Drugs A - Z

Propoxyphene Napsylate Oral tablet

It is used to treat mild to moderate pain

Generic Name: propoxyphene  |  Brand Name: Darvon

Brand Names: Darvon-N, Darvon, Propoxyphene Hydrochloride, PP-Cap

There is an FDA Alert for this drug. Click here to view it.

Special Alerts:

On November 19, 2010, Xanodyne announced a voluntary withdrawal of propoxyphene-containing preparations (Darvon®, Darvocet®) from the US market. The withdrawal was requested by FDA following review of new data on cardiac risk. (See Cardiac Effects under Cautions.) FDA requested that manufacturers of generic propoxyphene-containing preparations also voluntarily withdraw these preparations from the US market.

[Posted 01/13/2011] ISSUE: FDA notified healthcare professionals that it has asked drug manufacturers to limit the strength of acetaminophen in prescription drug products, predominantly combinations of acetaminophen and opioids, to 325 mg per tablet, capsule, or other dosage unit, making these products safer for patients. This action will help to reduce the risk of severe liver injury and allergic reactions associated with acetaminophen. A Boxed Warning highlighting the potential for severe liver injury and a Warning highlighting the potential for allergic reactions (swelling of the face, mouth, and throat, difficulty breathing, itching, or rash) will be added to the label of all prescription drug products that contain acetaminophen.

BACKGROUND: Acetaminophen, one of the most commonly used drugs in the United States, is widely and effectively used in both prescription and over-the-counter (OTC) products to reduce pain and fever. Examples of prescription products that contain acetaminophen include hydrocodone with acetaminophen (Vicodin, Lortab), and oxycodone with acetaminophen (Tylox, Percocet). OTC products containing acetaminophen (e.g., Tylenol) are not affected by this action. Information about the potential for liver injury is already required on the label for OTC products containing acetaminophen. FDA is continuing to evaluate ways to reduce the risk of acetaminophen related liver injury from OTC products. No drug shortages are expected, because the 3-year implementation period should permit adequate time for necessary reformulations.

RECOMMENDATION: Healthcare professionals were reminded to advise patients not to exceed the acetaminophen maximum total daily dose (4 grams/day), and not to drink alcohol while taking acetaminophen-containing medications.

Healthcare professionals were encouraged to inform patients that there is no immediate danger to patients who take these combination pain medications, and patients should continue to take them as directed by their health care provider. The Drug Safety Communication provides additional information for healthcare professionals, information for patients, a data summary and a list of all affected products. For more information visit the FDA website at: [Web] and [Web].

REMS:

FDA approved a REMS for propoxyphene to ensure that the benefits of a drug outweigh the risks. The REMS may apply to one or more preparations of propoxyphene and consists of the following: medication guide. See the FDA REMS page ([Web]) or the ASHP REMS Resource Center ([Web]).

What is this medicine?

PROPOXYPHENE (proe POX i feen) is a pain reliever. It is used to treat mild to moderate pain.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:
  • dehydration
  • depression
  • drug abuse or addiction
  • heart disease
  • history of irregular heartbeat
  • if you often drink alcohol
  • kidney disease
  • liver disease
  • lung disease, asthma, or breathing problems
  • seizures
  • suicide attempts or thoughts
  • an unusual or allergic reaction to propoxyphene, methadone, opioid analgesics, other medicines, foods, dyes, or preservatives
  • pregnant or trying to get pregnant
  • breast-feeding

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 medicine 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.

Patients over 65 years old may have a stronger reaction and need a smaller dose.

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.

What may interact with this medicine?

Do not take this medicine with any of the following medications:
  • rasagiline
  • selegiline

This medicine may also interact with the following medications:

  • alcohol
  • antihistamines for allergy, cough and cold
  • barbiturates, like phenobarbital
  • medicines for blood pressure or the heart like carvedilol, metoprolol, propanolol
  • medicines for depression, anxiety, or psychotic disturbances
  • medicines for pain
  • medicines for seizures like carbamazepine, ethotoin, phenytoin
  • medicines for sleep
  • muscle relaxants
  • stimulant medicines like dextroamphetamine and others
  • warfarin

What should I watch for while using this medicine?

Tell your doctor or health care professional if your pain does not go away, if it gets worse, or if you have new or a different type of pain. You may develop tolerance to the medicine. Tolerance means that you will need a higher dose of the medicine for pain relief. Tolerance is normal and is expected if you take the medicine for a long time.

Do not suddenly stop taking your medicine because you may develop a severe reaction. Your body becomes used to the medicine. This does NOT mean you are addicted. Addiction is a behavior related to getting and using a drug for a non-medical reason. If you have pain, you have a medical reason to take pain medicine. Your doctor will tell you how much medicine to take. If your doctor wants you to stop the medicine, the dose will be slowly lowered over time to avoid any side effects.

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. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells. Alcohol may interfere with the effect of this medicine. Avoid alcoholic drinks.

The medicine may cause constipation. Try to have a bowel movement at least every 2 to 3 days. If you do not have a bowel movement for 3 days, call your doctor or health care professional.


Last Updated: November 22, 2010
Licensed from
The Healthline Site, its content, such as text, graphics, images, search results, HealthMaps, Trust Marks, and other material contained on the Healthline Site ("Content"), its services, and any information or material posted on the Healthline Site by third parties are provided for informational purposes only. None of the foregoing is a substitute for professional medical advice, examination, diagnosis, or treatment. Always seek the advice of a physician or other qualified healthcare provider with any questions you may have regarding a medical condition. Never disregard professional medical advice or delay in seeking it because of something you have read on the Healthline Site. If you think you may have a medical emergency, call your doctor or 911 immediately. Please read the Terms of Service for more information regarding use of the Healthline Site.
Advertisement
Advertisement