CHLORHEXIDINE GLUCONATE rinse

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L)

Available from:

Medline Industries, LP

INN (International Name):

CHLORHEXIDINE GLUCONATE

Composition:

CHLORHEXIDINE GLUCONATE 0.12 mg in 1 mL

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

Chlorhexidine gluconate oral rinse is supplied as a blue liquid in single dose amber plastic bottles with child-resistant dispensing closures. NDC 53329-301-24. Store at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F) [See USP controlled Room Temperature]. Rx Only. Revised: February 2016 Manufactured for: Medline Industries, Inc. Mundelein, IL 60060 1999MED15LBLB REF MDS096070 RA16XLI

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CHLORHEXIDINE GLUCONATE- CHLORHEXIDINE GLUCONATE RINSE
MEDLINE INDUSTRIES, LP
----------
301 CHLORHEXIDINE GLUCONATE 0.12% ORAL RINSE, USP
RX ONLY, NDC 53329-301-24
DESCRIPTION
0.12% chlorhexidine gluconate (CHG) is an oral rinse containing
(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. Chlorhexidine gluconate product 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
Chlorhexidine gluconate oral rinse provides antimicrobial activity
during oral rinsing. The
clinical significance of chlorhexidine gluconate 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 chlorhexidine gluconate oral rinse in a six month clinical
study did not result in
any significant changes in bacterial resistance, overgrowth of
potentially opportunistic
organisms or other adverse changes in the oral microbial ecosystem.
Three months
after chlorhexidine gluconate 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 chlorhexidine gluconate
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 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 .206 µg/g in humans 30
minutes after they
ingested a 300-mg dose of the drug. Detec