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
(pro METH a zeen)

Before you receive promethazine injection, tell your doctor if you are using any of the following drugs:

  • atropine (Donnatal, and others);

  • medicines to treat bladder incontinence, irritable bowel syndrome, digestion problems, stomach disorders, or excess salivation;

  • an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate);

  • medicines that make you sleepy (such as cold medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression or anxiety);

  • a barbiturate such as amobarbital (Amytal), butabarbital (Butisol), mephobarbital (Mebaral), secobarbital (Seconal), or phenobarbital (Luminal, Solfoton); or

  • narcotic medication such as fentanyl (Actiq, Duragesic, Ionsys), hydrocodone (Lortab, Vicodin), hydromorphone (Dilaudid, Palladone), levomethadyl (Orlaam), methadone (Dolophine, Methadose), morphine (Kadian, MS Contin, Oramorph), oxycodone (OxyContin, Percocet, Roxicodone), oxymorphone (Opana), pentazocine (Talacen, Talwin), or propoxyphene (Darvocet, Darvon).

This list is not complete and there may be other drugs that can interact with promethazine injection. 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.

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.

Tell your doctor right away if you have any of these serious side effects:

  • slow, shallow breathing;

  • decreased blood pressure (feeling light-headed, fainting);

  • increased blood pressure (severe headache, blurred vision, trouble concentrating, chest pain, numbness, seizure);

  • pain, burning, severe irritation, muscle weakness, or skin changes where the injection was given;

  • confusion, hallucinations, hysteria, seizure (black-out or convulsions);

  • muscle twitching or movement you cannot control;

  • fast or slow heartbeats;

  • fever, chills, body aches, flu symptoms;

  • easy bruising or bleeding, unusual weakness; or

  • jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

  • drowsiness, dizziness, tired feeling;

  • ringing in your ears;

  • problems with balance or coordination;

  • blurred vision;

  • feeling nervous or shaky;

  • sleep problems (insomnia);

  • skin rash or itching;

  • dry mouth, stuffy nose;

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect.

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