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:

Rebel Distributors Corp

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 1-pint (473 ml) amber plastic bottles with child-resistant dispensing closures. NDC 21695-025-16. Store at 20°C to 25°C (68°F-77°F). See USP Controlled Room Temperature. Rx Only. Manufactured by: Xttrium Laboratories, Inc. Chicago,IL 60609 Repackaged by: Rebel Distributors Corp Thousand Oaks, CA 91320

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CHLORHEXIDINE GLUCONATE- CHLORHEXIDINE GLUCONATE RINSE
REBEL DISTRIBUTORS CORP
----------
CHLORHEXIDINE GLUCONATE 0.12% ORAL RINSE, USP
RX ONLY, NDC 0116-2001-16
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.
Detectabl