PerioGard^® (Chlorhexidine Gluconate Oral Rinse, 0.12% - Rx Only)

Chlorhexidine gluconate provides antimicrobial activity during oral rinsing. The clinical significance of 0.12% chlorhexidine gluconate oral rinse's antimicrobial activities is not clear. Microbiological sampling of plaque has shown a general reduction of counts of certain assayed bacteria, both aerobic and anaerobic, ranging from 54-97% through six months' use. Use of a chlorhexidine gluconate oral rinse in a six-month clinical study did not result in any significant changes in bacterial resistance, overgrowth of potentially opportunistic organisms, or other adverse changes in the oral microbial ecosystem. Three months after chlorhexidine gluconate use was discontinued, the number of bacteria in plaque had returned to baseline levels and the resistance of plaque bacteria to chlorhexidine gluconate was equal to that at baseline.

PerioGard® should not be used by persons who are known to be hypersensitive to chlorhexidine gluconate or other formula ingredients.

General:

• For patients having coexisting gingivitis and periodontitis, the presence or absence of gingival inflammation following treatment with PerioGard^® 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 tooth staining. In clinical testing, 56% of the chlorhexidine gluconate oral rinse users exhibited a measurable increase in facial anterior stain, compared to 35% of control users after six months; 15% of the chlorhexidine gluconate 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 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 a chlorhexidine gluconate oral rinse. Rare instances of permanent taste alteration following chlorhexidine gluconate oral rinse use have been reported via postmarketing surveillance.

 

Carcinogenesis, Mutagenesis, Impairment of Fertility: In a drinking water study in rats, carcinogenic effects were not observed at doses up to 38 mg/kg/day. Mutagenic effects were not observed in two mammalian in vivo mutagensis studies with chlorhexidine gluconate. The highest doses of chlorhexidine used in a mouse dominant-lethal assay and a hamster cytogenetics test were 1000 mg/kg/day and 250 mg/kg/day, respectively. No evidence of impaired fertility was observed in rats at doses up to 100 mg/kg/day.

Pregnancy: Teratogenic Effects: Reproduction studies have been performed in rats and rabbits at chlorhexidine gluconate doses up to 300 mg/kg/day and 40 mg/kg/day, respectively, and have not revealed evidence of harm to the 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.

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 PerioGard^® is administered to a nursing woman. 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 up to 100 mg/kg/day.

Pediatric Use: Clinical effectiveness and safety of PerioGard^® have not been established in children under the age of 18.

Ingestion of 1 or 2 ounces of PerioGard® (Chlorhexidine Gluconate Oral Rinse USP, 0.12%) by a small child (~10 kg body weight) might result in gastric distress, including nausea, or signs of alcohol intoxication. Medical attention should be sought if more than 4 ounces of PerioGard® oral rinse is ingested by a small child or if signs of alcohol intoxication develop.