Self-medication for temporary relief of pain and itching associated with minor burns, sunburn, minor cuts or scrapes, insect bites, or minor skin irritations.
Hemorrhoids
Self-medication for temporary relief of pain, itching, and burning caused by hemorrhoids.
Dosage and Administration
Administration
Topical Administration
Apply topically to the skin as an ointment.
For external use only. Avoid contact with the eye(s).
Do not apply in large quantities, especially over denuded surfaces or blistered areas.
Prior to administration, cleanse the site with mild soap and warm water, rinse thoroughly, and gently dry with a soft cloth.
Gently apply to affected areas. For dermatologic conditions, cover with a light dressing, if necessary.
Wash hands following administration.
Dosage
Pediatric Patients
Dermatologic Conditions
Topical
Children ≥12 years of age: Apply to affected areas 3–4 times daily.
Hemorrhoids
Topical
Children ≥12 years of age: Apply to affected anal tissues 3–4 times daily (morning and evening and after each bowel movement).
Adults
Dermatologic Conditions
Topical
Apply to affected areas 3–4 times daily.
Hemorrhoids
Topical
Apply to affected anal tissues 3–4 times daily (morning and evening and after each bowel movement).
Prescribing Limits
Pediatric Patients
Dermatologic Conditions
Topical
Children ≥12 years of age: Apply maximum 4 times daily. Maximum: 7.5 g daily.
Hemorrhoids
Topical
Children ≥12 years of age: Apply maximum 4 times daily.
Adults
Dermatologic Conditions
Topical
Apply maximum 4 times daily. Maximum: 30 g daily.
Hemorrhoids
Topical
Apply maximum 4 times daily. Maximum: 30 g daily.
Special Populations
No special population dosage recommendations at this time.
Cautions
Contraindications
Known hypersensitivity to dibucaine, other amide-type local anesthetics, or any ingredient in the formulation.
Warnings/Precautions
Sensitivity Reactions
Sulfite Sensitivity
Commercially available rectal and topical formulations of dibucaine contain acetone sodium bisulfite. Possible risk of anaphylaxis and life-threatening or less severe asthmatic episodes in certain susceptible individuals.
If a rash or irritation develops or increases, discontinue drug and consult a clinician.
General Precautions
Administration
When used for self-medication, discontinue the drug and consult a clinician if the condition worsens, if symptoms persist for >7 days or clear and occur again within a few days, or if swelling, pain, bleeding, rash, or irritation occurs.
Serious Adverse Effects Associated with Local Anesthetics
Risk of serious adverse effects (e.g., seizures, coma, irregular heart beat, respiratory depression) with use of topical local anesthetics; generally reported following application of extemporaneously prepared topical preparations containing high concentrations of anesthetics.
Potential for life-threatening adverse effects (e.g., irregular heart beat, seizures, breathing difficulties, coma, death) when topical local anesthetics are applied to a large area of skin, when the area of application is covered with an occlusive dressing, if a large amount of topical anesthetic is applied, if the anesthetic is applied to irritated or broken skin, or if the skin temperature increases (from exercise or use of a heating pad).
Lidocaine 4% gel has been investigated to reduce discomfort during mammography. Whether such use could result in serious reactions has not been determined. Patients should speak with their clinician if they are considering using a topical anesthetic before obtaining a mammogram.
When a topical anesthetic is needed for a procedure, use of an FDA-approved preparation has been recommended. Use a preparation containing the lowest concentration of anesthetic likely to be effective; apply a small amount of the preparation to the affected area for the shortest period necessary for the desired effect, and do not apply to broken or irritated skin.
Specific Populations
Pregnancy
Safety and efficacy not established in pregnant women. Use with caution.
Lactation
Safety and efficacy not established in nursing women. Use with caution.
Pediatric Use
Children <12 years of age: use topical dibucaine only under clinical supervision.
Common Adverse Effects
Rash, irritation.
Interactions
No formal drug interaction studies to date.
Stability
Storage
Topical
Ointment
Tight, light-resistant containers at <40°C, preferably between 15–30°C.
Actions
Blocks nerve conduction near application site and produces temporary loss of feeling or sensation.
Blocks the generation and conduction of nerve impulses by decreasing the rate of depolarization of the nerve membrane.
Advice to Patients
Importance of discontinuing therapy and consulting clinician if a rash or irritation develops during therapy.
Importance of washing hands following administration.
Importance of avoiding contact with the eyes.
Importance of using as directed and not applying in large quantities, particularly over raw surfaces or blistered areas.
Importance of discontinuing therapy and consulting clinician if dermatologic condition worsens or symptoms persist for >7 days or if redness, irritation, or bleeding occurs.
Importance of women informing their clinician if they are or plan to become pregnant or plan to breast-feed.
Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses.
Importance of informing patients of other important precautionary information. (See Cautions.)
Preparations
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
Dibucaine
Routes
Dosage Forms
Strengths
Brand Names
Manufacturer
Rectal or Topical
Ointment
1%*
Nupercainal®Hemorrhoidal and Anesthetic Ointment (with acetone sodium bisulfite)
Novartis
* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name
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.
