Prescription Drugs

CLINICAL PHARMACOLOGY Auralgan (antipyrine, benzocaine and glycerin dehydrated) combines the hygroscopic property of dehydrated 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. Auralgan (antipyrine, benzocaine and glycerin dehydrated) does not blanch the tympanic membrane or mask the landmarks and, therefore, does not distort the otoscopic picture.

Auralgan (antipyrine, benzocaine, and dehydrated glycerin) DESCRIPTION Each mL contains: Antipyrine ............................................ 54.0 mg Benzocaine ........................................... 14.0 mg Glycerin dehydrated q.s. to ..................... 1.0 mL (contains not more than 0.6% moisture) (also contains oxyquinoline sulfate) TOPICAL DECONGESTANT AND ANALGESIC Auralgan is an otic solution containing antipyrine, benzocaine, and dehydrated glycerin. The solution congeals at 0° C (32° F), but returns to normal consistency, unchanged, at room temperature.

INDICATIONS 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 DOSAGE AND ADMINISTRATION ACUTE OTITIS MEDIA Instill Auralgan (antipyrine, benzocaine and glycerin dehydrated) 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 Auralgan (antipyrine, benzocaine and glycerin dehydrated) and insert into meatus. Repeat every one to two hours until pain and congestion are relieved. REMOVAL OF CERUMEN Before: Instill Auralgan (antipyrine, benzocaine and glycerin dehydrated) three times daily for two or three days to help detach cerumen from wall of canal and facilitate removal. After: Auralgan (antipyrine, benzocaine and glycerin dehydrated) is useful for drying out the canal or relieving discomfort. Before and after removal of cerumen, a cotton pledget moistened with Auralgan (antipyrine, benzocaine and glycerin dehydrated) should be inserted into the meatus following instillation. Note: Do not rinse dropper after use. Replace dropper in bottle after each use. Hold dropper assembly by screw cap and, without compressing the rubber bulb, insert into drug container and screw down tightly. Protect the solution from light and heat, and do not use if it is brown or contains a precipitate. DISCARD THIS PRODUCT SIX MONTHS AFTER DROPPER IS FIRST PLACED IN THE DRUG SOLUTION. HOW SUPPLIED Auralgan (antipyrine, benzocaine and glycerin dehydrated) ® Otic Solution, in package containing 10 mL bottle with separate dropper-screw cap attachment (NDC 0046-1000-10). Store at room temperature (approximately 25° C). Manufactured by: Ayerst Laboratories Inc. A Wyeth-Ayerst Company Philadelphia, PA 19101

PATIENT INFORMATION No Information Provided.

OVERDOSE No Information Provided. CONTRAINDICATIONS Hypersensitivity to any of the components or substances related to them. Perforated tympanic membrane is considered a contraindication to the use of any medication in the external ear canal.

SIDE EFFECTS No Information Provided. DRUG INTERACTIONS No Information Provided.

WARNINGS Discontinue promptly if sensitization or irritation occurs. PRECAUTIONS CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT OF FERTILITY No long-term studies in animals or humans have been conducted PREGNANCY CATEGORY C Animal reproduction studies have not been conducted with Auralgan (antipyrine, benzocaine and glycerin dehydrated) . It is also not known whether Auralgan (antipyrine, benzocaine and glycerin dehydrated) can cause fetal harm when administered to a pregnant woman, or can affect reproduction capacity. Auralgan (antipyrine, benzocaine and glycerin dehydrated) 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 Auralgan (antipyrine, benzocaine and glycerin dehydrated) is administered to a nursing woman.