Prescription Drugs

CLINICAL PHARMACOLOGY CERUMENEX Eardrops emulsify and disperse excess or impacted earwax. The triethanolamine polypeptide oleate, a surfactant, in a hygroscopic vehicle lyses cerumen to facilitate removal by subsequent water irrigation.

CERUMENEX® EARDROPS (triethanolamine polypeptide oleate-condensate) DESCRIPTION CERUMENEX Eardrops contain triethanolamine Polypeptide Oleate-Condensate (10%). Inactive Ingredients: Chlorobutanol 0.5%, Propylene Glycol and Water. Triethanolamine Polypeptide Oleate is a hygroscopic-miscible solution with low surface tension and optimal viscosity of 50-90 cps. It also has a slightly acid pH range (5.0-6.0) to approximate the surface of a normal ear canal.

INDICATIONS For removal of impacted cerumen prior to ear examination, otologic therapy and/or audiometry. DOSAGE AND ADMINISTRATION Fill ear canal with CERUMENEX Eardrops with the patient's head tilted at a 45° angle. Insert cotton plug and allow to remain 15-30 minutes. Then gently flush with lukewarm water, using a soft rubber syringe (avoid excessive pressure). Exposure of skin outside the ear to the drug should be avoided. The procedure may be repeated if the first application fails to clear the impaction. FOR EXTERNAL USE IN THE EAR ONLY HOW SUPPLIED CERUMENEX Eardrops (triethanolamine polypeptide oleate-condensate) are supplied in 6 Ml (NDC 0034-5490-06) and 12 mL (NDC 0034-5490-12) bottles with a cellophane wrapped dropper. Store at controlled room temperature 15-30°C (59-86°F). Store in a dry place. The Purdue Frederick Company, Stamford, CT 06901-3431. Revised: Nov 2001

OVERDOSE No information provided. CONTRAINDICATIONS Perforated tympanic membrane or otitis media is considered a contraindication to the use of this medication in the external ear canal. A history of hypersensitivity to CERUMENEX Eardrops or to any of its components is also a contraindication to the use of this medication.

SIDE EFFECTS Clinical Reactions Of Possible Allergic Origin Localized dermatitis reactions were reported in about 1% of 2,700 patients treated, ranging from a very mild erythema and pruritus of the external canal to a severe eczematoid reaction involving the external ear and periauricular tissue, generally with duration of 2-10 days. Other reactions which have been reported in connection with the use of CERUMENEX Eardrops include allergic contact dermatitis, skin ulcerations, burning and pain at the application site and skin rash. DRUG INTERACTIONS No information provided.

WARNINGS Discontinue promptly if sensitization or irritation occurs. PRECAUTIONS General It is recommended that the following precautions be observed in prescribing and administration of this agent: Extreme caution is indicated in patients with demonstrable dermatologic idiosyncrasies or with history of allergic reactions in general. Exposure of the ear canal to the CERUMENEX Eardrops should be limited to 15-30 minutes. When administering CERUMENEX Eardrops, care must be taken to avoid undue exposure of the skin outside the ear during the instillation and the flushing out of the medication. If the medication comes in contact with the skin, the area should be washed with soap and water. Use of proper technique (see DOSAGE AND ADMINSITRATION) will help avoid such undue exposure. CERUMENEX Eardrops should be used only with caution in external otitis. Carcinogenesis, Mutagenesis, Impairment Of Fertility Long-term animal studies have not been performed to evaluate the carcinogenic potential or the effect on fertility of CERUMENEX Eardrops. Pregnancy Teratogenic Effects Pregnancy Category C. Animal reproduction studies have not yet been conducted with CERUMENEX Eardrops. It is also not known whether CERUMENEX Eardrops can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. CERUMENEX Eardrops 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 CERUMENEX Eardrops are administered to a nursing mother. Pediatric Use Safety and effectiveness in children have not been established. Geriatric Use No overall clinical differences in safety or effectiveness have been observed between the elderly and other adult patients.