Dibucaine

Dibucaine
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Rabin Bista, M.B.B.S. [2]

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NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Overview

Dibucaine is a Local analgesic ointment that is FDA approved for the treatment of pain and itching due to hemorrhoids or other anorectal disorders, Sunburn, minor burns, minor cuts. Common adverse reactions include unusual warmth or flushing of skin, Contact dermatitis, Photosensitivity.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indications

• temporarily relieves pain and itching due to:

• hemorrhoids or other anorectal disorders, sunburn, minor burns, minor cuts
• scrapes, Insect Bites, minor skin irritation

Dosage

Directions

• if possible clean the affected area with mild soap and warm water and rinse thoroughly
• gently dry by patting or blotting with toilet tissue or a soft cloth before applying

• Adults and children 12 and over - apply externally to the affected area up to 3 to 4 times a day.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Dibucaine in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Dibucaine in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

• Children under 2 - 12 years of age - ask a doctor

• Infants under 2 years of age - DO NOT USE

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Dibucaine in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Dibucaine in pediatric patients.

Contraindications

There is limited information regarding Dibucaine Contraindications in the drug label.

Warnings

• For external use only.

• Allergy alert - certain persons san develop allergic reactions to ingredients in this product

• Do not use

• in or near the eyes
• do not get into the eyes
• in infants under 2 years of age
• in large quantities, particularly over raw surfaces or blistered areas
• do not put this product into rectum by using fingers or any mechanical device

• Stop use and ask a doctor if

• condition worsens, or does not improve within 7 days
• the symptom being treated does not subside or if redness, irritation, swelling, bleeding or other symptoms develop or increase

• If pregnant or breast feeding, as a health care professional before use

• Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away

Adverse Reactions

Clinical Trials Experience

There is limited information regarding clinical trial experience of Dibucaine in the drug label.

Postmarketing Experience

• unusual warmth or flushing of skin
• Contact dermatitis
• Photosensitivity
• Chest pain
• fast or irregular heartbeat
• tightness in the chest
• Hypersensitivity reaction

Drug Interactions

There is limited information regarding Dibucaine Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

• If pregnant or breast feeding, as a health care professional before use

Pregnancy Category (AUS):

• Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Dibucaine in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Dibucaine during labor and delivery.

Nursing Mothers

• If pregnant or breast feeding, as a health care professional before use

Pediatric Use

There is no FDA guidance on the use of Dibucaine with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Dibucaine with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Dibucaine with respect to specific gender populations.

Race

There is no FDA guidance on the use of Dibucaine with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Dibucaine in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Dibucaine in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Dibucaine in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Dibucaine in patients who are immunocompromised.

Administration and Monitoring

Administration

• topical

Monitoring

There is limited information regarding Monitoring of Dibucaine in the drug label.

IV Compatibility

There is limited information regarding IV Compatibility of Dibucaine in the drug label.

Overdosage

• Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away

Pharmacology

Mechanism of Action

There is limited information regarding Dibucaine Mechanism of Action in the drug label.

Structure

• Active ingredients - Dibucaine 1%
• Inactive Ingredients - acetone sodium bisulfite, lanolin, light mineral oil, purified water, white petrolatum

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Dibucaine in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Dibucaine in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Dibucaine in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Dibucaine in the drug label.

How Supplied

There is limited information regarding Dibucaine How Supplied in the drug label.

Storage

store at controlled room temperature 20 degrees to 25 degrees c

Images

Drug Images

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Package and Label Display Panel

Ingredients and Appearance

This image is provided by the National Library of Medicine.

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Patient Counseling Information

to secure child resistant cap; screw cap tightly. Then turn cap in opposite direction. If clicking sound is not heard, repeat procedure. - see crimp of tube for lot number and expiration date

Precautions with Alcohol

• Alcohol-Dibucaine interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

• DIBUCAINE®

Look-Alike Drug Names

There is limited information regarding the look alike names.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

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