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Benzocaine Rectal ointment

It is used to treat the itching, swelling, and pain of hemorrhoids

Generic Name: benzocaine topical  |  Brand Name: Benzocaine

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

Special Alerts:

[Posted 04/07/2011] ISSUE: FDA notified healthcare professionals and patients that FDA continues to receive reports of methemoglobinemia, a serious and potentially fatal adverse effect, associated with benzocaine products both as a spray, used during medical procedures to numb the mucous membranes of the mouth and throat, and benzocaine gels and liquids sold over-the-counter and used to relieve pain from a variety of conditions, such as teething, canker sores, and irritation of the mouth and gums.

BACKGROUND: Methemoglobinemia is a rare, but serious condition in which the amount of oxygen carried through the blood stream is greatly reduced. In the most severe cases, methemoglobinemia can result in death. Patients who develop methemoglobinemia may experience signs and symptoms such as pale, gray or blue colored skin, lips, and nail beds; headache; lightheadedness; shortness of breath; fatigue; and rapid heart rate. Methemoglobinemia has been reported with all strengths of benzocaine gels and liquids, and cases occurred mainly in children aged two years or younger who were treated with benzocaine gel for teething. The signs and symptoms usually appear within minutes to hours of applying benzocaine and may occur with the first application of benzocaine or after additional use. The development of methemoglobinemia after treatment with benzocaine sprays may not be related to the amount applied. In many cases, methemoglobinemia was reported following the administration of a single benzocaine spray.

RECOMMENDATIONS:

  • Benzocaine products should not be used on children less than two years of age, except under the advice and supervision of a healthcare professional.
  • Adult consumers who use benzocaine gels or liquids to relieve pain in the mouth should follow the recommendations in the product label. Consumers should store benzocaine products out of reach of children. FDA encourages consumers to talk to their healthcare professional about using benzocaine.
  • Read the two Drug Safety Communications below for other specific recommendations for Healthcare Professionals, for Consumers and Caregivers and the Data Summary which supports these recommendations.

FDA is continuing to evaluate the safety of benzocaine products and the Agency will update the public when it has additional information. FDA will take appropriate regulatory actions as warranted.

For more information visit the FDA website at: [Web] and [Web].

What is this medicine?

BENZOCAINE (BEN zoe kane) causes loss of feeling in the skin. It is used to treat the itching, swelling, and pain of hemorrhoids.

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

They need to know if you have any of these conditions:
  • hemorrhoids inside the rectum
  • skin infection
  • an unusual or allergic reaction to benzocaine, other medicines, foods, dyes, or preservatives
  • pregnant or trying to get pregnant
  • breast-feeding

How should I use this medicine?

This medicine is for external use only. Do not take by mouth. Follow the directions on the label or those given to you by your doctor or health care professional. Do not get this medicine in your eyes. If you do, rinse out with plenty of cool tap water. Do not put this medicine inside the rectum. Do not use this medicine more often than directed.

Talk to your pediatrician regarding the use of this medicine in children. While this medicine may be used on children as young as 12 years of age, precautions do apply.

What if I miss a dose?

If you miss a dose, use it as soon as you can. If it is almost time for your next dose, use only that dose. Do not use double or extra doses.

What may interact with this medicine?

  • sulfonamides like sulfacetamide, sulfamethoxazole, sulfisoxazole, and others

What should I watch for while using this medicine?

Stop using this medicine if your symptoms do not get better in 7 days or if they get worse. Tell your doctor right away if you have any rectal bleeding.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:
  • allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
  • breathing problems
  • dizziness or drowsiness
  • fast or slow heartbeat
  • headache
  • increased sweating
  • restlessness, nervousness, anxiety
  • seizures
  • tremors

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

  • redness, swelling, or pain

Where should I keep my medicine?

Keep out of the reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Do not freeze. Throw away any unused medicine after the expiration date.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.


Last Updated: March 19, 2009
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