PerioGard (Chlorhexidine Gluconate Oral Rinse, 0.12%) is an oral rinse containing 0.12% chlorhexidine gluconate [N,N?-bis (4-chlorophenyl)-3, 12-diimino-2, 4, 11, 13- tetraazatetradecanediimidamide di-D-gluconate] in a base containing water, 11.6% alcohol (%v/v), glycerin, polysorbate 20, flavour, sodium saccharin, and FD&C Blue No. 1. PERIOGARD Oral Rinse is a near-neutral solution (pH range 5-7). Chlorhexidine gluconate is a salt of chlorhexidine and gluconic acid, with a molecular formula of C22H30Cl2N10 ? 2C6H12O7 and a molecular weight calculated to be 897.77.

PerioGard (0.12% Chlorhexidine Gluconate Oral Rinse) provides antimicrobial activity during oral rinsing which is sustained between rinsings. Microbiological sampling of plaque has shown reduction of bacterial counts of certain assayed species, both aerobic and anaerobic, ranging from 54-97% through six months? use with a chlorhexidine containing mouthrinse. The activity of chlorhexidine in the oral cavity is promoted by binding to plaque, salivary pellicle, oral mucosa, and hard structures that may result in sustained release for up to 24 hours.

Use of a 0.12% 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 the use of a 0.12% chlorhexidine gluconate oral rinse use was discontinued, the number of bacteria in plaque had returned to baseline levels and resistance of plaque bacteria to chlorhexidine gluconate was equal to that at baseline.

Studies conducted on human subjects and animals demonstrate that chlorhexidine gluconate is poorly absorbed from the gastrointestinal tract. Excretion of chlorhexidine gluconate occurred primarily through feces (~90%). Less than 1% of the chlorhexidine gluconate ingested by these subjects was excreted in the urine.

PerioGard is to be used solely as a topical oral rinse, and not to be ingested. Pharmacokinetic studies with a 0.12% chlorhexidine gluconate oral rinse indicate approximately 30% of the active ingredient is retained in the oral cavity following rinsing. This retained drug is slowly released into 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.

PerioGard is indicated for use as part of a professional program for the treatment of moderate to severe gingivitis, and in addition for management of associated gingival bleeding and inflammation between dental visits. For patients having coexisting gingivitis and periodontitis, see PRECAUTIONS.

Persons who are known to be hypersensitive to chlorhexidine gluconate or other formula ingredients should not use PERIOGARD.

Use in Pregnancy: Preclinical studies with chlorhexidine gluconate have been conducted to evaluate reproduction and fertility. In rats and rabbits no evidence of fetal toxicity was observed at doses up to 300 mg/kg/day and 40 mg/kg/day respectively. Impaired fertility was not observed in rats at doses up to 100 mg/kg/day. These doses are approximately 40, 100, and 300 times that which would result in ingesting 30 mL of PERIOGARD per day. Since controlled studies in pregnant women have not been conducted, the benefits of the use of the drug in pregnant women should be weighed against the possible risk to the fetus.

Nursing Mothers: Excretion of the drug substance in human milk has not been determined. Caution should be exercised when PERIOGARD Oral Rinse is administered to a nursing woman. No evidence of impaired parturition or of toxic effects to suckling pup rats from parturition and lactation studies 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 of PERIOGARD per day.

Pediatric Use: Clinical effectiveness and safety of PERIOGARD have not been established in children. The benefits of its use should be weighed against possible risks.

1. 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.
2. 2. 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. Stain will be marked in patients who have heavier accumulations of unremoved plaque. Stain resulting from the use of PERIOGARD is not detrimental to the health of the gingivae or other oral tissues. Stain can be removed from most tooth surfaces by conventional prophylactic techniques. 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 professional 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 professional dental prophylaxis and on rare occasions may necessitate replacement of these restorations.
3. Some patients may experience an alteration in taste perception while undergoing treatment with a chlorhexidine gluconate oral rinse. Most patients undergoing treatment adapt to this effect with continued use. Rare instances of permanent taste alteration following chlorhexidine gluconate oral rinse use have been reported via post marketing surveillance.
4. Rinsing of the oral cavity, eating or drinking after using PERIOGARD Oral Rinse should be avoided for approximately 30 minutes to provide maximum effectiveness.

Common side effects associated with the use of 0.12% chlorhexidine gluconate oral rinses are: (1) an increase in staining of teeth and other oral surfaces, (2) an increase in calculus formation, and (3) an alteration in taste perception (see PRECAUTIONS). Oral irritation and local allergy-type symptoms have been spontaneously reported as side effects associated with use of chlorhexidine gluconate rinse. The following oral mucosal side effects were reported during placebo-controlled adult clinical trials: aphthous ulcer, grossly obvious gingivitis, trauma, ulceration, erythema, desquamation, coated tongue, keratinization, geographic tongue, mucocele, and short frenum. Each occurred at a frequency of less than 1.0%.

Among postmarketing reports, the most frequently reported oral mucosal symptoms associated with chlorhexidine gluconate oral rinse are stomatitis, gingivitis, glossitis, ulcer, dry mouth, hypesthesia, glossal edema, and paresthesia.

Minor irritation and superficial desquamation of the oral mucosa have been noted in patients using chlorhexidine gluconate oral rinses. There have been cases of parotid gland swelling and inflammation of the salivary glands (sialadentitis) reported in patients using chlorhexidine gluconate oral rinse.

Ingestion of 1 or 2 ounces (30 to 60 mL) of PERIOGARD by a small child (~10 kg body weight) might result in gastric distress, including nausea, or potential signs of alcohol intoxication. Medical attention should be sought if more than 4 ounces (120 mL) of PERIOGARD is ingested by a small child or in the event that signs of alcohol intoxication develop.

PERIOGARD therapy should be administered immediately following a dental prophylaxis. Patients using PerioGard Oral Rinse should be reevaluated and given a complete professional prophylaxis at intervals no longer than six months. As necessary, patients should be referred for periodontal consultation.

The recommended usage is twice daily oral rinsing for 30 seconds, morning and evening subsequent to toothbrushing. Usual dosage is 1/2 fl. oz. (?15 mL? mark on dosage cap) of undiluted PERIOGARD. PERIOGARD is not intended for ingestion. Product should be expectorated after rinsing. Patients should be instructed not to rinse with water or other mouthwashes, brush teeth, or eat immediately after using PERIOGARD.

Carcinogenicity
There are no reports of any evidence of carcinogenicity in two rat studies conducted in which chlorhexidine was administered to animals in their drinking water. Each study was two years in duration and the delivered dosage of chlorhexidine during these studies were to 200 mg/kg/day.

Mutagenicity
When chlorhexidine was evaluated by the dominant lethal assay in mice and micronucleus assay in hamsters, there was no observed evidence of mutagenicity.

PERIOGARD Oral Rinse is supplied as a blue liquid in 470 mL amber plastic bottles with child-resistant dosage cap. Store above freezing (15 - 25ºC).

Imported by Colgate Oral Pharmaceuticals, Toronto, ON M3C 1W3
*Reg?d. TM Colgate-Palmolive Canada Inc.
Made in U.S.A.