your child's doctor if your child has any condition that affects his/her breathing such as lung disease, asthma, sleep apnea (stops breathing for short periods of time during sleep). Tell your doctor or pharmacist about all the medications your child is taking, especially barbiturates such as phenobarbital (Luminal), medications for anxiety,narcotic medications for pain, sedatives, sleeping pills, and tranquilizers. Call your child's doctor immediately and get emergency medical treatment if your child has difficulty breathing, wheezes, slows or pauses in breathing, or stops breathing.

Talk to your doctor about the risks of giving promethazine to your child.

Why is this medication prescribed

Promethazine is used to relieve the symptoms of allergic reactions such as allergic rhinitis (runny nose and watery eyes caused by allergy to pollen, mold or dust), allergic conjunctivitis (red, watery eyes caused by allergies), allergic skin reactions, and allergic reactions to blood or plasma products. Promethazine is used with other medications to treat anaphylaxis (sudden, severe allergic reactions). Promethazine is also used to relax and sedate patients before and after surgery, during labor, and at other times. Promethazine is also used to prevent and control upset stomach and vomiting that may occur after surgery, and to help relieve pain after surgery. Promethazine is also used to prevent and treat motion sickness. Promethazine is in a class of medications called phenothiazines. It works by blocking the action of a certain natural substance in the body.

How should this medicine be used

Promethazine comes as a tablet and syrup (liquid) to take by mouth and as a suppository to use rectally.When promethazine is used to treat allergies, it is usually taken one to four times daily, before meals and/or at bedtime. When promethazine is used to treat motion sickness, it is taken 30-60 minutes before travel and again after 8-12 hours if needed. On longer trips, promethazine is usually taken in the morning and before the evening meal on each day of travel. When promethazine is used to treat or prevent upset stomach and vomiting it is usually taken every 4-6 hours as needed. Promethazine may also be taken at bedtime the night before surgery to relieve anxiety and produce quiet sleep. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take promethazine exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Promethazine suppositories are for rectal use only. Do not try to swallow the suppositories or insert in any other part of your body.

To insert a promethazine suppository, follow these steps:

• If the suppository feels soft, hold it under cold, running water for 1 minute. Remove the wrapper.
• Dip the tip of the suppository in water.
• Lie down on your left side and raise your right knee to your chest. (A left-handed person should lie on the right side and raise the left knee.)
• Using your finger, insert the suppository into the rectum, about 1/2 to 1 inch in children who are 2 years of age older and 1 inch in adults. Hold it in place for a few moments.
• Stand up after about 15 minutes. Wash your hands thoroughly and resume your normal activities.

Other uses for this medicine

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

What special precautions should I follow

Before taking promethazine:

• tell your doctor and pharmacist if you are allergic to promethazine, other phenothiazines (certain medications used to treat mental illness, upset stomach, vomiting, severe hiccups, and other conditions) or any other medications. Also tell your doctor and pharmacist if you have ever had an unusual or unexpected reaction when you took promethazine, another phenothiazine, or any other medication. Ask your doctor or pharmacist if you do not know if a medication you are allergic to is a phenothiazine.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements and herbal products you are taking or plan to take. Be sure to mention any of the following: antidepressants ('mood elevators') such as amitriptyline (Elavil), amoxapine (Asendin), clomipramine (Anafranil), desipramine (Norpramin), doxepin (Adapin, Sinequan), imipramine (Tofranil), nortriptyline (Aventyl, Pamelor), protriptyline (Vivactil), and trimipramine (Surmontil); antihistamines; azathioprine (Imuran);barbiturates such as phenobarbital (Luminal); cancer chemotherapy; epinephrine (Epipen); ipratropium (Atrovent)medications for anxiety, irritable bowel disease, mental illness, motion sickness, Parkinson's disease, seizures, ulcers, or urinary problems; monoamine oxidase inhibitors (MAOIs) such as isocarboxazid (Marplan), phenelzine (Nardil), tranylcypromine (Parnate), and selegiline (Eldepryl); narcotics and other pain medication; sedatives; sleeping pills;and tranquilizers.
• tell your doctor if you have or have ever had an enlarged prostate (a male reproductive gland); glaucoma (an eye disease); seizures; ulcers, blockage in the passage between the stomach and intestine; blockage in the bladder; asthma or other lung disease; sleep apnea; cancer;or heart, kidney, or liver disease. If you will be giving promethazine to a child, also tell the child's doctor if the child has any of the following symptoms before he or she receives the medication: vomiting, listlessness, drowsiness, confusion, aggression, seizures, yellowing of the skin or eyes, weakness, or flu-like symptoms. Also *tell the child's doctor if the child has not been drinking normally, has had excessive vomiting or diarrhea, or appears dehydrated.
• tell your doctor if you are pregnant or plan to become pregnant. If you become pregnant while taking promethazine, call your doctor. Do not breastfeed while you are taking promethazine.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking promethazine.
• you should know that this drug may make you drowsy. Do not drive a car or operate machinery until you know how this drug affects you. If you are giving promethazine to a child, watch the child to be sure he or she does not get hurt while riding a bike or participating in other activities that could be dangerous.
• remember that alcohol can add to the drowsiness caused by this medication.
• plan to avoid unnecessary or prolonged exposure to sunlight and to wear protective clothing, sunglasses, and sunscreen. *Promethazine may make your skin sensitive to sunlight.

What should I do if I forget a dose

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

Side effects

Mild side effects

Promethazine can cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• dry mouth
• drowsiness
• listlessness
• difficulty falling asleep or staying asleep
• nightmares
• dizziness
• ringing in ears
• blurred or double vision
• loss of coordination
• upset stomach
• vomiting
• nervousness
• restlessness
• hyperactivity
• abnormally happy mood
• stuffy nose
• itching

Severe side effects

Some side effects can be serious. If you experience any of the following symptoms, call your doctor immediately:

• wheezing
• slowed breathing
• breathing stops for a short time
• fever
• sweating
• stiff muscles
• decreased alertness
• fast or irregular pulse or heartbeat
• faintness
• abnormal or uncontrollable movements
• hallucinations (seeing things or hearing voices that do not exist)
• confusion
• overwhelming or unmanageable fear or emotion
• seizures
• shaking of a part of the body that you cannot control
• unusual bruising or bleeding
• sore throat, fever, chills, and other signs of infection
• uncontrolled eye movements
• tongue sticking out
• abnormal neck position
• inability to respond to people around you
• yellowing of the skin or eyes
• rash
• hives
• swelling of the face, eyes, lips, tongue, throat, arms, hands, feet, ankles, or lower legs
• hoarseness
• difficulty breathing or swallowing

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/MedWatch/report.htm] or by phone [1-800-332-1088].

What storage conditions are needed for this medicine

Keep this medication in the carton or container it came in, tightly closed, and out of reach of children. Store promethazine tablets and liquid at room temperature and away from excess heat and moisture (not in the bathroom). Store promethazine suppositories in the refrigerator. Protect the medication from light. Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

In case of emergency/overdose

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

Symptoms of overdose may include:

• difficulty breathing
• slowed or stopped breathing
• dizziness
• lightheadedness
• fainting
• loss of consciousness
• fast heartbeat
• tight muscles that are difficult to move
• loss of coordination
• continuous twisting movements of the hands and feet
• dry mouth
• wide pupils (black circles in the middle of the eyes)
• flushing
• upset stomach
• constipation
• abnormal excitement or agitation
• nightmares

What other information should I know

Keep all appointments with your doctor.

Promethazine can interfere with the results of home pregnancy tests. Talk to your doctor if you think you might be pregnant while you are taking promethazine. Do not try to test for pregnancy at home.

Before having any laboratory test, tell your doctor and the laboratory personnel that you are taking promethazine.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

Brand names

• Phenergan®
• Promacot®
• Promethegan®
• Promethazine HCl syrup®