promethazine (oral)

What is the most important information I should know about oral promethazine?

Stop using this medication and call your doctor at once if you have twitching or uncontrollable movements of your eyes, lips, tongue, face, arms, or legs. These could be early signs of dangerous side effects.

Promethazine should not be given to a child younger than 2 years old. Promethazine can cause severe breathing problems or death in a child younger than 2. Carefully follow your doctor's instructions when giving this medicine to a child of any age.

Promethazine can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Avoid drinking alcohol, which can increase some of the side effects of promethazine.

There are many other medicines that can interact with promethazine. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor. Keep a list with you of all the medicines you use and show this list to any doctor or other healthcare provider who treats you.

What is oral promethazine?

Promethazine is in a group of drugs called phenothiazines (FEEN-oh-THYE-a-zeens). It works by changing the actions of chemicals in your brain. Promethazine also acts as an antihistamine. It blocks the effects of the naturally occurring chemical histamine in your body.

Promethazine is used to treat allergy symptoms such as itching, runny nose, sneezing, itchy or watery eyes, hives, and itchy skin rashes.

Promethazine also prevents motion sickness, and treats nausea and vomiting or pain after surgery. It is also used as a sedative or sleep aid.

Promethazine is not for use in treating symptoms of asthma, pneumonia, or other lower respiratory tract infections.

Promethazine may also be used for other purposes not listed in this medication guide.

What should I discuss with my doctor before taking oral promethazine?

Promethazine should not be given to a child younger than 2 years old. Promethazine can cause severe breathing problems or death in a child younger than 2. Carefully follow your doctor's instructions when giving this medicine to a child of any age.

Do not use this medication if you have severe asthma, emphysema, or other breathing problem, or if you are allergic to promethazine or other phenothiazines such as chlorpromazine (Thorazine), fluphenazine (Permitil), perphenazine (Trilafon), prochlorperazine (Compazine, Compro), thioridazine (Mellaril), or trifluoperazine (Stelazine).

If you have certain conditions, you may need a dose adjustment or special tests to safely use this medication. Before you take promethazine, tell your doctor if you have:

• a history of seizures;
• heart disease or high blood pressure;
• liver or kidney disease;
• severe asthma, emphysema, chronic obstructive pulmonary disease (COPD) or other breathing problem;
• sleep apnea (breathing stops during sleep);
• glaucoma;
• a stomach ulcer or digestive obstruction;
• bone marrow depression;
• adrenal gland tumor (pheochromocytoma);
• enlarged prostate or problems with urination;
• low levels of calcium in your blood (hypocalcemia); or
• if you have ever had a serious side effect while using promethazine or any other phenothiazine.

FDA pregnancy category C. It is not known whether promethazine is harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether promethazine passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Older adults may be more likely to have side effects from this medication.

How should I take oral promethazine?

Take this medication exactly as prescribed by your doctor. Do not take it in larger amounts or for longer than recommended. Follow the directions on your prescription label.

Your doctor may occasionally change your dose to make sure you get the best results from this medication.

Promethazine can be taken with or without food or milk.

Measure liquid medicine with a marked measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

Call your doctor if your symptoms do not improve, or if they get worse while taking promethazine.

This medication can cause you to have unusual results with certain medical tests. Tell any doctor who treats you that you are using promethazine.

Store this medication at room temperature away from moisture, heat, and light.

What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine. Overdose symptoms may include severe drowsiness, dizziness, dry mouth, large pupils, flushing, nausea, vomiting, shallow breathing, and fainting.

What should I avoid while taking oral promethazine?

Promethazine can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

Avoid drinking alcohol. It can increase some of the side effects of promethazine.

Avoid exposure to sunlight or tanning beds. Promethazine can make your skin more sensitive to sunlight, and a sunburn may result. Wear sunscreen (SPF 15 or higher) and protective clothing if you must be outdoors.

What are the possible side effects of oral promethazine?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using promethazine and call your doctor at once if you have any of these serious side effects:

• twitching, or uncontrollable movements of your eyes, lips, tongue, face, arms, or legs;
• tremor (uncontrolled shaking), drooling, trouble swallowing, problems with balance or walking;
• feeling restless, jittery, or agitated;
• high fever, stiff muscles, confusion, sweating, fast or uneven heartbeats, rapid breathing;
• feeling like you might pass out;
• seizure (convulsions);
• pale skin, easy bruising or bleeding, fever, sore throat, flu symptoms;
• decreased night vision, tunnel vision, watery eyes, increased sensitivity to light;
• hallucinations, agitation;
• nausea and stomach pain, skin rash, and jaundice (yellowing of the skin or eyes);
• urinating less than usual or not at all;
• joint pain or swelling with fever, swollen glands, muscle aches, chest pain, vomiting, unusual thoughts or behavior, and patchy skin color; or
• slow heart rate, weak pulse, fainting, slow breathing (breathing may stop).

Less serious side effects may include:

• dizziness, drowsiness, anxiety;
• blurred vision, dry mouth, stuffy nose;
• ringing in your ears;
• weight gain, swelling in your hands or feet;
• impotence, trouble having an orgasm; or
• constipation.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect oral promethazine?

Cold or allergy medicine, sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression or anxiety can interact with promethazine and cause medical problems or increase side effects. Tell your doctor if you regularly use any of these medicines.

Also tell your doctor if you are using any of the following medicines:

• lithium (Eskalith, Lithobid);
• atropine (Atreza, Sal-Tropine), belladonna (Donnatal, and others), benztropine (Cogentin), dimenhydrinate (Dramamine), methscopolamine (Pamine), or scopolamine (Transderm-Scop);
• blood pressure medication such as guanadrel (Hylorel), guanethidine (Ismelin), propranolol (Inderal), and others;
• a blood thinner such as warfarin (Coumadin);
• bronchodilators such as ipratropium (Atrovent) or tiotropium (Spiriva);
• bladder or urinary medications such as oxybutynin (Ditropan, Oxytrol), solifenacin (Vesicare), and others;
• an MAO inhibitor such as isocarboxazid (Marplan), tranylcypromine (Parnate), phenelzine (Nardil), or selegiline (Eldepryl, Emsam); or
• medicines to treat Parkinson's disease, restless leg syndrome, or pituitary gland tumor (prolactinoma); or
• medicine to treat stomach ulcer or irritable bowel syndrome, such as dicyclomine (Bentyl), glycopyrrolate (Robinul), hyoscyamine (Anaspaz, Cystospaz, Levsin, and others), mepenzolate (Cantil), or propantheline (Pro-Banthine).

This list is not complete and there are many other medicines that can interact with promethazine. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor. Keep a list with you of all the medicines you use and show this list to any doctor or other healthcare provider who treats you.

Where can I get more information?

Your pharmacist can provide more information about oral promethazine.