Periogard Alcohol Free

Description

PerioGard® (Chlorhexidine Gluconate Oral rinse USP, 0.12%) is an oral rinse that contains 0.12% chlorhexidine gluconate, which is chemically defined as 1,1'-hexamethylene bis 5-(p-chlorophenyl) biguanide di-D-gluconate. The formulation includes inactive ingredients such as water, propylene glycol, glycerin, sorbitol, polyoxyl 40 hydrogenated castor oil, flavor, cetylpyridinium chloride, and FD&C blue no. 1. The product is characterized as a near neutral solution with a pH range of 5 to 7. Chlorhexidine gluconate is a salt formed 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 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, it is important to note that 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 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 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. However, 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 to complete the procedure. 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 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 difficult 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. No specific laboratory tests are recommended for monitoring during the use of this product.

Side Effects

Patients may experience a range of adverse reactions associated with the use of dental products containing chlorhexidine. 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.

In 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 reports have identified additional oral conditions such as stomatitis, gingivitis, glossitis, ulcer, dry mouth, hypesthesia, glossal edema, and paresthesia. Other side effects noted include oral irritation, local allergy-type symptoms, minor irritation and superficial desquamation of the oral mucosa, parotid gland swelling, and inflammation of the salivary glands (sialadenitis).

Warnings associated with the use of chlorhexidine products include the potential for anaphylaxis and serious allergic reactions, which have been reported during postmarketing use. Additionally, rare instances of permanent taste alteration following the use of chlorhexidine gluconate oral rinse USP, 0.12% have been documented through postmarketing product surveillance.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

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. Additionally, there is no specific information regarding geriatric use, dosage adjustments, or safety concerns for elderly patients provided in the prescribing information.

Healthcare providers should exercise caution when prescribing PerioGard® to geriatric patients, given the absence of established data. It is advisable to monitor this population closely for any potential adverse effects or complications that may arise during treatment.

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, 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 response, chlorhexidine gluconate 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 drug 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

There is no specific information regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be warranted in these patients to ensure safety and efficacy.

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 1 or 2 ounces of PerioGard® by a small child, approximately weighing 10 kg, may lead to gastric distress, which can manifest as nausea. It is important for healthcare professionals to be aware that such symptoms may arise from this level of exposure.

If a small child ingests more than 4 ounces of PerioGard® Oral Rinse, it is imperative to seek medical attention promptly. This recommendation is crucial to ensure appropriate evaluation and management of potential overdosage effects. Healthcare providers should monitor the child for any signs of adverse reactions and provide supportive care as necessary.

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 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 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.

Healthcare providers should inform patients that PerioGard® can cause staining of oral surfaces, including tooth surfaces, restorations, and the dorsum of the tongue. While not all patients will experience a visually significant increase in tooth staining, clinical testing has shown 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. Additionally, 15% of chlorhexidine gluconate oral rinse USP, 0.12% users developed what was judged to be heavy stain, in contrast to only 1% of control users after the same period. It should be noted that staining will be more pronounced in patients with heavier accumulations of unremoved plaque.

Healthcare providers should reassure patients that the stain resulting from the use of PerioGard® does not adversely affect the health of the gingivae or other oral tissues. Furthermore, stain can typically be removed from most tooth surfaces through conventional professional prophylactic techniques, although additional time may be required to complete the prophylaxis.

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

Patients may also experience an alteration in taste perception while undergoing treatment with chlorhexidine gluconate oral rinse USP, 0.12%. Rare instances of permanent taste alteration following the use of this rinse have been reported through postmarketing product surveillance.

It is recommended that patients using PerioGard® be reevaluated and receive a thorough prophylaxis at intervals no longer than six months. The recommended usage is twice daily oral rinsing for 30 seconds, both in the morning and evening after tooth brushing, with the usual dosage being 1/2 fl. oz. (the "15 mL" line in the dosage cap) of undiluted PerioGard®.

Storage and Handling

The product is supplied under the National Drug Code (NDC) number, which is essential for identification and inventory management. It should be stored at a temperature range of 20° to 25°C (68° to 77°F), with permissible excursions between 15° to 30°C (59° to 86°F) in accordance with USP Controlled Room Temperature guidelines.

As a prescription-only medication, it is crucial to keep this product out of reach of children to ensure safety. Special handling requirements should be observed to maintain the integrity of the product during storage.

Additional Clinical Information

Patients using PerioGard® should be informed about the potential for staining of oral surfaces, including teeth, restorations, and the dorsum of the tongue. It is important to note that while staining may occur, it does not adversely affect the health of the gingivae or other oral tissues. Clinicians should also advise patients about the possibility of altered taste perception during treatment, with rare reports of permanent taste alteration following the use of chlorhexidine gluconate oral rinse USP, 0.12%.

FDA Insert (PDF)

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

View full prescribing information (PDF)