Periogard Alcohol Free

Description

PerioGard® is an oral rinse formulation containing 0.12% chlorhexidine gluconate (1,1'-hexamethylene bis 5-(p-chlorophenyl) biguanide di-D-gluconate). The product is presented in a base that includes water, propylene glycol, glycerin, sorbitol, polyoxyl 40 hydrogenated castor oil, flavor, cetylpyridinium chloride, and FD&C blue no. 1. PerioGard® is characterized as a near neutral solution, with a pH range of 5 to 7. Chlorhexidine gluconate is a salt derived from chlorhexidine and gluconic acid.

Uses and Indications

PerioGard® (Chlorhexidine Gluconate Oral Rinse USP, 0.12%) is indicated for use between dental visits as part of a professional program for the treatment of gingivitis. This condition is characterized by redness and swelling of the gingivae, including gingival bleeding upon probing.

Limitations of Use: PerioGard® has not been tested in patients with acute necrotizing ulcerative gingivitis (ANUG). For patients presenting with coexisting gingivitis and periodontitis, healthcare professionals are advised to refer to the precautions section for appropriate guidance.

Dosage and Administration

PerioGard® (Chlorhexidine Gluconate Oral Rinse USP, 0.12%) therapy should be initiated immediately following dental prophylaxis. The recommended dosage is 1/2 fluid ounce (15 mL), which corresponds to the "15 mL" line on the dosage cap, to be used as an undiluted oral rinse.

Patients are advised to perform the rinsing twice daily, specifically in the morning and evening, for a duration of 30 seconds after tooth brushing. It is crucial that patients do not rinse with water or other mouthwashes, brush their teeth, or consume food immediately after using PerioGard®. Additionally, PerioGard® is not intended for ingestion; patients should expectorate the rinse after use.

Contraindications

PerioGard® is contraindicated in individuals with a known hypersensitivity to chlorhexidine gluconate or any other ingredients in the formulation. Use in these patients may lead to severe allergic reactions.

Warnings and Precautions

The effect of PerioGard® on periodontitis has not been established. Clinical studies have indicated an increase in supragingival calculus among users of chlorhexidine gluconate oral rinse USP, 0.12%, compared to control users. The potential impact of chlorhexidine gluconate on subgingival calculus remains undetermined. It is recommended that calculus deposits be removed through dental prophylaxis at intervals not exceeding six months.

Anaphylaxis and serious allergic reactions have been reported in postmarketing experiences with dental products containing chlorhexidine. Healthcare professionals should remain vigilant for these adverse reactions.

For patients with coexisting gingivitis and periodontitis, the presence or absence of gingival inflammation following treatment with PerioGard® should not be relied upon as a primary indicator of underlying periodontitis. Additionally, PerioGard® may cause staining of oral surfaces, including teeth, restorations, and the dorsum of the tongue. Not all patients will experience a significant increase in tooth staining; however, clinical testing revealed that 56% of users exhibited a measurable increase in facial anterior stain after six months, compared to 35% of control users. Furthermore, 15% of chlorhexidine gluconate users developed what was classified as heavy stain, in contrast to 1% of control users.

Staining is more pronounced in patients with substantial plaque accumulation. It is important to note that staining resulting from PerioGard® use does not adversely affect the health of the gingivae or other oral tissues. Most stains can be removed from tooth surfaces through conventional professional prophylactic techniques, although additional time may be necessary for thorough cleaning.

Healthcare professionals should exercise caution when prescribing PerioGard® to patients with anterior facial restorations that have rough surfaces or margins. If natural stains cannot be removed from these surfaces through dental prophylaxis, patients may need to be excluded from PerioGard® treatment if they find permanent discoloration unacceptable. In some cases, stains in these areas may be challenging to remove and could necessitate the replacement of restorations.

Patients may also experience alterations in taste perception during treatment with chlorhexidine gluconate oral rinse USP, 0.12%. Rare instances of permanent taste alteration have been reported through postmarketing surveillance.

Side Effects

Patients using the product may experience a range of adverse reactions, which can be categorized by frequency and seriousness.

Common side effects include an increase in staining of teeth and other oral surfaces, an increase in calculus formation, and an alteration in taste perception. These effects are generally mild and may not require medical intervention.

During clinical trials, several oral mucosal side effects were reported, including aphthous ulcer, grossly obvious gingivitis, trauma, ulceration, erythema, desquamation, coated tongue, keratinization, geographic tongue, mucocele, and short frenum. Each of these occurred at a frequency of less than 1.0%.

Postmarketing experience has revealed additional adverse reactions, such as stomatitis, gingivitis, glossitis, ulcer, dry mouth, hypesthesia, glossal edema, and paresthesia. Oral irritation and local allergy-type symptoms have also been spontaneously reported, along with minor irritation and superficial desquamation of the oral mucosa.

Serious adverse reactions, although rare, have been documented. Cases of parotid gland swelling and inflammation of the salivary glands (sialadenitis) have been reported. Furthermore, anaphylaxis and other serious allergic reactions have been associated with the use of dental products containing chlorhexidine. There have also been rare instances of permanent taste alteration following the use of chlorhexidine gluconate oral rinse USP, 0.12%, as noted in postmarketing product surveillance.

Drug Interactions

Serious allergic reactions, including anaphylaxis, have been reported in postmarketing experiences with dental products containing chlorhexidine. Healthcare professionals should be vigilant for signs of hypersensitivity in patients using these products and take appropriate action if such reactions occur.

The efficacy of PerioGard® in the treatment of periodontitis has not been established. Therefore, clinicians should exercise caution when considering its use for this indication and may need to monitor patients closely for any signs of treatment failure or adverse effects.

Packaging & NDC

The table below lists all NDC Code configurations of Periogard Alcohol Free (chlorhexidine gluconate), the U.S. brand-name prescription product. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Clinical effectiveness and safety of PerioGard® have not been established in pediatric patients under the age of 18. Therefore, its use in this population is not recommended until further data are available to support its efficacy and safety in children and adolescents.

Geriatric Use

Clinical effectiveness and safety of PerioGard® have not been established in children under the age of 18. While there are no specific recommendations for geriatric patients, healthcare providers should exercise caution when prescribing this medication to elderly patients.

Given the absence of established guidelines for this population, it is advisable to monitor geriatric patients closely for any potential adverse effects or changes in therapeutic response. Additionally, healthcare providers should consider individual patient factors, such as comorbidities and concurrent medications, when determining the appropriateness of PerioGard® for elderly patients.

No dosage adjustments or specific safety concerns have been identified for geriatric use; however, prudent clinical judgment is recommended to ensure optimal patient care.

Pregnancy

Reproduction studies conducted in rats and rabbits at chlorhexidine gluconate doses up to 300 mg/kg/day and 40 mg/kg/day, respectively, have not demonstrated evidence of harm to the fetus. However, adequate and well-controlled studies in pregnant women have not been performed. Due to the limitations of animal reproduction studies in predicting human response, this drug should be used during pregnancy only if clearly needed. Healthcare professionals are advised to weigh the potential benefits against any possible risks when considering the use of this medication in pregnant patients.

Lactation

It is not known whether chlorhexidine gluconate is excreted in human milk. Due to the potential for many drugs to be excreted in breast milk, caution should be exercised when administering PerioGard® (Chlorhexidine Gluconate Oral Rinse USP, 0.12%) to lactating mothers.

In animal studies involving parturition and lactation with rats, no evidence of impaired parturition or toxic effects on suckling pups was observed when chlorhexidine gluconate was administered to dams at doses exceeding 100 times the amount that would result from a human ingesting 30 mL (2 doses) of PerioGard® per day.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions outlined for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the available information.

Overdosage

Ingestion of PerioGard® (Chlorhexidine Gluconate Oral Rinse USP, 0.12%) can lead to adverse effects, particularly in small children. Specifically, the consumption of 1 or 2 ounces by a child weighing approximately 10 kg may result in gastric distress, which can manifest as nausea.

In cases where a small child ingests more than 4 ounces of PerioGard® Oral Rinse, it is imperative to seek medical attention promptly. Healthcare professionals should be prepared to assess the child for potential symptoms of overdosage and initiate appropriate management procedures. Monitoring and supportive care may be necessary to address any complications arising from the overdosage.

Nonclinical Toxicology

Reproduction studies conducted in rats and rabbits with chlorhexidine gluconate at doses of up to 300 mg/kg/day and 40 mg/kg/day, respectively, did not demonstrate teratogenic effects. However, it is important to note that adequate and well-controlled studies in pregnant women have not been performed. Due to the limitations of animal reproduction studies in predicting human outcomes, the use of this drug during pregnancy should be considered only when clearly necessary.

In a drinking water study involving rats, no carcinogenic effects were observed at doses up to 38 mg/kg/day. Additionally, mutagenic effects were not detected in two mammalian in vivo mutagenesis studies utilizing chlorhexidine gluconate. The highest doses administered in a mouse dominant-lethal assay and a hamster cytogenetics test were 1000 mg/kg/day and 250 mg/kg/day, respectively. Furthermore, no evidence of impaired fertility was noted in rats at doses up to 100 mg/kg/day.

Postmarketing Experience

Postmarketing experience has identified several adverse events associated with the use of dental products containing chlorhexidine. Reports of anaphylaxis and serious allergic reactions have been documented.

Among the oral mucosal symptoms frequently reported in association with chlorhexidine gluconate oral rinse USP, 0.12%, are stomatitis, gingivitis, glossitis, ulcer, dry mouth, hypesthesia, glossal edema, and paresthesia. Additionally, minor irritation and superficial desquamation of the oral mucosa have been observed in some patients.

Cases of parotid gland swelling and inflammation of the salivary glands (sialadenitis) have also been reported. Furthermore, rare instances of permanent taste alteration following the use of chlorhexidine gluconate oral rinse USP, 0.12% have been noted in postmarketing product surveillance.

Patient Counseling

Patients should be instructed not to rinse with water or other mouthwashes, brush their teeth, or eat immediately after using PerioGard®. It is important to emphasize that PerioGard® is not intended for ingestion and should be expectorated after rinsing. The recommended usage is twice daily oral rinsing for 30 seconds, both in the morning and evening, following tooth brushing. The usual dosage is 1/2 fl. oz. (the "15 mL" line in the dosage cap) of undiluted PerioGard®.

Healthcare providers should ensure that patients using PerioGard® are reevaluated and receive a thorough prophylaxis at intervals no longer than six months. It is also essential to inform patients that PerioGard® can cause staining of oral surfaces, including tooth surfaces, restorations, and the dorsum of the tongue. However, it should be noted that the staining resulting from the use of PerioGard® does not adversely affect the health of the gingivae or other oral tissues. Stains can typically be removed from most tooth surfaces through conventional professional prophylactic techniques.

Discretion should be exercised when prescribing PerioGard® to patients with anterior facial restorations that have rough surfaces or margins. If natural stains cannot be removed from these surfaces by dental prophylaxis, patients should be excluded from PerioGard® treatment if permanent discoloration is deemed unacceptable.

Additionally, healthcare providers should inform patients that some individuals may experience an alteration in taste perception while using chlorhexidine gluconate oral rinse USP, 0.12%. It is important to communicate that rare instances of permanent taste alteration following the use of this oral rinse have been reported through postmarketing product surveillance.

Storage and Handling

PerioGard® is supplied as a blue liquid in a 16-fluid ounce (473 mL) amber plastic bottle, equipped with a child-resistant dosage cap. The product is classified as Rx Only and should be kept out of reach of children.

For optimal storage, PerioGard® should be maintained at a temperature range of 20° to 25°C (68° to 77°F). Temporary excursions are permissible between 15° to 30°C (59° to 86°F), in accordance with USP Controlled Room Temperature guidelines.

Additional Clinical Information

Patients using chlorhexidine gluconate oral rinse USP, 0.12% should be aware of specific administration guidelines and potential adverse effects. The recommended route of administration is buccal, with a twice-daily oral rinsing for 30 seconds, ideally performed in the morning and evening after tooth brushing. Patients are advised not to rinse with water or other mouthwashes, brush their teeth, or eat immediately after using the product.

Clinicians should note that postmarketing experience has revealed serious allergic reactions, including anaphylaxis, associated with dental products containing chlorhexidine. Additionally, rare cases of permanent taste alteration have been reported. Common oral mucosal symptoms linked to the use of this rinse include stomatitis, gingivitis, glossitis, ulcers, dry mouth, hypesthesia, glossal edema, and paresthesia. There have also been reports of parotid gland swelling and inflammation of the salivary glands (sialadenitis) in patients using the rinse.

FDA Insert (PDF)

This document is the official FDA-approved prescribing information for Periogard Alcohol Free as submitted by Colgate Oral Pharmaceuticals, Inc.. It includes detailed information about indications, dosage, contraindications, warnings, and clinical pharmacology.

View full prescribing information (PDF)