The effect of PerioGard® on periodontitis has not been determined.
An increase in supragingival calculus was noted in clinical testing in
chlorhexidine gluconate oral rinse USP, 0.12% users compared with control
users. It is not known if chlorhexidine gluconate oral rinse use results in an
increase in subgingival calculus. Calculus deposits should be removed by a
dental prophylaxis at intervals not greater than six months. Anaphylaxis, as
well as serious allergic reactions, have been reported during postmarketing use
with dental products containing chlorhexidine. See CONTRAINDICATIONS.
For patients having coexisting gingivitis and
periodontitis, the presence or absence of gingival inflammation following
treatment with PerioGard® (Chlorhexidine Gluconate Oral Rinse USP, 0.12%)
should not be used as a major indicator of underlying periodontitis.
PerioGard® can cause staining of oral surfaces, such as
tooth surfaces, restorations, and the dorsum of the tongue. Not all patients
will experience a visually significant increase in toothstaining. In clinical
testing, 56% of the chlorhexidine gluconate oral rinse USP, 0.12% users
exhibited a measurable increase in facial anterior stain, compared to 35% of
control users after six months; 15% of the chlorhexidine gluconate oral rinse
USP, 0.12% users developed what was judged to be heavy stain, compared to 1% of
control users after six months. Stain will be more pronounced in patients who
have heavier accumulations of unremoved plaque. Stain resulting from the use of
PerioGard® does not adversely affect health of the gingivae or other oral
tissues. Stain can be removed from most tooth surfaces by conventional
professional prophylactic techniques. Additional time may be required to
complete the prophylaxis.
Discretion should be used when prescribing to patients with anterior facial
restorations with rough surfaces or margins. If natural stain cannot be removed
from these surfaces by a dental prophylaxis, patients should be excluded from
the PerioGard® treatment if permanent discoloration is unacceptable. Stain in
these areas may be difficult to remove by dental prophylaxis and on rare occasions
may necessitate replacement of these restorations.
Some patients may experience an alteration in taste
perception while undergoing treatment with chlorhexidine gluconate oral rinse
USP, 0.12%. Rare instances of permanent taste alteration following
chlorhexidine gluconate oral rinse USP, 0.12% use have been reported via
postmarketing product surveillance.
Pregnancy Category B
Reproduction studies have been performed in rats and
rabbits at chlorhexidine gluconate doses up to 300mg/kg/day and 40mg/kg/day
respectively, and have not revealed evidence of harm to fetus. However,
adequate and well-controlled studies in pregnant women have not been done.
Because animal reproduction studies are not always predictive of human
response, this drug should be used during pregnancy 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 PerioGard® (Chlorhexidine Gluconate Oral Rinse USP, 0.12%) is
administered to nursing women.
In parturition and lactation studies with rats, no
evidence of impaired parturition or of toxic effects to suckling pups was
observed when chlorhexidine gluconate was administered to dams at doses that
were over 100 times greater than that which would result from a person's
ingesting 30 ml (2 doses) of PerioGard® per day.
Clinical effectiveness and safety of PerioGard® have not
been established in children under the age of 18.
Carcinogenesis, Mutagenesis, Impairment Of Fertility
In a drinking water study in rats, carcinogenic effects
were not observed at doses up to 38mg/kg/day. Mutagenic effects were not
observed in two mammalian in vivo mutagenesis studies with chlorhexidine gluconate.
The highest doses of chlorhexidine used in a mouse dominant-lethal assay and a
hamster cytogenetics test were 1000mg/kg/day and 250mg/kg/day, respectively. No
evidence of impaired fertility was observed in rats at doses up to