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:

Proficient Rx LP

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 dispensing closures. NDC 63187-685-16 Store at 20°C to 25°C (68°F-77°F), excursions permitted to 15°C to 30°C (59°F to 86°F) [See USP controlled Room Temperature]. Rx Only. Revised: September 2015 Distributed by: Xttrium Laboratories, Inc. 1200 E. Business Center Dr. Mount Prospect, IL 60056 Relabeled by: Proficient Rx LP Thousand Oaks, CA 91320

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CHLORHEXIDINE GLUCONATE- CHLORHEXIDINE GLUCONATE RINSE
PROFICIENT RX LP
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CHLORHEXIDINE GLUCONATE 0.12%, ORAL RINSE, USP
RX ONLY, NDC 63187-685-16
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 mcg/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
Chlorhexidine gluconate oral rinse is indicated for use between dental
visits as part of a
professional program for the treatment of