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Drug Notebook

FDA Alerts

    Children <2 Years of Age
  • Promethazine is contraindicated in pediatric patients <2 years of age, because of risk of developing potentially fatal respiratory depression.
    Respiratory Depression
  • Postmarketing reports of respiratory depression, including fatalities, in pediatric patients <2 years of age receiving a wide range of weight-adjusted doses.
    Children ≥2 Years of Age
  • Administer with caution.
  • Use the lowest effective dose.
  • Avoid concomitant use with other respiratory depressant drugs.

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promethazine
(proe METH a zeen)

What is this medicine?
PROMETHAZINE (proe METH a zeen) is an antihistamine. It is used to treat allergic reactions and to treat or prevent nausea and vomiting from illness or motion sickness. It is also used to make you sleep before surgery, and to help treat pain or nausea after surgery.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

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What side effects may I notice from receiving this medicine?
Side effects that you should report to your doctor or health care professional as soon as possible:

  • blurred vision
  • irregular heartbeat, palpitations or chest pain
  • muscle or facial twitches
  • pain or difficulty passing urine
  • seizures
  • skin rash
  • slowed or shallow breathing
  • unusual bleeding or bruising
  • yellowing of the eyes or skin

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

  • headache
  • nightmares, agitation, nervousness, excitability, not able to sleep (these are more likely in children)
  • stuffy nose

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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How should I use this medicine?
Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. Take your doses at regular intervals. Do not take your medicine more often than directed.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed. This medicine should not be given to infants and children younger than 2 years old.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.

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What if I miss a dose?
If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

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What may interact with this medicine?
Do not take this medicine with any of the following medications:

  • medicines called MAO Inhibitors like Nardil, Parnate, Marplan, Eldepryl
  • other phenothiazines like trimethobenzamide

This medicine may also interact with the following medications:

  • barbiturates like phenobarbital
  • bromocriptine
  • certain antidepressants
  • certain antihistamines used in allergy or cold medicines
  • epinephrine
  • levodopa
  • medicines for sleep
  • medicines for mental problems and psychotic disturbances
  • medicines for movement abnormalities as in Parkinson's disease, or for gastrointestinal problems
  • muscle relaxants
  • prescription pain medicines

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

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Who should NOT use this medication?

  • Pediatric patients <2 years of age. (See Boxed Warning.)
  • Concomitant administration of large doses of other CNS depressants. (See Specific Drugs under Interactions.)
  • Comatose patients.
  • Known hypersensitivity or idiosyncrasy to promethazine or other phenothiazines.
  • Treatment of lower respiratory symptoms (e.g., asthma).
  • Some manufacturers state that promethazine also is contraindicated in patients with bone marrow depression, angle-closure glaucoma, prostatic hypertrophy, stenosing peptic ulcer, pyloroduodenal obstruction, or bladder neck obstruction; others state that the drug be used with caution in these patients.

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What should I watch for while using this medicine?
Tell your doctor or health care professional if your symptoms do not start to get better in 1 to 2 days.

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. To reduce the risk of dizzy or fainting spells, do not stand or sit up quickly, especially if you are an older patient. Alcohol may increase dizziness and drowsiness. Avoid alcoholic drinks.

Your mouth may get dry. Chewing sugarless gum or sucking hard candy, and drinking plenty of water may help. Contact your doctor if the problem does not go away or is severe.

This medicine may cause dry eyes and blurred vision. If you wear contact lenses you may feel some discomfort. Lubricating drops may help. See your eye doctor if the problem does not go away or is severe.

This medicine can make you more sensitive to the sun. Keep out of the sun. If you cannot avoid being in the sun, wear protective clothing and use sunscreen. Do not use sun lamps or tanning beds/booths.

If you are diabetic, check your blood-sugar levels regularly.

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What should I tell my health care provider before I take this medicine?
They need to know if you have any of these conditions:

  • glaucoma
  • high blood pressure or heart disease
  • kidney disease
  • liver disease
  • lung or breathing disease, like asthma
  • prostate trouble
  • pain or difficulty passing urine
  • seizures
  • an unusual or allergic reaction to promethazine or phenothiazines, other medicines, foods, dyes, or preservatives
  • pregnant or trying to get pregnant
  • breast-feeding

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Can I stop taking the medication if I feel better?
As a general rule, you should always take your medications exactly as prescribed and do not change the dosage or stop taking the medication without first discussing it with your healthcare provider.

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I am on so many medications; do I have to take them all?
This is called polypharmacy—many different medications being used at the same time by one person. Sometimes, being on multiple medications is acceptable and appropriate but at other times it may be problematic. If you are receiving your medications from multiple physicians you need to ensure that they all know what medications you are taking. The best way to do this is to make a list of all the medications you are currently using, including all nutritional supplements, homeopathic remedies, vitamins and over-the-counter drugs (if possible, also include all the diseases you have been diagnosed with). Give a copy to every doctor who takes care of you so they have it on file, this way they can avoid duplicating medications and perhaps even try to consolidate some. After every doctor's visit remember to update the list accordingly. Also, as much as you possibly can, try to use the same pharmacy to fill all your prescriptions, this way any potential drug interactions can be caught and averted.

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Where can I get more information?
More Information

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