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Promethazine HCl

What is Promethazine HCl?

Promethazine hydrochloride (HCl) (marketed as Phenergan) is an antihistamine used to treat the following conditions:

  • "hay fever" or a stuffy runny nose from allergy
  • watery, itchy eyes due to inhaled allergies and foods
  • mild allergic skin reactions
  • allergic reactions to blood or plasma
  • dermographism (a form of hives known as "skin writing")
  • serious allergic reactions along with epinephrine and other treatments
  • motion sickness

Promethazine is also used in the following circumstances:

  • sedation before or after surgery, or during child birth
  • prevention and control of nausea and vomiting after surgery
  • along with meperidine (Demerol) or other pain medications
  • sedation, relief of anxiety, and production of light sleep from which the patient can be easily aroused

Promethazine was approved by the U.S. Food and Drug Administration (FDA) in 1951.

Promethazine - FDA Alert

In April 2006, the FDA issued an alert notifying healthcare professionals and the public that promethazine HCl should not be given to children less than two years old, because of possible breathing problems. This warning pertains to promethazine in any form: syrups, suppositories, tablets, or injectables. The FDA has received reports of breathing problems (some fatal) when promethazine was administered to children less than two years old. Parents and caregivers should get a healthcare professional's advice about giving promethazine in any form to children age two and older. The labeling on all promethazine HCl products (both brand name and generic) has been changed to reflect these strengthened warnings. Click here to read more from the FDA.

Who Should Not Use Promethazine?

Promethazine should not be given to:

  • children under two years of age
  • patients who are unconscious
  • patients who are allergic to promethazine, any of the ingredients in promethazine, or to other phenothiazines
  • patients with lung symptoms including asthma
  • children who are vomiting, unless the vomiting is prolonged and there is a known cause

Promethazine Health Risks

Severe drowsiness and reduced mental alertness. Promethazine may cause drowsiness which may impair your ability to ride a bike, drive a car, or operate machinery. This may worsen if promethazine is taken with alcohol or other central nervous system (CNS) depressants, such as sedatives, pain medicines, tranquilizers, or certain medicines used to treat depression.

Serious breathing problems. Promethazine should not be used in patients with poor lung function, such as chronic obstructive lung disease or breathing problems while sleeping (sleep apnea).

Increased risk of seizures. Promethazine should be used with caution in patients with seizures, or patients who are on other medicines which may also increase the risk of seizures.

Bone-marrow problems and blood cell production. Promethazine should not be used in patients with bone-marrow problems, or used with other drugs that affect the bone marrow's production of blood cells.

Neuroleptic malignant syndrome. This potentially deadly syndrome includes symptoms such as fever, muscle rigidity, mental changes, changes in pulse or blood pressure, fast heartbeat, increased sweating or irregular heart rhythm.

Promethazine Side Effects

The most common side effects associated with promethazine use include:

  • drowsiness
  • changes in blood pressure
  • skin reactions
  • blood cell changes
  • breathing problems

Increased excitability or abnormal movements may occur after one dose of promethazine. If they do, consult your healthcare professional about using another medicine

What Should I Tell My Healthcare Professional?

Before you start taking promethazine, tell your healthcare professional if you:

  • have narrow-angle glaucoma
  • have an enlarged prostate
  • have a stomach ulcer
  • have an intestinal blockage
  • have a bladder blockage
  • have heart problems
  • have liver problems
  • have breathing or lung problems
  • have sleep apnea (breathing problems when sleeping)
  • have seizures
  • drink alcohol
  • are trying to become pregnant, are already pregnant, or are breast-feeding

Are There Any Interactions With Drugs or Foods?

Promethazine and certain other medicines can interact with each other. Tell your healthcare professional about all the medicines you take - including prescription and non-prescription medicines, vitamins, and herbal supplements - especially:

  • medicines that affect your brain, such as anti-anxiety medicine, sleeping pills, pain medicines, sedatives, narcotics, antidepressants or tranquilizers
  • epinephrine
  • a monoamine oxidase inhibitor (MAOI), which is used to treat depression or other mental disorders
  • medicines called anticholinergics

Promethazine - Getting Legal Help

While most medications have certain anticipated side effects, a drug manufacturer has a duty to make its products as reasonably safe as possible, and to inform the medical community and the public of known risks associated with its drugs. If a manufacturer fails to do so, it can be held legally responsible if patients are injured as the result of inadequate warnings or the unreasonably dangerous nature of the drug, under a legal theory called "product liability."

If you or a loved one have experienced any dangerous symptoms or unusual medical conditions while taking promethazine, you should first contact your doctor or other healthcare professional. You may also wish to meet with an experienced attorney to discuss your options and to protect your right to a legal remedy for any injuries caused by promethazine use.

  • Go here to learn more about an attorney's role in a pharmaceutical liability case.
  • To find an experienced attorney, use the "Find a Lawyer" tool on this page, or click here.
Next Steps
Contact a qualified product liability attorney to make sure
your rights are protected.
(e.g., Chicago, IL or 60611)

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