Benzocaine (injection)

Benzocaine (injection)
Black Box Warning
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: Deepika Beereddy, MBBS [2]

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Black Box Warning

ConditionName: See full prescribing information for complete Boxed Warning. ConditionName: Content

Overview

Benzocaine (injection) is a local anesthetic that is FDA approved for the treatment of {{{indication}}}. There is a Black Box Warning for this drug as shown here. Common adverse reactions include .

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Disorder of dental prosthesis - Pain due to any device, implant AND/OR graft

• Dosing Information

• Disorder of dental prosthesis - Pain due to any device, implant AND/OR graft: (10% oral rinse) swish and spit 15 mL; repeat after 1 h and up to 4 times daily
• Disorder of dental prosthesis - Pain due to any device, implant AND/OR graft: (6% oral strips) dissolve one strip on irritated area up to 4 times daily
• Disorder of dental prosthesis - Pain due to any device, implant AND/OR graft: (oral gel) apply thin layer of oral gel TOPICALLY to the affected areas up to 4 times daily, do not reinsert dental work until irritation/pain is relieved; rinse mouth well before reinserting dentures

Endoscopic procedure - Pain; Prophylaxis

• Dosing Information

• Endoscopic procedure - Pain; Prophylaxis: (20% anesthetic lubricant) apply evenly to exterior of tube or instrument prior to use

Insertion of nasogastric tube - Pain

• Dosing Information

• Insertion of nasogastric tube - Pain: (20% anesthetic lubricant) apply evenly to exterior of tube or instrument prior to use

Otitis - Topical local anesthetic

• Dosing Information

• Otitis - Topical local anesthetic: instill 4 to 5 drops of otic solution into external ear canal of affected ear(s), repeat every 1 to 2 h if necessary

Skin irritation - Topical local anesthetic

• Dosing Information

• Skin irritation - Topical local anesthetic: apply TOPICALLY to affected area not more than 3 to 4 times daily holding can 6 to 12 inches away from affected area

Stomatitis - Topical local anesthetic

• Dosing Information

• Stomatitis - Topical local anesthetic: apply TOPICALLY to affected areas up to 4 times daily

Toothache

• Dosing Information

• Toothache: apply gel, liquid, or ointment TOPICALLY to affected areas up to 4 times daily

Topical local anesthetic, For general use during catheterization and/or diagnostic and surgical procedures

• Dosing Information

• Topical local anesthetic, For general use during catheterization and/or diagnostic and surgical procedures: (20% anesthetic lubricant) apply evenly to exterior of tube or instrument prior to use

Topical local anesthetic - Ulcer of mouth

• Dosing Information

• Topical local anesthetic - Ulcer of mouth: apply TOPICALLY to affected areas up to 4 times daily

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

• There is limited information regarding Off-Label Guideline-Supported Use of Benzocaine (injection) in adult patients.

Non–Guideline-Supported Use

• There is limited information regarding Off-Label Non–Guideline-Supported Use of Benzocaine (injection) in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Disorder of dental prosthesis - Pain due to any device, implant AND/OR graft

• Dosing Information

• Dosage

Endoscopic procedure - Pain; Prophylaxis

• Dosing Information

• Endoscopic procedure - Pain; Prophylaxis: (ages 1 year and older) 20% anesthetic lubricant, apply evenly to exterior of tube or instrument prior to use

Insertion of nasogastric tube - Pain

• Dosing Information

• Insertion of nasogastric tube - Pain: (ages 1 year and older) 20% anesthetic lubricant, apply evenly to exterior of tube or instrument prior to use

Otitis - Topical local anesthetic

• Dosing Information

• Otitis - Topical local anesthetic: (age 1 y and older) instill 4 to 5 drops of otic solution into external ear canal of affected ear(s), repeat every 1 to 2 h if necessary

Skin irritation - Topical local anesthetic

• Dosing Information

• Skin irritation - Topical local anesthetic: (ages 2 years and older) apply TOPICALLY to affected area not more than 3 to 4 times daily holding can 6 to 12 inches away from affected area

Stomatitis - Topical local anesthetic

• Dosing Information

• Stomatitis - Topical local anesthetic: (ages 2 years and older) apply TOPICALLY to affected areas up to 4 times daily

Toothache

• Dosing Information

• Toothache: (2 years and older) apply gel, liquid, or ointment to affected areas up to 4 times daily

Topical local anesthetic, For general use during catheterization and/or diagnostic and surgical procedures

• Dosing Information

• Topical local anesthetic, For general use during catheterization and/or diagnostic and surgical procedures: (ages 1 year and older) 20% anesthetic lubricant, apply evenly to exterior of tube or instrument prior to use

Topical local anesthetic - Ulcer of mouth

• Dosing Information

• Topical local anesthetic - Ulcer of mouth: (ages 2 years and older) apply TOPICALLY to affected areas up to 4 times daily

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

• There is limited information regarding Off-Label Guideline-Supported Use of Benzocaine (injection) in pediatric patients.

Non–Guideline-Supported Use

• There is limited information regarding Off-Label Non–Guideline-Supported Use of Benzocaine (injection) in pediatric patients.

Contraindications

• Condition1

Warnings

ConditionName: See full prescribing information for complete Boxed Warning. ConditionName: Content

Allergy alert

Do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine, or other "caine" anesthetics

When using this product

   avoid contact with the eyes
   do not exceed recommended dosage
   do not use for more than 7 days unless directed by a doctor/dentist

Stop use and ask a doctor if

   sore mouth symptoms do not improve in 7 days
   irritation, pain, or redness persists or worsens
   swelling, rash, or fever develops

Keep out of reach of children.

If more than used for pain is accidentally 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 Benzocaine (injection) in the drug label.

Body as a Whole

Cardiovascular

Digestive

Endocrine

Hematologic and Lymphatic

Metabolic and Nutritional

Musculoskeletal

Neurologic

Respiratory

Skin and Hypersensitivy Reactions

Special Senses

Urogenital

Miscellaneous

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Benzocaine (injection) in the drug label.

Body as a Whole

Cardiovascular

Digestive

Endocrine

Hematologic and Lymphatic

Metabolic and Nutritional

Musculoskeletal

Neurologic

Respiratory

Skin and Hypersensitivy Reactions

Special Senses

Urogenital

Miscellaneous

Drug Interactions

• Drug

• Description

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

• Pregnancy Category

Pregnancy Category (AUS):

• Australian Drug Evaluation Committee (ADEC) Pregnancy Category

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

Labor and Delivery

There is no FDA guidance on use of Benzocaine (injection) during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Benzocaine (injection) with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Benzocaine (injection) with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Benzocaine (injection) with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Benzocaine (injection) with respect to specific gender populations.

Race

There is no FDA guidance on the use of Benzocaine (injection) with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Benzocaine (injection) in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Benzocaine (injection) in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Benzocaine (injection) in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Benzocaine (injection) in patients who are immunocompromised.

Administration and Monitoring

Administration

• Oral

• Intravenous

Monitoring

There is limited information regarding Monitoring of Benzocaine (injection) in the drug label.

• Description

IV Compatibility

There is limited information regarding IV Compatibility of Benzocaine (injection) in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

• Description

Management

• Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Benzocaine (injection) in the drug label.

Pharmacology

There is limited information regarding Benzocaine (injection) Pharmacology in the drug label.

Mechanism of Action

Structure

File:Benzocaine (injection)01.png

This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Benzocaine (injection) in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Benzocaine (injection) in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Benzocaine (injection) in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Benzocaine (injection) in the drug label.

How Supplied

Storage

There is limited information regarding Benzocaine (injection) Storage in the drug label.

Images

Drug Images

File:Benzocaine pdp 6.jpg

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Package and Label Display Panel

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Patient Counseling Information

Anbesol Regular and Maximum Strength Liquid

   adults and children 2 years of age and older:
       wipe liquid on with cotton, or cotton swab, or fingertip
       apply to the affected area up to 4 times daily or as directed by a doctor/dentist
   children under 12 years of age: adult supervision should be given in the use of this product
   children under 2 years of age: consult a doctor/dentist

Anbesol Regular and Maximum Strength Gel

   to open tube, cut tip of the tube on score mark with scissors
   adults and children 2 years of age and older: apply to the affected area up to 4 times daily or as directed by a doctor/dentist
   children under 12 years of age: adult supervision should be given in the use of this product
   children under 2 years of age: consult a doctor/dentist
   for denture irritation:
       apply thin layer to the affected area
       do not reinsert dental work until irritation/pain is relieved
       rinse mouth well before reinserting

Anbesol Jr. Gel

   to open tube, cut tip of the tube on score mark with scissors
   adults and children 2 years of age and older: apply to the affected area up to 4 times daily or as directed by a doctor/dentist
   children under 12 years of age: adult supervision should be given in the use of this product
   children under 2 years of age: consult a doctor/dentist

Precautions with Alcohol

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

Brand Names

Orajel, Americaine, Anacaine, Anbesol, Benzodent, Bi-Zets/Benzo-Troches, Chiggerex, Dent's.

Look-Alike Drug Names

• A® — B®

Drug Shortage Status

Price

References

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

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