Periogard Alcohol Free

Description

PerioGard® is an oral rinse formulated with 0.12% chlorhexidine gluconate (1,1'-hexamethylene bis 5-(p-chlorophenyl) biguanide di-D-gluconate). The product's base consists of 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, characterized by redness and swelling of the gingivae, including gingival bleeding upon probing.

This drug has not been tested in patients with acute necrotizing ulcerative gingivitis (ANUG). For patients presenting with coexisting gingivitis and periodontitis, healthcare professionals should refer to the PRECAUTIONS section for further guidance.

No teratogenic or nonteratogenic effects have been reported.

Dosage and Administration

PerioGard® (Chlorhexidine Gluconate Oral Rinse USP, 0.12%) therapy should be initiated immediately following a dental prophylaxis. The recommended dosage for adults is 1/2 fluid ounce (15 mL), which corresponds to the "15 mL" line on the dosage cap. Patients should perform oral rinsing twice daily for 30 seconds, ideally in the morning and evening after tooth brushing.

It is essential that patients are instructed not to rinse with water or other mouthwashes, brush their teeth, or consume food immediately after using PerioGard®. The solution is not intended for ingestion and should be expectorated following the rinsing process.

Patients utilizing PerioGard® should be reevaluated and provided with a thorough dental prophylaxis at intervals not exceeding six months to ensure continued effectiveness and safety of the treatment.

Contraindications

PerioGard® is contraindicated in individuals with a known hypersensitivity to chlorhexidine gluconate or any other ingredients in the formulation.

Additionally, the use of PerioGard® is not recommended for patients for whom permanent discoloration of anterior facial restorations is unacceptable, due to the potential for aesthetic concerns.

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 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. Additionally, there have been reports of anaphylaxis and serious allergic reactions associated with the use of dental products containing chlorhexidine.

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. It is important to note that PerioGard® may cause staining of oral surfaces, including teeth, restorations, and the dorsum of the tongue. While not all patients will experience significant staining, clinical testing revealed that 56% of users of chlorhexidine gluconate oral rinse USP, 0.12% exhibited a measurable increase in facial anterior stain after six months, compared to 35% of control users. Furthermore, 15% of chlorhexidine users developed what was classified as heavy stain, in contrast to 1% of control users.

Staining is more pronounced in patients with higher accumulations of unremoved plaque. Importantly, 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 required for thorough cleaning. Caution 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 during 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 difficult to remove and could necessitate the replacement of restorations.

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

Side Effects

Patients using chlorhexidine gluconate oral rinse, USP, 0.12% may experience a range of adverse reactions. Common adverse reactions include an increase in staining of teeth and other oral surfaces, an increase in calculus formation, and an alteration in taste perception.

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

Postmarketing experience has revealed additional adverse reactions, such as stomatitis, gingivitis, glossitis, ulcers, 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.

Furthermore, cases of parotid gland swelling and inflammation of the salivary glands (sialadenitis) have been documented. Rare instances of permanent taste alteration following the use of chlorhexidine gluconate oral rinse have been noted through postmarketing product surveillance. Serious allergic reactions, including anaphylaxis, have been reported in association with dental products containing chlorhexidine.

Drug Interactions

No specific drug interactions have been identified in the available data. Additionally, there are no reported interactions between the drug and laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on the current information.

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 profile in children and adolescents.

Geriatric Use

Clinical effectiveness and safety of PerioGard® have not been established in children under the age of 18. However, for elderly patients, there are no specific dosage adjustments or safety concerns indicated in the available data.

Healthcare providers should continue to monitor geriatric patients for any potential adverse effects or changes in response to treatment, as individual patient factors may influence the overall safety and efficacy of the medication.

Pregnancy

Pregnancy Category B. Reproduction studies have been conducted in rats and rabbits at chlorhexidine gluconate doses up to 300 mg/kg/day and 40 mg/kg/day, respectively, without revealing 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 PerioGard® (Chlorhexidine Gluconate Oral Rinse USP, 0.12%) is excreted in human milk. Due to the potential for many drugs to be excreted in human milk, caution should be exercised when administering this product 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 no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the insert text. Therefore, healthcare professionals should exercise caution and consider individual patient factors when prescribing to this population. Regular monitoring of renal function may be warranted in patients with reduced kidney function, although specific guidelines are not outlined.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to 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®, it is imperative to seek medical attention promptly. Healthcare professionals should be prepared to assess the child for potential symptoms and provide appropriate management based on the severity of the situation. 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 involving 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 patients using this oral rinse.

Cases of parotid gland swelling and inflammation of the salivary glands, known as sialadenitis, have also been reported in patients utilizing chlorhexidine gluconate oral rinse.

Patient Counseling

Patients should be informed that PerioGard® (Chlorhexidine Gluconate Oral Rinse USP, 0.12%) has been prescribed by their dentist to treat gingivitis, aiming to reduce gum redness and swelling, as well as to help control gum bleeding. It is essential for patients to use PerioGard® regularly, as directed by their dentist, in conjunction with daily brushing and flossing.

Patients must be advised to spit out the rinse after use, as PerioGard® should not be swallowed. They should be made aware of the potential for allergic reactions, which may include symptoms such as skin rash, itching, generalized swelling, breathing difficulties, lightheadedness, rapid heart rate, upset stomach, or diarrhea. In such cases, patients should seek medical attention immediately.

It is important to inform patients that PerioGard® is contraindicated for individuals with a known sensitivity to it or its components. They should also be made aware that the use of PerioGard® may lead to tooth discoloration or an increase in tartar (calculus) formation, particularly in areas where staining and tartar typically occur. Regular dental visits for the removal of any stain or tartar are crucial, with a recommendation to see their dentist at least every six months, or more frequently if advised.

Patients should be cautioned that PerioGard® may cause permanent discoloration of some front-tooth fillings. To minimize the risk of discoloration, they should be encouraged to maintain a diligent oral hygiene routine, including daily brushing and flossing, with particular attention to areas that begin to show discoloration.

Additionally, patients may experience a bitter taste from PerioGard®, which can alter the taste of foods and beverages. This taste interference is generally expected to diminish with continued use. To mitigate this effect, patients should be advised to rinse with PerioGard® after meals and to avoid rinsing with water or other mouthwashes immediately after using PerioGard®.

For any questions or comments regarding PerioGard®, patients should be encouraged to contact their dentist, pharmacist, or Colgate at the toll-free number 1-800-962-2345. They should also be instructed to call their healthcare provider for medical advice concerning side effects and to report any adverse effects to the FDA at 1-800-FDA-1088.

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 prescription 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

PerioGard® (Chlorhexidine Gluconate Oral Rinse USP, 0.12%) therapy is recommended to commence immediately following dental prophylaxis. The standard administration involves rinsing twice daily for 30 seconds, both morning and evening after tooth brushing, using a dosage of 1/2 fl. oz. (15 mL) of undiluted solution. Patients should refrain from rinsing with water or other mouthwashes, brushing their teeth, or eating immediately after using PerioGard®.

Clinicians should counsel patients on potential allergic reactions, including symptoms such as skin rash, swelling, breathing difficulties, and gastrointestinal upset, which require immediate medical attention. Patients may experience tooth discoloration and increased tartar formation, necessitating regular dental visits for removal. To mitigate discoloration, daily brushing and flossing are advised, particularly in areas prone to staining. Additionally, PerioGard® may impart a bitter taste and alter the taste of foods and beverages, though this typically diminishes with continued use. Postmarketing surveillance has identified serious allergic reactions, including anaphylaxis, and rare cases of permanent taste alteration. Common oral mucosal symptoms reported include stomatitis, gingivitis, and dry mouth, along with instances of parotid gland swelling and sialadenitis.

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)