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
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(pro METH a zeen)

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

Promethazine rectal should not be used in 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 take promethazine rectal by mouth. It is for use only in your rectum.

This medication comes with patient instructions for using the rectal suppository. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Try to empty your bowel and bladder just before using the promethazine rectal suppository or enema. Try to use the medicine at a time when you can lie down afterward and hold the medicine in. Avoid using the bathroom during this time. It may be best to use this medicine at bedtime.

Remove the outer wrapper from the suppository before inserting it. Avoid handling the suppository too long or it will melt in your hands.

Call your doctor immediately if you experience uncontrollable movements of your eyes, lips, tongue, face, arms, or legs. These could be early signs of dangerous side effects. Use caution when driving, operating machinery, or performing other hazardous activities. Promethazine may cause dizziness or drowsiness. If you experience dizziness or drowsiness, avoid these activities. Avoid drinking alcohol. Alcohol can increase drowsiness and dizziness caused by promethazine rectal.

What is promethazine rectal?

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

What should I discuss with my health care provider before using promethazine rectal?

Promethazine rectal should not be used in 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 promethazine rectal if you have asthma or other lung disease.

Before using promethazine rectal, tell your doctor if you have:

If you have any of these conditions, you may need a dose adjustment or special tests to safely use this medication.

FDA pregnancy category C. This medication may be 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 promethazine rectal without telling your doctor if you are breast-feeding a baby. If you are over 60 years of age, you may be more sensitive to the side effects of promethazine rectal.
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