Peridex Information
Peridex () Description
Peridex () is an oral rinse containing 0.12% chlorhexidine gluconate (1, 1-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:
Peridex () 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.
Peridex () 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 .
Peridex () Contraindications
Peridex () should not be used by persons who are known to be hypersensitive to chlorhexidine gluconate or other formula ingredients.
Peridex () 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 .
Peridex () Precautions
PREGNANCY: TERATOGENIC EFFECTS
NURSING MOTHERS:
PEDIATRIC USE:
CARCINOGENESIS, MUTAGENESIS, AND IMPAIRMENT OF FERTILITY:
Peridex () 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 and . 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 () .
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.
Peridex () 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.
Peridex () How Supplied
Peridex () is supplied as a blue liquid in the following sizes:
1 fluid ounce (15 ml) (NDC 48878-0620-4) amber plastic bottle with child resistant dispensing closure4 fluid ounce (118 ml) (NDC 48878-0620-3) amber plastic bottles with child resistant dispensing closure16 fluid ounce or 1 pint (473ml) (NDC 48878-0620-1) amber plastic bottles with child-resistant dispensing closure 64 fluid ounce (1893 ml) (NDC 48878-0620-2) white plastic bottle with pump dispensing closure
Peridex ()
Peridex () Principle Display Panel – Bottle Label
NDC 48878-0620-1
Peridex () ™
Oral rinse
containing water, 11.6% alcohol, glycerin, PEG-40 sorbitan
diisostearate, flavor, sodium saccharin and FD&C Blue No. !1.
KEEP OUT OF REACH OF CHILDREN
PLACE DISPENSING
INFORMATION HERE
Dispense in bottle as
Provided or in amber glass
3M ESPE
