ACTIONS AND CLINICAL PHARMCOLOGY
PERICHLOR® WITHOUT ALCOHOL (0.12% Chlorhexidine Gluconate Mouthwash) provides antimicrobial activity during oral rinsing which is maintained between rinsings. Microbiologic sampling of plaque has shown a general reduction of both aerobic and anaerobic bacterial counts ranging from 54-97% through six months’ clinical use. Rinsing with PERICHLOR® WITHOUT ALCOHOL inhibits the buildup and maturation of plaque by reducing certain microbes regarded as gingival pathogens, thereby reducing gingivitis. Chlorhexidine Gluconate Mouthwash provided antimicrobial activity during rinsing and for several hours thereafter.
INDICATIONS AND CLINICAL USE
PERICHLOR® WITHOUT ALCOHOL (0.12% Chlorhexidine Gluconate Mouthwash) is indicated for use as part of a professional program for the treatment of moderate to severe gingivitis, and for management of associated gingival bleeding and inflammation between dental visits.
- Sweetened with 10% xylitol
Chlorhexidine Gluconate 0.12%
Glycerin, Hydroxyethylcellulose, Purified Water, Hydrochloric Acid and Xylitol Crystals
DOSAGE AND ADMINISTRATION
Two times per day morning and evening
- Rinse for 30 seconds with 15 ml. Expectorate.
- Rinsing the mouth (with water or other mouthwashes), brushing teeth, or eating or drinking should be avoided for about 30 minutes after use.
- For patients having coexisting gingivitis and periodontitis, the absence of gingival inflammation following treatment with PERICHLOR® WITHOUT ALCOHOL (0.12% Chlorhexidine Gluconate Mouthwash) may not be indicative of the absence of underlying periodontitis. Appropriate treatment of periodontitis is therefore indicated.
- PERICHLOR® WITHOUT ALCOHOL may cause staining of oral surfaces such as the film on tooth surfaces, restorations, and the dorsum of the tongue. Stain will be more pronounced in patients who have heavier accumulations of un-removed plaque. Stain resulting from use of PERICHLOR® WITHOUT ALCOHOL does not adversely affect the health of gingivae or other oral tissue. 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 treating patients with exposed root surfaces or anterior facial restorations with rough surfaces or margins. If natural stains cannot be removed from these surfaces by a dental prophylaxis, patients should be excluded from PERICHLOR® WITHOUT ALCOHOL treatment if the risk of permanent discolouration is unacceptable. Stains in these areas may be difficult to remove by dental prophylaxis and on rare occasions may necessitate replacement of these restorations.
- A few patients may experience an alteration in taste perception while undergoing treatment with PERICHLOR® WITHOUT ALCOHOL. Most of these patients accommodate to this effect with continued use of Chlorhexidine Gluconate Mouthwash. Rare instances of permanent taste alteration following Chlorhexidine Gluconate Mouthwash use have been reported via postmarketing product surveillance.
- For maximum effectiveness the patient should avoid rinsing their mouth (with water or other mouthwashes), brushing their teeth, eating or drinking for about 30 minutes after using PERICHLOR® WITHOUT ALCOHOL.
Use in Pregnancy
Reproduction and fertility studies with chlorhexidine gluconate have been conducted. No evidence of impaired fertility was observed in male and female rats at doses up to 100 mg/kg/day, and no evidence of harm to the fetus was observed in rats and rabbits at doses up to 300 mg/kg/day and 40 mg/kg/day, respectively. These doses are approximately 100, 300, and 40 times that which would result from a person ingesting 30 mL (2 capfuls) of PERICHLOR® WITHOUT ALCOHOL (0.12% Chlorhexidine Gluconate Mouthwash) per day. Since controlled studies in pregnant women have not been conducted, the benefits of use of the drug in pregnant women should be weighed against possible risk to the fetus.
It is not known whether this drug is excreted in human milk. 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 the dose which would result if a person ingested the entire recommended dose of PERICHLOR® WITHOUT ALCOHOL (0.12% Chlorhexidine Gluconate Mouthwash) on a daily basis.
Use in children
Since the safety and efficacy of Chlorhexidine Gluconate Mouthwash in children has not yet been fully established, the benefits of its use should be weighed against the possible risks.