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Promethazine HCl FAQs

Q: What is promethazine HCl?

A: Promethazine hydrochloride (HCl) (marketed as Phenergan) is an antihistamine used to treat symptoms associated with allergic reactions. Promethazine was approved by the U.S. Food and Drug Administration (FDA) in 1951.

Q: Has there been any news regarding promethazine?

A: In 2006, the FDA issued an 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 given to children less than two years old.

In 2009, the FDA required manufacturers of promethazine to include a boxed warning – the FDA's most stringent warning – on the drug's packaging. The revised labels inform consumers that it is not safe to inject promethazine under the skin or into an artery because of the risk of severe tissue damage. The FDA advises that if promethazine is taken by injection, the drug should be injected deep into the muscle.

Q: Who should not use promethazine?

A: 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; and children who are vomiting, unless the vomiting is prolonged and there is a known cause.

Q: Are there any serious health risks associated with promethazine?

A: Promethazine may cause any of the following conditions: severe drowsiness and reduced mental alertness; serious breathing problems; increased risk of seizures; bone-marrow problems and changes in blood cell production; and neuroleptic malignant syndrome.

Q: What should I tell my healthcare professional before he or she prescribes Promethazine?

A: 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.

Q: What are the side effects associated with Promethazine?

A: The most common side effects associated with promethazine use include drowsiness, changes in blood pressure, skin reactions, blood cell changes, and 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

Q: Are there any interactions between Promethazine and other drugs or foods?

A: 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) (used to treat depression or other mental disorders), and medicines called anticholinergics.

Q: What should I do if I think I have been injured as a result of using Promethazine?

A: 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. It's also in your best interests to consult with a product liability attorney in order to learn more about any legal claims you may have against the drug's manufacturer.

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