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
Tessalon Warnings, Precautions, Pregnancy, Nursing, Abuse - Benzonatate
Tessalon Warnings, Precautions, Pregnancy, Nursing, Abuse - Benzonatate
WARNINGS
Severe hypersensitivity
reactions (including bronchospasm,
laryngospasm and cardiovascular
collapse) have been reported which are possibly related to local
anesthesia from sucking
or chewing the softgel instead of swallowing it. Severe reactions have
required intervention
with vasopressor agents
and supportive measures. Isolated instances of bizarre behavior, including
mental confusion and visual
hallucinations, have also been reported in patients taking benzonatate
in combination with other prescribed drugs.
PRECAUTIONS
Benzonatate is chemically related to anesthetic
agents of the para-aminobenzoic acid class
(e.g., procaine; tetracaine) and has been associated with adverse CNS
effects possibly related to a prior sensitivity
to related agents or interaction with concomitant
medication.
Information for Patients
Release of benzonatate
from the softgel in the mouth
can produce a temporary local anesthesia
of the oral mucosa
and choking could occur. Therefore,
the softgels should be swallowed without chewing.
Usage in Pregnancy
Pregnancy Category C. Animal reproduction
studies have not been conducted with benzonatate. It is also not known
whether benzonatate can cause
fetal harm when administered
to a pregnant woman
or can affect reproduction capacity. Benzonatate 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 benzonatate is administered to a nursing
woman.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Carcinogenicity, mutagenicity, and reproduction
studies have not been conducted with benzonatate.
Pediatric Use
Safety and effectiveness
in children below the age of 10
has not been established.
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