dibucaine topical ointment

Dibucaine topical ointment is a local anesthetic that is used for temporary relief of pain and itching caused by sunburn, cuts, abrasions, insect bites, skin irritation, hemorrhoids, and other anorectal disorders. Dibucaine is an amide type of anesthetic that locally numbs the region by preventing initiation and conduction of pain signals from the nerve ends to the brain. Dibucaine topical ointment is available over the counter (OTC) in the U.S.

Dibucaine binds to and blocks the sodium channels in the nerve cells (neurons), inhibiting the influx of sodium ions into the neurons. This stabilizes the neuronal membrane and prevents depolarization and conduction of signals by the neuron, blocking the transmission of pain signals to the brain, temporarily.

• Do not use dibucaine topical ointment if you are hypersensitive to any component of the formulation or to other amide anesthetics.
• Do not apply dibucaine topical ointment on children below 2 years of age.
• There have been reports of methemoglobinemia, associated with local anesthetics. Methemoglobinemia is a condition with high blood levels of methemoglobin, a form of hemoglobin that does not deliver oxygen to the cells. Monitor patients at higher risk, including patients with:
  • Glucose-6-phosphate dehydrogenase deficiency
  • Congenital or idiopathic methemoglobinemia
  • Cardiac or pulmonary compromise
  • Concurrent exposure to oxidizing agents or their metabolites
• Dibucaine topical ointment is for external use only. Do not apply inside the rectum.

Common side effects of dibucaine topical ointment include:

• Skin irritation and burning
• Skin sensitivity to sunlight (photosensitivity)
• Contact dermatitis
• Swelling beneath the skin and mucous membranes (angioedema)
• Flushing
• Eye irritation
• Chest pain
• Palpitations
• Diarrhea
• Nausea
• Vomiting

Call your doctor immediately if you experience any of the following symptoms or serious side effects while using this drug:

• Serious heart symptoms include fast or pounding heartbeats, fluttering in your chest, shortness of breath, and sudden dizziness;
• Severe headache, confusion, slurred speech, severe weakness, vomiting, loss of coordination, feeling unsteady;
• Severe nervous system reaction with very stiff muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, and feeling like you might pass out; or
• Serious eye symptoms include blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights.

This is not a complete list of all side effects or adverse reactions that may occur from the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may also report side effects or health problems to the FDA at 1-800-FDA-1088.

Ointment

• 10%

Adult and Pediatric:

Topical Pain

• Indicated for temporary relief of pain and itching caused by sunburn, cuts, abrasions, insect bites, skin irritation, hemorrhoids, and other anorectal disorders

Children below 2 years (or below 15 kg)

• Safety and efficacy not established

Children above 2 years (and above 15 kg)

• Apply topically to affected area up to 3-4 times/day; do not exceed 7.5 g/day

Adults:

• Apply topically to affected area up to 3-4 times/day; do not exceed 30 g/day

Dosing Considerations

• Prolonged use not recommended

Administration

• Wash hands before and after administration
• May cover with light dressing if necessary
• Do not apply to open wounds, burns, broken or inflamed skin; do not apply in nose, mouth or eyes
• Pediatric patients should be monitored closely after administration to ensure that medication does not get in eyes or mouth

Overdose

• Topical application of dibucaine ointment is unlikely to result in overdose. Dibucaine is highly toxic if orally ingested. Overdose from oral ingestion can cause convulsions, low tissue oxygen saturation (hypoxia), excessive acidity of body fluids (acidosis), abnormally slow heart rate (bradycardia), irregular heart rhythm (arrhythmia), and cardiac arrest.
• Overdose treatment is symptomatic and supportive care, including gastric lavage to eliminate undigested drug in the gastrointestinal tract, respiratory assistance and cardiac life support measures, if required.

Inform your doctor of all medications you are currently taking, who can advise you on any possible drug interactions. Never begin taking, suddenly discontinue, or change the dosage of any medication without your doctor’s recommendation.

• Dibucaine topical ointment has no known severe or serious interactions with other drugs.
• Moderate interactions of dibucaine topical ointment include:
  • Methemoglobinemia associated agents
• Dibucaine topical ointment has no known mild interactions with other drugs.

The drug interactions listed above are not all of the possible interactions or adverse effects. For more information on drug interactions, visit the RxList Drug Interaction Checker.

It is important to always tell your doctor, pharmacist, or health care provider of all prescription and over-the-counter medications you use, as well as the dosage for each, and keep a list of the information. Check with your doctor or health care provider if you have any questions about the medication.

• Dibucaine topical ointment should be used during pregnancy with caution, only if clearly needed.
• It is not known if topical dibucaine is systemically absorbed adequately to be present in breastmilk.
• Do not use any OTC drug, including dibucaine topical ointment, without first checking with your healthcare provider, if you are pregnant or breastfeeding.

• Use dibucaine topical ointment exactly as prescribed or as per label instructions.
• Do not exceed recommended dose unless recommended by your physician.
• Do not use on large areas of the skin or for prolonged periods.
• Dibucaine topical ointment is for external use only. Avoid contact with eyes, nose and mouth. Do not apply inside the rectum.
• Dibucaine topical ointment can cause photosensitivity. Avoid exposure to direct sunlight.
• Discontinue dibucaine topical ointment and contact your healthcare provider if:
  • Condition does not improve within a week and symptoms persist, or the condition becomes worse
  • Redness, irritation, swelling, bleeding or other symptoms develop or increase
• Store dibucaine topical ointment safely out of reach of children.
• In case of oral ingestion and overdose, seek medical help immediately or contact Poison Control.