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ANTIPYRINE AND BENZOCAINE
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DESCRIPTION: Each mL contains:
Antipyrine..........54 mg (5.4%)
Benzocaine..........14.0 mg (1.4%)
(also contains glycerin and oxyquinoline sulfate)
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-phyl-3-pyrazolin-5-one. 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 ingredients are represented by the following structural formula.
Antipyrine and Benzocaine Otic Solution comibine the hygroscopic
property of anhydrous glycerin with the analgesic action of antipyrine and
benzocaine to relieve pressure, reduce inflammation and congestion, and
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.
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, epecially 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 Otic Solution is contraindicated in any person with
hypersensitivity to any of the components or substances related tot hem. This
product is contraindicated in the presence of spontaneous perforation of the
tympanic membrane or discharge.
FOR USE IN EARS ONLY NOT FOR USE IN EYES
KEEP OUT OF REACH OF CHILDREN
Discontinue promptly if sensitization or irritation occurs.
Information for Patients:
Avoid contaminating the dropper tip with material from
the ear fingers or other source.
CARCONOGENESIS, MUTAGENESIS, IMPAIRMENT OF FERTILITY:
long-term studies in animals or humans 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.
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
DOSAGE AND ADMINISTRATION
ACUTE OTITIS MEDIA:
Instill Antipyrine and Benzocaine Otic Soution permitting the solution to run along the wall of the canal until it is filled. Avoid touching the ear with dropper. Then moisten a cotton pledget with Antipyrine Benzocaine Otic Solution and insert into the meatus. Repeat every one to two hours until pain an congestion are relieved.
REMOVAL OF CERUMEN:
Before: Instill Antipyrine and Benzocaine Otic Solution three times daily for two to three days to help detach cerumen from wall of canal and facilitate removal.
After: Antipyrine and Benzocaine Otic Solution is useful for drying out the canal or relieving discomfort.
Before and after removal of cerumen, a cotten pledget moistened with Antipyrine and Benzocaine Otic Solution should be inserted into the meatus following installation.
Note: After use, do not rinse dropper tip, replace cap and close tightly
Protect solution from light and heat, and do not use if it is brown or contains a precipitate.
DISCARD THIS PRODUCT 6 MONTHS AFTER OPENING.
Antipyrine and Benzocaine Otic Solution is supplied in a
Store at 20-25C (68-77F); excursions permitted to 1530C (59-86F) see USP Controlled Room Temperature).
Manufactured for: Acella Pharmaceuticals, LLC
9005 Westside Parkway, Alpharetta, GA 30009
Relabeling of "Additional barcode" label by:
Revised: 03/2011 Physicians Total Care, Inc.
Reproduced with permission of U.S. National Library of Medicine
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