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Nupercainal

Generic Name: Dibucaine
Class: Antipruritics and Local Anesthetics
ATC Class: C05AD04
VA Class: DE700
CAS Number: 85-79-0

Introduction

Local anesthetic.a c

Uses for Nupercainal

Dermatologic Conditions

Self-medication for temporary relief of pain and itching associated with minor burns, sunburn, minor cuts or scrapes, insect bites, or minor skin irritations.a c

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Hemorrhoids

Self-medication for temporary relief of pain, itching, and burning caused by hemorrhoids.a c

Nupercainal Dosage and Administration

Administration

Topical Administration

Apply topically to the skin as an ointment.a c

For external use only.c Avoid contact with the eye(s).a c

Do not apply in large quantities, especially over denuded surfaces or blistered areas.a

Prior to administration, cleanse the site with mild soap and warm water, rinse thoroughly, and gently dry with a soft cloth.c

Gently apply to affected areas.a For dermatologic conditions, cover with a light dressing, if necessary.a c

Wash hands following administration.c

Dosage

Pediatric Patients

Dermatologic Conditions
Topical

Children ≥12 years of age: Apply to affected areas 3–4 times daily.a c

Hemorrhoids
Topical

Children ≥12 years of age: Apply to affected anal tissues 3–4 times daily (morning and evening and after each bowel movement).a c

Adults

Dermatologic Conditions
Topical

Apply to affected areas 3–4 times daily.a c

Hemorrhoids
Topical

Apply to affected anal tissues 3–4 times daily (morning and evening and after each bowel movement).a c

Prescribing Limits

Pediatric Patients

Dermatologic Conditions
Topical

Children ≥12 years of age: Apply maximum 4 times daily.c Maximum: 7.5 g daily.a

Hemorrhoids
Topical

Children ≥12 years of age: Apply maximum 4 times daily.c

Adults

Dermatologic Conditions
Topical

Apply maximum 4 times daily.c Maximum: 30 g daily.a

Hemorrhoids
Topical

Apply maximum 4 times daily.c Maximum: 30 g daily.a

Special Populations

No special population dosage recommendations at this time.c

Cautions for Nupercainal

Contraindications

  • Known hypersensitivity to dibucaine, other amide-type local anesthetics, or any ingredient in the formulation.a

Warnings/Precautions

Sensitivity Reactions

Sulfite Sensitivity

Commercially available rectal and topical formulations of dibucaine contain acetone sodium bisulfite.a c Possible risk of anaphylaxis and life-threatening or less severe asthmatic episodes in certain susceptible individuals. a

If a rash or irritation develops or increases, discontinue drug and consult a clinician.a c

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.a c

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.d

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).101 102

Lidocaine 4% gel has been investigated to reduce discomfort during mammography.101 103 Whether such use could result in serious reactions has not been determined.101 103 Patients should speak with their clinician if they are considering using a topical anesthetic before obtaining a mammogram.101

When a topical anesthetic is needed for a procedure, use of an FDA-approved preparation has been recommended.d 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,d and do not apply to broken or irritated skin.101 d

Specific Populations

Pregnancy

Safety and efficacy not established in pregnant women.c Use with caution.c

Lactation

Safety and efficacy not established in nursing women.c Use with caution.c

Pediatric Use

Children <12 years of age: use topical dibucaine only under clinical supervision.c

Common Adverse Effects

Rash, irritation.a

Interactions for Nupercainal

No formal drug interaction studies to date.c

Stability

Storage

Topical

Ointment

Tight, light-resistant containers at <40°C, preferably between 15–30°C.a c

Actions

  • Blocks nerve conduction near application site and produces temporary loss of feeling or sensation.b

  • Blocks the generation and conduction of nerve impulses by decreasing the rate of depolarization of the nerve membrane.b

Advice to Patients

  • Importance of discontinuing therapy and consulting clinician if a rash or irritation develops during therapy.a c

  • Importance of washing hands following administration.c

  • Importance of avoiding contact with the eyes.a c

  • Importance of using as directed and not applying in large quantities, particularly over raw surfaces or blistered areas.a

  • Importance of discontinuing therapy and consulting clinician if dermatologic condition worsens or symptoms persist for >7 days or if redness, irritation, or bleeding occurs.a c

  • Importance of women informing their clinician if they are or plan to become pregnant or plan to breast-feed.c

  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses.c

  • 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.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Dibucaine

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Rectal or Topical

Ointment

1%*

Nupercainal Hemorrhoidal and Anesthetic Ointment (with acetone sodium bisulfite)

Novartis

AHFS DI Essentials. © Copyright, 2004-2014, Selected Revisions August 1, 2009. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

101. Food and Drug Administration. FDA Public Health Advisory: Potential hazards of skin products containing numbing ingredients for relieving pain from mammography and other medical tests and conditions. 2009 Jan 16. From FDA website.

102. Food and Drug Administration. Topical Anesthetics. MedWatch alert. Rockville, MD; 2009 Jan 16. From FDA website.

103. Lambertz CK, Johnson CJ, Montgomery PG et al. Premedication to reduce discomfort during screening mammography. Radiology. 2008; 248:765-72. [PubMed 18647845]

a. AHFS drug information 2004. McEvoy GK, ed. Dibucaine. Bethesda, MD: American Society of Health-System Pharmacists; 2007: 3537.

b. AHFS drug information 2007. McEvoy GK, ed. Local Anesthetics, Parenteral, General Statement. Bethesda, MD: American Society of Health-Systems Pharmacists; 2007: 3255-8.

c. Novartis. Freemont, MI: Personal communication.

d. Food and Drug Administration. FDA Public Health Advisory: Life-threatening side effects with use of skin products containing numbing ingredients for cosmetic procedures. 2007 Feb 6, updated 2007 Feb 9. From FDA website.

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