Antipyrine/Benzocaine

# Disclaimer
WikiDoc MAKES NO GUARANTEE OF VALIDITY. WikiDoc is not a professional health care provider, nor is it a suitable replacement for a licensed healthcare provider.  WikiDoc is intended to be an educational tool, not a tool for any form of healthcare delivery.  The educational content on WikiDoc drug pages is based upon the FDA package insert, National Library of Medicine content and practice guidelines / consensus statements.  WikiDoc does not promote the administration of any medication or device that is not consistent with its labeling. Please read our full disclaimer here.

# Overview
Antipyrine/Benzocaine is a topical decongestant and analgesic that is FDA approved for the treatment of acute otitis media of various etiologies, prompt relief of pain and reduction of inflammation in the congestive and serous stages, adjuvant therapy during systemic antibiotic administration for resolution of the infection, removal of cerumen.   Common adverse reactions include Itching, burning, redness, or oozing sores in the ear.

# Adult Indications and Dosage

## FDA-Labeled Indications and Dosage (Adult)

### Acute Otitis Media
- Dosing information
- Instill antipyrine and benzocaine otic solution, permitting the solution to run along the wall of the ear canal until it is filled. Avoid touching the ear with dropper. Then moisten a cotton pledget with antipyrine and benzocaine otic solution and insert into meatus. Repeat every one to two hours until pain and congestion are relieved.

### Removal of Cerumen
- Dosing information
- Before: Instill antipyrine and benzocaine otic solution three times daily for two or three days to help detach cerumen from wall of ear canal and facilitate removal.
- After: Antipyrine and benzocaine otic solution is useful for drying out the ear canal or relieving discomfort.
- Before and after removal of cerumen, a cotton pledget moistened with antipyrine and benzocaine otic solution should be inserted into the meatus following instillation.

## Off-Label Use and Dosage (Adult)

### Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of antipyrine/benzocaine in adult patients.

### NonGuideline-Supported Use
There is limited information regarding Off-Label NonGuideline-Supported Use of antipyrine/benzocaine in adult patients.

# Pediatric Indications and Dosage

## FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding FDA-labeled indications and dosage information of antipyrine/benzocaine in pediatric patients.

## Off-Label Use and Dosage (Pediatric)

### Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of antipyrine/benzocaine in pediatric patients.

### NonGuideline-Supported Use
There is limited information regarding Off-Label NonGuideline-Supported Use of antipyrine/benzocaine in pediatric patients.

# Contraindications
- The product is contraindicated in any person with hypersensitivity to any of the components or substances related to them.
- This product is contraindicated in the presence of spontaneous perforation of the tympanic membrane or discharge.

# Warnings
FOR USE IN EARS ONLY-NOT FOR USE IN EYES
Discontinue promptly if sensitization or irritation occurs.

# Adverse Reactions

## Clinical Trials Experience
FDA package insert for antipyrine/benzocaine contains no information regarding clinical trial experience.

## Postmarketing Experience
FDA package insert for antipyrine/benzocaine contains no information regarding post marketing experience.

# Drug Interactions
FDA package insert for antipyrine/benzocaine contains no information regarding drug interaction.

# Use in Specific Populations

### Pregnancy
Pregnancy Category (FDA): C
Animal reproduction studies have not been conducted with antipyrine and benzocaine otic solution.
It is also not known whether antipyrine and benzocaine otic solution can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Antipyrine and benzocaine 
-tic solution should be given to a pregnant woman only if clearly needed.
Pregnancy Category (AUS): 
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Antipyrine/Benzocaine in women who are pregnant.

### Labor and Delivery
There is no FDA guidance on use of Antipyrine/Benzocaine during labor and delivery.

### Nursing Mothers
It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when antipyrine and benzocaine otic solution is administered to a nursing woman.

### Pediatric Use
There is no FDA guidance on the use of Antipyrine/Benzocaine in pediatric settings.

### Geriatic Use
There is no FDA guidance on the use of Antipyrine/Benzocaine in geriatric settings.

### Gender
There is no FDA guidance on the use of Antipyrine/Benzocaine with respect to specific gender populations.

### Race
There is no FDA guidance on the use of Antipyrine/Benzocaine with respect to specific racial populations.

### Renal Impairment
There is no FDA guidance on the use of Antipyrine/Benzocaine in patients with renal impairment.

### Hepatic Impairment
There is no FDA guidance on the use of Antipyrine/Benzocaine in patients with hepatic impairment.

### Females of Reproductive Potential and Males
There is no FDA guidance on the use of Antipyrine/Benzocaine in women of reproductive potentials and males.

### Immunocompromised Patients
There is no FDA guidance one the use of Antipyrine/Benzocaine in patients who are immunocompromised.

# Administration and Monitoring

### Administration
Instill antipyrine and benzocaine otic solution, permitting the solution to run along the wall of the ear canal until it is filled.

### Monitoring
FDA package insert for antipyrine/benzocaine contains no information regarding drug monitoring.

# IV Compatibility
There is limited information about the IV compatibility.

# Overdosage
FDA package insert for antipyrine/benzocaine contains no information regarding overdosage.

# Pharmacology
There is limited information regarding Antipyrine/Benzocaine Pharmacology in the drug label.

## Mechanism of Action
Antipyrine and benzocaine otic solution combines the hygroscopic property of anhydrous glycerin with the analgesic action of antipyrine and benzocaine to relieve pressure, reduce inflammation and congestion, and to alleviate pain and discomfort in acute otitis media.
Antipyrine and benzocaine otic solution does not blanch the tympanic membrane or mask the landmarks and, therefore, does not distort the otoscopic picture.

## Structure
Antipyrine and benzocaine otic solution is an otic solution containing antipyrine, benzocaine, oxyquinoline sulfate, and anhydrous glycerin for use in the ear. The solution congeals at 0C (32F), but returns to normal consistency, unchanged, at room temperature.
Antipyrine is an analgesic with local anesthetic action, it is chemically 2,3-dimethyl-1-phenyl-3-pyrazolin-5- one. 
The active ingredient is represented by the structural formula:
Antipyrine occurs as colorless crystals or white powder, has a slightly bitter taste and is soluble in water and alcohol.
Benzocaine is a local anesthetic. It is chemically ethyl p-aminobenzoate or benzoic acid, 4-amino-, ethyl ester. 
The active ingredient is represented by the structural formula:
It occurs as white crystals or white crystalline powder and is slightly soluble in water and soluble in organic solvents.

## Pharmacodynamics
There is limited information about the pharmacodynamics.

## Pharmacokinetics
There is limited information about the pharmacokinetics.

## Nonclinical Toxicology
No long term studies have been conducted.

# Clinical Studies
FDA package insert for antipyrine/benzocaine contains no information regarding clinical studies.

# How Supplied
Antipyrine and benzocaine otic solution is supplied in a 15 mL light-resistant dropper-bottle with a screwtop bottle cap. Tamper evident seal on bottle cap. Do not use if seal is broken.

## Storage
Store at 20-25C (68-77F) . Protect from heat and light. Protect from freezing.

# Images

## Drug Images

## Package and Label Display Panel

# Patient Counseling Information
Information for Patients: Avoid contaminating the dropper with material from the ear, fingers or other source.

# Precautions with Alcohol
Alcohol-antipyrine/benzocaine interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

# Brand Names
Aurodex

# Look-Alike Drug Names
There is limited information about the look-like drug names.

# Drug Shortage Status

# Price