r 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 chlorhexidine gluconate oral rinse 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. rare instances of permanent taste alteration following chlorhexidine gluconate oral rinse use have been reported via post-marketing product surveillance. pregnancy: teratogenic effects pregnancy category b. 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 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 chlorhexidine gluconate oral rinse 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 capfuls) of chlorhexidine gluconate oral rinse per day. pediatric use: clinical effectiveness and safety of chlorhexidine gluconate oral rinse have not been established in children under the age of 18. carcinogenesis, mutagenesis, and 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 mutagenesis 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.

superficial desquamation of the oral mucosa have been noted in patients using chlorhexidine gluconate oral rinse. there have been cases of parotid gland swelling and inflammation of the salivary glands (sialadenitis) reported in patients using chlorhexidine gluconate oral rinse.

the active ingredient, chlorhexidine gluconate, is retained in the oral cavity following rinsing. this retained drug is slowly released in the oral fluids. studies conducted on human subjects and animals demonstrate chlorhexidine gluconate is poorly absorbed from the gastrointestinal tract. the mean plasma level of chlorhexidine gluconate reached a peak of 0.206 μg/g in humans 30 minutes after they ingested a 300 mg dose of the drug. detectable levels of chlorhexidine gluconate were not present in the plasma of these subjects 12 hours after the compound was administered. excretion of chlorhexidine gluconate occurred primarily through the feces (~90%). less than 1% of the chlorhexidine gluconate ingested by these subjects was excreted in the urine.