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:

Xttrium Laboratories, Inc.

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 1-pint (473 mL) amber plastic bottles with child resistant closures. NDC 59883-175-16 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: March 2017 Manufactured for: DenMat Holdings, LLC 1017 W. Central Ave. Lompoc, CA 93436 Manufactured by: Xttrium Laboratories, Inc. 1200 E. Business Center Dr. Mount Prospect, IL 60056 1999DM16LBL

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CHLORHEXIDINE GLUCONATE- CHLORHEXIDINE GLUCONATE RINSE
XTTRIUM LABORATORIES, INC.
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PRO-DEN RX
ORAL RINSE USP 0.12% CHLORHEXIDINE GLUCONATE 16OZ
DESCRIPTION:
Chlorhexidine gluconate 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. 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:
ProDenRx
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 of use.
Use of chlorhexidine gluconate oral rinse in a six month clinical
study did not result in
any significant change 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 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 0.206 μg/g in humans 30
minutes after they
ingested a 300 mg dose of the drug