Skin antisepsis, oral cleansing, nasal antisepsis

Sage Products, Inc.
Sage Products, Inc.

Peridex (chlorhexidine gluconate 0.12%)Oral Rinse

FULL PRESCRIBING INFORMATION: CONTENTS*

• Description
• CLINICAL PHARMACOLOGY
• PHARMACOKINETICS
• INDICATION
• SKIN ANTISEPSIS, ORAL CLEANSING, NASAL ANTISEPSIS CONTRAINDICATIONS
• WARNINGS
• PRECAUTIONS
• PREGNANCY: TERATOGENIC EFFECTS
• NURSING MOTHERS
• PEDIATRIC USE
• CARCINOGENESIS, MUTAGENESIS, AND IMPAIRMENT OF FERTILITY
• SKIN ANTISEPSIS, ORAL CLEANSING, NASAL ANTISEPSIS ADVERSE REACTIONS
• OVERDOSAGE
• SKIN ANTISEPSIS, ORAL CLEANSING, NASAL ANTISEPSIS DOSAGE AND ADMINISTRATION
• HOW SUPPLIED

FULL PRESCRIBING INFORMATION

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:

CLINICAL PHARMACOLOGY

Peridex Oral Rinse provides antimicrobial activity during oral rinsing. The clinical significance of Peridex Oral Rinse'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 Oral Rinse 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 Oral Rinse indicate approximately 30% of the active ingredient, chlorhexidine gluconate, is retained in the oral cavity following rinsing. This retained drug is slowly released in 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 Oral Rinse 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 Oral Rinse has not been tested among patients with acute necrotizing ulcerative gingivitis (ANUG). For patients having coexisting gingivitis and periodontitis, see PRECAUTIONS.

SKIN ANTISEPSIS, ORAL CLEANSING, NASAL ANTISEPSIS CONTRAINDICATIONS

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

WARNINGS

The effect of Peridex Oral Rinse on periodontitis has not been determined. An increase in supragingival calculus was noted in clinical testing in Peridex Oral Rinse users compared with control users. It is not known if Peridex Oral Rinse 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

• For patients having coexisting gingivitis and periodontitis, the presence or absence of gingival inflammation following treatment with Peridex Oral Rinse should not be used as a major indicator of underlying periodontitis.
• Peridex Oral Rinse 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 Oral Rinse users exhibited a measurable increase in facial anterior stain, compared to 35% of control users after six months; 15% of Peridex Oral Rinse 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 Oral Rinse 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 Oral Rinse 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.
• Some patients may experience an alteration in taste perception while undergoing treatment with Peridex Oral Rinse. Rare instances of permanent taste alteration following Peridex Oral Rinse 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 Oral Rinse per day.

PEDIATRIC USE

Clinical effectiveness and safety of Peridex Oral Rinse 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.

SKIN ANTISEPSIS, ORAL CLEANSING, NASAL ANTISEPSIS 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 Oral Rinse 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 Oral Rinse. There have been cases of parotid gland swelling and inflammation of the salivary glands (sialadenitis) reported in patients using Peridex Oral Rinse.

OVERDOSAGE

Ingestion of 1 or 2 ounces of Peridex Oral Rinse 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 Oral Rinse is ingested by a small child or if signs of alcohol intoxication develop.

SKIN ANTISEPSIS, ORAL CLEANSING, NASAL ANTISEPSIS DOSAGE AND ADMINISTRATION

Peridex Oral Rinse therapy should be initiated directly following a dental prophylaxis. Patients using Peridex Oral Rinse 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 15 mL of undiluted Peridex Oral Rinse. Patients should be instructed to not rinse with water or other mouthwashes, brush teeth or eat immediately after using Peridex Oral Rinse. Peridex Oral Rinse is not intended for ingestion and should be expectorated after rinsing.

HOW SUPPLIED

Peridex Oral Rinse is supplied as a blue liquid in single dose amber plastic bottles with child-resistant dispensing closures.  Store above freezing (32°F or 0°C).

Revised:  April 2009

Made in USA for:
3M Health Care/3M ESPE Dental Products
St. Paul, MN 55144-1000 (U.S.A.) 1-800-228-3957

CHG Surgical Continuum System
Ultra-Soft Tooth Brush with Applicator Swab CHG compatible

Peridex Oral Rinse Label
NDC 48878–0620–4

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NDC 053462–705–23

Skin antisepsis, oral cleansing, nasal antisepsis kit
NDC 53462–007–27

3M Skin and Nasal Antiseptic
NDC 17518–060–04