Periogard
PerioGard
FULL PRESCRIBING INFORMATION: CONTENTS*
- PERIOGARD DESCRIPTION
- CLINICAL PHARMACOLOGY
- PERIOGARD INDICATIONS AND USAGE
- PERIOGARD CONTRAINDICATIONS
- WARNINGS
- PRECAUTIONS
- PERIOGARD ADVERSE REACTIONS
- OVERDOSAGE
- PERIOGARD DOSAGE AND ADMINISTRATION
- HOW SUPPLIED
- PRINCIPAL DISPLAY PANEL - 473 mL Label
FULL PRESCRIBING INFORMATION
PERIOGARD DESCRIPTION
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, glycerin, polysorbate 20, flavor, 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 C22H30Cl2N1O•2C6H12O7 and a molecular weight calculated to be 897.77.
Its chemical structure is:
CLINICAL PHARMACOLOGY
PerioGard Oral Rinse 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 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 resistance of plaque bacteria to chlorhexidine gluconate was equal to that at baseline.
Pharmacokinetics
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 INDICATIONS AND USAGE
PerioGard Oral Rinse is indicated for use between dental visits as part of a professional program for the treatment of gingivitis as characterized by redness and swelling of the gingivae, including gingival bleeding upon probing. PerioGard Oral Rinse has not been tested among patients with acute necrotizing ulcerative gingivitis (ANUG). For patients having coexisting gingivitis and periodontitis, see PRECAUTIONS.
PERIOGARD CONTRAINDICATIONS
PerioGard Oral Rinse should not be used by persons who are known to be hypersensitive to chlorhexidine gluconate or other formula ingredients.
WARNINGS
The effect of PerioGard Oral Rinse on periodontitis has not been determined. An increase in supragingival calculus was noted in clinical testing with users of chlorhexidine gluconate oral rinse compared with control users. It is not known if chlorhexidine gluconate use results in an increase in subgingival calculus. Calculus deposits should be removed by a dental prophylaxis at intervals not greater than six months. Hypersensitivity and generalized allergic reactions have occurred. See CONTRAINDICATIONS.
PRECAUTIONS
General
- For patients having coexisting gingivitis and periodontitis, the presence or absence of gingival inflammation following treatment with PerioGard Oral Rinse should not be used as a major indicator of underlying periodontitis.
- PerioGard Oral Rinse 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 Oral Rinse 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 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 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
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 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 Oral Rinse is administered to nursing women. In parturition and lactation studies with rats, no evidence of impaired parturation 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 PerioGard Oral Rinse per day.
Pediatric Use
Clinical effectiveness and safety of PerioGard Oral Rinse have not been established in children under the age of 18.
PERIOGARD ADVERSE REACTIONS
The most common side effects associated with 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 WARNINGS and 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, uIcer, 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.
OVERDOSAGE
Ingestion of 1 or 2 ounces of PerioGard Oral Rinse 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.
PERIOGARD DOSAGE AND ADMINISTRATION
PerioGard Oral Rinse therapy should be initiated directly following a dental prophylaxis. Patients using PerioGard Oral Rinse should be reevaluated and given a thorough prophylaxis at intervals no longer than six months. Recommended use is twice daily oral rinsing for 30 seconds, morning and evening after toothbrushing. Usual dosage is 1/2 fl. oz. ("15 mL" line on dosage cap) of undiluted PerioGard Oral Rinse. Patients should be instructed not to rinse with water or other mouthwashes, brush teeth, or eat immediately after using PerioGard Oral Rinse. PerioGard Oral Rinse is not intended for ingestion and should be expectorated after rinsing.
HOW SUPPLIED
PerioGard Oral Rinse is supplied as a blue liquid in 16 fluid ounce amber plastic bottle with child-resistant dosage cap. Store above freezing (32°F).
Colgate Oral Pharmaceuticals, Inc., a subsidiary of Colgate-Palmolive Company
New York, NY 10022 U.S.A.
Questions/Comments: 1-800-962-2345
www.colgateprofessional.com
P10000593
Rev. 12/08
PRINCIPAL DISPLAY PANEL - 473 mL Label
Colgate ®
NDC 0126-0271-16
PerioGard
®
(Chlorhexidine Gluconote
Oral Rinse, 0.12%)
For questions or comments contact
your dentist or pharmacist.
KEEP OUT OF REACH OF CHILDREN
PLACE PHARMACY
LABEL HERE
Dispense in original container
or in amber glass.
16 fl oz (473 mL)
Rx ONLY
PeriogardChlorhexidine Gluconate LIQUID
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
