Peridex (Chlorhexidine Gluconate)

PERIDEX®

Zila Pharmaceuticals

Chlorhexidine Gluconate

Antigingivitis

Action And Clinical Pharmacology: Chlorhexidine provides antimicrobial activity during oral rinsing which is maintained between rinsings. Microbiologic sampling of plaque has shown a general reduction of both aerobic and anaerobic bacterial counts ranging from 54 to 97% through 6 months’ clinical use. Rinsing with chlorhexidine inhibits the buildup and maturation of plaque by reducing certain microbes regarded as gingival pathogens, thereby reducing gingivitis. Chlorhexidine provided antimicrobial activity during rinsing and for several hours thereafter.

No significant changes in bacterial sensitivity, overgrowth of potentially opportunistic organisms or other adverse changes in the oral microbial flora were observed following the use of chlorhexidine for 6 months. Three months after chlorhexidine use was discontinued, the number of bacteria in plaque had returned to pretreatment levels and sensitivity of plaque bacteria to chlorhexidine remained unchanged.

Pharmacokinetics: Studies conducted with human subjects and animals demonstrate that any ingested chlorhexidine is poorly absorbed from the gastrointestinal tract. Excretion of chlorhexidine occurred primarily through the feces (approximately 90%). Less than 1% of the chlorhexidine ingested by these subjects was excreted in the urine.

Indications And Clinical Uses: For use as part of a professional program for the treatment of moderate to severe gingivitis, and for management of associated gingival bleeding and inflammation between dental visits. For patients having coexisting gingivitis and periodontitis, see Precautions.

Contra-Indications: Should not be used by persons who are known to be hypersensitive to chlorhexidine or other formula ingredients.

Manufacturers’ Warnings In Clinical States: Pregnancy: Reproduction and fertility studies with chlorhexidine have been conducted. No evidence of impaired fertility was observed in male and female rates at doses up to 100 mg/kg/day, and no evidence of harm to the fetus was observed in rats and rabbits at doses up to 300 mg/kg/day and 40 mg/kg/day, respectively. These doses are approximately 100, 300, and 40 times that which would result from a person ingesting 30 mL of 0.12% chlorhexidine/day. Since controlled studies in pregnant women have not been conducted, the benefits of use of the drug in pregnant women should be weighed against possible risk to the fetus.

Lactation: It is not known whether this drug is excreted in human milk. In parturition and lactation studies with rats, no evidence of impaired parturition or of toxic effects to suckling pups was observed when chlorhexidine was administered to dams at doses that were over 100 times greater than the dose which would result if a person ingested the entire recommended dose of chlorhexidine on a daily basis.

Children: Since the safety and efficacy of chlorhexidine in children has not yet been fully established, the benefits of its use should be weighed against the possible risks.

Precautions: For patients having coexisting gingivitis and periodontitis, the absence of gingival inflammation following treatment with chlorhexidine may not be indicative of the absence of underlying periodontitis. Appropriate treatment of periodontitis is therefore indicated.

Chlorhexidine may cause staining of oral surfaces such as the film on tooth surfaces, restorations, and the dorsum of the tongue. Stain will be more pronounced in patients who have heavier accumulations of unremoved plaque.

Stain resulting from use of chlorhexidine does not adversely affect the health of gingivae or other oral tissue. Stain can be removed from most tooth surfaces by conventional professional prophylactic techniques. Additional time may be required to complete the prophylaxis.

Discretion should be used when treating patients with exposed root surfaces or anterior facial restorations with rough surfaces or margins. If natural stains cannot be removed from these surfaces by a dental prophylaxis, patients should be excluded from chlorhexidine treatment if the risk of permanent discoloration is unacceptable. Stains in these areas may be difficult to remove by dental prophylaxis and on rare occasions may necessitate replacement of these restorations.

A few patients may experience an alteration in taste perception while undergoing treatment with chlorhexidine. Most of these patients accommodate to this effect with continued use of chlorhexidine.

Rare instances of permanent taste alteration following chlorhexidine use have been reported via postmarketing product surveillance.

For maximum effectiveness the patient should avoid rinsing their mouth (with water or other mouthwashes), brushing their teeth, eating or drinking for about 30 minutes after using chlorhexidine.

Adverse Reactions: No serious systemic reactions associated with the use of chlorhexidine were observed in clinical testing. However, some adverse reactions have been reported in studies with Peridex or other chlorhexidine-containing mouth rinses. The most common side effects associated with chlorhexidine oral rinses are an increase in staining of oral surfaces; an increase in supra gingival calculus; and an alteration in taste perception to which most patients accommodate (see Precautions). Epithelial irritation and superficial desquamation of the oral mucosa have been noted in studies of children using chlorhexidine which were reversible upon discontinuation.

There have been rare cases of parotid gland swelling and inflammation of the salivary glands, in patients using chlorhexidine.

Oral irritation and local allergy-type symptoms have been spontaneously reported as side effects associated with use of chlorhexidine rinse.

The following oral mucosal side effects were reported during placebo-controlled adult clinical trials: apthous ulcer, grossly obvious gingivitis, trauma, ulcerations, erythema, desquamation, coated tongue, keratinization, geographic tongue, mucocele, and short frenum. Each occurred at a frequency of less than 1%.

Among postmarketing reports, the most frequently reported oral mucosal symptoms associated with chlorhexidine are stomatitis, gingivitis, glossitis, ulcer, dry mouth, hypesthesia, glossal edema and paresthesia.

Symptoms And Treatment Of Overdose: Symptoms and Treatment: Ingestion of 30 or 60 mL of chlorhexidine by a small child (10 kg or less body weight) might result in gastric distress, including nausea, or signs of alcohol intoxication. Medical attention should be sought if more than 120 mL chlorhexidine is ingested by a small child or if signs of alcohol intoxication develop. tag_DosageDosage

Dosage And Administration: Chlorhexidine therapy should be initiated directly following a dental prophylaxis. Patients using chlorhexidine should be re-evaluated and given a thorough prophylaxis at intervals no longer than 6 months; they should be referred for periodontal consultation as necessary.

Recommended use is twice daily oral rinsing for 30 seconds, morning and evening after tooth brushing. Usual dosage is 15 mL (marked in cap) of undiluted chlorhexidine. Chlorhexidine is not intended for ingestion and should be expectorated after rinsing. Rinsing the mouth (with water or other mouthwashes), brushing the teeth, or eating or drinking should be avoided for about 30 minutes after using chlorhexidine.

The suggested initial course of therapy is 3 months, at which time patients should be recalled for evaluation. At the time of the recall visit, the dental professional should: evaluate progress, remove any stain, and reinforce proper home care techniques; if gingival inflammation and bleeding is controlled, discontinue therapy and recall the patient in 3 months to assess gingival health; if gingival inflammation and bleeding persists, continue chlorhexidine therapy for an additional 3 months and schedule a 3-month recall for evaluation; evaluate for evidence of epithelial irritation, desquamation and parotitis.

An occasional missed dose can be ignored if the patient is generally compliant with the prescribed regimen.

Availability And Storage: Each mL of blue oral rinse contains: chlorhexidine gluconate 0.12%. Nonmedicinal ingredients: alcohol, FD&C Blue No. 1, flavor, glycerin, PEG-40 sorbitan di-isostearate, saccharin sodium and water. Amber plastic bottles of 475 mL with child-resistant dispensing closures. Store above freezing (0°C).

PERIDEX® Zila Pharmaceuticals Chlorhexidine Gluconate Antigingivitis

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