Peridex

Description

Peridex™ (Chlorhexidine Gluconate 0.12%) Oral Rinse is an oral antiseptic solution that contains 0.12% chlorhexidine gluconate, chemically defined as 1,1-hexamethylene bis 5-(p-chlorophenyl) biguanide di-D-gluconate. The formulation includes a base composed of water, 11.6% alcohol, glycerin, PEG-40 sorbitan diisostearate, flavoring agents, sodium saccharin, and FD&C Blue No. 1. Peridex is characterized as a near-neutral solution, with a pH range of 5 to 7. Chlorhexidine gluconate serves as the active ingredient, functioning as a salt of chlorhexidine and gluconic acid.

Uses and Indications

This drug 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.

Peridex 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

Peridex therapy should be initiated immediately following a dental prophylaxis. The recommended dosage for adults is 15 mL of undiluted Peridex, which should be measured using the cap provided. Patients are advised to perform oral rinsing twice daily for 30 seconds, specifically in the morning and evening after tooth brushing.

It is essential that patients do not rinse with water or other mouthwashes, brush their teeth, or consume food immediately after using Peridex to ensure optimal efficacy. Additionally, Peridex is not intended for ingestion; patients should expectorate the solution after rinsing.

Patients utilizing Peridex should be reevaluated and provided with a thorough dental prophylaxis at intervals not exceeding six months to maintain oral health and assess the ongoing need for therapy.

Contraindications

Peridex 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 Peridex on periodontitis has not been established. Clinical studies have indicated an increase in supragingival calculus among users of Peridex compared to control groups. The impact of Peridex 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 signs of these reactions in patients using Peridex.

For patients with concurrent gingivitis and periodontitis, the presence or absence of gingival inflammation following Peridex treatment should not be relied upon as a primary indicator of underlying periodontitis.

Peridex may cause staining of oral surfaces, including teeth, restorations, and the dorsum of the tongue. While not all patients will experience significant staining, clinical data show that 56% of Peridex users exhibited a measurable increase in facial anterior stain after six months, compared to 35% of control users. Furthermore, 15% of Peridex users developed what was classified as heavy staining, in contrast to 1% of control users. Staining is more pronounced in individuals with higher plaque accumulation. Importantly, staining does not adversely affect the health of the gingiva or other oral tissues and can typically be removed through standard professional prophylactic techniques, although additional time may be required. Caution is advised when prescribing Peridex to patients with anterior facial restorations that have rough surfaces or margins, as natural stains may be difficult to remove and could lead to permanent discoloration, necessitating restoration replacement in rare cases.

Patients may also experience alterations in taste perception during treatment with Peridex. There have been rare reports of permanent taste alterations following its use, as noted in post-marketing surveillance.

No specific laboratory tests are recommended for monitoring the use of Peridex. Healthcare professionals should ensure that patients are informed of these potential effects and monitor them accordingly throughout the treatment period.

Side Effects

Patients using dental products containing chlorhexidine may experience a range of adverse reactions. Common side effects include an increase in staining of teeth and other oral surfaces, an increase in calculus formation, and alterations in taste perception. Notably, 56% of Peridex users exhibited a measurable increase in facial anterior stain, with 15% developing heavy staining. Additionally, there have been rare instances of permanent taste alteration reported.

Oral mucosal side effects, which were observed during placebo-controlled adult clinical trials with a frequency of less than 1.0%, include aphthous ulcers, grossly obvious gingivitis, trauma, ulceration, erythema, desquamation, coated tongue, keratinization, geographic tongue, mucocele, and short frenum.

Postmarketing experiences have revealed further oral mucosal adverse reactions, such as stomatitis, gingivitis, glossitis, ulcers, dry mouth, hypesthesia, glossal edema, paresthesia, minor irritation, superficial desquamation of the oral mucosa, parotid gland swelling, and inflammation of the salivary glands (sialadenitis).

It is important to note that serious allergic reactions, including anaphylaxis, have been reported during postmarketing use of chlorhexidine-containing dental products. General precautions should be taken regarding the potential for staining of oral surfaces, including tooth surfaces, restorations, and the dorsum of the tongue.

Drug Interactions

Anaphylaxis and serious allergic reactions have been reported in postmarketing use with dental products containing chlorhexidine. Healthcare professionals should be vigilant for signs of hypersensitivity in patients using these products.

The effect of Peridex on periodontitis remains undetermined. Therefore, clinicians should exercise caution when interpreting laboratory test results related to periodontal health in patients using this product. Regular monitoring and assessment of the patient's condition are recommended to ensure appropriate management.

Packaging & NDC

The table below lists all NDC Code configurations of Peridex (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 Peridex have not been established in pediatric patients under the age of 18. Therefore, caution is advised when considering the use of this medication in this population.

Geriatric Use

Elderly patients may experience specific considerations when using Peridex. Clinical effectiveness and safety have not been established in individuals under the age of 18, and while the data does not specifically address geriatric patients, caution is warranted given the potential for altered pharmacodynamics in this population.

In clinical testing, an increase in supragingival calculus was observed among Peridex users compared to control users. Although it remains unclear whether Peridex use leads to an increase in subgingival calculus, healthcare providers should monitor elderly patients for any changes in oral health status.

Patients, including geriatric individuals, should be reevaluated and provided with thorough prophylaxis at intervals no longer than six months to ensure optimal oral health management. Additionally, some patients may experience alterations in taste perception during treatment with Peridex. It is important to note that rare instances of permanent taste alteration have been reported through post-marketing surveillance, which may be of particular concern for elderly patients.

Caution is advised when administering Peridex to nursing women, as the effects on lactation are not fully understood. Furthermore, anaphylaxis and serious allergic reactions have been documented during post-marketing use of dental products containing chlorhexidine, necessitating careful monitoring for any signs of hypersensitivity in geriatric patients.

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 responses, 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 this drug is excreted in human milk. Due to the potential for many drugs to be excreted in human milk, caution should be exercised when administering Peridex to lactating mothers.

In 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 capfuls) of Peridex per day.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

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 Peridex by a small child, approximately weighing 10 kg, may lead to gastric distress characterized by symptoms such as nausea. Additionally, there is a potential for the child to exhibit signs of alcohol intoxication as a result of the overdosage.

In cases where a small child ingests more than 4 ounces of Peridex, or if any signs of alcohol intoxication are observed, it is imperative to seek medical attention promptly. Healthcare professionals should be prepared to assess the child's condition and provide appropriate management based on the severity of the symptoms presented.

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 with 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 found 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. Anaphylaxis and serious allergic reactions have been reported. Additionally, oral irritation and local allergy-type symptoms have been spontaneously reported in association with chlorhexidine gluconate rinse.

Among the most frequently reported oral mucosal symptoms linked to Peridex are stomatitis, gingivitis, glossitis, ulcer, dry mouth, hypesthesia, glossal edema, and paresthesia. Minor irritation and superficial desquamation of the oral mucosa have also been noted in patients using Peridex. 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 Peridex have been reported through post-marketing product surveillance.

Patient Counseling

Advise patients that Peridex™ (Chlorhexidine Gluconate 0.12%) Oral Rinse has been prescribed by their dentist to treat gingivitis, aiming to reduce gum redness and swelling while helping to control gum bleeding. It is essential for patients to use Peridex regularly as directed by their dentist, in conjunction with daily brushing. Patients should be instructed to spit out the rinse after use and to avoid swallowing it.

Inform patients to seek immediate medical attention if they experience any allergic symptoms, which may include skin rash, itching, generalized swelling, breathing difficulties, lightheadedness, rapid heart rate, upset stomach, or diarrhea. Emphasize that Peridex should not be used by individuals who have a known sensitivity to it or its components.

Patients should be made aware that Peridex may lead to tooth discoloration or an increase in tartar (calculus) formation, particularly in areas where stains and tartar typically accumulate. It is important for patients to visit their dentist for the removal of any stains or tartar at least every six months, or more frequently if advised by their dentist. Both stains and tartar can be effectively removed by a dentist or hygienist. Additionally, inform patients that Peridex may cause permanent discoloration of some front-tooth fillings.

To minimize the risk of discoloration, patients should be encouraged to brush and floss daily, paying special attention to areas that begin to show discoloration. Patients may find that Peridex has a bitter taste and can alter the taste of foods and beverages; however, this effect typically diminishes with continued use. To mitigate taste interference, recommend that patients rinse with Peridex after meals and avoid rinsing with water or other mouthwashes immediately afterward.

For any questions or comments regarding Peridex, patients should be advised to contact their dentist, pharmacist, or 3M ESPE Dental Products at 1-800-634-2249. Additionally, patients should be instructed to call their healthcare provider for medical advice concerning side effects and to report any side effects to the FDA at 1-800-FDA-1088.

Storage and Handling

Peridex is supplied as a blue liquid in the following package configurations: 4-ounce (118 ml), 1-pint (473 ml), and 64-ounce (1893 ml) white or amber plastic bottles, each equipped with child-resistant dispensing closures.

It is recommended to store Peridex at a temperature range of 20°C to 25°C (68°F to 77°F), with permissible excursions between 15°C to 30°C (59°F to 86°F) in accordance with USP controlled room temperature guidelines. Additionally, it is essential to keep this product out of reach of children to ensure safety.

Additional Clinical Information

Patients should be instructed to use Peridex as an oral rinse twice daily for 30 seconds, ideally in the morning and evening after tooth brushing. It is crucial that patients do not rinse with water or other mouthwashes, brush their teeth, or eat immediately after using Peridex to ensure optimal effectiveness.

Clinicians should counsel patients on potential allergic reactions, including symptoms such as skin rash, itching, swelling, breathing difficulties, lightheadedness, rapid heart rate, upset stomach, or diarrhea, and advise them to seek immediate medical attention if these occur. Patients may experience tooth discoloration and increased tartar formation, particularly in areas prone to staining. Regular dental visits for cleaning and maintenance are recommended, as both stain and tartar can be removed by dental professionals. To minimize discoloration, patients should maintain a daily oral hygiene routine. Additionally, Peridex may impart a bitter taste and alter the taste of foods and beverages, though this typically diminishes with continued use. Reports from postmarketing surveillance indicate that serious allergic reactions, including anaphylaxis, and rare instances of permanent taste alteration have occurred. Common oral mucosal symptoms associated with Peridex include stomatitis, gingivitis, glossitis, and dry mouth, among others. There have also been reports of parotid gland swelling and sialadenitis in some patients.

FDA Insert (PDF)

This document is the official FDA-approved prescribing information for Peridex as submitted by Xttrium Laboratories, Inc.. It includes detailed information about indications, dosage, contraindications, warnings, and clinical pharmacology.

View full prescribing information (PDF)