Antipyrine and Benzocaine

Stratus Pharmaceuticals

ANTIPYRINE AND BENZOCAINE OTIC SOLUTION

FULL PRESCRIBING INFORMATION: CONTENTS*

• ANTIPYRINE AND BENZOCAINE DESCRIPTION
• EACH mL CONTAINS
• CLINICAL PHARMACOLOGY
• ANTIPYRINE AND BENZOCAINE INDICATIONS AND USAGE
  • Acute Otitis media of various etiologies
  • Removal of Cerumen
• ANTIPYRINE AND BENZOCAINE CONTRAINDICATIONS
• WARNINGS
• PRECAUTIONS
  • Information for Patients
  • Carcinogenesis, Mutagenesis, Impairment of Fertility
  • Pregnancy
  • Nursing Mothers
• ANTIPYRINE AND BENZOCAINE DOSAGE AND ADMINISTRATION
  • Acute Otitis media
  • Removal of Cerumen
• HOW SUPPLIED
  • Storage
• PRINCIPAL DISPLAY PANEL - 15 mL Bottle Label

FULL PRESCRIBING INFORMATION

EAR SOLUTION

Topical Decongestant and Analgesic

Rx Only

ANTIPYRINE AND BENZOCAINE DESCRIPTION

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 0°C (32°F), 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:

It occurs as white crystals or white crystalline powder and is slightly soluble in water and soluble in organic solvents.

EACH mL CONTAINS

Actives: Antipyrine 54 mg, Benzocaine 14 mg; Inactives: Glycerine (anhydrous), Oxyquinoline Sulfate.

CLINICAL PHARMACOLOGY

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.

ANTIPYRINE AND BENZOCAINE INDICATIONS AND USAGE

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.

Because of the close anatomical relationship of the eustachian tube to the nasal cavity, otitis media is a frequent problem, especially in children in whom the tube is shorter, wider and more horizontal than in adults.

Removal of Cerumen

• -facilitates the removal of excessive or impacted cerumen.

ANTIPYRINE AND BENZOCAINE 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.

PRECAUTIONS

Information for Patients

Avoid contaminating the dropper with material from the ear, fingers or other source.

Carcinogenesis, Mutagenesis, Impairment of Fertility

No long term studies have been conducted.

Pregnancy

Category 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 Otic Solution should be given to a pregnant woman only if clearly needed.

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.

ANTIPYRINE AND BENZOCAINE DOSAGE AND ADMINISTRATION

Acute Otitis media

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

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.

HOW SUPPLIED

Antipyrine and Benzocaine Otic Solution is supplied in plastic bottles containing 15 mL NDC #58980-200-15. A tamper evident seal is on the bottle cap. Do not dispense if the seal is broken.

Storage

Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (between 59°F and 86°F). Protect from heat and light. Protect from freezing. [See USP Controlled Room Temperature].

Manufactured for:
Stratus Pharmacueticals Inc
12379 SW 130th Street
Miami, Florida 33186
Customer Service: 800-442-7882

PRINCIPAL DISPLAY PANEL - 15 mL Bottle Label

NOT FOR USE IN EYES

STRATUS
PHARMACEUTICALS INC

NDC 58980-200-15

ANTIPYRINE &
BENZOCAINE
Otic Solution, USP

Rx Only

FOR USE IN THE
EARS ONLY

15 mL (1/2 fl. oz.)