A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Cerumenex Patient, Information, Instructions - Triethanolamine Polypeptide
Cerumenex Patient, Information, Instructions - Triethanolamine Polypeptide
Information for Patients
1. Patients should be cautioned to avoid placing the applicator
tip into the ear canal.
2. Patients should be cautioned to gently flush the ear
with lukewarm water.
3. Patients should be warned to use CERUMENEX Eardrops in
ears only. Surrounding skin should be promptly rinsed of any excess drops.
4. Patients should be instructed not to leave CERUMENEX
Eardrops in the ear for longer than 30 minutes. A second application may be
made, if needed, but more frequent use must be indicated by the physician.
5. Patients must be instructed not to exceed the time of
exposure, nor to use the medication more frequently than directed by the physician.
6. Patients should be advised to discontinue the use of
the medication in case of a possible reaction and to consult their physician
promptly.
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.
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