"The U.S. Food and Drug Administration today announced its intention to take enforcement action against companies that manufacture and/or distribute certain unapproved prescription ear drop products (known as otic products) labeled to relieve ear "...
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 (triethanolamine polypeptide) Eardrops should be limited to 15-30 minutes.
- When administering CERUMENEX (triethanolamine polypeptide) 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 (triethanolamine polypeptide) 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 (triethanolamine polypeptide) Eardrops.
Teratogenic Effects: Pregnancy Category C. Animal reproduction studies have not yet been conducted with CERUMENEX (triethanolamine polypeptide) Eardrops. It is also not known whether CERUMENEX (triethanolamine polypeptide) Eardrops can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. CERUMENEX (triethanolamine polypeptide) Eardrops 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 CERUMENEX (triethanolamine polypeptide) Eardrops are administered to a nursing mother.
Safety and effectiveness in children have not been established.
No overall clinical differences in safety or effectiveness have been observed between the elderly and other adult patients.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 4/27/2009
Additional Cerumenex Information
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