Peridex™ (CHLORHEXIDINE GLUCONATE 0.12%) ORAL RINSE

peridex (chlorhexidine gluconateliquid 
[Zila Pharmaceuticals, Inc.]

DESCRIPTION

Peridex is an oral rinse containing 0.12% chlorhexidine gluconate (1, 11-hexamethylene bis [5-(p-chlorophenyl) biguanide] di-D-gluconate) in a base containing water, 11.6% alcohol, glycerin, PEG-40 sorbitan diisostearate, flavor, sodium saccharin, and FD&C Blue No. 1. Peridex oral rinse is a near-neutral solution (pH range 5-7). Chlorhexidine gluconate is a salt of chlorhexidine and gluconic acid. Its chemical structure is:

Image from Drug Label Content

CLINICAL PHARMACOLOGY

Peridex provides antimicrobial activity during oral rinsing. The clinical significance of Peridex's antimicrobial activities is not clear. Microbiological sampling of plaque has shown a general reduction of counts of certain assayed bacteria, both aerobic and anaerobic, ranging from 54-97% through six months use.

Use of Peridex oral rinse in a six month clinical study did not result in any significant changes in bacteria resistance, overgrowth of potentially opportunistic organisms or other adverse changes in the oral microbial ecosystem. Three months after Peridex use was discontinued, the number of bacteria in plaque had returned to baseline levels and resistance of plaque bacteria to chlorhexidine gluconate was equal to that at baseline.

PHARMACOKINETICS: Pharmacokinetic studies with Peridex indicate approximately 30% of the active ingredient, chlorhexidine gluconate, is retained in the oral cavity following rinsing. This retained drug is slowly released into the oral fluids. Studies conducted on human subjects and animals demonstrate chlorhexidine gluconate is poorly absorbed from the gastrointestinal tract. The mean plasma level of chlorhexidine gluconate reached a peak of 0.206μg/g in humans 30 minutes after they ingested a 300-mg dose of the drug. Detectable levels of chlorhexidine gluconate were not present in the plasma of these subjects 12 hours after the compound was administered. Excretion of chlorhexidine gluconate occurred primarily through the feces (~90%). Less than 1% of the chlorhexidine gluconate ingested by these subjects was excreted in the urine.

INDICATION

Peridex is indicated for use between dental visits as part of a professional program for the treatment of gingivitis as characterized by redness and swelling of the gingivae, including gingival bleeding upon probing. Peridex has not been tested among patients with acute necrotizing ulcerative gingivitis (ANUG). For patients having coexisting gingivitis and periodontitis, see PRECAUTIONS.

CONTRAINDICATIONS

Peridex should not be used by persons who are known to be hypersensitive to chlorhexidine gluconate or other formula ingredients.

WARNINGS

The effect of Peridex on periodontitis has not been determined. An increase in supragingival calculus was noted in clinical testing in Peridex users compared with control users. It is not known if Peridex use results in an increase in subgingival calculus. Calculus deposits should be removed by a dental prophylaxis at intervals not greater than six months. Hypersensitivity and generalized allergic reactions have occurred. SEE CONTRAINDICATIONS.

PRECAUTIONS

GENERAL

  1. For patients having coexisting gingivitis and periodontitis, the presence or absence of gingival inflammation following treatment with Peridex should not be used as a major indicator of underlying periodontitis.
  2. Peridex can cause staining of oral surfaces, such as tooth surfaces, restorations, and the dorsum of the tongue. Not all patients will experience a visually significant increase in toothstaining. In clinical testing, 56% of Peridex users exhibited a measurable increase in facial anterior stain, compared to 35% of control users after six months; 15% of Peridex users developed what was judged to be heavy stain, compared to 1% of control users after six months. Stain will be more pronounced in patients who have heavier accumulations of unremoved plaque. Stain resulting from use of Peridex does not adversely affect health of the gingivae or other oral tissues. 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 prescribing to patients with anterior facial restorations with rough surfaces or margins. If natural stain cannot be removed from these surfaces by a dental prophylaxis, patients should be excluded from Peridex treatment if permanent discoloration is unacceptable. Stain in these areas may be difficult to remove by dental prophylaxis and on rare occasions may necessitate replacement of these restorations.
  3. Some patients may experience an alteration in taste perception while undergoing treatment with Peridex. Rare instances of permanent taste alteration following Peridex use have been reported via post-marketing product surveillance.

PREGNANCY

TERATOGENIC EFFECTS Pregnancy Category B. Reproduction studies have been performed in rats and rabbits at chlorhexidine gluconate doses up to 300mg/kg/day and 40mg/kg/day, respectively, and have not revealed evidence of harm to fetus. However, adequate and well-controlled studies in pregnant women have not been done. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

NURSING MOTHERS: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Peridex is administered to nursing women.

In parturition and lactation studies with rats, no evidence of impaired parturition or of toxic effects to suckling pups was observed when chlorhexidine gluconate was administered to dams at doses that were over 100 times greater than that which would result from a person's ingesting 30ml (2 capfuls) of Peridex per day.

PEDIATRIC USE: Clinical effectiveness and safety of Peridex have not been established in children under the age of 18.

CARCINOGENESIS, MUTAGENESIS, AND IMPAIRMENT OF FERTILITY: In a drinking water study in rats, carcinogenic effects were not observed at doses up to 38mg/kg/day. Mutagenic effects were not observed in two mammalian in vivo mutagenesis studies with chlorhexidine gluconate. The highest doses of chlorhexidine used in a mouse dominant-lethal assay and a hamster cytogenetics test were 1000mg/kg/day and 250mg/kg/day, respectively. No evidence of impaired fertility was observed in rats at doses up to 100mg/kg/day.

ADVERSE REACTIONS

The most common side effects associated with chlorhexidine gluconate oral rinses are: 1) an increase in staining of teeth and other oral surfaces; 2) an increase in calculus formation; and 3) an alteration in taste perception, see WARNINGS and PRECAUTIONS. Oral irritation and local allergy-type symptoms have been spontaneously reported as side effects associated with use of chlorhexidine gluconate rinse.

The following oral mucosal side effects were reported during placebo-controlled adult clinical trials: aphthous ulcer, grossly obvious gingivitis, trauma, ulceration, erythema, desquamation, coated tongue, keratinization, geographic tongue, mucocele, and short frenum. Each occurred at a frequency of less than 1.0%. Among post marketing reports, the most frequently reported oral mucosal symptoms associated with Peridex are stomatitis, gingivitis, glossitis, ulcer, dry mouth, hypesthesia, glossal edema, and paresthesia.

Minor irritation and superficial desquamation of the oral mucosa have been noted in patients using Peridex.

There have been cases of parotid gland swelling and inflammation of the salivary glands (sialadenitis) reported in patients using Peridex.

OVERDOSAGE

Ingestion of 1 or 2 ounces of Peridex by a small child (~10 kg body weight) might result in gastric distress, including nausea, or signs of alcohol intoxication. Medical attention should be sought if more than 4 ounces of Peridex is ingested by a small child or if signs of alcohol intoxication develop.

DOSAGE AND ADMINISTRATION

Peridex therapy should be initiated directly following a dental prophylaxis. Patients using Peridex should be reevaluated and given a thorough prophylaxis at intervals no longer than six months. Recommended use is twice daily oral rinsing for 30 seconds, morning and evening after toothbrushing. Usual dosage is 15ml (marked in cap) of undiluted Peridex. Patients should be instructed to not rinse with water or other mouthwashes, brush teeth or eat immediately after using Peridex. Peridex is not intended for ingestion and should be expectorated after rinsing.

HOW SUPPLIED

Peridex is supplied as a blue liquid in 1-pint (473ml) amber plastic bottles with child-resistant dispensing closures. Store above freezing (32°F).

Caution: Federal law prohibits dispensing without prescription.

Revised: January 2007

Manufactured for:
Zila Pharmaceuticals, Inc.
Phoenix, AZ 86014

433422-6


Peridex (chlorhexidine gluconate)
PRODUCT INFO
Product Code51284-620Dosage FormLIQUID
Route Of AdministrationORALDEA Schedule
INGREDIENTS
Name (Active Moiety)TypeStrength
chlorhexidine gluconate (chlorhexidine) Active1.2 MILLIGRAM  In 1 MILLILITER
waterInactive 
alcoholInactive 
glycerinInactive 
PEG-40 sorbitan diisosterateInactive 
flavorInactive 
sodium saccharinInactive 
FD&C Blue No. 1Inactive 
IMPRINT INFORMATION
CharacteristicAppearanceCharacteristicAppearance
ColorScore
ShapeSymbol
Imprint CodeCoating
Size
PACKAGING
#NDCPackage DescriptionMultilevel Packaging
151284-620-12118 MILLILITER In 1 BOTTLE, PLASTICNone
251284-620-22473 MILLILITER In 1 BOTTLE, PLASTICNone
351284-620-321893 MILLILITER In 1 BOTTLE, PUMPNone

Revised: 01/2008Zila Pharmaceuticals, Inc.