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. This product is characterized by a near-neutral pH, with a range of 5 to 7. Chlorhexidine gluconate serves as a salt derived from chlorhexidine and gluconic acid, contributing to its antimicrobial properties.

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 treatment effectiveness.

Contraindications

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

Additionally, the use of Peridex is not recommended for patients who find permanent discoloration of anterior facial restorations unacceptable, as this may occur with treatment.

Warnings and Precautions

The effect of Peridex on periodontitis has not been established. Clinical trials 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 during the use of Peridex. Healthcare professionals should ensure that patients are informed of these potential effects and monitor for any adverse reactions throughout the treatment period.

Side Effects

Patients using Peridex may experience a range of adverse reactions, which can be categorized by their 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. In clinical trials, 56% of Peridex users exhibited a measurable increase in facial anterior stain after six months, compared to 35% of control users. Additionally, 15% of Peridex users developed what was judged to be heavy stain, in contrast to only 1% of control users. It is important to note that staining does not adversely affect the health of the gingivae or other oral tissues and can typically be removed through conventional professional prophylactic techniques.

Oral mucosal side effects, reported during placebo-controlled adult clinical trials with a frequency of less than 1%, include aphthous ulcer, grossly obvious gingivitis, trauma, ulceration, erythema, desquamation, coated tongue, keratinization, geographic tongue, mucocele, and short frenum.

Postmarketing experience has revealed additional adverse reactions, such as stomatitis, gingivitis, glossitis, ulcer, dry mouth, hypesthesia, glossal edema, paresthesia, minor irritation and superficial desquamation of the oral mucosa, parotid gland swelling, and inflammation of the salivary glands (sialadenitis).

Serious allergic reactions, including anaphylaxis, have been reported during postmarketing use of dental products containing chlorhexidine.

Patients should be advised that while Peridex can cause staining of oral surfaces, not all individuals will experience a visually significant increase in tooth staining. Discretion is recommended when prescribing to patients with anterior facial restorations, as stain may be difficult to remove and could necessitate replacement of these restorations. Furthermore, some patients may experience an alteration in taste perception, with rare instances of permanent taste alteration reported through post-marketing surveillance.

Drug Interactions

Anaphylaxis and serious allergic reactions have been reported in patients using dental products containing chlorhexidine. Healthcare professionals should monitor patients for signs of hypersensitivity during treatment and be prepared to manage any severe allergic reactions.

Chlorhexidine gluconate is known to cause staining of oral surfaces, including teeth, restorations, and the dorsum of the tongue. Patients should be informed about this potential effect, and dental professionals may consider advising on oral hygiene practices to mitigate staining.

Additionally, some patients may experience alterations in taste perception while using Peridex. There have been rare reports of permanent taste alteration following the use of this product. It is advisable for healthcare providers to counsel patients regarding this possibility and to monitor for any changes in taste during and after treatment.

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™ (Chlorhexidine Gluconate 0.12%) Oral Rinse 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 Peridex™ (Chlorhexidine Gluconate 0.12%) Oral Rinse 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. It is advisable to monitor for any potential adverse effects, as the pharmacokinetics and pharmacodynamics may differ in this population. Additionally, no dosage adjustments have been specified for geriatric patients; however, clinical judgment should guide the use of this product in individuals aged 65 and older, considering their overall health status and potential comorbidities.

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, 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 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 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

In a drinking water study conducted in 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 these studies included 1000 mg/kg/day in a mouse dominant-lethal assay and 250 mg/kg/day in a hamster cytogenetics test. 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, particularly Peridex. Reports of anaphylaxis and serious allergic reactions have been documented. Additionally, rare cases of permanent taste alteration have been noted through post-marketing surveillance.

Among the oral mucosal symptoms reported, stomatitis, gingivitis, glossitis, ulcers, dry mouth, hypesthesia, glossal edema, and paresthesia were the most frequently observed. Minor irritation and superficial desquamation of the oral mucosa have also been reported in patients using Peridex. Furthermore, instances of parotid gland swelling and inflammation of the salivary glands, known as sialadenitis, have been recorded.

Patient Counseling

Patients should be informed that Peridex™ (Chlorhexidine Gluconate 0.12%) Oral Rinse has been prescribed by their dentist to treat gingivitis, reduce gum redness and swelling, and help 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 advised to spit out the rinse after use and not to swallow it.

Healthcare providers should instruct 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. It is important to note 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 staining and tartar typically occur. Regular dental visits for the removal of any stain or tartar are recommended, at least every six months or more frequently if advised by their dentist. Both stain and tartar can be effectively removed by a dentist or hygienist. Additionally, patients should be informed 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. It is also important to inform patients that Peridex may have a bitter taste and can alter the taste of foods and beverages, although this effect typically diminishes with continued use. To mitigate taste interference, patients should be advised to rinse with Peridex after meals and to avoid rinsing with water or other mouthwashes immediately afterward.

Patients are encouraged to reach out to their dentist, pharmacist, or 3M ESPE Dental Products at 1-800-634-2249 if they have any questions or comments regarding Peridex. Furthermore, they should be instructed to contact their healthcare provider for medical advice about any side effects experienced and may report 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.

Storage conditions require that Peridex be maintained 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). It is essential to keep this product out of reach of children to ensure safety.

Additional Clinical Information

Patients using Peridex should be instructed to perform oral rinsing 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 efficacy.

Clinicians should counsel patients on potential allergic reactions, including symptoms such as skin rash, swelling, breathing difficulties, and gastrointestinal upset, advising 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 monitoring are recommended, as both stain and tartar can be removed by dental professionals. To minimize discoloration, patients should maintain a diligent 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 rare occurrences of anaphylaxis, serious allergic reactions, and permanent taste alterations, as well as various oral mucosal symptoms such as stomatitis and dry mouth.

FDA Insert (PDF)

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

View full prescribing information (PDF)